Peptides · Neuro & cognitive (under FDA review)

Selank

Tuftsin-analog peptide with physician-request review.

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Selank molecular structure (Tuftsin-derived heptapeptide)

Why this needs to be personal

Why Personalized Selank

The evidence base for Selank is concentrated in Russian-language clinical and mechanistic literature, including anxiety-related use abroad. That foreign experience has not produced an FDA-approved US product or a US prescribing standard.

Physicians may submit patient-specific prescription requests for Selank 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 is part of an evolving FDA review process for peptide-related bulk substances used in compounding.

A physician-submitted request is not the same as importing a foreign-labeled nasal spray or buying research peptide. Pharmacy review must decide whether the patient-specific request fits US compounding requirements and the evidence record.

In brief

Selank Explained

Selank is a short synthetic peptide developed by Russian researchers at the Institute of Molecular Genetics in Moscow 23. Its structure is based on a natural immune-system peptide called tuftsin, with three extra amino acids added at the end to slow how quickly the body breaks it down. In Russia, Selank is sold as a nasal spray for generalized anxiety disorder and adjustment-related anxiety 11. It is not approved by the FDA in the United States, and almost all of the published primary clinical literature is in Russian.

Selank 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.

At a glance

Quick Facts About Selank

Category
Synthetic heptapeptide; modified tuftsin analog (Thr-Lys-Pro-Arg-Pro-Gly-Pro)
Active ingredient
Selank (TP-7), a seven-residue peptide consisting of the tuftsin sequence Thr-Lys-Pro-Arg extended at the C-terminus with Pro-Gly-Pro for protease stability
FDA-approved branded forms
None. Selank is not an FDA-approved drug substance and has no approved branded product in the United States.
Russian regulatory status
Category 2, evolving FDA review process. Valid patient-specific prescription required; supporting clinical rationale may be requested.
Evidence posture
Emerging in Russian-language clinical literature; preclinical in the broader peer-reviewed PubMed-indexed corpus. Small Russian clinical reports describe anxiolytic activity in generalized anxiety disorder and anxiety-asthenic states; no FDA-recognized phase III program and minimal independent Western validation.
FDA-approval status
Category 2, evolving FDA review process. Valid patient-specific prescription required; supporting clinical rationale may be requested.
Compounded under
Physicians may submit patient-specific prescription requests for pharmacy review. Availability is determined case by case.
WADA status
Category 2, evolving FDA review process. Valid patient-specific prescription required; supporting clinical rationale may be requested.

Prescription review

Patient-Specific Prescription Only

Physicians may submit patient-specific prescription requests for Selank 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.
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Real medicine, not gray market

How This Differs from a Research-Use-Only Website

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 Selank?

Selank is a synthetic heptapeptide with the primary sequence Thr-Lys-Pro-Arg-Pro-Gly-Pro. The N-terminal four residues correspond to tuftsin, a tetrapeptide naturally produced by enzymatic cleavage of the immunoglobulin G heavy chain in the spleen, with documented immunomodulatory activity. The C-terminal tripeptide Pro-Gly-Pro is appended to tuftsin to slow proteolytic degradation in plasma and extend the in vivo half-life sufficient for pharmacologic activity after intranasal administration 2322.

Selank was developed in the 1990s at the Institute of Molecular Genetics of the Russian Academy of Sciences (Moscow), the same laboratory that developed the ACTH-derived neuropeptide Semax. The compound was registered in the Russian Federation as Selank Nasal Spray (also known by the research code TP-7) for use in generalized anxiety disorder, adjustment disorders, and related anxiety-asthenic conditions. It has no FDA approval and no equivalent regulatory registration in the United States, European Union, United Kingdom, Canada, Australia, or Japan 111628.

Selank is not available as an FDA-approved manufactured pharmaceutical product in the United States. Material sold under the Selank name in the US peptide marketplace is not subject to FDA bulk-drug-substance review, USP General Chapter <797> sterility standards, or pharmacist verification of identity, potency, or purity. The substance is currently on FDA's Category 2 list in the bulk-drug-substance review for use in 503A compounding 30.

How it works

How Selank Works

Class
Tuftsin-derived heptapeptide
First studied
1990s-2000s
Current status
Category 2, evolving FDA review process
Compounding category
Patient-specific 503A on physician request, pending broader FDA review

Selank's proposed anxiolytic mechanism is multimodal and incompletely characterized 1. The most consistently reported molecular interaction is inhibition of enkephalin-degrading enzymes, including aminopeptidase N, dipeptidyl peptidase III, neutral endopeptidase, and angiotensin-converting enzyme, in human plasma and rodent brain 25. By slowing the degradation of endogenous Met- and Leu-enkephalin, selank is hypothesized to indirectly amplify endogenous opioid tone and to produce anxiolytic effects partially reversed by naloxone in rodent studies.

GABAergic modulation has been characterized at the level of gene expression. Volkova et al. (2016) reported that selank administration affected the expression of genes involved in GABAergic neurotransmission, including GABA-A receptor subunits and glutamic acid decarboxylase, in mouse brain. Filatova et al. (2017) extended this finding in vitro in IMR-32 neuroblastoma cells, where GABA, selank, and olanzapine each altered the expression of GABAergic neurotransmission genes 1719. Povarov et al. (2017) reported electrophysiologic effects on spontaneous synaptic activity in rat hippocampal CA1 neurons 21.

