MOTS-c: where it stands with the FDA, and what it costs
Marketed by longevity clinics for metabolism and exercise. No FDA-approved drug contains it.
Go to clinicLowest per monthMOTS-c injection
Enhanced · from $109/mo
Go to clinicLowest at a clinic we link toMOTS-c injection (5ml)
Affinity Direct · $186.15/mo
Where MOTS-c stands today
No FDA-approved drug contains MOTS-c. FDA had it in 503A Category 2 from September 29, 2023 until April 22, 2026 (nomination withdrawn). On July 23, 2026 the advisory committee voted 7-5 (2 abstentions, per law-firm reports) to recommend listing it, against FDA staff's proposal. HHS's October 30, 2026 interim policy covers MOTS-c acetate for subcutaneous or intramuscular injection, single-ingredient, under ten conditions; it does not cover 503B facilities. It is not on the 503A or 503B bulks list.
For pharmacies compounding one patient's prescription (section 503A)
Not on the 503A bulks list and in no FDA category (removed from Category 2 on April 22, 2026 after its nominations were withdrawn). Since Oct 30, 2026 it is one of six peptides in HHS's interim enforcement discretion policy for 503A compounding, limited to the form and routes below and ten conditions.
“Bulk drug substances nominated but withdrawn ... MOTs-C 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.”
““MOTs-C” has been removed from category 2 because the nomination was withdrawn by the nominator.”
HHS interim enforcement discretion policy (Office of the Secretary, not FDA)
“HHS does not intend to take enforcement action against a State-licensed pharmacy, Federal facility, or licensed physician compounding a drug product using a bulk drug substance in Appendix A.”
Form and routes HHS covers
“Based on the identified updated information, enforcement discretion for MOTS-c acetate is appropriate subcutaneous or intramuscular injectable dosage forms that are compounded from API accompanied by a CoA meeting the conditions of this policy.”
“MOTS-c was in Category 2 from September 29, 2023, until April 22, 2026, and neither the placement nor the removal changed its status under section 503A; CDER recommended against listing either form, and the PCAC voted in favor of both forms.”
One of the ten conditions: single-ingredient products only (no blends)
“The compounded drug product contains only a single Active Pharmaceutical Ingredient (API) listed in Appendix A.”
The Federal Register notice calls the policy a draft; written comments closed two weeks after publication
“HHS is announcing the availability of a draft”
21 CFR 216.23(a), the 503A bulks list itself: six substances (Brilliant Blue G, cantharidin, diphenylcyclopropenone, N-acetyl-D-glucosamine, squaric acid dibutyl ester, thymol iodide); none of the compounds in this file
“The following bulk drug substances can be used in compounding under section 503A(b)(1)(A)(i)(III) of the Federal Food, Drug, and Cosmetic Act.”
For outsourcing facilities (section 503B)
Not on the 503B bulks list and not in any 503B category (FDA's 503B nominations list, updated March 21, 2025, does not name it)
“Outsourcing facilities, which operate under section 503B of the Federal Food, Drug, and Cosmetic Act (FD&C Act), may not compound a drug product that includes a bulk drug substance unless: The bulk drug substance appears on a list identifying bulk drug substances for which there is a clinical need (the 503B bulks list), or”
The 503B bulks list holds five substances (diphenylcyclopropenone, glycolic acid, quinacrine HCl oral, squaric acid dibutyl ester, trichloroacetic acid); none of the compounds in this file
“FDA has evaluated the following bulk drug substances and determined that there is a clinical need for outsourcing facilities to compound drug products using these bulk drug substances under section 503B of the FD&C Act:”
The HHS policy names 503A compounders only; it does not cover 503B outsourcing facilities
“HHS does not intend to take enforcement action against a State-licensed pharmacy, Federal facility, or licensed physician”
The FDA's compounding advisory committee
23 July 2026: Should MOTS-c (free base) and MOTS-c acetate be placed on the 503A bulks list? (use FDA reviewed: obesity and osteoporosis). Vote: 7 yes, 5 no, 2 abstentions (both forms), per law-firm reports. Committee recommended inclusion, against FDA staff's proposal; no FDA rule yet; HHS cited the vote in its Oct 30, 2026 interim policy
“VOTE: Should MOTS-c (free base) be placed on the list? ... VOTE: Should MOTS-c acetate be placed on the list?”
For athletes who are tested
Prohibited at all times (in and out of competition) (World Anti-Doping Agency, 2026 Prohibited List (in force 1 Jan 2026; WADA approved a 2027 list in Sept 2026, effective 1 Jan 2027, not read here)).
“mitochondrial open reading frame of the 12S rRNA-c (MOTS-c)”
Our reading
A 503A pharmacy can compound MOTS-c acetate injections for a patient-specific prescription under HHS's enforcement discretion if every condition is met; oral or other routes and blends fall outside it. Not legal status: the policy can be revisited and states may restrict.
Every source above was checked again on 14 November 2026.
What 76 clinics charge
- EnhancedMOTS-c injectionfrom $109/mo
- ArgoMOTS-c injection$125/mo
- Ascend VitalityMOTS-c injectionfrom $119/mosupply not stated, counted as 4 weeks: ≈ $128 per 30 days
- PepScribeMOTS-c injectionfrom $129/mo
- Try NovaMOTS-c injection (10mg)$133/mo
What MOTS-c is
- What it is
- Mitochondria-derived peptide
- How it works
- A 16-amino-acid peptide encoded in mitochondrial DNA, studied in animals for its effects on metabolism.
- How it is given
- Subcutaneous injection
MOTS-c side by side
About MOTS-c
Is MOTS-c FDA-approved?
No. No FDA-approved drug contains MOTS-c. What clinics sell is compounded by a pharmacy for a prescription, and the FDA does not review compounded products before they are sold.
Is MOTS-c legal in the US?
Whether a pharmacy may compound it for your prescription is what decides it. No FDA-approved drug contains MOTS-c. FDA had it in 503A Category 2 from September 29, 2023 until April 22, 2026 (nomination withdrawn). On July 23, 2026 the advisory committee voted 7-5 (2 abstentions, per law-firm reports) to recommend listing it, against FDA staff's proposal. HHS's October 30, 2026 interim policy covers MOTS-c acetate for subcutaneous or intramuscular injection, single-ingredient, under ten conditions; it does not cover 503B facilities. It is not on the 503A or 503B bulks list.
How much does MOTS-c cost?
76 clinics publish a price. The lowest that compares per month is from $109/mo at Enhanced, and the middle of 55 clinics' lowest monthly prices is about $219. What a month buys differs by clinic, so each price lists what it includes. every MOTS-c price
What forms does MOTS-c come in?
Clinics sell it as injection (76 prices), other (8 prices).