For clinicians
MOTS-c for prescribers: status, evidence and what FDA has said
A neutral reference. It reports MOTS-c's regulatory status, the quality of its human evidence and what FDA has said about it. It does not suggest a dose, a protocol or a source.
Status reviewed 2026-10-01 · By the Grey Peptides Editorial Board · Regulatory fields generated from our tracker
| Also known as | Mitochondrial ORF of the 12S rRNA type-c |
| Substances FDA reviewed | MOTS-c (free base) and MOTS-c acetate |
| FDA approval | Not FDA-approved |
| Compounding (503A) | Not compoundable; PCAC recommended it 7–5 (Jul 2026), FDA has not acted |
| Outsourcing (503B) | No 503B status recorded |
| FDA advisory committee | Reviewed July 23–24, 2026 (docket FDA-2025-N-6895): recommended, 7–5, 2 abstentions |
| WADA 2026 List | Prohibited (S4.4.1) |
| WADA 2027 List | Prohibited (S4.4.1) |
| Evidence grade | Low |
| Status reviewed | 2026-10-01 |
What FDA has said
FDA staff's position, in its briefing for the July 23–24, 2026 committee meeting: FDA proposes not adding either MOTS-c substance to the 503A Bulks List. Of the seven, this evaluation records the emptiest file: no nonclinical data to inform safety for the potential clinical uses, and no clinical studies of safety or effectiveness in humans.
The use FDA evaluated. Nominated for insulin resistance, obesity, osteoporosis, vascular calcification, muscle and fat metabolism, and longevity. FDA evaluated obesity and osteoporosis.
FDA's objections
FDA says MOTS-c (free base) is not well characterised, citing nomenclature inconsistency and the absence of quality control attributes — impurities, aggregates, endotoxins — in the published literature, plus no Certificate of Analysis in the nomination. It also flags missing water-solubility data, which prevented a conclusion on whether solubility would affect the proposed formulation.
FDA describes the extent of use in compounding as unknown.
No clinical studies assessing effectiveness in humans.
No available nonclinical data to inform safety considerations for potential clinical uses, and no clinical studies in humans. FDA notes it lacks the information needed to assess immunogenicity risk for a 16-amino-acid peptide.
Specific to MOTS-c
MOTS-c appears as a prohibited substance in the Global Drug Reference Online database, which draws on the 2024 WADA Prohibited List — under hormone and metabolic modulators. As with TB-500, a compounding decision would not change anti-doping status.
FDA's own internet search found a holistic clinic stating it works with compounding pharmacies to obtain compounded MOTS-c products, and a wellness clinic promoting an IV therapy cocktail containing MOTS-c without disclosing the other ingredients.
MOTS-c is popularly discussed as a longevity and exercise-mimetic compound. FDA evaluated it for obesity and osteoporosis — the uses the nomination proposed that it had enough information to assess.
FDA lists MOTs-C among substances it has identified as potentially presenting significant safety risks outside Category 2 (page current as of 2026-04-22). In FDA's words:
Compounded drugs containing MOTs-C may pose significant risk for immunogenicity for certain routes of administration and may have complexities with regard to peptide-related impurities and API characterization. FDA has not identified any human exposure data on drug products containing MOTs-C administered via any route of administration. FDA lacks important information regarding any safety issues raised by MOTs-C, including whether it would cause harm if administered to humans.
Monitoring: what the literature does and does not say
- No label. MOTS-c has no FDA-approved label, and therefore no labelled guidance on monitoring.
- What FDA has said about its risks is quoted above, from its list of bulk substances that may present significant safety risks.
- Immunogenicity. FDA's July 2026 review found no adequate information to assess the risk that MOTS-c provokes an immune response.
- What is in the vial. FDA judged the substance not well characterised physically and chemically — the property FDA relies on to know what a compounded product actually contains.
- Findings specific to MOTS-c. FDA's review also describes points particular to this compound, some of them safety signals; they are set out above in FDA's own terms.
These are gaps, not a monitoring schedule. This page does not supply one, and for a compound in this position the human evidence would not support one.
Compounding: where it stands
Today's position for MOTS-c: Not compoundable; PCAC recommended it 7–5 (Jul 2026), FDA has not acted. An FDA advisory committee's vote is a non-binding recommendation; until FDA acts, a vote does not change what may be compounded. Our explainer on the 503A and 503B categories sets out what each status means, and the regulatory tracker is updated as FDA acts.
The evidence
Grey Peptides grades MOTS-c's evidence base as low. It is preclinical and early translational work — largely mouse studies and human observational associations. FDA's finding of no clinical studies in humans is consistent with that.
The encyclopedia entry lists the human and animal studies we hold, each with its PMID and FDA's full briefing is summarised on our page for the July 2026 review.
What this page leaves out
Doses, regimens, cycle lengths and sources. That is deliberate. A reference that reports status and evidence is useful only if it is not also a protocol, and for a compound in this position there is no approved one to report.
Sources
- US Food and Drug Administration. Pharmacy Compounding Advisory Committee meeting, July 23–24, 2026: briefing documents, docket FDA-2025-N-6895. FDA
- US Food and Drug Administration. Certain Bulk Drug Substances for Use in Compounding that May Present Significant Safety Risks. Content current as of 2026-04-22; read 2026-10-01. FDA
- Grey Peptides regulatory tracker, row for MOTS-c, reviewed 2026-10-01. Tracker · dataset
- World Anti-Doping Agency. Prohibited List 2027, dated August 26, 2026, in force January 1, 2027. WADA
This page is a reference for qualified professionals. It is not medical advice, it does not recommend any treatment, and it is not a substitute for the prescriber's own judgement and their state and federal obligations.
Others in this group: BPC-157 · Emideltide (DSIP) · Epitalon · KPV · Semax · TB-500