Vyleesi is sold as one product: a 1.75 mg subcutaneous autoinjector, one dose per 24 hours, no more than eight doses per month. That fixed dose came out of the RECONNECT trials, which enrolled premenopausal women with HSDD and reported nausea in roughly 40 percent of subjects, flushing in 20 percent, and a transient post-dose blood-pressure bump in almost everyone. The label was set for that average. It was not set for your tolerance to nausea, your baseline blood pressure, your weight, the medications you take that already nudge your heart rate, or whether you are male and have been prescribed this for a different indication than the one the FDA reviewed.
A compounding pharmacy fills the gap that one-dose, one-autoinjector packaging leaves open. The molecule is the same heptapeptide the FDA reviewed; what changes is everything around it. A prescriber who knows your chart can start at a fraction of the labeled 1.75 mg, titrate up only if the first dose is tolerated, or cap your monthly count below eight if nausea or pressure response says so. Vial-and-syringe presentations let a patient draw a smaller dose than the autoinjector physically allows. None of that is exotic. It is what the prescription, the pharmacist, and the patient-specific order were originally for.
This is the older arrangement that pre-dates mass manufacturing: a doctor writes the order, a pharmacist prepares it for one named patient, and the dose belongs to that patient. Modern 503A oversight keeps it honest.
In brief
Bremelanotide / PT-141 Explained
Bremelanotide, sold as Vyleesi, is an injection used to treat low sexual desire (hypoactive sexual desire disorder, HSDD) in premenopausal women 291. The FDA approved it in June 2019. It is taken as needed before anticipated sexual activity, not every day.
Bremelanotide works on a brain pathway called the melanocortin system, which helps regulate sexual arousal in the hypothalamus. This is a different mechanism from PDE-5 inhibitors like sildenafil (Viagra), which act on blood flow rather than the brain. The most common side effects are nausea (about 40% of women), facial flushing, and a small, short-lived increase in blood pressure after each dose. Because of the blood-pressure effect, it is not used in people with uncontrolled high blood pressure or known cardiovascular disease.
At a glance
Quick Facts About Bremelanotide / PT-141
Category
Cyclic heptapeptide melanocortin receptor agonist (non-selective; MC1R, MC5R, with relevant central activity at MC3R and MC4R)
Active ingredient
Bremelanotide acetate, a synthetic analog of α-melanocyte-stimulating hormone (α-MSH); a metabolite of the earlier compound melanotan II
FDA-approved branded form
Vyleesi (bremelanotide 1.75 mg subcutaneous autoinjector), FDA-approved June 2019 for acquired, generalized hypoactive sexual desire disorder (HSDD) in premenopausal women
Route
Subcutaneous injection, as-needed (approximately 45 minutes before anticipated sexual activity); not for chronic daily use
Evidence posture
Phase 3 RECONNECT trials [kingsberg2019] supported FDA approval of Vyleesi for premenopausal HSDD. Earlier intranasal and subcutaneous trials in male erectile dysfunction [diamond2004, rosen2004, safarinejad2008] did not progress to approval after the intranasal formulation was discontinued for blood-pressure effects.
FDA-approval status
Vyleesi is FDA-approved for premenopausal HSDD. Compounded bremelanotide preparations are not FDA-approved.
Boxed/major warnings
Transient increases in blood pressure and decreases in heart rate after each dose; contraindicated in uncontrolled hypertension and known cardiovascular disease per the Vyleesi label.
Compounded under
503A, patient-specific prescription only, when the manufactured Vyleesi autoinjector cannot meet a documented clinical need
Important compounding caution
Bremelanotide is widely marketed online as a 'research peptide' and is heavily used off-label for male erectile dysfunction. Off-label male ED use is supported by weak, predominantly small randomized evidence [diamond2004, rosen2004, diamond2005, safarinejad2008] and was the indication abandoned by the developer when intranasal trials were halted for hypertension. RonanRx compounds bremelanotide only on a patient-specific prescription with documented medical need, not as a direct-to-consumer 'libido' or 'tanning peptide' product.
Prescription review
Patient-Specific Prescription Only
Bremelanotide / PT-141 on this page is a 503A compounded preparation. Every dose is made on a prescription, for a named patient, by a licensed pharmacist. It is not a stocked, mass-manufactured product.
Made to order, not off a shelf. No batch sits in a warehouse waiting for buyers. Your prescription is what triggers the prep.
Named-patient label. The bottle carries your name. The batch records carry your prescription.
Dose, strength, and route chosen for you. A prescriber who knows your chart decides what gets compounded, not a manufacturer who set the strength for a trial population.
Licensed pharmacist on the hook. A real person, with a license that can be pulled, signs off on every prep. State inspectors check the facility.
Compounded drugs are not FDA-approved. They should not be evaluated using branded-drug trial data. Availability varies by state and prescribed medication.
A research-use-only website ships a vial from a warehouse. There is no prescription, no pharmacist, no facility inspection, and no way to recall the product if something is wrong with it. If the vial is mislabeled, contaminated, or under-potent, there is nobody whose license is at stake.
A 503A compounding pharmacy is the other thing. Your doctor writes the prescription. A licensed pharmacist, whose name is on the label, prepares the medicine in a facility the state inspects. If something goes wrong, there is a person and a license on the hook, and a documented chain of custody on every lot. That accountability is what makes it safe.
What it is
What is Bremelanotide / PT-141?
Bremelanotide is a cyclic seven-amino-acid peptide (Ac-Nle-cyclo[Asp-His-D-Phe-Arg-Trp-Lys]-OH) that is a synthetic analog of α-melanocyte-stimulating hormone (α-MSH). It is the active metabolite of an earlier compound, melanotan II, originally synthesized in the 1990s in academic and industry programs investigating melanocortin pharmacology for skin pigmentation and sexual function. Bremelanotide is a non-selective agonist at the melanocortin receptors MC1R, MC3R, MC4R, and MC5R, with the central sexual effects attributed predominantly to MC4R and MC3R 1316.
The molecule was developed by Palatin Technologies; commercial-development rights for the female sexual dysfunction indication were licensed to AMAG Pharmaceuticals, which carried the product through FDA approval as Vyleesi in June 2019. Vyleesi is supplied as a single-dose, single-use 1.75 mg subcutaneous autoinjector. It is administered subcutaneously in the abdomen or thigh approximately 45 minutes before anticipated sexual activity, with no more than one dose per 24-hour period and no more than eight doses per month per labeling 29.
How it works
How Bremelanotide / PT-141 Works
Class
Melanocortin receptor agonist
First studied
2000s development; FDA-approved 2019 (Vyleesi)
Common forms
Compounded subcutaneous injection
Compounding category
503A, patient-specific prescription
Bremelanotide activates the central melanocortin system, a neuropeptide network that links hypothalamic energy-balance and arousal circuits. Within this system, MC4R is densely expressed in hypothalamic nuclei (paraventricular nucleus, medial preoptic area) and brainstem regions implicated in sexual desire and arousal; MC3R has overlapping but distinct distribution 1318. Stimulation of MC4R in the medial preoptic area is sufficient to elicit proceptive sexual behavior in female rats and to enhance penile erection in male animal models 151412.
Mechanistically, bremelanotide acts upstream of the dopaminergic and oxytocinergic outputs that mediate sexual desire and arousal, distinct from the peripheral nitric-oxide / cGMP / smooth-muscle relaxation mechanism of PDE-5 inhibitors such as sildenafil and tadalafil. This pharmacology is the basis for the brand positioning of Vyleesi: a central, on-demand pharmacotherapy for desire rather than a peripheral vasodilator for erectile function 191.
