The evidence base for CJC-1295 includes human endocrine studies and a discontinued clinical development program. The long-acting albumin-binding design raises different safety questions from short-acting GHRH analogs, including sustained GH and IGF-1 axis exposure.
Physicians may submit patient-specific prescription requests for CJC-1295 for pharmacy review. Certain preparations may be available now when clinically appropriate, lawfully prescribed, supported by patient-specific documentation, and approved by the dispensing pharmacy. Availability is determined case by case. This is not a consumer access promise; it is a clinical, sourcing, formulation, and regulatory review process. This ingredient remains part of an evolving FDA review process after prior Pharmacy Compounding Advisory Committee consideration.
The regulated route is not a CJC-1295 and ipamorelin stack sold as a wellness protocol. It is a prescriber-submitted request for one patient, reviewed against the safety record, the formulation, and the legal status at the time of review.
In brief
CJC-1295 Explained
CJC-1295 is a synthetic peptide designed in the early 2000s to release growth hormone over a long duration 12. It is a modified version of the first 29 amino acids of growth-hormone-releasing hormone (GHRH), the natural signal the brain sends to the pituitary gland. CJC-1295 has never been approved by the FDA, and human drug development was discontinued by its original sponsor (ConjuChem) in the late 2000s after a cardiovascular safety signal appeared during an HIV-lipodystrophy program.
There are two variants in the literature. The DAC (drug affinity complex) version permanently attaches to a blood protein called albumin after injection, extending its half-life to roughly one to two weeks. The non-DAC version, sometimes called 'mod-GRF 1-29' or 'modified GHRH,' lacks this albumin linker and is cleared in about half an hour. Both are widely advertised in gray-market anti-aging and bodybuilding channels, RonanRx flags this honestly and does NOT participate in that market.
CJC-1295 has no FDA approval in the United States. This ingredient is part of an evolving FDA review process. Physicians may submit patient-specific prescription requests for pharmacy review. Availability is determined case by case, and availability may change after FDA review, PCAC discussion, final agency action, or state-board guidance.
Tetrasubstituted GHRH(1-29), substitutions at D-Ala2, Gln8, Ala15, Leu27 confer DPP-IV resistance and extended plasma stability. The DAC variant adds a maleimidopropionyl-Lys30 linker that covalently binds plasma albumin via Cys34, extending half-life from hours to days; the non-DAC variant (sometimes labeled 'modified GHRH' or 'mod-GRF 1-29') retains only the tetra-substitution and has a half-life of approximately 30 minutes
FDA-approval status
Category 2, evolving FDA review process. Valid patient-specific prescription required; supporting clinical rationale may be requested.
503A bulk substances status
Category 2, evolving FDA review process. Valid patient-specific prescription required; supporting clinical rationale may be requested.
WADA status
Category 2, evolving FDA review process. Valid patient-specific prescription required; supporting clinical rationale may be requested.
RonanRx availability
Physicians may submit patient-specific prescription requests for pharmacy review. Availability is determined case by case.
Prescription review
Patient-Specific Prescription Only
Physicians may submit patient-specific prescription requests for CJC-1295 for pharmacy review. Certain preparations may be available now when clinically appropriate, lawfully prescribed, and approved by the dispensing pharmacy. Availability is determined case by case.
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 CJC-1295?
CJC-1295 is a synthetic peptide based on the N-terminal 29 amino acids of human growth-hormone-releasing hormone (GHRH 1-29), the biologically active fragment of the 44-amino-acid hypothalamic hormone 4. The parent GHRH(1-29) sequence is the same scaffold used by sermorelin (FDA-approved as Geref in 1997 and withdrawn from the U.S. market in 2008) and the FDA-approved HIV-lipodystrophy product tesamorelin (Egrifta, 2010).
CJC-1295 incorporates four amino-acid substitutions designed to confer enzymatic stability against dipeptidyl peptidase-IV (DPP-IV) and serum endopeptidases: D-alanine at position 2 (the canonical DPP-IV cleavage site), glutamine at position 8, alanine at position 15, and leucine at position 27. These substitutions extend the in vivo half-life of the unmodified peptide from approximately 7 minutes (native GHRH) to roughly 30 minutes, the basis for the non-DAC variant sometimes labeled 'mod-GRF 1-29' or 'modified GHRH(1-29)' in research and gray-market literature 4.
The DAC (drug affinity complex) variant additionally appends a maleimidopropionyl (MPA) reactive group to an added Lys30 residue 4. After subcutaneous injection, the MPA group forms an irreversible thioether bond with the free thiol of Cys34 of circulating human serum albumin, generating a covalent peptide-albumin bioconjugate. This bioconjugation slows renal clearance and proteolytic degradation, producing a circulating depot with a terminal half-life on the order of one to two weeks 12. The DAC variant is the molecule originally developed by ConjuChem under the designation CJC-1295; the non-DAC variant is a derivative used in research and in the gray market under the looser label 'CJC-1295 without DAC.'
There is no FDA-approved CJC-1295 product 4. Clinical development by ConjuChem proceeded to small phase 1/2 trials in healthy adults 23 and a phase 2 program in HIV-associated lipodystrophy. The HIV-lipodystrophy program was discontinued after an emerging cardiovascular safety signal, and no New Drug Application was filed.
How it works
How CJC-1295 Works
Class
GHRH analog (long-acting peptide)
First studied
2000s
Current status
Category 2, evolving FDA review process
Compounding category
Patient-specific 503A on physician request, pending broader FDA review
CJC-1295 binds and activates the GHRH receptor, a class B G-protein-coupled receptor expressed on somatotroph cells in the anterior pituitary 1. Receptor activation elevates intracellular cAMP, drives PKA-mediated phosphorylation of CREB, and triggers pulsatile growth hormone (GH) release into systemic circulation. GH in turn stimulates hepatic and peripheral production of insulin-like growth factor 1 (IGF-1), which mediates most of the anabolic and growth-promoting downstream effects of the GH axis.
