No human exposure dataMOTS-c is not FDA-approved.[1] The FDA wrote in 2026 that it "has not identified, any clinical studies or human exposure data for MOTS-c via any route of administration."[2] The calculator does arithmetic only.
What is MOTS-c?
The WADA list spells the name out as "mitochondrial open reading frame of the 12S rRNA-c".[5] The FDA describes it as a mitochondrial-derived peptide "encoded by the genic region 12S rRNA".[2] Its sequence is MRWQEMGYIFYPRKLR, 16 amino acids, molecular weight 2,174.6 g/mol.[9]
Regulatory status in November 2026
MOTS-c is not FDA-approved. In 2026 it left the FDA's Category 2 list and was added to a non-binding HHS compounding policy.
| Date | What happened |
|---|---|
| Sept 29, 2023 | Placed in 503A Category 2. FDA: MOTS-c "may pose significant risk for immunogenicity for certain routes of administration" and the agency "lacks important information regarding any safety issues".[3] |
| Apr 22, 2026 | Nomination withdrawn; moved to FDA's "nominated but withdrawn" table with the same wording.[3] |
| July 23, 2026 | FDA proposes not adding MOTS-c to the 503A bulks list, after reviewing it for obesity and osteoporosis.[2] HHS reports the advisory committee voted in favor.[4] |
| Oct 30, 2026 | Draft, non-binding HHS enforcement-discretion policy covers MOTS-c acetate for injection under the skin or into muscle, under ten conditions.[4] |
The HHS policy cites "a randomized placebo-controlled trial of a MOTS-c analogue" as part of its reasoning.[4] That analogue is a different molecule, described below. WADA's 2026 list names MOTS-c under S4.4.1, metabolic modulators that activate AMPK, prohibited at all times.[5] The sport page lists every peptide WADA names.
What the human evidence says
MOTS-c itself: no published human trial. FDA's adverse event database held no reports.[2] A phase 2a trial of MOTS-c under the skin in people with prediabetes was registered in 2026 and is recruiting; no dose is listed on the registry.[8]
The only completed human study is of CB4211, which its developer described as "a novel and improved analog of MOTS-c". It is not MOTS-c.
| Item | Detail |
|---|---|
| Trial | NCT03998514, phase 1a/1b, 88 enrolled, completed April 2021; no results posted on the registry[6] |
| Phase 1b | 20 adults with obesity and fatty liver (11 drug, 9 placebo); 25 mg under the skin daily for 4 weeks[7] |
| Safety | No serious adverse events; injection-site reactions were the only events above 10%, "transient and generally mild to moderate" |
| Liver fat | −5.03% vs −4.88% on placebo: no separation |
| Liver enzymes | ALT −21% vs +4%; AST −28% vs −11% |
| Publication | Company press release only; no peer-reviewed paper found |
MOTS-c side effects: what is known
MOTS-c's side effects in people are unknown: there is no published human study and no report in the FDA's adverse event database.[2]
- The FDA lists "significant risk for immunogenicity" and impurity concerns.[3]
- The analog CB4211, a different molecule, caused mostly mild injection-site reactions and no serious adverse events in 20 adults over 4 weeks, per its developer.[7]
MOTS-c peptide dosage chart for 5 and 10 mg vials
A dose-neutral chart. Nanomoles use 2,174.6 g/mol, so 1 mg is 460 nmol.
| Vial + liquid | mg/mL | mcg per unit | nmol per unit | Units per 100 mcg |
|---|---|---|---|---|
| 5 mg + 1 mL | 5 | 50 | 22.99 | 2 |
| 5 mg + 2 mL | 2.5 | 25 | 11.5 | 4 |
| 5 mg + 3 mL | 1.667 | 16.67 | 7.66 | 6 |
| 10 mg + 1 mL | 10 | 100 | 45.99 | 1 |
| 10 mg + 2 mL | 5 | 50 | 22.99 | 2 |
| 10 mg + 3 mL | 3.333 | 33.33 | 15.33 | 3 |
Example arithmetic: 10 mg in 2 mL is 5 mg/mL, or 50 mcg per unit, so 1 mg is 20 units. The calculator above starts in mg; switch the unit to mcg if you need it.
Other peptide pages
The peptides most often looked up alongside this one. Each page gives that peptide's FDA status, compounding status and published human evidence, with sources; the status table has all 23 in one place.
- SS-31 (elamipretide)FDA-approved Forzinity, approved 2025 for Barth syndrome. Ready-to-use; no mixing.
- CagrilintideNot approved Amylin analogue; CagriSema under FDA review.
- BPC-157Not approved 15-amino-acid peptide. Human data: a few tiny, uncontrolled studies.
- TB-500Not approved A 7-amino-acid fragment of thymosin beta-4. No human trials of TB-500 itself.
- BPC-157 + TB-500 blendNot approved Two peptides in one vial: the arithmetic of a fixed ratio.
- TesamorelinFDA-approved Egrifta SV and Egrifta WR. Labeled doses, diluents and volumes.
Frequently asked questions
Is MOTS-c FDA-approved?
No. There is no FDA-approved MOTS-c product and no application on file.[1]
Has MOTS-c been tested in humans?
Is MOTS-c banned in sport?
Yes. WADA's 2026 list names it under S4.4.1 as an AMPK activator, prohibited at all times.[5]
Sources
- openFDA Drugs@FDA searches for BPC-157, thymosin, CJC-1295, ipamorelin, MOTS-c and prezatide (no application found)
- FDA briefing document: MOTS-c-related bulk drug substances
- Certain bulk drug substances for use in compounding that may present significant safety risks
- Enforcement discretion policy regarding 503A compounding using certain peptide bulk drug substances (91 FR 68526)
- World Anti-Doping Code: Prohibited List 2026
- NCT03998514: CB4211 (a MOTS-c analog) phase 1a/1b
- CohBar: topline results from the phase 1a/1b study of CB4211
- NCT07505745: MOTS-c phase 2a in prediabetes (recruiting)
- PubChem CID 146675088: MOTS-c