Regulatory record
- April 2020
- FDA warns a Kentucky compounding pharmacy that drug products it compounded using Selank and twenty-one other substances are not eligible for the exemptions in section 503A(a).
- August 2026
- Selank acetate (TP-7) appears in FDA's table of substances nominated but withdrawn and in no category of the 503A list published May 14, 2026. FDA's published finding is that it lacks important information regarding any safety issues raised by selank acetate administered to humans.
Status verified for this index · August 2026
Definition
Selank is a synthetic heptapeptide built from the immunomodulatory fragment tuftsin with a stabilizing tripeptide tail. It was developed in Russia as an anxiolytic intended to act without the sedation and dependence associated with benzodiazepines.
Like Semax, it belongs to a family of regulatory peptides developed and registered within one national system. Unlike Semax, it has never been placed on the agenda of a United States advisory committee, which leaves it with the thinnest official record of any molecule in this index.
Evidence
Across three name variants PubMed returns 89 indexed records, of which 22 carry the Humans subject heading, 3 the clinical-trial publication type, and 2 the randomized-controlled-trial type [1].
All three trial-type records were opened and read. They are a 2008 study of the peptide in generalized anxiety disorder and neurasthenia [2], a 2014 comparison of its anxiolytic effect and tolerability against a benzodiazepine [3], and a 2015 report on optimizing treatment of anxiety disorders with it [1]. All three were published in Russian, in the same journal, between 2008 and 2015.
There is no trial of this compound in the English-language literature, and the observation is a measurement rather than an impression: the union of every name variant, filtered to trial publication types, returns those three records and nothing else [1]. A reader should draw the modest conclusion available — that a small national trial literature exists, that it has not been replicated elsewhere, and that no regulator outside that system has evaluated it.
Lawful access
There is no lawful United States supply route. Selank acetate was placed in Category 2 of FDA's interim section 503A bulks list and now appears in the agency's table of substances nominated but withdrawn; it is in no category of the 503A bulks list published on May 14, 2026 [4][5].
FDA's published finding is that compounded drugs containing selank acetate may pose a risk for immunogenicity for certain routes of administration due to the potential for aggregation and peptide-related impurities, and that the agency lacks important information regarding any safety issues raised by selank acetate administered to humans [5]. The withdrawal removed the substance from the category; it did not retract that finding.
In April 2020 FDA warned a compounding pharmacy that products it compounded using Selank and twenty-one other substances were not eligible for the exemptions in section 503A(a) [6]. Material sold under this name is research-use-only chemical supply, produced outside pharmacy licensure and prescriber oversight; see research-only.
Elsewhere in this index
Filed under
- Research-onlyNomination withdrawn
- Neuropeptides5 molecules in this class
- The molecule indexEvery molecule, filterable by status and class
Reference tables
- The 2026 recordWhat happened to United States peptide compounding law in 2026, in order?
- The nomination trackerWhat became of each peptide's nomination to the 503A bulks list?
- The human trial recordHow many human clinical trials exist for each peptide in this index?
Same class
- SemaxPCAC-recommended · pending
- DSIPNo lawful route
- DihexaNo lawful route
- Kisspeptin-10No lawful route
References
- PubMed, National Library of Medicine. Census run 2026-08-31 across three name variants — "Selank" OR "TP-7 peptide" OR "Thr-Lys-Pro-Arg-Pro-Gly-Pro" — returning 89 indexed records, 22 carrying the Humans MeSH term, 3 under "clinical trial"[Publication Type] and 2 under "randomized controlled trial"[Publication Type]. All 3 trial-type records were retrieved and read individually; all three are anxiety-disorder studies published in Russian in a single journal between 2008 and 2015, the third being a 2015 report on optimizing treatment of anxiety disorders with the peptide. The publication-type filter was proved live in the same run against a control term returning 8,904 records under the clinical-trial type and 6,113 under the randomized type; the invalid tag clinicaltrial[pt] returned 0 for that control term in the same run, and a deliberately invalid record identifier errored in the same run. Source
- Zozulia AA, Neznamov GG, Siuniakov TS, 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;108(4):38–48. Russian. PMID 18454096
- Medvedev VE, Tereshchenko ON, Israelian AIu, et al. [A comparison of the anxiolytic effect and tolerability of selank and phenazepam in the treatment of anxiety disorders]. Zh Nevrol Psikhiatr Im S S Korsakova. 2014;114(7):17–22. Russian. PMID 25176261
- US Food and Drug Administration. Bulk Drug Substances Nominated for Use in Compounding Under Section 503A of the Federal Food, Drug, and Cosmetic Act, updated May 14, 2026. Read in full 2026-08-31: Selank appears in none of Category 1, Category 2, or Category 3. Source
- US Food and Drug Administration. Certain Bulk Drug Substances for Use in Compounding that May Present Significant Safety Risks, content current as of April 22, 2026, entry for Selank acetate (TP-7) in the table of substances nominated but withdrawn. Read 2026-08-31. Source
- US Food and Drug Administration. Warning letter, Tailor Made Compounding LLC, case 594743, April 1, 2020. Read 2026-08-31. Source