Additional reported effects include modulation of serotonergic and dopaminergic systems 137; potentiation of diazepam-mediated anxiolysis in rodent unpredictable chronic mild stress 20; modulation of pro- and anti-inflammatory cytokine gene expression in spleen and brain 141527; and altered functional brain connectivity in a small EEG-based functional connectomic study 26. The Vyunova et al. (2018) review of selank-receptor molecular interactions integrates these strands but notes that no single canonical receptor target has been definitively established 23.

Research history

Selank Research History

Selank originated in the 1990s at the Institute of Molecular Genetics of the Russian Academy of Sciences (Moscow) as a tuftsin-analog peptide designed for anxiolytic activity with extended in vivo stability via the C-terminal Pro-Gly-Pro extension. Initial mechanistic work in the early 2000s characterized inhibition of enkephalin-degrading enzymes in human plasma as a candidate mechanism: Zozulya et al. (2001) reported the inhibitory effect of selank on enkephalin-degrading enzymes as a possible mechanism of its anxiolytic activity; Kost et al. (2001) reported that semax and selank inhibit enkephalin-degrading enzymes from human serum; and Sokolov et al. (2002) extended the finding in mice with different emotional and stress phenotypes 123. Zolotarev et al. (2004) used tritium-labeled Leu-enkephalin to characterize the inhibitory effect on plasma enkephalin-degrading enzymes 5.

Behavioral and physiologic characterization in rodents followed. Kozlovskii et al. (2002) reported optimizing effects on active avoidance conditioning; Semenova et al. (2005) characterized seasonal effects in hibernating animals; Meshavkin et al. (2006) demonstrated naloxone-blocked attenuation of apomorphine-induced hyperdopaminergic behaviors, supporting the endogenous-opioid mechanism 467. Pavlov et al. (2007) reported gastric mucosal homeostasis effects, Semenova et al. (2008) characterized correction of integrative brain activity and biogenic amine levels after antenatal hypoxia, and Sarkisova et al. (2008) reported effects on depression-like behavior in WAG/Rij and Wistar rats 8910.

Russian-language clinical reports emerged in the late 2000s. Zozulia et al. (2008) described efficacy and mechanisms in generalized anxiety disorder and neurasthenia; Uchakina et al. (2008) reported immunomodulatory effects in patients with anxiety-asthenic disorders; Medvedev et al. (2015) reported optimization of selank treatment in anxiety disorders 111216. Subsequent mechanistic and preclinical work in the 2010s and 2020s characterized GABAergic gene expression effects 1719, cytokine and inflammatory gene expression 141527, hippocampal synaptic activity 21, ethanol-induced memory protection 24, morphine withdrawal attenuation 29, and a small functional connectomic study 26. The Vyunova et al. (2018) review of selank biological activity at the molecular level 23 and the Siebert et al. (2017) review of tuftsin and its analogs 22 are the most-cited English-language summaries; the Doyno (2021) Journal of Clinical Pharmacology review surveys selank among GABA-acting agents available outside the United States 28.

