Peptide evidence preview
Selank: Legal Status, Safety, and Human Evidence
Selank is an unapproved, tuftsin-derived peptide registered in Russia. What its small human studies found, what is only preclinical, and its legal status.
Also known as: Selanc · TP-7 · N-acetyl-Selank · Selank acetate
Direct answer
Direct answer
Selank is a synthetic peptide derived from tuftsin and developed in Russia. Limited human studies report anxiety-related and neuroimaging signals, but the evidence base is small and geographically concentrated; most proposed mechanisms are preclinical. It is not approved by the U.S. Food and Drug Administration or Health Canada.
Status at a glance
As of October 27, 2026
- United States (FDA)
- Not approved. FDA has never reviewed Selank for safety or efficacy. U.S. Food and Drug Administration
- FDA compounding
- Selank acetate (TP-7) is listed as nominated but withdrawn (previously in category 2) among bulk substances that may present significant safety risks. FDA cites a possible immunogenicity risk and says it lacks important safety information. U.S. Food and Drug Administration
- Canada (Health Canada)
- No authorized drug product in Health Canada's Drug Product Database. Health Canada
- Russia
- Registered as an anxiolytic in the Russian Federation. PubMed
- Sport (WADA)
- Not named on the 2026 Prohibited List. Section S0 prohibits at all times any substance not addressed elsewhere on the List that has no current approval by any government health regulator for human therapeutic use. Athletes should ask their anti-doping organization how this applies. World Anti-Doping Agency
WADA updates its Prohibited List every January; the 2027 List takes effect January 1, 2027. Athletes should check the list in force and their own federation's rules.
Public Evidence Passport preview
Limited human signals + mostly preclinical mechanism
Small human studies report signals, but the body of clinical evidence lacks large, independent, multicenter placebo-controlled trials. Most mechanistic claims remain laboratory or animal findings.
- Strongest source tier
- Tier 3 — small comparative or placebo-controlled human study
- Editorial review
- October 27, 2026
- Source coverage
- 8 inspectable records in this public preview
What matters
- Proposed GABAergic, neurotrophic, monoaminergic, and immune mechanisms are mostly preclinical.
- The most cited clinical comparison was small, single-country, and not placebo-controlled.
- An acute neuroimaging study found connectivity changes, not a demonstrated clinical or cognitive benefit.
- Long-term safety and interactions with other central nervous system agents are not adequately characterized.
Has Selank been studied in humans?
Yes, but the clinical evidence is limited. One published comparison included 62 patients and used an active drug comparator. That is a narrower basis than large, independently replicated placebo-controlled trials.
| Source | Study design | Finding | Limit |
|---|---|---|---|
| Zozulia et al., 2008 | Comparative study of 62 patients with generalized anxiety disorder or neurasthenia: 30 received Selank and 32 medazepam. | The abstract reports similar anxiety-related effects in the two groups. | The comparator was an active drug, not placebo. This small study does not establish broad cognitive benefits or long-term safety. |
Source notes updated . Added the clinical comparison's group sizes and comparator, with a direct explanation of what that design leaves unanswered.
What Selank is
Selank is a synthetic heptapeptide derived from the immunomodulatory peptide tuftsin. It was developed in Russia and is registered there as an anxiolytic; its clinical studies there enrolled people with generalized anxiety disorder or neurasthenia. Registration in one jurisdiction does not establish approval or evidence acceptance elsewhere.
Proposed mechanisms
Laboratory and animal studies describe indirect interaction with GABA-related signaling, changes in monoamine metabolism, neurotrophic signaling, enkephalin biology, and immune pathways. One cell study found no direct effect from Selank alone on the measured GABAergic gene-expression markers but reported modulation in the presence of GABA.
These findings help form hypotheses. They do not establish a primary human mechanism or a clinical outcome.
What the human evidence shows
A Russian study of 62 patients with generalized anxiety disorder or neurasthenia compared Selank with the benzodiazepine medazepam. It reported similar anxiety effects for both, plus antiasthenic effects with Selank. It had no placebo group and has limited external validity. A separate placebo-controlled acute neuroimaging study in 52 healthy volunteers reported changes in functional connectivity involving the amygdala and temporal regions.