Non-selectivity across the melanocortin receptor family accounts for several characteristic adverse effects. MC1R activity in epidermal melanocytes drives the focal hyperpigmentation and (in earlier melanotan analogs) the global tanning effect; sympathetic outflow contributes to the transient post-dose blood-pressure elevation and reflex bradycardia 294.
Research history
Bremelanotide / PT-141 Research History
Bremelanotide's lineage begins with melanotan II, a non-selective superpotent α-MSH analog synthesized by the Hadley group at the University of Arizona in the 1980s and 1990s for studies of melanocortin pharmacology, originally as a candidate sunless-tanning agent 29. Early clinical observation that melanotan II produced sexual side effects (spontaneous erections, increased libido) motivated systematic investigation of melanocortins in sexual function. Wessells et al. (2000) provided the first proof of concept in men with organic erectile dysfunction using a related α-MSH analog 12. Van der Ploeg et al. (2002) established MC4R as the principal receptor mediating the sexual-function effects of melanocortin agonists 13. Pfaus and colleagues extended this work into preclinical models of female sexual behavior 141516.
Palatin Technologies developed bremelanotide as the active metabolite of melanotan II for clinical use. Intranasal bremelanotide was studied for male erectile dysfunction in early-phase trials 7 showing pharmacodynamic erectogenic activity and additive effect with sildenafil 789. Safarinejad and Hosseini (2008) reported a randomized placebo-controlled study of intranasal bremelanotide in men who had failed sildenafil 1129. The intranasal male-ED program was halted in 2008 after transient blood-pressure elevations were judged to preclude a path to approval 78.
Subcutaneous dosing for female sexual dysfunction was advanced as the next program. Clayton et al. (2016) reported a phase 2b dose-finding randomized trial of subcutaneous bremelanotide in premenopausal women with female sexual dysfunctions, establishing the 1.75 mg dose carried into phase 3 5. The two pivotal trials, RECONNECT Study 301 and Study 302, were identical in design, randomized 1,247 premenopausal women with acquired, generalized HSDD to subcutaneous bremelanotide 1.75 mg as needed vs placebo over 24 weeks, and met co-primary endpoints on the FSFI desire subscale and the FSDS-DAO item 13 1. A long-term safety/efficacy open-label extension to 52 weeks supported the chronic-use posture 2. AMAG Pharmaceuticals received FDA approval for Vyleesi on June 21, 2019, for acquired, generalized HSDD in premenopausal women 29. Pre-specified subgroup analyses 3 and an integrated safety analysis 4 were published subsequently. Independent re-analyses 2122 argued that effect sizes on patient-meaningful endpoints are small.
Timeline
Bremelanotide / PT-141 Timeline
2000Wessells et al 12. (Urology) report the first proof-of-concept for α-MSH analogs in human erectile dysfunction
2000Hadley (Annals NY Acad Sci) reviews melanotropic peptide development, including the lineage leading to bremelanotide
2002Van der Ploeg et al 13. (PNAS) establish MC4R as the principal melanocortin receptor mediating sexual function
2004Diamond et al 7. (Int J Impotence Res) report phase 1 intranasal PT-141 (bremelanotide) safety, PK, and PD in healthy men and men with erectile dysfunction
2004Rosen et al 8. (Int J Impotence Res) report phase 1 subcutaneous PT-141 in healthy men and men with inadequate response to sildenafil
2004Pfaus et al 14. (PNAS) demonstrate melanocortin receptor agonist-induced sexual solicitation in female rats
2005Diamond et al 9. (Urology) show additive erectogenic effect of intranasal PT-141 with low-dose sildenafil in men with erectile dysfunction
2006Diamond et al 10. (J Sex Med) report the first study of subcutaneous bremelanotide in premenopausal women with sexual arousal disorder, demonstrating an effect on subjective sexual response
2006Rössler et al 15. (Pharmacol Biochem Behav), melanotan II enhances proceptive sexual behavior in female rats independent of locomotor effects
2007Pfaus, Giuliano, and Gelez (J Sex Med) review bremelanotide preclinical CNS effects on female sexual function 16
2007Shadiack, Sharma, and Earle review melanocortins in the treatment of male and female sexual dysfunction 17
2008Safarinejad and Hosseini (J Urology), intranasal bremelanotide as salvage therapy in sildenafil non-responders; intranasal male-ED development halted thereafter over blood-pressure findings 11
2016Clayton et al 5. (Women's Health), phase 2b dose-finding randomized trial of subcutaneous bremelanotide in premenopausal women with female sexual dysfunctions; established the 1.75 mg dose for phase 3
2017Clayton et al 6. (Clinical Therapeutics), phase 1 randomized study of bremelanotide co-administered with ethanol; no clinically significant interaction
2019Kingsberg et al 1. (Obstet Gynecol) publish RECONNECT, two identically designed phase 3 randomized double-blind placebo-controlled trials (Studies 301 and 302) of subcutaneous bremelanotide 1.75 mg in 1,247 premenopausal women with HSDD
2019Simon et al 2. (Obstet Gynecol) report 52-week open-label safety/efficacy extension from RECONNECT
2019FDA approves Vyleesi (bremelanotide 1.75 mg subcutaneous autoinjector) for acquired, generalized hypoactive sexual desire disorder in premenopausal women (June 21, 2019) 29
2020Mayer and Lynch (Ann Pharmacother), practitioner-facing summary of Vyleesi approval and clinical considerations 23
2021Spielmans (J Sex Res) re-analyzes the phase 3 RECONNECT data and argues that effect sizes on sexually satisfying events are small relative to the regulatory claim 21
2022Simon et al 3. (J Women's Health), prespecified and integrated subgroup analyses from the RECONNECT phase 3 studies
2022Clayton et al 4. (J Women's Health), integrated safety profile of bremelanotide across the clinical development program
2022Pfaus, Sadiq, and Spana (CNS Spectrums) review the neurobiology of bremelanotide for premenopausal HSDD 19
2022Spana et al 20. (Diabetes Obes Metab), two phase 1 trials of daily bremelanotide on body weight in obese women
2023Cipriani et al 24. (Expert Opin Pharmacother) evaluate bremelanotide injection for HSDD
2024Spielmans and Ellefson (J Sex Res), extended critique of bremelanotide phase 3 outcomes 22
2025Barakeh et al 26. (Ann Pharmacother) review pharmacotherapy of HSDD in premenopausal women, including the bremelanotide and flibanserin evidence base
Natural role
Biological Role of Bremelanotide / PT-141
The melanocortin system is one of the central regulators of energy balance, autonomic function, skin pigmentation, and sexual behavior. α-MSH released from POMC neurons in the arcuate nucleus of the hypothalamus acts on downstream MC4R-expressing neurons in the paraventricular nucleus to suppress food intake; the same circuit and adjacent melanocortin-responsive neurons in the medial preoptic area contribute to female sexual proceptive behavior and to male erectile function 1316.
α-MSH and the related melanocyte-stimulating hormones also bind MC1R on epidermal melanocytes, driving eumelanin synthesis (skin tanning and focal hyperpigmentation). MC2R is the ACTH receptor (cortisol regulation); MC3R contributes to energy and behavioral regulation; MC5R has exocrine-gland and immune functions. Non-selective melanocortin agonists like bremelanotide engage all of these receptors, which explains the dermatologic and autonomic adverse effects seen alongside the desired central sexual effects 1929.
