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Selank: small anxiety trials against benzodiazepines, no placebo, and an FDA flag

Selank is a tuftsin analogue from the same Russian laboratory as Semax, studied for anxiety in randomised comparisons of 60 to 70 patients against medazepam and phenazepam. No placebo-controlled trial, no independent replication. FDA Category 2 in 2023, then withdrawn. Grade C + X.

By FormBlends editorial teamUpdated September 4, 2026Educational, not medical advice

Selank is Semax's sibling: same laboratory, same stabilising tail, same pattern of small studies in Russian journals, marketed in the West as a calm-without-sedation nootropic. The anxiety studies are real and randomised. What they lack is a placebo, and that turns out to matter a great deal for an anxiolytic.

What it is

Selank is a synthetic heptapeptide built from tuftsin, a natural tetrapeptide fragment of immunoglobulin G with immunomodulatory activity, plus a Pro-Gly-Pro extension for stability. It was developed at the Institute of Molecular Genetics in Moscow and is registered in Russia as a nasal preparation for anxiety. Animal studies attribute its effects to inhibition of enkephalin-degrading enzymes and to GABAergic modulation.

The human evidence

Human studies of Selank indexed in PubMed, September 2026
YearDesignResultPubMed
2008Randomised comparison, 62 patients with generalised anxiety disorder or neurasthenia: selank (30) vs medazepam (32); Hamilton, Zung and CGI scales; serum enkephalin activityAnxiolytic effect similar to medazepam; selank additionally described as anti-asthenic. No placebo.18454096
2014Comparative study, 60 patients with anxiety-phobic and somatoform disorders: selank vs phenazepamPronounced anxiolytic and mild nootropic effects reported; effect described as lasting a week after the last dose. Open design.25176261
2015Randomised, 70 patients: phenazepam alone (30) vs phenazepam plus selank (40); HDRS, CGI, Spielberger, UKU side-effect scaleCombination reported to reach effect earlier and to reduce phenazepam side effects (sedation, memory, orthostasis). No placebo.26356395

Anxiety trials have among the largest placebo responses in medicine. A study that shows a new drug performs about as well as a benzodiazepine, without a placebo arm, has not shown that either drug beat placebo in that sample. An add-on study that reports fewer benzodiazepine side effects in the combination arm is interesting, but its open design cannot exclude reporting bias. These are the limits of the Selank literature, and they are limits of design, not of the authors' honesty.

No trial has been published from any group outside the developer's network, and none for the "focus and calm" use sold to healthy people.

Regulatory status

FDA placed selank acetate (TP-7) in Category 2 on September 29, 2023. The Category 2 page (content current as of April 22, 2026) shows it as nominated but withdrawn and retains the concern: possible immunogenicity from aggregation and peptide-related impurities, and "FDA lacks important information regarding any safety issues raised by selank acetate administered to humans."

Selank appears on the agenda for the second day of the Pharmacy Compounding Advisory Committee meeting, July 24, 2026. It is not on the 503A bulks list, not in Category 1, and not an ingredient of any FDA-approved drug. Our 503A explainer sets out what each of those phrases means in practice.

Safety signals

FDA's concern is the absence of safety information for the routes nominated in the US. The Russian studies report good tolerability in the small numbers treated, by the nasal route. Injectable use, which some sellers describe, has no published human exposure at all.

Grade: C + X

C because randomised controlled comparisons exist, with the placebo caveat above weighing heavily. X for FDA's published safety concern. The methodology page explains why an active-comparator study without placebo sits in C rather than B regardless of how many patients it enrolled.

Questions people ask

Has Selank been shown to reduce anxiety?

In three small Russian studies it performed comparably to a benzodiazepine (medazepam in 2008, PubMed 18454096; phenazepam in 2014, PubMed 25176261) or reduced benzodiazepine side effects when added to phenazepam (2015, PubMed 26356395). None included a placebo arm, so none can separate the drug's effect from expectation and time. No trial has been run outside the group that developed it.

Is Selank approved anywhere?

It is registered in Russia as a nasal anxiolytic. It has no FDA or EMA review and no approved product in the United States or European Union.

What is Selank made from?

It is a synthetic analogue of tuftsin, a natural four-amino-acid fragment of immunoglobulin G, extended with the same Pro-Gly-Pro tail used in Semax to slow breakdown. The proposed anxiolytic mechanism involves enkephalin-degrading enzymes and GABA signalling, shown mainly in animal work.

Canonical URL: https://formblendspeptides.com/peptides/selank. Written by the FormBlends editorial team. This page is educational and is not medical advice; see the medical disclaimer.