Unlike growth-hormone secretagogues acting at the ghrelin (GHS-R1a) receptor (ipamorelin, GHRP-2, GHRP-6, hexarelin, MK-677), CJC-1295 acts only at the GHRH receptor and therefore preserves the physiologic feedback architecture mediated by somatostatin and by GH/IGF-1 negative feedback. Ionescu and Frohman (2006) demonstrated that pulsatile GH secretion is preserved during continuous CJC-1295 exposure in healthy adults 3, a pharmacodynamic distinction from recombinant human growth hormone (rhGH), which delivers a flat exogenous GH exposure 1.
The DAC modification does not change the receptor pharmacology; it changes only the pharmacokinetic profile. Bound to albumin, the bioconjugate continues to engage the GHRH receptor over days to weeks, producing sustained elevation of serum GH and IGF-1 251.
Research history
CJC-1295 Research History
CJC-1295 was developed by ConjuChem Inc. (Montreal) in the early 2000s using the company's proprietary DAC platform for covalent albumin bioconjugation. The discovery and receptor-activation chemistry was reported by Jetté and colleagues in Endocrinology in 2005 1. Initial phase 1 single-ascending-dose and multiple-ascending-dose studies in healthy adults were reported by Teichman and colleagues (J Clin Endocrinol Metab 2006) 2 and Ionescu and Frohman (J Clin Endocrinol Metab 2006) 3, establishing the once-weekly to once-every-two-weeks subcutaneous dosing interval and confirming preservation of pulsatile GH secretion 15. Alba and colleagues (Am J Physiol Endocrinol Metab 2006) provided the corresponding preclinical efficacy data in GHRH-deficient mice 412. Sackmann-Sala and colleagues (Growth Horm IGF Res 2009) characterized downstream serum protein changes 51411.
ConjuChem advanced CJC-1295 into phase 2 development for HIV-associated lipodystrophy, an indication where tesamorelin (a different short-acting GHRH analog) would later receive FDA approval as Egrifta (2010). The CJC-1295 HIV-lipodystrophy program was discontinued after an emerging cardiovascular safety signal, the specific event profile has not been published in the peer-reviewed literature, but the discontinuation is acknowledged in subsequent regulatory and review documents. ConjuChem ceased clinical development of CJC-1295 and no New Drug Application was filed 6.
Following discontinuation, the published literature on CJC-1295 is dominated by analytical chemistry: development of immuno-affinity, immuno-PCR, LC-MS/MS, and high-resolution mass spectrometric methods for detecting CJC-1295 and related GHRH analogs in human and equine plasma and urine at picogram-per-milliliter sensitivity 910. Qualitative social-science work has documented the gray-market use of CJC-1295 in bodybuilding and anti-aging communities 78, and recent review articles in sports-medicine and orthopaedic journals catalog the unapproved-peptide therapy landscape including CJC-1295 13.
FDA's Pharmacy Compounding Advisory Committee (PCAC) reviewed CJC-1295 in 2023 as part of the broader bulk-substances-for-503A-compounding nomination review and recommended against placement on the Category 1 (503A-eligible) list, citing absence of an adequate human safety database and concerns about uncontrolled long-acting GH/IGF-1 axis stimulation 17. CJC-1295 remains on the Category 2 list and is part of an evolving FDA review process 16.
Timeline
CJC-1295 Timeline
2005Jetté et al 1. (Endocrinology), hGRF(1-29)-albumin bioconjugates activate the GHRH receptor on rat anterior pituitary; establishes the DAC platform for CJC-1295
2006Teichman et al 2. (J Clin Endocrinol Metab), phase 1 single- and multiple-ascending-dose study of CJC-1295 in 36 healthy adults; demonstrates sustained GH and IGF-1 elevation with terminal half-life ~5.8-8.1 days
2006Ionescu and Frohman (J Clin Endocrinol Metab), pulsatile GH secretion preserved during continuous CJC-1295 exposure in healthy adults 3
2006Alba et al 4. (Am J Physiol Endocrinol Metab), once-daily CJC-1295 normalizes growth in GHRH-deficient (lit/lit) mice
2009Sackmann-Sala et al 5. (Growth Horm IGF Res), CJC-1295 produces a coordinated GH/IGF-1-axis serum protein signature in normal adult subjects
late 2000sConjuChem discontinues phase 2 development of CJC-1295 for HIV-associated lipodystrophy after a cardiovascular safety signal; no New Drug Application filed
2010Henninge et al 6. (Drug Test Anal), analytical identification of CJC-1295 in an unknown pharmaceutical preparation seized from the gray market
2016Brennan et al 78. (Subst Use Misuse; Forensic Sci Int), netnographic and forum-based studies of gray-market CJC-1295 use in bodybuilding and female anti-aging communities
2019Esposito et al 910. (Drug Test Anal), LC-MS/MS confirmation and immuno-PCR screening methods for CJC-1295 in equine plasma at pg/mL sensitivity
2021Drug Testing and Analysis review, advances in detection of GHRH releasing-hormone synthetic analogs including CJC-1295 in doping control 11
2023FDA Pharmacy Compounding Advisory Committee (PCAC) reviews CJC-1295 and recommends against placement on the Category 1 (503A-eligible) bulk substances list; CJC-1295 remains on Category 2 and is part of an evolving FDA review process for 503A compounding 1716
2026Multiple review articles in sports-medicine, orthopaedic-medicine, and gerontology journals catalog CJC-1295 within the unapproved-peptide therapy landscape and document widespread gray-market availability outside the regulated supply chain 12131415
Natural role
Biological Role of CJC-1295
GHRH is the hypothalamic neuropeptide that drives somatotroph proliferation and GH secretion from the anterior pituitary. The GH/IGF-1 axis regulates linear growth in childhood and, in adults, modulates body composition (lean mass vs adiposity), insulin sensitivity, bone turnover, and several aspects of metabolic homeostasis 2. GH secretion is pulsatile, dominated by overnight slow-wave-sleep-associated bursts, and declines progressively from young adulthood onward, the basis of the contested 'somatopause' construct.