Timeline

Selank Timeline

  1. 1990s Selank (TP-7) developed at the Institute of Molecular Genetics of the Russian Academy of Sciences (Moscow) as a tuftsin-analog peptide anxiolytic with C-terminal Pro-Gly-Pro extension for protease resistance 2322
  2. 2001 Zozulya et al 1. (Bull Exp Biol Med) report the inhibitory effect of selank on enkephalin-degrading enzymes as a candidate anxiolytic mechanism
  3. 2001 Kost et al 2. (Bioorg Khim) report that semax and selank inhibit enkephalin-degrading enzymes from human serum
  4. 2002 Sokolov et al 3. (Bull Exp Biol Med) characterize selank effects on behavior and plasma enkephalin-degrading enzyme activities in mice with different emotional and stress phenotypes
  5. 2002 Kozlovskii et al 4. report optimizing action of synthetic peptide selank on active avoidance conditioning in rats
  6. 2004 Zolotarev et al 5. (Bioorg Khim) use tritium-labeled Leu-enkephalin to characterize selank inhibition of plasma enkephalin-degrading enzymes
  7. 2005 Semenova et al 6. (Bull Exp Biol Med) report seasonal effects of selank on behavior in hibernating animals
  8. 2006 Meshavkin et al 7. (Bull Exp Biol Med) report naloxone-blocked attenuation of apomorphine-induced hyperdopaminergic behavior, endogenous-opioid mechanism evidence
  9. 2007 Pavlov et al 8. (Bull Exp Biol Med) report that selank and its metabolites maintain homeostasis in the gastric mucosa
  10. 2008 Semenova et al 9. (Neurosci Behav Physiol) report use of selank to correct integrative brain activity and biogenic amine levels after antenatal hypoxia in adult rats
  11. 2008 Sarkisova et al 10. report effects of selank on genetically-based and situation-provoked depression-like behavior in WAG/Rij and Wistar rats
  12. 2008 Zozulia et al 11. (Zh Nevrol Psikhiatr Im S S Korsakova) report efficacy and proposed mechanisms of selank in the therapy of generalized anxiety disorder and neurasthenia (Russian-language clinical report)
  13. 2008 Uchakina et al 12. report immunomodulatory effects of selank in patients with anxiety-asthenic disorders (Russian-language clinical report)
  14. 2009 Semenova et al 13. (Eksp Klin Farmakol) compare effects of selank and tuftsin on serotonin metabolism in rats pretreated with PCPA
  15. 2011 Kolomin et al 14. (Regul Pept) report expression of inflammation-related genes in mouse spleen under tuftsin analog selank
  16. 2014 Kolomin et al 15. (Mol Immunol) characterize temporary dynamics of inflammation-related gene expression under selank
  17. 2015 Medvedev et al 16. (Zh Nevrol Psikhiatr Im S S Korsakova) report optimization of the treatment of anxiety disorders with selank (Russian-language clinical report)
  18. 2016 Volkova et al 17. (Front Pharmacol) report that selank administration affects expression of genes involved in GABAergic neurotransmission
  19. 2016 Vasil'eva et al 18. (Eksp Klin Farmakol) compare pharmacological effects of selank after intranasal vs intraperitoneal administration to BALB/c and C57BL/6 mice
  20. 2017 Filatova et al 19. (Front Pharmacol) characterize effects of GABA, selank, and olanzapine on expression of GABAergic neurotransmission genes in IMR-32 neuroblastoma cells
  21. 2017 Kasian et al 20. (Behav Neurol) report that selank enhances the effect of diazepam in reducing anxiety in unpredictable chronic mild stress conditions in rats
  22. 2017 Povarov et al 21. (Bull Exp Biol Med) report effects of selank on spontaneous synaptic activity in rat hippocampal CA1 neurons
  23. 2017 Siebert et al 22. (Curr Med Chem) publish a review of tuftsin and its analogs including selank
  24. 2018 Vyunova et al 23. (Protein Pept Lett) review the molecular aspects of heptapeptide selank biological activity
  25. 2019 Kolik et al 24. (Bull Exp Biol Med) report that selank protects against ethanol-induced memory impairment by regulating hippocampal BDNF in rats
  26. 2020 Panikratova et al 26. (Dokl Biol Sci) report a functional connectomic study of selank and semax effects in humans
  27. 2021 Leonidovna et al 27. (Curr Rev Clin Exp Pharmacol) characterize the influence of selank on cytokine levels under 'social' stress conditions
  28. 2021 Doyno et al 28. (J Clin Pharmacol) publish an English-language review of sedative-hypnotic agents that impact GABA receptors, including selank among GABA-acting agents available outside the United States
  29. 2022 Konstantinopolsky et al 29. (Bull Exp Biol Med) report that selank attenuates aversive signs of morphine withdrawal in rats

Compounded use

Compounded Selank (503A)

Physicians may submit patient-specific prescription requests for pharmacy review. For Selank, 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 Selank is concentrated in Russian-language clinical and mechanistic literature, including anxiety-related use abroad. That foreign experience has not produced an FDA-approved US product or a US prescribing standard.

This ingredient is part of an evolving FDA review process. RonanRx is monitoring FDA's PCAC process and any subsequent agency action. This ingredient is part of an evolving FDA review process for peptide-related bulk substances used in compounding. Availability may change after FDA review, PCAC discussion, final agency action, or state-board guidance. For Selank, 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 Selank are reviewed before any preparation is made or released. A physician-submitted request is not the same as importing a foreign-labeled nasal spray or buying research peptide. Pharmacy review must decide whether the patient-specific request fits US compounding requirements and the evidence record.

Formulations and routes

Selank Formulations and Routes

FormConcentrationDescription
Intranasal solution (Russian manufactured product) 0.15% Selank in aqueous solution, delivered as nasal drops or spray Selank Nasal Spray (and nasal drops) is the form registered in the Russian Federation. The intranasal route is the studied delivery method in the Russian clinical literature and in the rodent pharmacology characterized by Vasil'eva et al. (2016) comparing intranasal and intraperitoneal administration.111618
Research-grade synthetic heptapeptide — Selank is available from peptide chemistry suppliers as a synthetic heptapeptide for research use only. It is not an FDA-approved drug substance, has no US-manufactured pharmaceutical product, and is on FDA's Category 2 list for 503A compounding.30

Dosing

Selank Dosing

No FDA-labeled or US-trial-validated dosing regimen exists for Selank. The Russian-language clinical literature describes intranasal administration of 0.15% Selank Nasal Spray at doses on the order of 900 µg per day (typically divided across several intranasal applications) for generalized anxiety disorder and adjustment disorder 30. These regimens come from Russian-language reports and are not the result of FDA-recognized phase III development 1116. Independent Western validation of these dose regimens is not available in the PubMed-indexed clinical literature.

RonanRx does not publish a consumer dosing schedule for Selank. Any request requires a valid patient-specific prescription, supporting clinical rationale, and pharmacist review. Route, strength, dosing interval, monitoring expectations, and dispensing quantity would be determined case by case from the prescriber's documentation and pharmacy feasibility review.

Doses listed are literature context, not patient instructions. Dosing decisions are made by the prescribing doctor and tailored to the individual patient.

Safety

Selank Safety

Safety overview

No FDA-reviewed human safety data are indexed for Selank. The Russian-language clinical literature describes Selank Nasal Spray as generally well tolerated in small open-label and single-center studies of generalized anxiety disorder, anxiety-asthenic states, and neurasthenia, with most reports characterizing adverse effects as mild and transient 111216. Independent multicenter randomized placebo-controlled safety data are not available in PubMed-indexed Western literature. Absence of acute toxicity in small Russian cohorts does not establish a safety profile equivalent to that supported by an FDA-recognized phase III program.

