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Synthetic heptapeptide

Selank — evidence

What has been published, classified by the kind of document it is. This is not a protocol, not a score, and not a recommendation for use.

Evidence overview

2 records in this file

  • REVIEW1
  • REGULATORY1

Research areas. Originating-programme literature; United States compounding.

Publication span. 2013–2026.

What we know

  • A tuftsin analogue (TKPRPGP) with a literature concentrated in the originating Russian programme.
  • No US approved product. FDA withdrawn nomination cites missing safety information in the nomination.
  • Not named on the WADA 2026 Prohibited List.

Editorial reading of the records below, labelled as Therapept analysis. How records are built

What remains uncertain

  • Independent Western interventional trials.
  • How much of the originating corpus would survive a systematic review with independent replication as an inclusion criterion.

Regulatory notes

No FDA-approved product

  • No approved drug product exists in Drugs@FDA.
  • Listed as “Selank acetate (TP-7)” on FDA's table of bulk substances nominated for compounding and withdrawn by the nominator.
  • FDA's published concerns include aggregation and immunogenicity risk, and state that the nomination lacked important information regarding safety issues.
  • Not named on the WADA 2026 Prohibited List.

Regulatory status describes how a substance is classified. It is not a safety assessment of any particular material.

Studies and documents

  1. REGULATORY2026Regulatory listing

    FDA table of bulk drug substances — Selank acetate (TP-7), nomination withdrawn

    U.S. Food and Drug AdministrationFDA compounding communications

    Objective
    To record FDA's published compounding position.
    Endpoint investigated
    Compounding classification

    Listed as “Selank acetate (TP-7)” on the withdrawn-nominations table. Published concerns include aggregation and immunogenicity risk, and that the nomination lacked important information regarding safety issues. Not named on the WADA 2026 Prohibited List.

    Limitations. US compounding classification. Does not evaluate the Russian-language clinical corpus in detail.

    FDA — Certain bulk drug substances for use in compounding may present significant safety risksReviewed 12 September 2026

  2. REVIEW2013Narrative review of the originating programme

    A new generation of drugs: synthetic peptides based on natural regulatory peptides

    Kolomin T, Shadrina M, Slominsky P, Limborska S, Myasoedov NNeuroscience & Medicine

    Objective
    To summarise the Russian regulatory-peptide programme that includes selank (tuftsin analogue TP-7).
    Endpoint investigated
    Preclinical and limited clinical literature of that programme

    Review from the originating network describing synthetic peptides based on natural regulatory peptides, including the tuftsin analogue selank. Useful as a map of that literature. Western independent trials are scarce.

    Limitations. Originating-group review. Not a systematic review of independent RCTs. No United States approved product.

    DOI 10.4236/nm.2013.44035Kolomin et al., Neurosci Med (2013)Reviewed 12 September 2026

Last reviewed 3 September 2026 · Compiled by Therapept Editorial · How these records are built