Pharmacologic agents that act on the GH axis fall into three categories: (1) recombinant human GH itself (somatropin), which delivers exogenous GH directly; (2) GHRH receptor agonists (sermorelin, tesamorelin, CJC-1295), which act upstream on the pituitary somatotroph; and (3) ghrelin receptor (GHS-R1a) agonists (ipamorelin, GHRP-2/6, hexarelin, MK-677), which act through a parallel receptor system. The GHRH-receptor agonists preserve the pulsatile architecture of GH secretion and the somatostatin negative-feedback loop, which is the pharmacological rationale that distinguishes them from exogenous rhGH 3. CJC-1295 is the longest-acting GHRH receptor agonist designed for clinical use to date 2.
Hypothesized indication based on pharmacology; no published randomized controlled trials of CJC-1295 in adult GHD. Sermorelin (short-acting) was previously studied in this space; tesamorelin carries an FDA approval in a related indication (HIV-lipodystrophy).
Evidence should be interpreted in context for CJC-1295. Any patient-specific request requires prescriber rationale and pharmacy review; availability is determined case by case.234
Phase 2 program was conducted and discontinued. Tesamorelin is the FDA-approved GHRH-analog in this indication; CJC-1295 is not FDA-approved.
ConjuChem advanced CJC-1295 into phase 2 development for HIV-associated lipodystrophy in the mid-to-late 2000s. The program was discontinued following an emerging cardiovascular safety signal, and no peer-reviewed efficacy or safety results were published. Tesamorelin (Egrifta), a non-DAC, short-acting GHRH(1-44) analog, subsequently received FDA approval in 2010 for HIV-associated lipodystrophy. CJC-1295 has no published evidence base in this or any other patient population 17.
Age-related GH/IGF-1 decline ('somatopause') in healthy adults preclinical
Widely marketed in gray-market anti-aging and wellness channels. No FDA-approved indication. The premise that pharmacologically restoring younger-adult GH/IGF-1 levels improves long-term outcomes in healthy older adults is not established by randomized controlled trial evidence for any GH-axis agent.
There are no randomized controlled trials of CJC-1295 in healthy aging adults for any clinical outcome 15. The molecule is widely marketed outside the regulated pharmacy framework, in anti-aging clinics, telehealth gray-market vendors, and direct-to-consumer peptide retailers, for body-composition, sleep, and 'wellness' indications 1314. Qualitative research 78 documents this use pattern but provides no controlled efficacy data. Reviews of the broader unapproved-peptide landscape catalog CJC-1295 within this category and flag the absence of regulated-pathway safety data 12. RonanRx does not participate in this market.
Athletic performance, body composition, and physique modification preclinical
Prohibited at all times under WADA S2. No legitimate clinical role.
CJC-1295 is on the WADA prohibited list under section S2 (peptide hormones, growth factors, related substances and mimetics) at all times in and out of competition 19611. A substantial analytical-chemistry literature exists for detecting CJC-1295 in human and equine doping-control samples 910. There is no published controlled trial evidence supporting use of CJC-1295 for athletic performance, body composition, or physique modification, and the regulatory framework does not permit it 1213.
Off-label use
Off-Label Uses of CJC-1295
Gray-market 'anti-aging' and wellness use outside the regulated pharmacy framework preclinical
Evidence should be interpreted in context for CJC-1295. Any patient-specific request requires prescriber rationale and pharmacy review; availability is determined case by case.
Evidence should be interpreted in context for CJC-1295. Any patient-specific request requires prescriber rationale and pharmacy review; availability is determined case by case.781617
FDA-approved use
FDA-Approved Uses of CJC-1295
There are no FDA-approved CJC-1295 products. No New Drug Application has been filed. ConjuChem's clinical development program was discontinued in the late 2000s following a cardiovascular safety signal in the HIV-associated lipodystrophy phase 2 program. Several other GHRH-axis agents exist within the FDA framework: sermorelin acetate (Geref) was FDA-approved in 1997 for pediatric growth hormone deficiency and withdrawn from the U.S. market in 2008; tesamorelin acetate (Egrifta) is FDA-approved for HIV-associated lipodystrophy (2010). CJC-1295 is not among them.
CJC-1295 has no FDA approval in the United States. This ingredient is part of an evolving FDA review process. Physicians may submit patient-specific prescription requests for pharmacy review. Availability is determined case by case, and availability may change after FDA review, PCAC discussion, final agency action, or state-board guidance.
Compounded use
Compounded CJC-1295 (503A)
Physicians may submit patient-specific prescription requests for pharmacy review. For CJC-1295, certain preparations may be available now when clinically appropriate, lawfully prescribed, and approved by the dispensing pharmacy. Availability is determined case by case and may depend on patient-specific documentation, ingredient status, source qualification, formulation feasibility, state requirements, and pharmacist judgment. The review starts with the evidence constraint: The evidence base for CJC-1295 includes human endocrine studies and a discontinued clinical development program. The long-acting albumin-binding design raises different safety questions from short-acting GHRH analogs, including sustained GH and IGF-1 axis exposure.
This ingredient is part of an evolving FDA review process. RonanRx is monitoring FDA's PCAC process and any subsequent agency action. This ingredient remains part of an evolving FDA review process after prior Pharmacy Compounding Advisory Committee consideration. Availability may change after FDA review, PCAC discussion, final agency action, or state-board guidance. For CJC-1295, RonanRx ties that monitoring to the evidence limits described above and to any patient-specific documentation submitted by the prescriber.
Valid patient-specific prescription required. Supporting clinical rationale may be requested. Compounded medications are not FDA-approved. No consumer self-ordering, no office stock, no bulk dispensing. Requests for CJC-1295 are reviewed before any preparation is made or released. The regulated route is not a CJC-1295 and ipamorelin stack sold as a wellness protocol. It is a prescriber-submitted request for one patient, reviewed against the safety record, the formulation, and the legal status at the time of review.
Sterile lyophilized peptide reconstituted in bacteriostatic water for subcutaneous administration. Used in phase 1/2 healthy-volunteer trials in the mid-2000s. No commercial formulation has ever been FDA-approved.23
Lyophilized peptide sold outside the regulated pharmacy framework by 'research chemical' retailers. Content, purity, sterility, and identity are not verifiable to USP standards. RonanRx does not endorse or dispense these products. Analytical chemistry studies have documented variable identity and purity in seized gray-market preparations [henninge2010].6
Routes used in published literature: subcutaneous.
