CognitiveNot approvedEvidence tier: Human Observational

Selank

Last updated October 21, 2026. Approval line checked October 21, 2026. Compounding sources checked October 10, 2026.

FDA status

Not approved

Not approved. This record is not an FDA-approved drug product. Approval, where it exists, is specific to a drug product, indication, and route.

FDA primary source on file

Evidence tier

Human Observational. The tier is the highest indexed study type. It is not a safety rating and it is not an FDA approval. Confidence score 3/5. 125 PubMed citations indexed.

Selank in the literature

Synthetic heptapeptide analog of tuftsin modulating GABA-A receptor sensitivity and increasing BDNF expression; approved as nootropic/anxiolytic in Russia.

What the literature studies

Anxiolytic & Cognitive Enhancement

Evidence tier

Human Observational

Compounding record

Status not verified

Confidence
3/5

Regulatory record

Status not verified. Status not verified. Exact FDA substance context: Selank acetate: Nomination withdrawn. The record does not specify acetate; do not extrapolate to other salts or analogs. Previously in Category 2; FDA still identifies potential significant safety risks for the named withdrawn substance. Withdrawal is not FDA approval or a determination of safety or compounding eligibility. Research information is not evidence of FDA approval. Approval, where applicable, is specific to a drug product, indication and route.

Regulatory source checked October 10, 2026. This compounding label is separate from the approval line above.

FDA primary source 1 FDA primary source 2

limited Western RCT data.

Questions

Educational only. Not medical advice. This page does not give doses or sourcing. See the medical and editorial disclaimer.

Short answer

Selank is a synthetic tuftsin analog studied in small Russian trials for anxiety and neurasthenia; it is not FDA-approved, FDA lists selank acetate among nominated-but-withdrawn bulk substances with insufficient human safety information, and there are no English-language placebo-controlled RCTs establishing efficacy.

What it is

Synthetic heptapeptide derived from the immune peptide tuftsin (with a Pro-Gly-Pro C-terminal extension in the marketed Russian construct) [R1].

Legal / FDA status (as of Oct 27 2026)

Not FDA-approved. FDA lists "Selank acetate (TP-7)" under bulk substances nominated but withdrawn, stating compounded products may pose immunogenicity risk from aggregation/impurities and that FDA "lacks important information regarding any safety issues raised by selank acetate administered to humans" [FDA-RISK]. Selank was not on the Jul 23-24 2026 PCAC agenda that covered several other peptides [FDA-PCAC]. Russian registration, where claimed in secondary reviews, is not US approval.

Human evidence

  • Comparative study (n=62) of selank vs medazepam in generalized anxiety disorder and neurasthenia: authors reported similar anxiolytic effects with additional antiasthenic/psychostimulant effects for selank; psychometric scales and serum enkephalin half-life were measured [R1]. Published in Russian.
  • Additional Russian comparative reports (2014-2015) versus benzodiazepines appear in the same journal family; no English-language multicenter placebo-controlled RCT was identified on PubMed [R1].
  • No ClinicalTrials.gov interventional trials under the name Selank were identified as of this check.

Animal / lab evidence

Rodent pharmacology includes GABAergic interaction studies (e.g., with diazepam) [secondary reviews]. Animal anxiolysis is not evidence of clinical benefit in people.

Risks and unknowns

FDA: insufficient human safety information; immunogenicity/impurity concerns for compounded forms [FDA-RISK]. Gray-market nasal sprays and injectables: identity/purity unverified. Russian trial literature has not been independently replicated in English-language journals.

What's coming

No US NDA path identified. Not on the near-term PCAC calendar items publicly listed for selank specifically [FDA-PCAC]. Watch interim peptide compounding policy text when published [OIRA].

Sources

  1. [R1] Zozulya AA et al. Efficacy and possible mechanisms of action of a new peptide anxiolytic selank in the therapy of generalized anxiety disorders and neurasthenia. Zh Nevrol Psikhiatr Im S S Korsakova 2008. PMID 18454096
  2. [FDA-RISK] FDA. Certain Bulk Drug Substances for Use in Compounding that May Present Significant Safety Risks (Selank acetate entry). https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks
  3. [FDA-PCAC] FDA. July 23-24, 2026 Meeting of the Pharmacy Compounding Advisory Committee. https://www.fda.gov/advisory-committees/advisory-committee-calendar/july-23-24-2026-meeting-pharmacy-compounding-advisory-committee-07232026
  4. [OIRA] OIRA. Pending EO 12866 Review, RIN 0910-ZD94. https://www.reginfo.gov/public/do/eoDetails?rrid=1568964

Last checked 2026-10-27

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