Selank

Grade B: Human evidence, not approved for this use

TL;DR: Selank is a synthetic heptapeptide analog of the endogenous immunomodulatory peptide tuftsin, developed in Russia by the Institute of Molecular Genetics and licensed there as an anxiolytic nasal spray. Human RCT evidence exists but is entirely from small, single-center Russian studies, conducted outside the regulatory standards (Good Clinical Practice frameworks) required by the FDA or EMA for drug approval. Published trials report reductions in anxiety measures in generalized anxiety disorder and neurasthenia, and comparison studies suggest tolerability comparable to benzodiazepines for some anxiety endpoints. These results are consistent with a Grade B designation but carry a significant evidence-quality caveat: none of the trials meet Western regulatory evidentiary standards, sample sizes are small, and independent replication outside Russia has not been published. The compound should not be presented as having an established anxiolytic efficacy profile equivalent to approved Western therapeutics.

Key Takeaways

Grade B: Human evidence, not approved for this use
Not FDA approved: Not FDA-approved for any indication; approved in Russia as a nasal spray anxiolytic; removed from FDA Category 2 compounding restriction April 2026, with PCAC review pending July 2026.
Compounding: The nomination to add Selank to the FDA 503A or 503B bulk-substances list was withdrawn; it is not on an active FDA bulks list and is not eligible for routine pharmacy compounding.

Selank chemical structure — Structure via PubChem CID 11765600

Mechanism

Selank inhibits enkephalin-degrading peptidases, prolonging the activity of endogenous enkephalins, while also acting as a tuftsin analog to modulate innate immune cytokine responses, producing anxiolytic and possible nootropic effects through convergent neuroimmune pathways.

Evidence

Selank is a synthetic heptapeptide analog of the endogenous immunomodulatory peptide tuftsin, developed in Russia by the Institute of Molecular Genetics and licensed there as an anxiolytic nasal spray. Human RCT evidence exists but is entirely from small, single-center Russian studies, conducted outside the regulatory standards (Good Clinical Practice frameworks) required by the FDA or EMA for drug approval. Published trials report reductions in anxiety measures in generalized anxiety disorder and neurasthenia, and comparison studies suggest tolerability comparable to benzodiazepines for some anxiety endpoints. These results are consistent with a Grade B designation but carry a significant evidence-quality caveat: none of the trials meet Western regulatory evidentiary standards, sample sizes are small, and independent replication outside Russia has not been published. The compound should not be presented as having an established anxiolytic efficacy profile equivalent to approved Western therapeutics.

Safety and risks

Controlled human safety data from US or EU regulatory-grade trials do not exist. Selank modulates the opioid/enkephalin system by inhibiting enkephalin-degrading enzymes (confirmed in published research, PMID 18454096), which extends the half-life of endogenous opioid peptides involved in mood, pain, and stress regulation; the clinical implications of chronic enkephalin-system modulation in humans are not characterized. Selank also retains the immunomodulatory properties of its parent peptide tuftsin, with documented effects on cytokine profiles (IL-6, TNF-alpha suppression); the safety consequences of sustained immune modulation, particularly in patients with autoimmune conditions, infections, or malignancies, are unknown. Adverse effects reported in Russian trials are mild (nasal irritation from the spray, transient headache, dizziness), but these trials were not powered to detect rare or delayed adverse events. Because evidence comes exclusively from Russian academic settings, publication bias and non-independent oversight cannot be ruled out. The risk profile for Western populations remains uncharacterized.

Interactions

Demonstrated enhancement of diazepam's anxiolytic effect in preclinical models; concurrent use with benzodiazepines or other GABAergic agents may produce additive CNS depression, though this has not been evaluated in human trials. Immunomodulatory properties suggest caution with immunosuppressive or immunostimulatory drugs.

Federal compounding status

Nomination withdrawn (was Category 2) as of 2026-06-02.

This substance was nominated for the FDA 503A or 503B bulk-substances list and previously sat in the Category 2 (significant safety risk) group; the nomination was later withdrawn, so it is not on an active FDA bulks list and is not eligible for routine pharmacy compounding. FDA source

Federal status only, from public FDA records. State pharmacy-board rules vary and are not covered here. This is regulatory reporting, not legal advice. All compounds.

Compounding legality

The nomination to add Selank to the FDA 503A or 503B bulk-substances list was withdrawn; it is not on an active FDA bulks list and is not eligible for routine pharmacy compounding.

Sources

Selank is Not FDA approved. PeptideGrids presents evidence and regulatory status for informational purposes only. We do not sell, supply, source, or help anyone obtain this compound, and we provide no dosing or administration guidance. This is not medical advice; consult a licensed clinician. Full disclaimer.

Last reviewed June 1, 2026 by PeptideGrids editorial team (independently audited).