Single subcutaneous doses of 30, 60, 125, and 250 µg/kg studied in single-ascending-dose phase 1 [teichman2006]; multiple-ascending-dose phase 1 used weekly subcutaneous dosing at 60 and 90 µg/kg with up to 4 doses [teichman2006]. No phase 3 dose has ever been established because the program did not advance.
Up to 4 weekly doses in the published multiple-ascending-dose phase 1 study
Phase 1 single- and multiple-ascending-dose in healthy adults2
There is no FDA-labeled dose for CJC-1295. The phase 1 doses published by Teichman and colleagues in 2006 2 are the only systematically studied human regimens; phase 3 dose-finding has never been performed because clinical development was discontinued. Gray-market dosing protocols circulating in bodybuilding and anti-aging communities, typically 1-2 mg subcutaneously once weekly for the DAC variant, or 100-200 µg multiple times daily for the non-DAC 'mod-GRF 1-29' variant, have no controlled-trial evidence base 78.
RonanRx does not prescribe or compound CJC-1295. This section exists to document the historical regimen for context and to make clear that informal gray-market protocols are not supported by published controlled evidence.
Doses listed are literature context, not patient instructions. Dosing decisions are made by the prescribing doctor and tailored to the individual patient.
Safety
CJC-1295 Safety
Safety overview
The published human safety database for CJC-1295 is small and short-duration. Teichman and colleagues (2006) reported on 36 healthy adults across single- and multiple-ascending-dose phase 1 cohorts; the most commonly reported adverse events were transient injection-site reactions and flushing, with no severe events at the doses studied over the limited follow-up window 2. Ionescu and Frohman (2006) reported a similar short-term safety profile in a smaller pulsatility-focused cohort 3. These data establish acute tolerability at trial doses; they do not establish long-term safety of sustained pharmacologic GH/IGF-1 axis elevation in any patient population.
Clinical development of CJC-1295 was discontinued by ConjuChem after a cardiovascular safety signal emerged in the phase 2 HIV-associated lipodystrophy program. The detailed event profile has not been published in the peer-reviewed literature. The discontinuation is documented in FDA's PCAC review materials and in the broader regulatory record 17. Because the molecule has not advanced through regulated late-phase development, there is no published systematic adverse-event characterization comparable to the SURPASS- or SURMOUNT-style datasets available for FDA-approved peptide therapeutics.
Theoretical safety considerations of sustained GH/IGF-1 axis activation, extrapolated from rhGH and tesamorelin labeling and from the broader GH/IGF-1 literature, include insulin resistance and impaired glucose tolerance, fluid retention with peripheral edema and arthralgias, carpal tunnel syndrome, increased intracranial pressure, and IGF-1-mediated theoretical risk of accelerated proliferation of pre-existing malignancy. The DAC variant's long half-life means these effects, if they occur, cannot be reversed by dose interruption on the timescale of days. None of these considerations is documented as a CJC-1295-specific event in the public literature; all are extrapolations from the GH/IGF-1 axis class.
Quality-control safety is a distinct concern. Analytical chemistry investigations of seized gray-market CJC-1295 preparations have documented variable identity, purity, and concentration 6. Recent reviews of the unapproved-peptide therapy market emphasize that the safety profile of pharmacy-grade, regulated-supply-chain product is not transferable to gray-market preparations 121314. Physicians may submit patient-specific prescription requests for pharmacy review. Availability is determined case by case.
Contraindications
Honest gap. No FDA-labeled contraindications exist because CJC-1295 has never been FDA-approved. No regulator-defined contraindication list has been published. Class-extrapolated contraindications from tesamorelin (Egrifta) labeling, known hypersensitivity to GHRH analogs, active malignancy, pituitary disease with disrupted hypothalamic-pituitary axis, pregnancy, would apply on a pharmacologic basis if CJC-1295 were ever used clinically, but this is extrapolation from a related FDA-approved agent rather than a CJC-1295-specific contraindication list. Physicians may submit patient-specific prescription requests for pharmacy review. Availability is determined case by case.
Searched: PubMed, FDA PCAC review materials, FDA bulk substances 503A lists on 2026-05-11 · terms CJC-1295 contraindications; CJC-1295 labeled warnings.
Drug interactions
Honest gap. No CJC-1295-specific drug interaction data have been published. Extrapolation from tesamorelin and rhGH labeling suggests potential interactions with glucocorticoids (mutual antagonism), insulin and oral antidiabetic agents (CJC-1295 expected to reduce insulin sensitivity via the GH/IGF-1 axis), and substrates of CYP3A4 (where rhGH labeling notes potential induction). These are class extrapolations, not CJC-1295-specific findings. Physicians may submit patient-specific prescription requests for pharmacy review. Availability is determined case by case.
Searched: PubMed, FDA PCAC review materials on 2026-05-11 · terms CJC-1295 drug interactions; GHRH analog drug interactions; growth hormone drug interactions.
Adverse events
Acute adverse events reported in the small published phase 1 healthy-volunteer trials 23 were limited to transient injection-site reactions (redness, warmth, pruritus) and self-limited flushing typically appearing within minutes of subcutaneous administration. No drug-related serious adverse events were reported in the published phase 1 cohorts. These data describe only acute tolerability at trial doses over a short observation window and do not characterize the long-term safety profile 15.
The phase 2 HIV-associated lipodystrophy program, discontinued by ConjuChem, reportedly disclosed an emerging cardiovascular safety signal whose detailed event profile has not been published in the peer-reviewed literature. This signal is the proximate explanation for ConjuChem's decision to halt development and is referenced in subsequent regulatory review materials 17. Without published trial-level data, the signal cannot be characterized further here.
Gray-market adverse-event reporting for CJC-1295 is unsystematic. Case reports of injection-site reactions, water retention, transient hyperglycemia, and acromegalic-pattern soft-tissue changes appear in online community forums but do not constitute regulated pharmacovigilance data 78. The recent sports-medicine and orthopaedic-medicine reviews of the unapproved-peptide market emphasize that the absence of structured AE reporting in the gray-market channel is itself a safety problem 121314.