Clinical contexts studied
Clinical Contexts for Bremelanotide / PT-141
Acquired, generalized hypoactive sexual desire disorder (HSDD) in premenopausal women fda approved
FDA-approved indication for manufactured Vyleesi.
Vyleesi (bremelanotide 1.75 mg subcutaneous autoinjector) is FDA-approved for acquired, generalized HSDD in premenopausal women. Phase 3 evidence comes from RECONNECT Studies 301 and 302 1, two identically designed, randomized, double-blind, placebo-controlled trials enrolling 1,247 premenopausal women with HSDD. At 24 weeks, both trials met their co-primary endpoints on the FSFI desire subscale and the FSDS-DAO item 13 2728. An open-label extension to 52 weeks 2 supported chronic intermittent use; pre-specified subgroup analyses 3 and an integrated safety profile 4 were published subsequently. Vyleesi is not indicated in postmenopausal women or in men, and is not indicated for performance enhancement in patients without HSDD 29. Independent re-analyses 2122 caution that effect sizes on sexually satisfying events are small.
Off-label; small dated phase 1/2 evidence with the discontinued intranasal formulation and limited subcutaneous data. The intranasal male-ED program was halted in 2008 over blood-pressure findings; no FDA-approved bremelanotide product exists for male ED.
Phase 1 intranasal PT-141 in men with erectile dysfunction produced dose-dependent increases in penile rigidity 7. Phase 1 subcutaneous PT-141 in healthy men and men with inadequate response to sildenafil showed comparable PD effects 8. Diamond et al. (2005) reported additive erectogenic effect of intranasal PT-141 combined with sub-therapeutic sildenafil 9. Safarinejad and Hosseini (2008) reported intranasal bremelanotide as salvage therapy in 342 men who had failed sildenafil, with statistically significant but modest improvements in IIEF and successful intercourse rates 11. The intranasal male-ED program was discontinued in 2008 over transient hypertension findings, and the subcutaneous program pivoted to female HSDD. Off-label use of compounded subcutaneous bremelanotide for male ED is widespread but is not supported by a 503A-grade evidence base or by an FDA-approved indication.
Female sexual arousal disorder (FSAD) in premenopausal women emerging
Off-label; small early-phase evidence with subcutaneous PT-141 predating the HSDD development program.
Diamond et al. (2006) reported the first study of subcutaneous bremelanotide in 18 premenopausal women with female sexual arousal disorder using a laboratory paradigm of erotic visual stimulation, demonstrating an effect on subjective sexual response measures 10. Subsequent development consolidated around the HSDD indication, which carries the Vyleesi approval; FSAD is not a separate FDA indication for bremelanotide.
Widespread off-label and online use; small, dated trial evidence; the original intranasal male-ED development was halted in 2008 over blood-pressure findings.
Off-label compounded bremelanotide for male ED relies on intranasal- and subcutaneous-formulation phase 1/2 trials 811. Effect sizes were modest, hypertension was the dose-limiting toxicity, and the developer abandoned the male-ED indication. RonanRx considers this an emerging indication with weak evidence and counsels accordingly 79.
Off-label; Vyleesi is approved only in premenopausal women. No phase 3 evidence in the postmenopausal population.
The RECONNECT phase 3 program enrolled only premenopausal women, and the Vyleesi labeling restricts use to premenopausal HSDD 291. Use in postmenopausal women is off-label and not supported by adequate trial data; the cardiovascular-risk profile is also relatively more concerning in this population.
FDA-approved use
FDA-Approved Uses of Bremelanotide / PT-141
Brand
Indication
Year
Route
Vyleesi
Acquired, generalized hypoactive sexual desire disorder (HSDD) in premenopausal women
2019
Subcutaneous injection (single-use 1.75 mg autoinjector), as needed approximately 45 minutes before anticipated sexual activity
Vyleesi (bremelanotide injection) was approved by FDA on June 21, 2019 for the treatment of acquired, generalized hypoactive sexual desire disorder (HSDD) in premenopausal women 291. 'Acquired' means HSDD that developed after a period of normal sexual function; 'generalized' means it occurs across partners and situations rather than only in specific contexts 4. Vyleesi is not indicated for HSDD that is due to a co-existing medical or psychiatric condition, problems within a relationship, or the effect of a medication or drug substance. It is not indicated for use in postmenopausal women or in men, and it is not indicated to enhance sexual performance.
The Vyleesi label includes warnings for transient increases in blood pressure and decreases in heart rate after each dose, focal hyperpigmentation in the face, gums, and breasts (more likely with darker baseline pigmentation and with frequent dosing), and severe nausea. Vyleesi is contraindicated in patients with uncontrolled hypertension or known cardiovascular disease 29. The labeled regimen limits use to no more than one dose per 24-hour period and no more than eight doses per month.
Compounded use
Compounded Bremelanotide / PT-141 (503A)
Compounded bremelanotide is dispensed under 503A only when the prescribing clinician documents a patient-specific clinical need that the manufactured Vyleesi 1.75 mg autoinjector cannot meet 294. Documented needs typically fall into a small number of categories: (1) the patient cannot operate the single-use autoinjector device (e.g., dexterity or visual impairment) and requires a different container closure; (2) the patient has documented excipient sensitivity to a component of the Vyleesi formulation; or (3) the prescriber documents a clinically required dose individualization outside the 1.75 mg increment, with corresponding informed-consent documentation 3130.
Most online and direct-to-consumer marketing of 'PT-141' positions the peptide as a libido or 'sexual wellness' enhancer for men and women without a documented HSDD diagnosis. This use is off-label, is not supported by the RECONNECT evidence base (which enrolled only premenopausal women with HSDD), and does not meet the 503A patient-specific medical-need standard. RonanRx treats compounded bremelanotide for male erectile dysfunction or for general libido enhancement as 'essentially-a-copy'-pattern use and does not fill such prescriptions absent a documented patient-specific clinical reason that the manufactured Vyleesi product is not appropriate 2912.
Compounded bremelanotide preparations are typically dispensed as sterile injectable solutions for subcutaneous administration 29. The compounded preparation is not bioequivalent to Vyleesi; clinicians and patients should understand that PK/PD characteristics, particularly the transient hypertensive response, may differ from the labeled product when concentration, excipients, or container closure differ from the reference autoinjector. The published RECONNECT phase 3 evidence base is generated with the manufactured 1.75 mg autoinjector and does not transfer to compounded preparations without separate stability, PK, and tolerability evaluation 3.
Bremelanotide is not on the FDA drug shortage list 29. The shortage exception under section 503A(b)(1)(D) does not apply, and compounding of essentially-a-copy preparations is restricted by the existing FDA guidance 30. Bremelanotide is also widely marketed online as a 'research peptide' or 'tanning peptide' (the latter exploiting MC1R activity); RonanRx does not fill prescriptions written for those purposes.
Formulations and routes
Bremelanotide / PT-141 Formulations and Routes
Form
Concentration
Description
Sterile subcutaneous injection (compounded)
Custom, typically prepared on a patient-specific basis to mirror the 1.75 mg dose unless prescriber-documented variance applies
Sterile solution prepared under USP <797> standards for sterile compounding on a patient-specific prescription. Container closure, excipient profile, and concentration are documented per batch and matched to the patient's clinical profile.32
Vyleesi is supplied as a single-dose, single-use disposable subcutaneous autoinjector containing 1.75 mg bremelanotide in 0.3 mL solution. Administered in the abdomen or thigh; not for use more than once per 24 hours or more than eight doses per month per labeling.29
Routes used in published literature: subcutaneous.
