Safety findings

Regulatory recordSupporting passage inspected

FDA's bulk drug substance safety review lists Selank acetate (also known as TP-7) as a withdrawn compounding nomination. FDA states it lacks important safety information for selank acetate administered to humans and is concerned about immunogenicity related to aggregation and peptide-related impurities for certain routes.[2]

  • An evidence gap identified by a regulator is not proof of either safety or harm.
  • This regulator source does not itself supply human outcome data for selank; see the separate small comparative clinical study record for that.
Inspection history

Clinical review: not reviewed by a qualified clinician.

· New source relationship identified and added in the peptide-misc batch on 2026-09-09 while rereading the FDA bulk-safety page; proposed addition awaits independent editorial review.

Clinical & experimental findings

Human observational studyAbstract inspected

A small comparative study in patients with anxiety disorders reported symptom changes with Selank and medazepam. The abstract’s limited methods do not establish a robust effect estimate, healthy-person cognitive enhancement or freedom from dependence.[1]

  • Population, formulation and study-design uncertainty restrict applicability.
  • PubMed's own indexing tags this record as a randomized controlled trial, but the abstract text itself does not describe the randomization or blinding procedure used; it is treated here as an uncontrolled comparative report.
Inspection history

Clinical review: not reviewed by a qualified clinician.

· Independently inspected the listed passages; replaced or qualified inherited assertions. No qualified clinical review has occurred.

· Freshly reread the abstract via NCBI E-utilities; confirmed sample sizes (30/32) and flagged the indexing-vs-abstract-description discrepancy. No qualified clinical review.

What remains unresolved

Editorial assessment

These notes describe the scope of this review. Linked PMIDs are audit identifiers; an identifier alone does not verify a claim.

Retained the limited comparative patient study and explicitly recorded missing allocation/masking/formulation detail.

  • High-quality clinical estimates, dependence outcomes, healthy cognition and kinetics remain unverified.
  • Other inherited assertions not supported by the published claim set remain unverified; no qualified clinician review has occurred.

This reference does not supply a dosing plan, monitoring timetable or recovery regimen. Discuss personal symptoms, medicines and laboratory results with a qualified clinician.

Explore the interaction evidence for this compound →

References

  1. [Efficacy and possible mechanisms of action of a new peptide anxiolytic selank in the therapy of generalized anxiety disorders and neurasthenia].

    2008. PMID:18454096 Abstract only.

    Inspected location: Abstract: methods and results

    Study context and inspection record
  2. FDA: Certain bulk drug substances for compounding that may present significant safety risks

    US Food and Drug Administration. FDA web page. The footer states "Content current as of: 04/22/2026" (22 April 2026), independently verified on 2026-09-09 by two separate fetch methods. The ibutamoren mesylate row's own dated actions remain the applicable dates for that row's content. 2026-04-22. Regulatory document.

    Inspected location: Ibutamoren mesylate row of the 503A/503B category-2 bulk-substances table: congestive-heart-failure safety-risk description and the row's own dated entries (503A added September 29, 2023; 503B added December 29, 2022). Also inspected for this batch: the category-2 table row for kisspeptin-10, and the withdrawn-nomination rows for BPC-157, cathelicidin LL-37, emideltide (DSIP), epitalon, GHK-Cu, melanotan II, MOTs-C, selank acetate (TP-7), semax (heptapeptide) and thymosin alpha-1; and the earlier named GHRP-6, PEG-MGF, GHK-Cu and GHRP-2 rows

    Study context and inspection record

Source inspection and clinical review are separate. An abstract check is not a full-text review. The records above identify what was actually inspected and do not certify the complete literature.

Recorded verification attempts
  • peptide-pmid-18454096: Abstract: methods and results

View this compound in the research library →

Related records in this class

Grouped under Peptides for navigation only. Shared class membership does not make findings, formulations or evidence interchangeable between records.

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