Superseded public profile

Safety review recordSafety records

Superseded · version 2: MOTS-c

Related names recorded in this version: MOTS-C

A mitochondrial-derived peptide represented in FDA compounding-risk and advisory-committee records.

This is preserved historical wording.
It is no longer the current profile. Read the canonical profile and its correction notice.
Update · July 29, 2026

We added FDA's dedicated briefing and advisory-committee meeting record, while preserving the pending and nonbinding nature of the review. 23

What this version reported

FDA presented MOTS-c briefing material at its July 2026 pharmacy-compounding advisory-committee meeting. Committee recommendations are nonbinding, and FDA says its final determination will follow completion of the committee process and relevant reviews.

Organizations named in cited records:

Sources for this version

  1. 1
    Certain bulk drug substances for use in compounding that may present significant safety risks ↗

    U.S. Food and Drug Administration · Official source · Source checked July 29, 2026

  2. 2
    FDA briefing document for MOTS-c ↗

    U.S. Food and Drug Administration · Official source · Source checked July 29, 2026

  3. 3
    July 23-24, 2026 Pharmacy Compounding Advisory Committee meeting ↗

    U.S. Food and Drug Administration · Official source · Source checked July 29, 2026