Dosing
Bremelanotide / PT-141 Dosing
Route
Population
Range
Duration
Study type
Subcutaneous
Premenopausal women with acquired, generalized HSDD (Vyleesi labeled regimen)
1.75 mg subcutaneously in the abdomen or thigh approximately 45 minutes before anticipated sexual activity; no more than one dose per 24 hours; no more than 8 doses per month. Discontinue after 8 weeks if no improvement.
Doctor-prescribed and doctor-titrated. The Vyleesi label specifies a single 1.75 mg subcutaneous dose approximately 45 minutes before anticipated sexual activity, with the option to remain effective for up to 24 hours. The label limits use to one dose per 24-hour period and no more than eight doses per month, and recommends discontinuation after 8 weeks of use if there is no improvement in symptoms 29.
Compounded bremelanotide preparations should mirror the manufactured-product 1.75 mg dose and the as-needed dosing schedule unless the prescriber documents a patient-specific reason for variance 11. Higher doses and chronic daily dosing have not been studied for the HSDD indication and are not supported by the RECONNECT evidence 1. Use for off-label male erectile dysfunction is supported only by small, dated phase 1/2 trials and is not an indication for which a labeled regimen exists 789.
Doses listed are literature context, not patient instructions. Dosing decisions are made by the prescribing doctor and tailored to the individual patient.
Safety
Bremelanotide / PT-141 Safety
Safety overview
Bremelanotide safety in the RECONNECT phase 3 program and in the integrated safety analysis by Clayton et al 2. (2022) is dominated by gastrointestinal and autonomic adverse effects. Nausea was reported in approximately 40% of bremelanotide-treated participants across the development program (vs <2% on placebo), with approximately 13% rating it as severe and approximately 8% discontinuing for nausea 41. Anti-emetic pre-medication is described in clinical practice as a tolerability strategy. Flushing was reported in approximately 20%, headache in approximately 11%, and injection-site reactions in approximately 13% 4.
Transient post-dose increases in blood pressure (approximately 6 mmHg systolic and approximately 3 mmHg diastolic on average, peaking 2, 4 hours after dosing) and decreases in heart rate (approximately 5 bpm) were observed across the development program 294. These changes typically resolve within 12 hours. The Vyleesi label contraindicates use in patients with uncontrolled hypertension or known cardiovascular disease. The earlier intranasal male-ED development program was halted in 2008 over a related blood-pressure signal 78; the subcutaneous program with the 1.75 mg dose and as-needed schedule was designed to mitigate this finding, but the autonomic effect remains a class-defining safety consideration 2.
Focal hyperpigmentation was reported in approximately 1, 3% of bremelanotide-treated participants in RECONNECT, more common in patients with darker baseline pigmentation and with more frequent dosing 4292. Hyperpigmentation is attributable to MC1R activity on epidermal melanocytes; reversibility on discontinuation is variable. Less common adverse effects include vomiting, paresthesia, dizziness, and fatigue. Severe hypersensitivity has not been a characteristic finding.
Important: compounded preparations may differ from the manufactured Vyleesi autoinjector in concentration, excipients, and container closure. The autonomic and hyperpigmentation profile observed in RECONNECT with the 1.75 mg single-dose autoinjector cannot be assumed to translate without modification to compounded preparations dispensed at different concentrations or with chronic dosing schedules, and is a specific consideration in the off-label use of compounded bremelanotide for male erectile dysfunction or for chronic libido enhancement 302.
Contraindications
Bremelanotide (Vyleesi) is contraindicated in patients with uncontrolled hypertension and in patients with known cardiovascular disease, on the basis of the characteristic transient post-dose blood-pressure elevation 29. The label advises against use in patients at high risk for cardiovascular disease.
Vyleesi is not indicated for use in postmenopausal women or in men, and is not indicated for performance enhancement in patients without HSDD. It is not indicated for HSDD that is due to a co-existing medical or psychiatric condition, problems within a relationship, or the effect of a medication or drug substance. Use during pregnancy is not recommended; female patients of reproductive potential should use effective contraception during treatment and discontinue if pregnancy occurs.
Drug interactions
Bremelanotide slows gastric emptying, which can reduce or delay the absorption of orally administered medications. The Vyleesi label specifically advises that bremelanotide may decrease the exposure of orally administered drugs that depend on gastric emptying for absorption, naltrexone is the labeled example, with a documented reduction in oral naltrexone exposure that may make bremelanotide unsuitable for patients taking oral naltrexone for alcohol or opioid use disorder 29.
Concomitant use with oral hormonal contraception should be discussed with the prescriber, as the same delayed-gastric-emptying mechanism could in principle reduce contraceptive absorption. Co-administration with PDE-5 inhibitors (sildenafil, tadalafil, vardenafil) has not been systematically characterized in approved-labeling studies; some early intranasal-formulation work showed additive erectogenic effect and additive blood-pressure effect 9. Concomitant administration with antihypertensives should consider the transient post-dose blood-pressure increase. A phase 1 study of bremelanotide co-administered with ethanol 6 did not identify a clinically significant interaction.
Adverse events
Across RECONNECT Studies 301 and 302 and the integrated phase 3 safety analysis 14, the most common adverse events on bremelanotide vs placebo were: nausea (40.0% vs 1.3%), flushing (20.3% vs 0.3%), injection-site reactions (13.2%), headache (11.3% vs 1.9%), and vomiting (4.8% vs 0.2%). Less common adverse events included cough, fatigue, hot flush, paresthesia, dizziness, and nasal congestion. Adverse-event-driven discontinuation was 18.0% on bremelanotide vs 2.2% on placebo, with nausea the most common cause of discontinuation (8% of bremelanotide-treated participants).
Focal hyperpigmentation occurred in approximately 1, 3% of bremelanotide-treated participants and was more common in patients with darker baseline pigmentation and with more frequent dosing 429. Transient post-dose increases in systolic blood pressure (approximately 6 mmHg on average; peaking 2, 4 hours after dosing and returning to baseline by 12 hours) and decreases in heart rate (approximately 5 bpm) were observed 29. Serious adverse events were uncommon; the 52-week open-label safety extension 2 did not identify new safety signals beyond the phase 3 program. Pharmacovigilance for compounded melanocortin peptides is more limited than for manufactured products, and adverse events reported in off-label male-ED use of compounded preparations are not represented in the RECONNECT dataset.
Monitoring
Monitoring Bremelanotide / PT-141 Therapy
Baseline assessment should include a focused sexual-function history to confirm acquired, generalized HSDD per DSM-5 criteria and to exclude HSDD due to a co-existing medical or psychiatric condition, relationship factors, or medication effects. Blood pressure, heart rate, and a cardiovascular risk assessment should be documented prior to initiation. Pregnancy status should be confirmed in patients of reproductive potential, and effective contraception should be in place during treatment.
On therapy: re-assess response and tolerability after 8 weeks per the Vyleesi label, with discontinuation recommended if there is no improvement in symptoms. Patients should be counseled on the as-needed dosing schedule (no more than one dose per 24 hours, no more than eight doses per month), on the timing of administration (approximately 45 minutes before anticipated sexual activity), and on the transient post-dose blood-pressure and hyperpigmentation considerations 29.
