The Longevity Registry

§ — Substance profile

C

MOTS-c

Mitochondrial ORF of the 12S rRNA type-c · Mitochondrial-derived peptide

01 — Regulatory status

Regulatory status · United States · as of September 2026

Not FDA-approved. Reviewed by PCAC on July 23, 2026; FDA proposed not to add it to the 503A Bulks List. Not eligible for compounding.

Source: FDA 503A Bulks List · PCAC meeting records · verified September 2026

A
Approved drug with randomized controlled trials for the approved indication
B
Human clinical data exists, but no approval for the researched use
C
Animal or in-vitro data only, no controlled human trials
D
No published clinical data; use rests on anecdote

Reviewed September 2026 · Sources: FDA, EMA

02 — Researched for

What is being studied.

Insulin sensitivity, exercise capacity, metabolic regulation, aging biology.

03 — What the evidence shows

The published record.

Mouse studies show improved insulin sensitivity and exercise capacity. A single small human phase 1 trial of a synthetic analogue reported safety; no efficacy data in humans.

04 — What is claimed but not shown

Claimed, not demonstrated.

Fat loss, 'exercise in a pill', extended healthspan in humans.

05 — Known risks

Documented risks.

Unknown; no human safety dataset beyond phase 1; sourcing unregulated.

06 — Researched for these goals

Where MOTS-c appears.

07 — Questions for your physician

Six questions worth printing.

  1. 01What is your primary board certification, and in what year did you obtain it?
  2. 02Is this peptide approved for what you are prescribing it for — and if not, what is the legal basis on which you are supplying it?
  3. 03Which human trials support this use, and what were their size and duration?
  4. 04Where does the product come from, and can you show me a certificate of analysis for this batch?
  5. 05What outcome will we measure, when, and what happens if it does not improve?
  6. 06What is the total cost for the first three months, in writing?

Reviewed September 2026 · Sources: FDA, EMA

This page reports on the state of research and regulation for orientation. It is not medical advice, not a recommendation for or against any substance, and not an offer. Regulatory status changes; the date shown is the date of our last verification. Discuss any treatment with a licensed physician.