Because Selank is on FDA's Category 2 bulk-substance list for 503A compounding 30, FDA has identified either safety concerns or an information gap that must be evaluated 15. Clinicians considering Selank-containing preparations from non-503A sources should be aware that such products are not subject to FDA bulk-substance review, USP <797> sterility standards, or pharmacist verification of identity and potency. Availability through RonanRx is determined case by case after pharmacy review.

Preclinical rodent studies report short-term tolerability across a range of model systems, anxiolytic-like behavior, ethanol- and morphine-related models, hippocampal electrophysiology, hepatic morphology under chronic foot-shock stress, gastric mucosal homeostasis, and immune gene expression 25814. Longer-term toxicology, reproductive toxicity, carcinogenicity, and detailed human pharmacokinetic data are not available in the indexed literature. Selank is prohibited at all times by the World Anti-Doping Agency under S0 (non-approved substances) 28 2429.

Contraindications

Honest gap. No FDA-recognized human contraindications for Selank are indexed in the English-language literature. Selank is not an FDA-approved drug substance and has no US prescribing-information label. FDA Category 2 bulk-substance status precludes 503A compounding pending reclassification. Russian product labeling for Selank Nasal Spray exists but is not FDA-reviewed.

Searched: PubMed, FDA bulk-substance review documents on 2026-05-11 · terms selank AND (contraindication OR contraindicated OR hypersensitivity).

Drug interactions

Honest gap. No FDA-recognized human drug-interaction studies for Selank are indexed at the time of review. Preclinical rodent work has described pharmacodynamic interactions consistent with the proposed mechanism, including potentiation of diazepam-mediated anxiolysis in unpredictable chronic mild stress [kasian2017] and naloxone-reversible attenuation of apomorphine-induced hyperdopaminergic behaviors [meshavkin2006]. These are mechanistic findings in rodents and do not constitute validated human drug-interaction characterization.

Searched: PubMed, DailyMed on 2026-05-11 · terms selank AND (drug interaction OR pharmacokinetic interaction).

Adverse events

Honest gap. No FDA-recognized human adverse-event series for Selank are indexed in English-language PubMed. Russian-language clinical reports describe Selank Nasal Spray as generally well tolerated in small cohorts. Preclinical rodent studies report short-term tolerability without consistent organ-toxicity signals at experimental doses. Detailed human adverse-event characterization equivalent to an FDA-recognized phase III safety database is not available.

Searched: PubMed, FDA Adverse Event Reporting System (FAERS) on 2026-05-11 · terms selank AND (adverse event OR adverse effect OR side effect).

Monitoring

Monitoring Selank Therapy

No RonanRx-specific monitoring protocol has been established for Selank. 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

Selank in Special Populations

Pregnancy

No FDA-recognized use guidance for Selank in this population is established. Any patient-specific request would require prescriber rationale, patient-specific risk review, and pharmacist approval before dispensing.

Lactation

No FDA-recognized human lactation data for Selank are indexed 30.

Pediatric

No FDA-recognized pediatric data for Selank are indexed. Russian product labeling exists but is not FDA-reviewed 30.

Geriatric

No FDA-recognized geriatric data for Selank are indexed 30.

Renal impairment

No FDA-recognized renal-impairment data for Selank are indexed 30.

Hepatic impairment

No FDA-recognized hepatic-impairment data for Selank are indexed 30.

Evidence quality

Selank Evidence Quality

The Selank evidence base is dominated by Russian-language primary literature with minimal independent Western validation 212429. PubMed-indexed studies include: foundational mechanistic work on enkephalin-degrading enzymes; behavioral and electrophysiologic characterization in rodents; GABAergic gene expression studies in vitro and in mouse brain 1719; cytokine and inflammation gene expression studies 141527; route comparison (intranasal vs intraperitoneal) in mice 18; hepatic morphology under chronic stress 25; gastric mucosal homeostasis 8; serotonergic and dopaminergic mechanism work 137; a small functional connectomic study in humans 26; and small Russian-language clinical reports of efficacy in generalized anxiety disorder, neurasthenia, and anxiety-asthenic conditions 111216. Class reviews summarize the molecular pharmacology 2322 and place Selank among GABA-acting agents available outside the United States 28.

No FDA-recognized randomized multicenter placebo-controlled phase III efficacy program for Selank exists 123. No FDA-approved branded product exists. Independent Western replication of the Russian clinical findings is minimal. Selank is currently on FDA's Category 2 bulk-substance list for 503A compounding 30 1020. The mechanistic and preclinical evidence is internally consistent and biologically plausible, and the Russian clinical reports describe a generally favorable safety and tolerability profile in small cohorts, but the corpus does not meet the standard of evidence that supports FDA-recognized clinical claims 5. Any clinical claim about Selank in US patients extrapolates from foreign-language and preclinical-grade evidence and should be framed accordingly 469.