Special populations
Bremelanotide / PT-141 in Special Populations
Pregnancy
Bremelanotide is not recommended during pregnancy. Limited human data are available; animal studies showed adverse developmental effects at clinically relevant exposures. Female patients of reproductive potential should use effective non-oral or barrier contraception during treatment, in part because of the delayed-gastric-emptying interaction with oral medications 29.
Lactation
There are no data on the presence of bremelanotide in human milk, its effects on the breastfed infant, or its effects on milk production. The developmental and health benefits of breastfeeding should be considered alongside the patient's clinical need for bremelanotide and any potential adverse effects on the breastfed child 29.
Pediatric
Safety and effectiveness have not been established in pediatric patients. Vyleesi is indicated only in adult premenopausal women with HSDD 29.
Geriatric
Vyleesi is not indicated in postmenopausal women and was not studied in geriatric populations in RECONNECT. The cardiovascular risk profile and the post-dose blood-pressure response argue for particular caution in older adults if the drug is considered off-label 291.
Renal impairment
Bremelanotide is cleared primarily by the kidneys; systemic exposure is increased in renal impairment. The Vyleesi label notes the lack of dedicated renal-impairment dosing studies and recommends caution; co-administration with drugs that affect renal clearance has not been systematically characterized 29.
Hepatic impairment
Dedicated hepatic-impairment PK studies have not been published; the Vyleesi label does not require dose adjustment but does note the absence of hepatic-impairment-specific data 29.
Evidence quality
Bremelanotide / PT-141 Evidence Quality
Evidence supporting the manufactured Vyleesi product for acquired, generalized HSDD in premenopausal women is the two identically designed phase 3 RECONNECT trials (Studies 301 and 302) reported by Kingsberg et al. (2019) 1, with a long-term open-label extension by Simon et al. (2019) 2 and pre-specified subgroup analyses 3 and integrated safety analysis 4 published subsequently. Both pivotal trials met their co-primary endpoints. Effect sizes are statistically significant but clinically modest: the difference vs placebo on the FSFI desire subscale was approximately 0.30, 0.35 points (on a 1, 5 scale), and the proportion of patients meeting responder criteria favored bremelanotide 11. Independent re-analyses 2122 argue that effect sizes on patient-meaningful endpoints (e.g., sexually satisfying events) are small relative to the regulatory framing, and reviews of the broader HSDD pharmacotherapy landscape 252624 contextualize bremelanotide alongside flibanserin and other agents.
Evidence for off-label male erectile dysfunction is limited to small, dated phase 1/2 trials with the discontinued intranasal formulation and limited subcutaneous data 79. The intranasal program was halted in 2008 over blood-pressure findings and never advanced to FDA approval. There is no phase 3 program supporting male-ED use of bremelanotide, and the safety profile (particularly the autonomic and hypertension findings that ended the original program) argues against routine off-label use.
Evidence specifically supporting compounded preparations is absent, there is no parallel efficacy or safety program for compounded subcutaneous bremelanotide. Compounded use is an extrapolation from the manufactured Vyleesi autoinjector evidence base, justified case by case by a patient-specific clinical factor that the manufactured product cannot accommodate. Compounded preparations may differ in concentration, excipient profile, and container closure; PK/PD equivalence and the autonomic side-effect profile should not be assumed to transfer without local evaluation 30318.
Two identically designed, randomized, double-blind, placebo-controlled phase 3 trials of subcutaneous bremelanotide 1.75 mg vs placebo as needed in premenopausal women with acquired, generalized HSDD
1247
24 weeks core phase
Both trials met co-primary endpoints on FSFI desire subscale (mean change vs placebo +0.30, 0.35) and FSDS-DAO item 13 1. Statistically significant improvements in 'sexually satisfying events' were small in magnitude and the subject of subsequent re-analysis. Adverse events dominated by nausea (40%), flushing (20%), and headache (11%); discontinuation for adverse events 18.0% on bremelanotide vs 2.2% placebo.
52-week open-label safety/efficacy extension following RECONNECT Studies 301 and 302
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52 weeks
Long-term safety profile consistent with the 24-week phase 3 data; no new safety signals; durability of effect on desire and distress endpoints in patients who continued treatment 2.
Pre-specified and integrated subgroup analyses across RECONNECT Studies 301 and 302
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—
Effect on desire and distress endpoints was directionally consistent across pre-specified subgroups (age, baseline severity, HSDD subtype) without identifying a differential responder profile that would refine the labeled population 3.
Phase 2b randomized, placebo-controlled, dose-finding trial of subcutaneous bremelanotide 0.75, 1.25, and 1.75 mg in premenopausal women with female sexual dysfunctions
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12 weeks
Established the 1.75 mg dose subsequently carried into phase 3 RECONNECT; demonstrated activity on FSFI and FSDS-DAO endpoints with the characteristic AE profile 5.
Randomized, double-blind, placebo-controlled, cross-over study of subcutaneous bremelanotide in premenopausal women with female sexual arousal disorder using a laboratory erotic-stimulus paradigm
18
Single-dose laboratory sessions
Bremelanotide improved subjective sexual response measures versus placebo in a small early-phase study; supported the subsequent HSDD development program 10.
Phase 1 randomized, double-blind, placebo-controlled study of intranasal PT-141 in healthy men and men with mild-to-moderate erectile dysfunction
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—
Intranasal PT-141 produced dose-dependent increases in penile rigidity and self-reported arousal vs placebo; transient blood-pressure increases were observed, particularly at higher doses 7.
Phase 1 study of subcutaneously administered PT-141 in healthy men and men with inadequate response to sildenafil
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—
Subcutaneous PT-141 produced pharmacodynamic erectogenic effects comparable to the intranasal route; established the SC formulation that was subsequently developed for women 8.
Randomized, double-blind, placebo-controlled crossover of intranasal PT-141 with low-dose sildenafil in men with erectile dysfunction
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—
Combined PT-141 and sub-therapeutic sildenafil produced enhanced erectile response vs either alone; transient additive blood-pressure effects observed 9.
Randomized, double-blind, placebo-controlled study of intranasal bremelanotide in men with erectile dysfunction who had previously failed sildenafil
342
12 weeks
Intranasal bremelanotide produced statistically significant but modest improvements in IIEF and successful intercourse rates vs placebo in sildenafil non-responders 11. Last major intranasal male-ED study before program discontinuation.
Mechanistic review integrating preclinical and clinical pharmacology of bremelanotide for premenopausal HSDD
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—
Synthesized the MC3R/MC4R hypothalamic mechanism with dopaminergic and oxytocinergic downstream effects, in the context of the RECONNECT phase 3 outcomes 19.
Independent re-analysis of phase 3 RECONNECT outcomes data
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—
Argued that effect sizes on sexually satisfying events and patient-meaningful endpoints were small relative to the regulatory framing and discontinuation rates 21.
Preclinical study using MC4R-selective ligands and MC4R-knockout mice to define the receptor mediating melanocortin sexual-function effects
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—
MC4R is the principal melanocortin receptor mediating sexual function effects in animal models; mechanistic foundation for bremelanotide and other melanocortin sexual pharmacology 13.
Preclinical study of selective facilitation of sexual solicitation behavior in female rats by a melanocortin receptor agonist
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—
Melanocortin receptor agonism selectively increased solicitation behaviors without nonspecific locomotor stimulation; preclinical translational basis for the female-sexual-function program 14.
Preclinical study of melanotan II-induced proceptive sexual behaviors in female rats
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—
Melanotan II enhanced proceptive behaviors in female rats independent of locomotor effects; reinforced the central melanocortin sexual-behavior pharmacology 15.