Monitoring
Monitoring CJC-1295 Therapy
No RonanRx-specific monitoring protocol has been established for CJC-1295. If a patient-specific prescription is submitted, supporting clinical rationale may be requested, and monitoring expectations would be reviewed case by case against the published evidence, route, sterile or nonsterile status, concomitant therapies, and patient risk factors.
Special populations
CJC-1295 in Special Populations
Pregnancy
There are no published data on CJC-1295 in pregnancy. No CJC-1295-specific reproductive toxicology has been disclosed. The molecule is not FDA-approved and is not compounded by RonanRx. Class extrapolation from tesamorelin (Egrifta) labeling suggests avoidance in pregnancy.
Lactation
There are no published data on CJC-1295 in lactation. The molecule is not FDA-approved and is not compounded by RonanRx.
Pediatric
There are no published pediatric data for CJC-1295. The molecule has no FDA approval in any indication, has not been studied in pediatric growth hormone deficiency or any other pediatric indication, and is not compounded by RonanRx. Pediatric GHRH-receptor agonism is historically the domain of sermorelin (FDA approval in 1997 for pediatric GHD, U.S. market withdrawn 2008) and recombinant human growth hormone.
Geriatric
There are no published controlled trials of CJC-1295 in older adults for any clinical outcome. Gray-market use is concentrated in middle-aged and older adults in anti-aging and wellness contexts 7815, but this use has no controlled-trial evidence base and falls entirely outside the regulated pharmacy framework. The geriatric implications of sustained pharmacologic GH/IGF-1 axis elevation, including effects on glucose tolerance, fluid status, and theoretical malignancy risk, have not been characterized for CJC-1295 specifically.
Renal impairment
No CJC-1295 pharmacokinetic data in renal impairment have been published. The DAC variant's albumin bioconjugate is expected to undergo predominantly proteolytic clearance with minor renal contribution, but this has not been characterized in renally impaired humans.
Hepatic impairment
No CJC-1295 pharmacokinetic data in hepatic impairment have been published.
Evidence quality
CJC-1295 Evidence Quality
The CJC-1295 evidence base is small, dated, and concentrated in healthy-volunteer phase 1/2 pharmacodynamic studies from the mid-2000s 6910. No randomized placebo-controlled efficacy trial in any clinical indication has been published. The phase 2 HIV-associated lipodystrophy program was discontinued before publication of trial-level results, and clinical development has not resumed. There are no published systematic AE characterizations, no dedicated cardiovascular outcomes data, no long-term safety follow-up, and no patient-reported-outcome data 121415.
The post-2010 literature is dominated by analytical chemistry for doping control and by social-science characterization of gray-market use 7813. Recent review articles in sports medicine, orthopaedic medicine, and gerontology catalog CJC-1295 within the broader unapproved-peptide market and document the absence of a regulated-pathway evidence base 123.
From a 503A perspective, the FDA Pharmacy Compounding Advisory Committee reviewed CJC-1295 in 2023 and recommended against Category 1 placement on the basis of insufficient human safety data 1745. The molecule remains on the Category 2 bulk substances list 16. RonanRx's position is that this evidence posture does not support 503A compounding and that the appropriate response is informational documentation rather than dispensing 11.
Preclinical pharmacology, receptor activation studies of hGRF(1-29)-albumin bioconjugates on rat anterior pituitary cells in vitro and after subcutaneous administration in rats
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The MPA-Lys30 modification produces a covalent albumin bioconjugate that retains full GHRH receptor agonism in vitro and produces sustained GH elevation in vivo, established the DAC platform that became CJC-1295 1
Phase 1 single-ascending-dose and multiple-ascending-dose, double-blind, placebo-controlled, in healthy adult volunteers
36
Single dose with 28-day follow-up; multiple-dose cohort with up to 4 weekly doses
Single subcutaneous doses of CJC-1295 (30, 60, 125, 250 µg/kg) produced 2- to 10-fold elevation in mean serum GH over 6 days and 1.5- to 3-fold elevation in IGF-1 over 9-11 days; terminal half-life approximately 5.8-8.1 days; injection-site reactions and transient flushing were the most common adverse events at the doses studied 2. Establishes the human PK/PD profile.