Major studies

Major Selank Clinical Studies

StudyDesignParticipantsDurationFinding
Zozulya et al. (2001, Bull Exp Biol Med), Enkephalin-degrading enzyme inhibition In vitro biochemical characterization of selank inhibition of enkephalin-degrading enzymes in human plasma — — Selank inhibits human plasma enkephalin-degrading enzymes; proposed as a candidate mechanism for the anxiolytic phenotype via prolongation of endogenous enkephalin half-life 1
Kost et al. (2001, Bioorg Khim), Semax and selank inhibit enkephalin-degrading enzymes In vitro biochemical characterization in human serum — — Both semax and selank inhibit enkephalin-degrading enzymes in human serum, consistent with a shared mechanistic feature of Russian-developed peptide neuromodulators 2
Sokolov et al. (2002, Bull Exp Biol Med), Behavior and plasma enkephalin-degrading enzymes Behavioral and biochemical study in mice with different emotional and stress reactivity phenotypes — — Selank alters behavior and plasma enkephalin-degrading enzyme activity differently across mouse strains, supporting strain-dependent expression of the proposed mechanism 3
Zozulia et al. (2008, Zh Nevrol Psikhiatr Im S S Korsakova), GAD and neurasthenia clinical report Russian-language clinical report describing efficacy and proposed mechanisms of action of selank in the therapy of generalized anxiety disorder and neurasthenia — — Open-label and single-center observations of anxiolytic activity in GAD and neurasthenia with a generally favorable tolerability profile; not an FDA-recognized phase III program 11
Uchakina et al. (2008), Immunomodulatory effects in anxiety-asthenic disorders Russian-language clinical report in patients with anxiety-asthenic disorders — — Selank exhibited immunomodulatory effects (cytokine profile changes) alongside reported anxiolytic activity in the studied cohort 12
Medvedev et al. (2015, Zh Nevrol Psikhiatr Im S S Korsakova), Optimization of selank in anxiety disorders Russian-language clinical report on optimization of selank treatment in anxiety disorders — — Open-label clinical observations of dosing strategy and response in anxiety disorders; the study describes treatment optimization in a Russian clinical context 16
Volkova et al. (2016, Front Pharmacol), GABAergic gene expression Gene-expression study of selank effects on transcripts involved in GABAergic neurotransmission — — Selank administration altered expression of GABA-A receptor subunit and glutamic acid decarboxylase genes; mechanistic link to GABAergic anxiolysis 17
Filatova et al. (2017, Front Pharmacol), GABA, selank, olanzapine in IMR-32 cells In vitro gene-expression study in IMR-32 neuroblastoma cells — — GABA, selank, and olanzapine each altered the expression of genes involved in GABAergic neurotransmission, supporting a transcriptional component of selank's GABAergic effect 19
Kasian et al. (2017, Behav Neurol), Selank potentiates diazepam in UCMS Rodent unpredictable chronic mild stress (UCMS) model with co-administration of selank and diazepam — — Selank enhanced the anxiolytic effect of diazepam in rats subjected to unpredictable chronic mild stress, supporting a GABAergic pharmacodynamic interaction 20
Vyunova et al. (2018, Protein Pept Lett), Molecular biology of selank activity Narrative review of the molecular aspects of heptapeptide selank biological activity — — Integrates the molecular pharmacology evidence, enkephalin-degrading enzyme inhibition, GABAergic transcriptional effects, serotonergic/dopaminergic modulation, cytokine modulation, into a coherent class summary; no single canonical receptor target is established 23
Doyno et al. (2021, J Clin Pharmacol), GABA-acting agents review Narrative review of sedative-hypnotic agents that impact GABA receptors, including selank among GABA-acting agents available outside the United States — — Surveys the English-language pharmacology of selank, characterizes the Russian regulatory context, and notes WADA prohibition under S0 (non-approved substances); identifies selank as not FDA-approved and not subject to FDA evidence review 28
Siebert et al. (2017, Curr Med Chem), Tuftsin and analogs review Narrative review of tuftsin and its analog peptides including selank — — Places selank in the tuftsin-analog class with the C-terminal Pro-Gly-Pro extension as the structural rationale for in vivo stability; summarizes immunomodulatory and CNS activity 22
Kolik et al. (2019, Bull Exp Biol Med), Ethanol memory protection Rodent ethanol-induced memory impairment model with selank intervention — — Selank protected against ethanol-induced memory impairment with concurrent regulation of hippocampal BDNF content, supporting a neuroprotective component of the mechanism 24
Konstantinopolsky et al. (2022, Bull Exp Biol Med), Morphine withdrawal Rodent model of morphine withdrawal with selank intervention — — Selank attenuated aversive signs of morphine withdrawal in rats, consistent with the endogenous-opioid component of the proposed mechanism 29
Panikratova et al. (2020, Dokl Biol Sci), Functional connectomic study Small functional connectomic approach to studying selank and semax effects in humans — — Reported alterations in functional brain connectivity patterns associated with selank administration; small exploratory study, not an efficacy trial 26
Vasil'eva et al. (2016, Eksp Klin Farmakol), Intranasal vs intraperitoneal route Pharmacological comparison of selank effects after intranasal vs intraperitoneal administration in BALB/c and C57BL/6 mice — — Both routes produced biological activity with route- and strain-dependent differences; supports intranasal delivery as a viable administration route for CNS effects 18

Pharmacology

Selank Pharmacokinetics & Pharmacodynamics

Pharmacokinetics

No FDA-recognized human pharmacokinetic studies of Selank are indexed. The C-terminal Pro-Gly-Pro extension was incorporated specifically to slow proteolytic degradation in plasma relative to the parent tuftsin tetrapeptide, and rodent route-comparison work has characterized intranasal vs intraperitoneal administration with respect to biological activity rather than detailed PK parameters 1823. Selank is reported to cross into the central nervous system after intranasal administration, with rodent studies and a small human functional connectomic study consistent with CNS pharmacodynamic effects 26.