Early human proof-of-concept study of an α-MSH analog (Melanotan II) in men with organic erectile dysfunction
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—
α-MSH analog produced penile erection and increased sexual desire in men with erectile dysfunction; foundational human pharmacology that motivated subsequent bremelanotide development 12.
Two phase 1 randomized controlled trials of daily bremelanotide on body weight in obese women
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—
Daily bremelanotide produced modest weight reductions vs placebo; a separate pharmacology program from the HSDD indication that did not progress to a weight-loss indication 20.
Mechanism detail
Detailed Mechanism of Bremelanotide / PT-141
The melanocortin system comprises five GPCRs (MC1R, MC5R), the endogenous agonists α-, β-, and γ-MSH and ACTH derived from POMC processing, and the endogenous inverse agonists agouti and AgRP. MC4R, a Gs-coupled receptor signaling through cAMP, is highly expressed in the paraventricular nucleus of the hypothalamus, lateral hypothalamus, medial preoptic area, and dorsal vagal complex, circuits that integrate appetite, autonomic outflow, and reproductive behavior 13. Genetic loss-of-function variants in MC4R produce hyperphagic obesity in humans and rodents, and pharmacological activation of MC4R in animal models facilitates penile erection and lordosis/solicitation behavior in females, providing the translational rationale for melanocortin sexual pharmacology 131415.
Preclinical pharmacology of bremelanotide and its parent compound melanotan II established proof of concept in this domain. Pfaus and colleagues showed selective facilitation of sexual solicitation in female rats following melanocortin receptor agonism 14, with downstream dopaminergic and oxytocinergic mediation 1716. Rössler et al. (2006) demonstrated melanotan II-induced proceptive behaviors in female rats independent of overt locomotor effects 15. Wessells et al. (2000) reported that an α-MSH analog produced penile erection and increased sexual desire in men with organic erectile dysfunction in an early proof-of-concept human study 12.
In healthy adults, intranasal bremelanotide (the discontinued formulation) produced increases in penile rigidity and self-reported sexual desire in men with erectile dysfunction 798. The intranasal program was halted in 2008 after dose-dependent transient blood-pressure elevations in male-ED studies precluded a path to approval 78. Development pivoted to subcutaneous administration in women with HSDD, building on dose-finding data from Clayton et al. (2016) 5 that established the 1.75 mg subcutaneous dose carried into RECONNECT phase 3 1. The neurobiology of bremelanotide for the approved female-HSDD indication is reviewed in Pfaus et al. (2022) 19.
Pharmacokinetically, subcutaneous bremelanotide reaches peak plasma concentration approximately 1 hour after dosing, with a terminal elimination half-life of 2.7 hours; clearance is renal. The drug is administered on demand because of its short half-life and the autonomic side-effect profile, rather than chronically 29. The autoinjector delivers a single 1.75 mg dose. Spana et al. (2022) reported weight-reduction effects in two phase 1 studies in obese women with chronic daily dosing of bremelanotide 20, a separate pharmacology program that did not progress to a weight indication.
Bremelanotide is a cyclic heptapeptide (acetylated, cyclized, 1024 Da). After subcutaneous administration of 1.75 mg, peak plasma concentration is reached at approximately 1 hour, and the terminal elimination half-life is approximately 2.7 hours. Plasma protein binding is approximately 21%. The drug is eliminated primarily through renal excretion of unchanged drug and peptide hydrolysis products 29.
The short half-life supports the as-needed (rather than chronic daily) dosing posture and limits the duration of the transient post-dose hemodynamic effects. Compounded immediate-use sterile injectable preparations may differ from the manufactured autoinjector formulation in concentration, excipient profile, container closure, and storage conditions; PK characteristics published for Vyleesi should not be assumed to translate without local stability and PK data.
Pharmacodynamics
Pharmacodynamic effects include central melanocortin receptor agonism (predominantly MC3R and MC4R) producing increases in subjective sexual desire and arousal in premenopausal women with HSDD 119, non-selective activity at MC1R producing the characteristic focal hyperpigmentation with frequent dosing, and autonomic effects producing transient post-dose increases in systolic blood pressure (approximately 6 mmHg on average) with reflex decreases in heart rate (approximately 5 bpm) 294. Gastric emptying is delayed, which is the basis for the labeled drug-drug interaction with oral naltrexone and the prominent nausea AE.
FSFI desire subscale change and FSDS-DAO item 13 change are the principal clinically measured pharmacodynamic endpoints in HSDD. In phase 1 male-ED studies with the intranasal formulation, penile rigidity by RigiScan was the principal PD endpoint 78.
Comparative formulations
Comparing Bremelanotide / PT-141 Formulations
The manufactured product is Vyleesi, a single-use disposable 1.75 mg/0.3 mL subcutaneous autoinjector. The autoinjector form factor was specifically designed to support intermittent at-home use by patients with HSDD. Other historical formulations include the discontinued intranasal PT-141 (developed for male erectile dysfunction; halted in 2008 over blood-pressure findings) and the parent compound melanotan II (used in academic pharmacology research and widely marketed online as an unregulated 'tanning peptide', not an approved formulation) 7.
Compounded sterile injectable preparations vary in concentration, excipient profile, and container closure. They are not bioequivalent to Vyleesi; clinicians should anticipate that local PK and tolerability, including the autonomic and hyperpigmentation profile, may differ from manufactured-product published data and should re-evaluate the safety posture when prescribing compounded preparations 3029.
Storage
Bremelanotide / PT-141 Storage and Handling
Manufactured Vyleesi autoinjectors are stored at controlled room temperature (20, 25°C; excursions permitted 15, 30°C) in the original package to protect from light. The autoinjector is single-use. Compounded sterile injectable bremelanotide is stored per the pharmacy's stability data and beyond-use date assignment under USP <797>; refrigerated storage is typical for multi-dose preparations 2932.
Patients should be educated on storage requirements at home and on the as-needed (not chronic daily) dosing posture, particularly for the manufactured autoinjector.
RonanRx operations
Bremelanotide / PT-141 Compounding & Operations
503A compounding
Compounded bremelanotide is prepared under 503A on patient-specific prescriptions in state-licensed compounding pharmacies. RonanRx prepares sterile injectable preparations per USP General Chapter <797>, the official compendial standard for sterile pharmaceutical compounding, with documented active ingredient sourcing, gravimetric and analytical verification, sterility and endotoxin testing per the pharmacy's quality-management system, and full lot traceability 3233. For any nonsterile preparative steps the corresponding USP General Chapter <795> applies; however, the finished injectable product is governed by <797> in full.
Beyond-use dating, ingredient identity verification, sterility assurance, and stability assessment follow USP <797> requirements. Each compounded batch is documented per state board of pharmacy retention rules with full traceability from API lot through dispensing. Bremelanotide is not on the FDA drug shortage list and the section 503A(b)(1)(D) shortage exception does not apply; compounded preparations are dispensed only where a patient-specific clinical reason that the manufactured Vyleesi product cannot meet is documented by the prescriber 303132.
Pharmacist review
Each prescription for compounded bremelanotide undergoes pharmacist review prior to dispensing 30. The review confirms: a documented patient-specific clinical reason that the manufactured Vyleesi 1.75 mg autoinjector is not appropriate (autoinjector device limitation, documented excipient sensitivity, or other documented factor); absence of contraindications (uncontrolled hypertension, known cardiovascular disease, pregnancy or planned pregnancy without effective contraception) 29; consistency with the labeled population (acquired, generalized HSDD in premenopausal women, where Vyleesi is the reference product); and a prescribed regimen consistent with FDA-label dosing (1.75 mg as needed, no more than once per 24 hours, no more than eight doses per month) unless the prescriber documents a patient-specific reason for variance.