Preclinical efficacy study in lit/lit (GHRH-deficient) mice receiving once-daily CJC-1295
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Once-daily CJC-1295 normalized growth and IGF-1 levels in GHRH-deficient mice, validating the long-acting GHRH agonism phenotype in a defined genetic model of GH-axis failure 4
Translational pharmacodynamic study, serum protein profile changes in normal adult subjects receiving CJC-1295
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CJC-1295 produced a coordinated serum protein signature consistent with sustained GH/IGF-1 axis activation; supports the persistence of pharmacodynamic effect over the dosing interval 5
Analytical chemistry case study, LC-MS identification of CJC-1295 in a seized unknown pharmaceutical preparation
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Confirms presence of CJC-1295 in gray-market pharmaceutical preparations and demonstrates an analytical method for detection; documents the post-discontinuation gray-market supply of the molecule 6
Netnographic qualitative study of online forums focused on female use of synthetic growth hormone analogs including CJC-1295
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Documents demographics, dosing self-reports, perceived effects, and adverse-event narratives from female gray-market CJC-1295 users; the data are entirely self-reported and unverified by clinical assessment 7
Qualitative analysis of internet forums to characterize the production and distribution of doping substances including CJC-1295
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Maps the gray-market supply chain for CJC-1295 and related peptides; documents the scale and structure of the market outside the regulated pharmacy framework 8
Review article, advances in the detection of growth hormone releasing hormone synthetic analogs in human and equine doping control
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Summarizes the analytical-chemistry literature on CJC-1295 and related GHRH analogs through 2021; documents that CJC-1295 remains an active doping-control target with sensitive methods available 11
Narrative review of safety and efficacy of approved and unapproved peptide therapies for musculoskeletal injuries and athletic performance, including CJC-1295
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Catalogues CJC-1295 within the unapproved-peptide category and flags absence of regulated-pathway controlled-trial evidence; emphasizes safety and quality concerns of gray-market supply 12
Critical review of peptide and peptide-analog drug use in recreational and professional sport and bodybuilding, including CJC-1295
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Documents the scale of peptide-drug use in sport and bodybuilding, the regulatory and detection landscape, and the specific role of CJC-1295 within the long-acting-GHRH category 13
Review article for orthopaedic and sports-medicine physicians on injectable peptide therapy, including unapproved agents like CJC-1295
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Cautions practitioners on the regulatory status, evidence gaps, and safety considerations for injectable peptide therapies including CJC-1295; recommends against use outside FDA-approved indications 14
Narrative review of therapeutic peptides used in gerontology, including GHRH analogs and CJC-1295
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Reviews the proposed mechanisms and applications of peptide therapy in healthy aging; flags the absence of randomized controlled evidence for CJC-1295 in age-related GH/IGF-1 decline 15
Mechanism detail
Detailed Mechanism of CJC-1295
Native GHRH(1-44) is rapidly inactivated in plasma by DPP-IV-mediated cleavage of the N-terminal Tyr-Ala dipeptide, yielding GHRH(3-44), which lacks receptor agonism 3. Substitution of D-alanine for L-alanine at position 2 of GHRH(1-29) renders this bond DPP-IV-resistant. The additional substitutions at positions 8 (Gln for Asp), 15 (Ala for Gly), and 27 (Leu for Met) stabilize the peptide against trypsin-like serum endopeptidases and against methionine oxidation. The resulting tetrasubstituted GHRH(1-29), the non-DAC variant, retains full GHRH receptor agonism with an extended plasma half-life of approximately 30 minutes 1.
The DAC technology developed at ConjuChem appends a maleimidopropionyl (MPA) chemoselective linker to the C-terminus of the tetrasubstituted GHRH(1-29) scaffold. The MPA group is selective for free thiols at physiologic pH; after subcutaneous administration the linker reacts preferentially with the unique free cysteine at position 34 of human serum albumin, generating a 1:1 albumin-peptide bioconjugate. Jetté and colleagues (Endocrinology 2005) demonstrated that the resulting bioconjugate retains GHRH receptor agonism on rat anterior pituitary somatotrophs in vitro and in vivo 1. Teichman and colleagues (J Clin Endocrinol Metab 2006) reported in 36 healthy adults that a single subcutaneous dose of CJC-1295 produced a 2- to 10-fold elevation in mean serum GH over 6 days and a 1.5- to 3-fold elevation in IGF-1 over 9 to 11 days, with an apparent terminal half-life of the bioconjugate of approximately 5.8 to 8.1 days 23.
Alba and colleagues (Am J Physiol Endocrinol Metab 2006) demonstrated in GHRH-deficient little (lit/lit) mice that once-daily CJC-1295 normalized linear growth and IGF-1 levels with sustained exposure, validating the long-acting GHRH agonism phenotype in a defined genetic model 4. Sackmann-Sala and colleagues (Growth Horm IGF Res 2009) characterized serum protein profile changes in normal adult subjects receiving CJC-1295 and reported a coordinated GH/IGF-1-axis-activated proteomic signature consistent with sustained somatotropic stimulation 53.
Pharmacodynamic consequences of sustained GH/IGF-1 elevation include the canonical GH effects on lipolysis, hepatic gluconeogenesis, insulin resistance, sodium retention, and IGF-1-mediated mitogenesis in cartilage and other peripheral tissues 3. The duration of GH/IGF-1 elevation in the DAC variant is on the order of weeks per dose, distinct from sermorelin (half-life ~10-20 minutes) and tesamorelin (half-life ~26-38 minutes in healthy subjects), both of which produce short, sermorelin-like or GHRH-like exposure pulses rather than sustained agonism.
Pharmacology
CJC-1295 Pharmacokinetics & Pharmacodynamics
Pharmacokinetics
CJC-1295 (DAC variant) pharmacokinetics in healthy adults were characterized by Teichman and colleagues in 2006 2. After subcutaneous administration, the maleimidopropionyl-Lys30 linker reacts with the Cys34 free thiol of plasma albumin within hours, generating a covalent peptide-albumin bioconjugate 1. The apparent terminal half-life of this bioconjugate in healthy adults is approximately 5.8 to 8.1 days. Mean serum GH was elevated 2- to 10-fold over baseline for approximately 6 days after a single subcutaneous dose; IGF-1 was elevated 1.5- to 3-fold over 9 to 11 days. Steady-state albumin-bioconjugate concentrations are anticipated after approximately 3 to 4 weekly doses on pharmacokinetic modeling grounds.
The non-DAC variant (sometimes labeled 'mod-GRF 1-29' or 'modified GHRH(1-29)') retains only the four amino-acid substitutions that confer DPP-IV resistance, without the albumin-bioconjugate linker 1. Its apparent plasma half-life is approximately 30 minutes, biologically closer to sermorelin (~10-20 minutes) than to the DAC variant. The non-DAC variant has not been characterized in formal regulatory-grade phase 1 pharmacokinetic studies.
Neither variant has published pharmacokinetic data in renal impairment, hepatic impairment, pregnancy, lactation, pediatric, or geriatric populations 1. No mass-balance or human-radiolabel studies have been disclosed.
Pharmacodynamics
Pharmacodynamic effects of CJC-1295 are mediated through sustained GHRH receptor agonism on pituitary somatotrophs, producing elevated mean serum GH and elevated serum IGF-1 over the dosing interval. Ionescu and Frohman (2006) demonstrated preservation of pulsatile GH secretion under continuous CJC-1295 exposure, distinguishing GHRH receptor agonism from exogenous rhGH delivery 32. Sackmann-Sala and colleagues (2009) characterized the downstream serum protein signature consistent with coordinated GH/IGF-1 axis activation 5.