Validated human PK parameters, including Cmax, Tmax, bioavailability, terminal half-life, and volume of distribution, are not available in PubMed-indexed Western literature at the time of review.

Pharmacodynamics

Reported pharmacodynamic endpoints in preclinical studies include anxiolytic-like behavior in rodent models (elevated plus maze, open field, social interaction, UCMS-induced anxiety) 20; ethanol-induced memory impairment with hippocampal BDNF as a molecular readout 24; aversive signs of morphine withdrawal 29; expression of GABAergic-neurotransmission genes in vitro and in vivo 1719; expression of pro- and anti-inflammatory cytokines in spleen and brain 141527; serotonergic and dopaminergic neurochemistry 137; and electrophysiology of hippocampal CA1 synaptic activity 21. In small Russian clinical reports the principal endpoint is clinician-rated anxiety severity in generalized anxiety disorder and anxiety-asthenic conditions 1116. No validated US clinical pharmacodynamic biomarker for Selank exists.

RonanRx operations

Selank Compounding & Operations

503A compounding

Physicians may submit patient-specific prescription requests for pharmacy review. For Selank, 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 Selank is concentrated in Russian-language clinical and mechanistic literature, including anxiety-related use abroad. That foreign experience has not produced an FDA-approved US product or a US prescribing standard.

This ingredient is part of an evolving FDA review process. RonanRx is monitoring FDA's PCAC process and any subsequent agency action. This ingredient is part of an evolving FDA review process for peptide-related bulk substances used in compounding. Availability may change after FDA review, PCAC discussion, final agency action, or state-board guidance. For Selank, 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 Selank are reviewed before any preparation is made or released. A physician-submitted request is not the same as importing a foreign-labeled nasal spray or buying research peptide. Pharmacy review must decide whether the patient-specific request fits US compounding requirements and the evidence record.

Pharmacist review

For Selank, 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 Selank 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 313332.

Cold chain

If a Selank 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 Selank

Can physicians request Selank 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.3031

What is Selank?

Selank (TP-7) is a synthetic heptapeptide with the sequence Thr-Lys-Pro-Arg-Pro-Gly-Pro 23. The N-terminal four residues correspond to tuftsin, a natural immunomodulatory tetrapeptide, and the C-terminal Pro-Gly-Pro extension confers protease resistance 22. It was developed in the 1990s at the Institute of Molecular Genetics of the Russian Academy of Sciences (Moscow) as an anxiolytic peptide.

Is Selank approved anywhere?

Selank is registered in the Russian Federation as Selank Nasal Spray for generalized anxiety disorder and adjustment-related anxiety 111628. It is not approved by the FDA in the United States and has no equivalent registration in the European Union, United Kingdom, Canada, Australia, or Japan.

What does the published evidence look like?

The primary clinical literature is almost entirely Russian-language: small open-label or single-center reports in generalized anxiety disorder, neurasthenia, and anxiety-asthenic conditions 111216. The preclinical literature is more substantial and includes mechanistic work on enkephalin-degrading enzymes, GABAergic gene expression, serotonergic and dopaminergic modulation, and cytokine and inflammation gene expression. The English-language review by Doyno (2021) is the most-cited Western summary 28. There is no FDA-recognized phase III program 23.

Can physicians request Selank 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.3031

What about athletes and WADA?

Selank is prohibited at all times by the World Anti-Doping Agency under category S0 (non-approved substances). Athletes subject to the WADA Code must not use Selank in or out of competition 28.

Could Selank move from FDA Category 2 to Category 1?

Possibly, if the agency receives sufficient evidence to evaluate safety and clinical utility in a US regulatory framework. The Category 2 designation reflects FDA's current assessment of the evidence base and is not a permanent finding. RonanRx will track future bulk-substance review revisions and will reconsider compounding only if and when Selank is moved to Category 1 30.

Clinician resource

Download the Selank 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.