A brain-imaging signal is not the same as improved anxiety, cognition, or daily function. Large independent trials and systematic clinical syntheses are absent.
Safety and uncertainty
Available reports suggest low acute toxicity, but the evidence is limited and does not establish long-term safety. Potential interactions with sedating, GABA-active, serotonergic, opioid, or other psychiatric medicines have not been adequately studied in humans.
Selank is not approved by the U.S. Food and Drug Administration or Health Canada. Questions about an individual’s symptoms, medicines, or suitability require a licensed healthcare provider.
Regulatory and sport context
Selank has never been reviewed by the FDA for safety or efficacy. FDA lists selank acetate among bulk substances nominated for compounding that were placed in category 2, which flags possible significant safety risks, and then withdrawn by the nominators. Health Canada’s Drug Product Database lists no product containing it. In Russia it is registered as an anxiolytic. It is not named on the 2026 WADA Prohibited List.
Common questions
Is Selank FDA approved?
No. Selank is not approved by the FDA and has never been reviewed by it for safety or efficacy. FDA lists selank acetate among bulk substances nominated for compounding that were placed in category 2, which flags possible significant safety risks, and then withdrawn by the nominators.
Sources:Certain bulk drug substances for use in compounding that may present significant safety risks
Is Selank legal in Canada?
It is not authorized as a drug. Health Canada's Drug Product Database lists no product containing Selank. A product without a Drug Identification Number has not been assessed by Health Canada for safety, efficacy or quality.
Is Selank good for anxiety?
Not established. The most cited study compared Selank, in 30 patients, with the benzodiazepine medazepam, in 32 patients, among Russian adults with generalized anxiety disorder or neurasthenia, and reported similar anxiety effects. It had no placebo group. No large, independent, placebo-controlled trial has tested it.
Is Selank safe?
Long-term safety is not established. The human data come from small, short, mostly Russian studies that were not designed to detect rare or long-term harms. Interactions with sedating, GABA-active, serotonergic, opioid or other psychiatric medicines have not been studied adequately in humans. FDA flags a possible immunogenicity risk for compounded selank and says it lacks important safety information in humans.
Sources:Efficacy and possible mechanisms of action of a new peptide anxiolytic selank in the therapy of generalized anxiety disorders and neurastheniaCertain bulk drug substances for use in compounding that may present significant safety risks
Is Selank addictive?
Not established either way. No study in this entry was designed to test dependence or withdrawal. The main Russian comparison with medazepam was small and short, and its published abstract reports anxiety and asthenia outcomes, not dependence testing. Absence of evidence of harm is not evidence of safety.
What is the difference between Selank and Semax?
They are different peptides. Selank is derived from tuftsin, an immune peptide, and is registered in Russia as an anxiolytic. Semax is an analog of the ACTH(4-10) hormone fragment. A small brain-imaging study gave each to healthy volunteers and found both shared and specific changes in amygdala connectivity, an acute signal rather than a clinical outcome.
Sources:Functional Connectomic Approach to Studying Selank and Semax EffectsDevelopment of Peptide Biopharmaceuticals in Russia
Inspect the record
Sources
- 01Efficacy and possible mechanisms of action of a new peptide anxiolytic selank in the therapy of generalized anxiety disorders and neurastheniaPubMed
Russian-language study of 62 patients comparing Selank with medazepam; no placebo group.
- 02GABA, Selank, and Olanzapine Affect the Expression of Genes Involved in GABAergic Neurotransmission in IMR-32 CellsPubMed
In-vitro mechanistic study.
- 03Functional Connectomic Approach to Studying Selank and Semax EffectsPubMed
Acute neuroimaging signal in healthy participants, not a clinical outcome.
- 04PubMed
- 05Development of Peptide Biopharmaceuticals in RussiaPubMed
Narrative review; its table of peptide products registered in Russia lists Selank as an anxiolytic. Documents registration, not efficacy.
- 06Certain bulk drug substances for use in compounding that may present significant safety risksU.S. Food and Drug Administration
Regulator list; selank acetate appears under nominated but withdrawn.
- 07Drug Product Database online queryHealth Canada
Searched for Selank; no authorized product.
- 08World Anti-Doping Agency
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