Downstream physiologic effects extrapolated from the GH/IGF-1 axis class would be expected to include lipolysis, hepatic gluconeogenesis, mild insulin resistance, sodium retention, and IGF-1-mediated peripheral mitogenesis. None of these has been characterized in a controlled trial of CJC-1295 in a defined patient population 2. Clinical efficacy endpoints (e.g., body composition, glycemic indices, quality-of-life measures, patient-reported outcomes) have not been reported.
Comparative formulations
Comparing CJC-1295 Formulations
Within the GHRH-analog class, three molecules are most often compared. Sermorelin acetate (Geref; FDA-approved 1997, withdrawn from the U.S. market 2008) is unmodified GHRH(1-29) with a plasma half-life of roughly 10-20 minutes. Tesamorelin acetate (Egrifta; FDA-approved 2010 for HIV-associated lipodystrophy) is a trans-3-hexenoic-acid-modified GHRH(1-44) analog with a plasma half-life of approximately 26-38 minutes in healthy subjects. CJC-1295 (DAC variant) is a tetrasubstituted GHRH(1-29) with a maleimidopropionyl-Lys30 albumin linker and an albumin-bioconjugate half-life of roughly 5.8-8.1 days 2, two to three orders of magnitude longer than sermorelin or tesamorelin. The non-DAC variant ('mod-GRF 1-29') is biologically closer to sermorelin than to the DAC variant.
If a CJC-1295 preparation is approved after pharmacy review, RonanRx applies source documentation, formulation records, lot traceability, release checks, and storage controls appropriate to the actual dosage form. Research-use vial storage practices do not substitute for pharmacy-assigned storage, beyond-use dating, sterility controls when applicable, or recallable batch records.
Storage
CJC-1295 Storage and Handling
CJC-1295 is not commercially manufactured and is not compounded by RonanRx; there is therefore no RonanRx-specific storage guidance to provide. In the historical phase 1 trials 2, the investigational product was a sterile lyophilized peptide reconstituted with bacteriostatic water and used promptly per the clinical protocol. Gray-market lyophilized peptide preparations sold outside the regulated supply chain have variable stability and identity 6 and should not be assumed to behave like a regulated drug product.
RonanRx operations
CJC-1295 Compounding & Operations
503A compounding
Physicians may submit patient-specific prescription requests for pharmacy review. For CJC-1295, certain preparations may be available now when clinically appropriate, lawfully prescribed, and approved by the dispensing pharmacy. Availability is determined case by case and may depend on patient-specific documentation, ingredient status, source qualification, formulation feasibility, state requirements, and pharmacist judgment. The review starts with the evidence constraint: The evidence base for CJC-1295 includes human endocrine studies and a discontinued clinical development program. The long-acting albumin-binding design raises different safety questions from short-acting GHRH analogs, including sustained GH and IGF-1 axis exposure.
This ingredient is part of an evolving FDA review process. RonanRx is monitoring FDA's PCAC process and any subsequent agency action. This ingredient remains part of an evolving FDA review process after prior Pharmacy Compounding Advisory Committee consideration. Availability may change after FDA review, PCAC discussion, final agency action, or state-board guidance. For CJC-1295, RonanRx ties that monitoring to the evidence limits described above and to any patient-specific documentation submitted by the prescriber.
Valid patient-specific prescription required. Supporting clinical rationale may be requested. Compounded medications are not FDA-approved. No consumer self-ordering, no office stock, no bulk dispensing. Requests for CJC-1295 are reviewed before any preparation is made or released. The regulated route is not a CJC-1295 and ipamorelin stack sold as a wellness protocol. It is a prescriber-submitted request for one patient, reviewed against the safety record, the formulation, and the legal status at the time of review.
Pharmacist review
For CJC-1295, the pharmacist review starts before any preparation is made. Valid patient-specific prescription required. Supporting clinical rationale may be requested. The pharmacist reviews ingredient status, sourcing, formulation feasibility, state requirements, patient-specific documentation, and whether dispensing is appropriate case by case.
Quality and traceability
If a CJC-1295 preparation is approved after pharmacy review, RonanRx applies source documentation, formulation records, lot traceability, release checks, and storage controls appropriate to the actual dosage form. Research-use vial storage practices do not substitute for pharmacy-assigned storage, beyond-use dating, sterility controls when applicable, or recallable batch records. The patient-specific framework and quality controls are documented in the cited compounding references 1820.
Cold chain
If a CJC-1295 preparation is approved after pharmacy review, RonanRx applies source documentation, formulation records, lot traceability, release checks, and storage controls appropriate to the actual dosage form. Research-use vial storage practices do not substitute for pharmacy-assigned storage, beyond-use dating, sterility controls when applicable, or recallable batch records.
FAQ
Frequently Asked Questions About CJC-1295
Can physicians request CJC-1295 through RonanRx?
Physicians may submit patient-specific prescription requests for pharmacy review. Certain preparations may be available now when clinically appropriate, lawfully prescribed, and approved by the dispensing pharmacy. Availability is determined case by case. Compounded medications are not FDA-approved, and no consumer self-ordering, office stock, or bulk dispensing is offered.1617
What is the difference between CJC-1295 with DAC and CJC-1295 without DAC?
Both share four amino-acid substitutions (D-Ala2, Gln8, Ala15, Leu27) that make the peptide resistant to DPP-IV degradation. The DAC variant additionally has a maleimidopropionyl group on Lys30 that covalently binds plasma albumin after injection, producing a half-life of about one to two weeks 1. The non-DAC variant ('mod-GRF 1-29') has only the substitutions and a half-life of roughly 30 minutes, pharmacokinetically closer to sermorelin. Both are on FDA's Category 2 list; neither is 503A-eligible 216.
Why was CJC-1295 never FDA-approved?
ConjuChem advanced CJC-1295 into phase 2 development for HIV-associated lipodystrophy in the mid-to-late 2000s. The program was discontinued after a cardiovascular safety signal emerged. No New Drug Application was filed 17. The detailed event profile from that phase 2 program has not been published in the peer-reviewed literature.
Is CJC-1295 legal in the United States?
For CJC-1295, physicians may submit patient-specific prescription requests for pharmacy review. Availability is determined case by case, and supporting clinical rationale may be requested.161719
What evidence exists for CJC-1295 in humans?