Download information packet ↓

References

References

  1. [zozulya2001] Zozulya AA, Neznamov GG, Siuniakov TS, Kost NV, Gabaeva MV, Sokolov OY, Serebriakova EV, Siranchieva OA, Andriushenko AV, Telesheva ES, Siuniakov SA, Smulevich AB, Miasoedov NF, Seredenin SB. The inhibitory effect of Selank on enkephalin-degrading enzymes as a possible mechanism of its anxiolytic activity. Bulletin of Experimental Biology and Medicine. 2001. PMID 11550013. (accessed 2026-05-11)
  2. [kost2001] Kost NV, Sokolov OY, Gabaeva MV, Grivennikov IA, Andreeva LA, Miasoedov NF, Zozulya AA. [Semax and selank inhibit the enkephalin-degrading enzymes from human serum]]. Bioorganicheskaia Khimiia. 2001. PMID 11443939. (accessed 2026-05-11)
  3. [sokolov2002] Sokolov OY, Meshavkin VK, Kost NV, Zozulya AA. Effects of Selank on behavioral reactions and activities of plasma enkephalin-degrading enzymes in mice with different phenotypes of emotional and stress reactions. Bulletin of Experimental Biology and Medicine. 2002. PMID 12432865. (accessed 2026-05-11)
  4. [kozlovskii2002] Kozlovskiĭ II, Danchev ND. [Optimizing action of synthetic peptide Selank on active avoidance conditioning test in rats]. Zhurnal Vysshei Nervnoi Deiatelnosti Imeni I P Pavlova. 2002. PMID 12449836. (accessed 2026-05-11)
  5. [zolotarev2004] Zolotarev IuA, Dadayan AK, Kost NV, Voevodina ME, Sokolov OY, Andreeva LA, Myasoedov NF. [Leu-enkephalin homogeneously labeled with tritium in studying the Selank inhibiting effect on the enkephalin-degrading enzymes of human plasma]. Bioorganicheskaia Khimiia. 2004. PMID 15344652. (accessed 2026-05-11)
  6. [semenova2005] Semenova TP, Kozlovskaia MM, Zuikov AV, Kozlovskiĭ II, Andreeva LA. Seasonal effects of Selank on the behavior of hibernating animals. Bulletin of Experimental Biology and Medicine. 2005. PMID 16848230. (accessed 2026-05-11)
  7. [meshavkin2006] Meshavkin VK, Kost NV, Kozik VS, Sokolov OY, Zozulya AA. Naloxone-blocked depriming effect of anxiolytic selank on apomorphine-induced behavioral manifestations of hyperfunction of dopamine system. Bulletin of Experimental Biology and Medicine. 2006. PMID 17415472. (accessed 2026-05-11)
  8. [pavlov2007] Pavlov TS, Sanzhieva LTs, Samonina GE, Andreeva LA, Myasoedov NF. Selank and its metabolites maintain homeostasis in the gastric mucosa. Bulletin of Experimental Biology and Medicine. 2007. PMID 18019011. (accessed 2026-05-11)
  9. [semenova2008] Semenova TP, Kozlovskaia MM, Zakharova NM, Kozlovskiĭ II. Use of Selank to correct measures of integrative brain activity and biogenic amine levels in adult rats resulting from antenatal hypoxia. Neuroscience and Behavioral Physiology. 2008. PMID 18197389. (accessed 2026-05-11)
  10. [sarkisova2008] Sarkisova KIu, Kozlovskaia MM, Kozlovskiĭ II. [Effects of heptapeptide selank on genetically-based and situation-provoked symptoms of depression in behavior in WAG/Rij and Wistar rats, and in BALB/c mice]. Zhurnal Vysshei Nervnoi Deiatelnosti Imeni I P Pavlova. 2008. PMID 18661785. (accessed 2026-05-11)
  11. [zozulia2008] Zozulia AA, Neznamov GG, Siuniakov TS, Kost NV, Gabaeva MV, Sokolov OY, Serebriakova EV, Siranchieva OA, Andriushenko AV, Telesheva ES, Siuniakov SA, Smulevich AB, Miasoedov NF, Seredenin SB. [Efficacy and possible mechanisms of action of a new peptide anxiolytic selank in the therapy of generalized anxiety disorders and neurasthenia]. Zhurnal Nevrologii i Psikhiatrii Imeni S S Korsakova. 2008. PMID 18454096. (accessed 2026-05-11)
  12. [uchakina2008] Uchakina ON, Uchakin PN, Miasoedov NF, Andreeva LA, Shcherbenko VE, Mezentseva MV, Gabaeva MV, Sokolov OY, Zozulya AA, Ershov FI. [Immunomodulatory effects of selank in patients with anxiety-asthenic disorders]. Zhurnal Nevrologii i Psikhiatrii Imeni S S Korsakova. 2008. PMID 18577961. (accessed 2026-05-11)
  13. [semenova2009] Semenova TP, Kozlovskaia MM, Zakharova NM, Kozlovskiĭ II, Andreeva LA. [Comparison of the effects of selank and tuftsin on the metabolism of serotonin in the brain of rats pretreated with PCPA]. Eksperimental'naia i Klinicheskaia Farmakologiia. 2009. PMID 19803361. (accessed 2026-05-11)
  14. [kolomin2011] Kolomin T, Shadrina M, Agniullin Y, Shram S, Slominsky P, Limborska S, Myasoedov N. Expression of inflammation-related genes in mouse spleen under tuftsin analog Selank. Regulatory Peptides. 2011. PMID 21609736. (accessed 2026-05-11)
  15. [kolomin2014] Kolomin T, Morozova M, Volkova A, Shadrina M, Andreeva L, Slominsky P, Limborska S, Myasoedov N. The temporary dynamics of inflammation-related genes expression under tuftsin analog Selank action. Molecular Immunology. 2014. PMID 24291245. (accessed 2026-05-11)