RonanRx does not fill prescriptions for compounded bremelanotide that read as direct-to-consumer 'libido peptide' or 'sexual wellness peptide' use, or as off-label male erectile dysfunction therapy in patients without documented PDE-5 inhibitor failure or contraindication and without documented prescriber discussion of the small, dated, intranasal-formulation evidence base 7811 and the original intranasal-program blood-pressure findings 30. The pharmacist review explicitly considers the autonomic risk profile and the focal-hyperpigmentation risk of repeated dosing.
Quality and traceability
Active pharmaceutical ingredients are sourced from FDA-registered facilities with documented certificates of analysis. Each batch is recorded with lot numbers traceable to API source, compounding date, beyond-use date, sterility test result, endotoxin test result, and dispensing pharmacist of record. Finished product lot records are retained per state board of pharmacy retention requirements.
Cold chain
Compounded sterile injectable bremelanotide is dispensed with refrigerated transport when stability data require it, with temperature monitoring through the shipment. Patients are advised to follow the pharmacy's labeled storage instructions and to inspect for temperature excursions on arrival. Manufactured Vyleesi autoinjectors are stored at controlled room temperature per labeling 29.
FAQ
Frequently Asked Questions About Bremelanotide / PT-141
Is compounded bremelanotide the same as Vyleesi?
No. Vyleesi is the FDA-approved manufactured bremelanotide product, a single-use 1.75 mg subcutaneous autoinjector indicated for acquired, generalized HSDD in premenopausal women. Compounded bremelanotide is pharmacy-prepared on a patient-specific prescription and is not bioequivalent to Vyleesi 29. Compounded drugs are not FDA-approved31.
When is compounded bremelanotide appropriate?
Per FDA guidance, a compounded version of an FDA-approved drug is generally restricted unless the prescriber documents a patient-specific clinical need that the manufactured product cannot meet, for example, dexterity or visual impairment that prevents safe use of the Vyleesi autoinjector, documented excipient sensitivity, or a clinically required dose individualization 30. Cost or preference does not qualify under section 503A.
Is bremelanotide approved for men?
No. Vyleesi is approved only for premenopausal women with acquired, generalized HSDD. The original PT-141 development program for male erectile dysfunction (intranasal formulation, with later subcutaneous studies) was halted in 2008 over transient hypertension findings, and no bremelanotide product has been approved for male ED 78. Compounded bremelanotide for male ED is off-label and rests on a small, dated trial corpus 1129.
How well does Vyleesi work for HSDD?
In the two phase 3 RECONNECT trials, both met their co-primary endpoints on the FSFI desire subscale and the FSDS-DAO item 13 121. Effect sizes are statistically significant but clinically modest (e.g., approximately 0.30, 0.35 points difference vs placebo on the 1, 5 FSFI desire subscale). Independent re-analyses have argued that effect sizes on 'sexually satisfying events' are small relative to the regulatory framing 22. About 18% of patients discontinue therapy for adverse events, primarily nausea 4.
What are the most common side effects?
Nausea is the dominant adverse event, reported in approximately 40% of bremelanotide-treated participants in phase 3 (severe in ~13%, leading to discontinuation in ~8%) 1. Flushing (~20%), injection-site reactions (~13%), and headache (~11%) are also common. Transient post-dose increases in blood pressure (~6 mmHg systolic) and decreases in heart rate (~5 bpm) typically resolve within 12 hours. Focal hyperpigmentation occurs in 1, 3% and is more common with repeated dosing 429.
Who should not take bremelanotide?
Vyleesi is contraindicated in uncontrolled hypertension and known cardiovascular disease. It is not indicated in postmenopausal women, in men, in pregnancy, or for HSDD due to a co-existing medical or psychiatric condition, relationship factors, or medication effects. Patients on oral naltrexone should not use bremelanotide, since bremelanotide reduces oral naltrexone absorption 29.
Why is bremelanotide marketed online as a 'tanning peptide' or 'libido peptide'?
Bremelanotide is non-selective across the melanocortin receptor family. MC1R activity on epidermal melanocytes can produce skin tanning and focal hyperpigmentation; MC3R/MC4R activity in the hypothalamus mediates the sexual-function effects. Online vendors exploit this pharmacology to market bremelanotide as an unregulated 'tanning' or 'libido' peptide 1929. These uses are not FDA-approved and are not the basis for legitimate 503A patient-specific compounding at RonanRx.
Does RonanRx sell compounded bremelanotide directly to patients?
No. Compounded bremelanotide requires a patient-specific prescription written by a licensed doctor for an identified patient with a documented clinical reason that the manufactured Vyleesi product is not appropriate, plus pharmacist review before dispensing 30. RonanRx is not a direct-to-consumer storefront and does not fill prescriptions for general 'libido enhancement' or off-label male ED in patients without documented medical need 31.
Clinician resource
Download the Bremelanotide / PT-141 Clinical Monograph (PDF)
The full white paper covers every section on this page plus chemical identity, evidence grading, indication-by-indication summaries, research gaps, and reference appendix. Suitable for sharing with prescribing doctors and pharmacist reviewers.