The published human evidence base is limited to small phase 1 healthy-volunteer pharmacokinetic and pharmacodynamic studies from the mid-2000s, Teichman 2006 (36 healthy adults, single- and multiple-ascending-dose) and Ionescu/Frohman 2006 (pulsatility preservation) 23. No randomized placebo-controlled efficacy trial has been published in any clinical indication. The post-2010 literature is dominated by analytical chemistry for doping control and by qualitative studies of gray-market use 78.
What about CJC-1295 and ipamorelin stacks?
For CJC-1295, physicians may submit patient-specific prescription requests for pharmacy review. Availability is determined case by case, and supporting clinical rationale may be requested.7816
If CJC-1295 is on Category 2 today, could it move to Category 1?
FDA periodically re-reviews substances on the Category 2 list as new safety and efficacy data become available 1617. A reclassification to Category 1 would require, at minimum, a substantially expanded human safety database, which does not exist today and is unlikely to be generated outside a formal regulatory pathway such as an IND-supported clinical trial. RonanRx will reassess CJC-1295 if and when FDA reclassifies it.
Clinician resource
Download the CJC-1295 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.
[jette2005] Jetté L, Léger R, Thibaudeau K, Benquet C, Robitaille M, Pellerin I, Paradis V, van Wyk P, Pham K, Bridon DP. Human growth hormone-releasing factor (hGRF)1-29-albumin bioconjugates activate the GRF receptor on the anterior pituitary in rats: identification of CJC-1295 as a long-lasting GRF analog. Endocrinology. 2005. PMID 15817669. (accessed 2026-05-11)
[teichman2006] Teichman SL, Neale A, Lawrence B, Gagnon C, Castaigne JP, Frohman LA. Prolonged stimulation of growth hormone (GH) and insulin-like growth factor I secretion by CJC-1295, a long-acting analog of GH-releasing hormone, in healthy adults. The Journal of Clinical Endocrinology and Metabolism. 2006. PMID 16352683. (accessed 2026-05-11)
[ionescu2006] Ionescu M, Frohman LA. Pulsatile secretion of growth hormone (GH) persists during continuous stimulation by CJC-1295, a long-acting GH-releasing hormone analog. The Journal of Clinical Endocrinology and Metabolism. 2006. PMID 17018654. (accessed 2026-05-11)
[alba2006] Alba M, Fintini D, Sagazio A, Lawrence B, Castaigne JP, Frohman LA, Salvatori R. Once-daily administration of CJC-1295, a long-acting growth hormone-releasing hormone (GHRH) analog, normalizes growth in the GHRH knockout mouse. American Journal of Physiology. Endocrinology and Metabolism. 2006. PMID 16822960. (accessed 2026-05-11)
[sackmannsala2009] Sackmann-Sala L, Ding J, Frohman LA, Kopchick JJ. Activation of the GH/IGF-1 axis by CJC-1295, a long-acting GHRH analog, results in serum protein profile changes in normal adult subjects. Growth Hormone & IGF Research. 2009. PMID 19386527. (accessed 2026-05-11)
[henninge2010] Henninge J, Pepaj M, Hullstein I, Hemmersbach P. Identification of CJC-1295, a growth-hormone-releasing peptide, in an unknown pharmaceutical preparation. Drug Testing and Analysis. 2010. PMID 21204297. (accessed 2026-05-11)
[brennan2016] Brennan R, Wells JS, Van Hout MC. Netnography of Female Use of the Synthetic Growth Hormone CJC-1295: Pulses and Potions. Substance Use & Misuse. 2016. PMID 26771670. (accessed 2026-05-11)
[brennan2016_forum] Brennan R, Wells JS, Van Hout MC. The study of doping market: How to produce intelligence from Internet forums. Forensic Science International. 2016. PMID 27710891. (accessed 2026-05-11)
[esposito2019_plasma] Esposito S, Deventer K, Goeman J, Van der Eycken J, Van Eenoo P. A method for confirming CJC-1295 abuse in equine plasma samples by LC-MS/MS. Drug Testing and Analysis. 2019. PMID 30938069. (accessed 2026-05-11)
[esposito2019_screen] Esposito S, Deventer K, Geldof L, Van Eenoo P. An immuno polymerase chain reaction screen for the detection of CJC-1295 and other growth-hormone-releasing hormone analogs in equine plasma. Drug Testing and Analysis. 2019. PMID 30489688. (accessed 2026-05-11)
[drugtest2021_review] Knoop A, Thomas A, Thevis M. Advances in the detection of growth hormone releasing hormone synthetic analogs. Drug Testing and Analysis. 2021. PMID 34665524. (accessed 2026-05-11)
[peptides_review_2026_sports]Safety and Efficacy of Approved and Unapproved Peptide Therapies for Musculoskeletal Injuries and Athletic Performance. Sports Medicine. 2026. PMID 41966639. (accessed 2026-05-11)
[peptides_review_2026_jspmpf]A new era of doping? Use of peptide and peptide-analog drugs in recreational and professional sport and bodybuilding: a critical review. The Journal of Sports Medicine and Physical Fitness. 2026. PMID 41880199. (accessed 2026-05-11)
[peptides_review_2026_ajsm]Injectable Peptide Therapy: A Primer for Orthopaedic and Sports Medicine Physicians. The American Journal of Sports Medicine. 2026. PMID 41476424. (accessed 2026-05-11)
[peptides_review_2026_gerontology]Therapeutic peptides in gerontology: mechanisms and applications for healthy aging. Frontiers in Aging. 2026. PMID 42021992. (accessed 2026-05-11)
[wada_prohibited_list] World Anti-Doping Agency. The Prohibited List — World Anti-Doping Code International Standard. WADA International Standard. 2025. https://www.wada-ama.org/en/prohibited-list (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)
How to access
How to Access CJC-1295
Physicians may submit patient-specific prescription requests for CJC-1295 for pharmacy review. Availability is determined case by case, and RonanRx is monitoring FDA's PCAC process and any subsequent agency action.
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