  16. [medvedev2015] Medvedev VE, Tereshchenko OY, Israelyan AY, Chobanu IK, Kost NV, Andryushchenko AV. [Optimization of the treatment of anxiety disorders with selank]. Zhurnal Nevrologii i Psikhiatrii Imeni S S Korsakova. 2015. PMID 26356395. (accessed 2026-05-11)
  17. [volkova2016] Volkova A, Shadrina M, Kolomin T, Andreeva L, Limborska S, Myasoedov N, Slominsky P. Selank Administration Affects the Expression of Some Genes Involved in GABAergic Neurotransmission. Frontiers in Pharmacology. 2016. PMID 26924987. (accessed 2026-05-11)
  18. [vasileva2016] Vasil'eva EV, Kondrakhin EA, Salimov RM, Kovalev GI. [COMPARISON OF PHARMACOLOGICAL EFFECTS OF HEPTAPEPTIDE SELANK AFTER INTRANASAL AND INTRAPERITONEAL ADMINISTRATION TO BALB/c AND C57BL/6 MICE.]. Eksperimental'naia i Klinicheskaia Farmakologiia. 2016. PMID 29787664. (accessed 2026-05-11)
  19. [filatova2017] Filatova E, Kasian A, Kolomin T, Rybalkina E, Alieva A, Andreeva L, Limborska S, Myasoedov N, Pavlova G, Slominsky P, Shadrina M. GABA, Selank, and Olanzapine Affect the Expression of Genes Involved in GABAergic Neurotransmission in IMR-32 Cells. Frontiers in Pharmacology. 2017. PMID 28293190. (accessed 2026-05-11)
  20. [kasian2017] Kasian A, Kolomin T, Andreeva L, Bondarenko E, Myasoedov N, Slominsky P, Shadrina M. Peptide Selank Enhances the Effect of Diazepam in Reducing Anxiety in Unpredictable Chronic Mild Stress Conditions in Rats. Behavioural Neurology. 2017. PMID 28280289. (accessed 2026-05-11)
  21. [povarov2017] Povarov IS, Kondratenko RV, Derevyagin VI, Ostrovskaya RU, Skrebitsky VG. Effect of Selank on Spontaneous Synaptic Activity of Rat Hippocampal CA1 Neurons. Bulletin of Experimental Biology and Medicine. 2017. PMID 28361410. (accessed 2026-05-11)
  22. [siebert2017] Siebert A, Gensicka-Kowalewska M, Cholewinski G, Dzierzbicka K. Tuftsin - Properties and Analogs. Current Medicinal Chemistry. 2017. PMID 28745220. (accessed 2026-05-11)
  23. [vyunova2018] Vyunova TV, Andreeva LA, Shevchenko KV, Myasoedov NF. Peptide-based Anxiolytics: The Molecular Aspects of Heptapeptide Selank Biological Activity. Protein and Peptide Letters. 2018. PMID 30255741. (accessed 2026-05-11)
  24. [kolik2019] Kolik LG, Nadorova AV, Antipova TA, Kruglov SV, Kudrin VS, Durnev AD. Selank, Peptide Analogue of Tuftsin, Protects Against Ethanol-Induced Memory Impairment by Regulating of BDNF Content in the Hippocampus and Prefrontal Cortex in Rats. Bulletin of Experimental Biology and Medicine. 2019. PMID 31625062. (accessed 2026-05-11)
  25. [fomenko2019] Fomenko EV, Chernukha IM, Kotenkova EA, Fedulova LV, Korotkevich OS. Effect of Selank on Morphological Parameters of Rat Liver in Chronic Foot-Shock Stress. Bulletin of Experimental Biology and Medicine. 2019. PMID 31243679. (accessed 2026-05-11)
  26. [panikratova2020] Panikratova YR, Tomyshev AS, Abdullina EG, Rodionov GI, Andryushchenko AV, Lebedeva IS, Kost NV. Functional Connectomic Approach to Studying Selank and Semax Effects. Doklady Biological Sciences. 2020. PMID 32342318. (accessed 2026-05-11)
  27. [leonidovna2021] Leonidovna YA, Vyacheslavovna VT, Igorevna LD, Vladimirovna KK, Aleksandrovna AL, Fedorovich MN. The Influence of Selank on the Level of Cytokines Under the Conditions of "Social" Stress. Current Reviews in Clinical and Experimental Pharmacology. 2021. PMID 32621722. (accessed 2026-05-11)
  28. [doyno2021] Doyno CR, White CM. Sedative-Hypnotic Agents That Impact Gamma-Aminobutyric Acid Receptors: Focus on Flunitrazepam, Gamma-Hydroxybutyric Acid, Phenibut, and Selank. Journal of Clinical Pharmacology. 2021. PMID 34396551. (accessed 2026-05-11)
  29. [konstantinopolsky2022] Konstantinopolsky MA, Kolik LG, Durnev AD. Selank, a Peptide Analog of Tuftsin, Attenuates Aversive Signs of Morphine Withdrawal in Rats. Bulletin of Experimental Biology and Medicine. 2022. PMID 36322304. (accessed 2026-05-11)
  30. [fda_cat2_peptides] U.S. Food and Drug Administration. Bulk Drug Substances Nominated for Use in Compounding Under Section 503A of the FD&C Act — Category 2 List. FDA Drug Compounding. 2024. https://www.fda.gov/drugs/human-drug-compounding/bulk-drug-substances-used-compounding-under-section-503a-fdc-act (accessed 2026-05-11)
  31. [fda503a] U.S. Food and Drug Administration. Compounding Laws and Policies — Section 503A of the Federal Food, Drug, and Cosmetic Act. FDA Drug Compounding. 2024. https://www.fda.gov/drugs/human-drug-compounding/compounding-laws-and-policies (accessed 2026-05-11)
  32. [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)
  33. [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)

How to access

How to Access Selank

Physicians may submit patient-specific prescription requests for Selank 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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Patient without a doctor

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