[kingsberg2019] Kingsberg SA, Clayton AH, Portman D, Williams LA, Krop J, Jordan R, Lucas J, Simon JA. Bremelanotide for the Treatment of Hypoactive Sexual Desire Disorder: Two Randomized Phase 3 Trials. Obstetrics and Gynecology. 2019. PMID 31599840. (accessed 2026-05-11)
[simon2019] Simon JA, Kingsberg SA, Portman D, Williams LA, Krop J, Jordan R, Lucas J, Clayton AH. Long-Term Safety and Efficacy of Bremelanotide for Hypoactive Sexual Desire Disorder. Obstetrics and Gynecology. 2019. PMID 31599847. (accessed 2026-05-11)
[simon2022] Simon JA, Kingsberg SA, Portman D, Williams LA, Krop J, Jordan R, Lucas J, Clayton AH. Prespecified and Integrated Subgroup Analyses from the RECONNECT Phase 3 Studies of Bremelanotide. Journal of Women's Health (2002). 2022. PMID 35230162. (accessed 2026-05-11)
[clayton2022] Clayton AH, Kingsberg SA, Portman D, Williams LA, Krop J, Jordan R, Lucas J, Simon JA. Safety Profile of Bremelanotide Across the Clinical Development Program. Journal of Women's Health (2002). 2022. PMID 35147466. (accessed 2026-05-11)
[clayton2016] Clayton AH, Althof SE, Kingsberg S, DeRogatis LR, Kroll R, Goldstein I, Kaminetsky J, Spana C, Lucas J, Jordan R, Portman DJ. Bremelanotide for female sexual dysfunctions in premenopausal women: a randomized, placebo-controlled dose-finding trial. Women's Health (London, England). 2016. PMID 27181790. (accessed 2026-05-11)
[clayton2017] Clayton AH, Lucas J, DeRogatis LR, Jordan R. Phase I Randomized Placebo-controlled, Double-blind Study of the Safety and Tolerability of Bremelanotide Coadministered With Ethanol in Healthy Male and Female Participants. Clinical Therapeutics. 2017. PMID 28189361. (accessed 2026-05-11)
[diamond2004] Diamond LE, Earle DC, Rosen RC, Willett MS, Molinoff PB. Double-blind, placebo-controlled evaluation of the safety, pharmacokinetic properties and pharmacodynamic effects of intranasal PT-141, a melanocortin receptor agonist, in healthy males and patients with mild-to-moderate erectile dysfunction. International Journal of Impotence Research. 2004. PMID 14963471. (accessed 2026-05-11)
[rosen2004] Rosen RC, Diamond LE, Earle DC, Shadiack AM, Molinoff PB. Evaluation of the safety, pharmacokinetics and pharmacodynamic effects of subcutaneously administered PT-141, a melanocortin receptor agonist, in healthy male subjects and in patients with an inadequate response to Viagra. International Journal of Impotence Research. 2004. PMID 14999221. (accessed 2026-05-11)
[diamond2005] Diamond LE, Earle DC, Garcia WD, Spana C. Co-administration of low doses of intranasal PT-141, a melanocortin receptor agonist, and sildenafil to men with erectile dysfunction results in an enhanced erectile response. Urology. 2005. PMID 15833522. (accessed 2026-05-11)
[diamond2006] Diamond LE, Earle DC, Heiman JR, Rosen RC, Perelman MA, Harning R. An effect on the subjective sexual response in premenopausal women with sexual arousal disorder by bremelanotide (PT-141), a melanocortin receptor agonist. Journal of Sexual Medicine. 2006. PMID 16839319. (accessed 2026-05-11)
[safarinejad2008] Safarinejad MR, Hosseini SY. Salvage of sildenafil failures with bremelanotide: a randomized, double-blind, placebo controlled study. Journal of Urology. 2008. PMID 18206919. (accessed 2026-05-11)
[wessells2000] Wessells H, Gralnek D, Dorr R, Hruby VJ, Hadley ME, Levine N. Effect of an alpha-melanocyte stimulating hormone analog on penile erection and sexual desire in men with organic erectile dysfunction. Urology. 2000. PMID 11018622. (accessed 2026-05-11)
[vanderploeg2002] Van der Ploeg LH, Martin WJ, Howard AD, Nargund RP, Austin CP, Guan X, Drisko J, Cashen D, Sebhat I, Patchett AA, Figueroa DJ, DiLella AG, Connolly BM, Weinberg DH, Tan CP, Palyha OC, Pong SS, MacNeil T, Rosenblum C, Vongs A, Tang R, Yu H, Sailer AW, Fong TM, Huang C, Tota MR, Chang RS, Stearns R, Tamvakopoulos C, Christ G, Drazen DL, Spar BD, Nelson RJ, MacIntyre DE. A role for the melanocortin 4 receptor in sexual function. Proceedings of the National Academy of Sciences of the United States of America. 2002. PMID 12172010. (accessed 2026-05-11)
[pfaus2004] Pfaus JG, Shadiack A, Van Soest T, Tse M, Molinoff P. Selective facilitation of sexual solicitation in the female rat by a melanocortin receptor agonist. Proceedings of the National Academy of Sciences of the United States of America. 2004. PMID 15226502. (accessed 2026-05-11)
[rossler2006] Rössler AS, Pfaus JG, Kia HK, Bernabé J, Alexandre L, Giuliano F. The melanocortin agonist, melanotan II, enhances proceptive sexual behaviors in the female rat. Pharmacology, Biochemistry, and Behavior. 2006. PMID 17113634. (accessed 2026-05-11)
[pfaus2007] Pfaus J, Giuliano F, Gelez H. Bremelanotide: an overview of preclinical CNS effects on female sexual function. Journal of Sexual Medicine. 2007. PMID 17958619. (accessed 2026-05-11)
[shadiack2007] Shadiack AM, Sharma SD, Earle DC, Spana C, Hallam TJ. Melanocortins in the treatment of male and female sexual dysfunction. Current Topics in Medicinal Chemistry. 2007. PMID 17584134. (accessed 2026-05-11)
[pfaus2009] Pfaus JG. Pathways of sexual desire. Journal of Sexual Medicine. 2009. PMID 19453889. (accessed 2026-05-11)
[pfaus2022] Pfaus JG, Sadiq A, Spana C, Clayton AH. The neurobiology of bremelanotide for the treatment of hypoactive sexual desire disorder in premenopausal women. CNS Spectrums. 2022. PMID 33455598. (accessed 2026-05-11)
[spana2022] Spana C, Jordan R, Fischkoff S. Effect of bremelanotide on body weight of obese women: Data from two phase 1 randomized controlled trials. Diabetes, Obesity and Metabolism. 2022. PMID 35170192. (accessed 2026-05-11)
[spielmans2021] Spielmans GI. Re-Analyzing Phase III Bremelanotide Trials for "Hypoactive Sexual Desire Disorder" in Women. Journal of Sex Research. 2021. PMID 33678061. (accessed 2026-05-11)
[spielmans2024] Spielmans GI, Ellefson EM. Small Effects, Questionable Outcomes: Bremelanotide for Hypoactive Sexual Desire Disorder. Journal of Sex Research. 2024. PMID 36809187. (accessed 2026-05-11)
[mayer2020] Mayer D, Lynch SE. Bremelanotide: New Drug Approved for Treating Hypoactive Sexual Desire Disorder. Annals of Pharmacotherapy. 2020. PMID 31893927. (accessed 2026-05-11)
[cipriani2023] Cipriani S, Alfaroli C, Maseroli E, Vignozzi L. An evaluation of bremelanotide injection for the treatment of hypoactive sexual desire disorder. Expert Opinion on Pharmacotherapy. 2023. PMID 36242769. (accessed 2026-05-11)
[nappi2023] Nappi RE, Tiranini L, Cucinella L, Martini E, Bosoni D, Righi A, Cassani C, Gardella B. Pharmacotherapy for female sexual dysfunctions (FSDs): what is on the market and where is this field heading?. Expert Opinion on Pharmacotherapy. 2023. PMID 35430926. (accessed 2026-05-11)
[barakeh2025] Barakeh D, Mdaihly H, Karaoui LR. Pharmacotherapy of Hypoactive Sexual Desire Disorder in Premenopausal Women. Annals of Pharmacotherapy. 2025. PMID 38767282. (accessed 2026-05-11)
[kingsberg2018] Kingsberg SA, Woodard T. Evaluation and Management of Hypoactive Sexual Desire Disorder. Sexual Medicine. 2018. PMID 29523488. (accessed 2026-05-11)
[kingsberg2020] Kingsberg SA, Simon JA. Female Hypoactive Sexual Desire Disorder: A Practical Guide to Causes, Clinical Diagnosis, and Treatment. Journal of Women's Health (2002). 2020. PMID 32460605. (accessed 2026-05-11)
[fda_essentially_a_copy] U.S. Food and Drug Administration. Compounded Drug Products That Are Essentially Copies of Approved Drug Products Under Section 503A of the Federal Food, Drug, and Cosmetic Act — Guidance for Industry. FDA Guidance for Industry. 2018. https://www.fda.gov/media/98973/download (accessed 2026-05-11)
[usp_797] United States Pharmacopeia. USP General Chapter <797> Pharmaceutical Compounding — Sterile Preparations. USP Compounding Compendium. 2023. https://www.usp.org/compounding/general-chapter-797 (accessed 2026-05-11)
[usp_795] United States Pharmacopeia. USP General Chapter <795> Pharmaceutical Compounding — Nonsterile Preparations. USP Compounding Compendium. 2023. https://www.usp.org/compounding/general-chapter-795 (accessed 2026-05-11)
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