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MOTS-c regulatory status

Current status of MOTS-c in the United States: Under FDA review. In sport: WADA prohibited. Details, sources, and the dated timeline follow.

By the PeptideAgent Editorial Team. Draft, pending editorial review.  Last verified

What is the current status of MOTS-c?

Regulatory: Under FDA reviewWADA: WADA prohibitedVerified: Verified Sep 27, 2026
FDA and compounding
MOTS-c was placed on the FDA 503A Category 2 list (substances with significant safety risks) in 2023 and removed from it on April 15, 2026. On July 23 to 24, 2026 the Pharmacy Compounding Advisory Committee recommended adding MOTS-c to the 503A bulks list. As of the last verification date FDA has not published a final rule, so compounding pharmacies and state boards vary in whether they will fill it. It is not an FDA approved drug and is not eligible for 503B outsourcing.
WADA
WADA prohibited
Access path
  1. No lawful compounded access path yet: PCAC recommended it for the 503A bulks list in July 2026, but until FDA publishes a final rule a 503A pharmacy has no federal basis to compound it from bulk.
  2. Not available as an FDA approved product.
  3. Products labeled research use only are not lawful for human use and are not verified for purity.

Full MOTS-c page: evidence, dosing in the literature, and sources

Is MOTS-c FDA approved?

No. MOTS-c is not an FDA approved drug for any use. FDA placed it on the 503A Category 2 list in 2023 and removed it on April 15, 2026, and the Pharmacy Compounding Advisory Committee recommended it for the 503A bulks list on July 23 to 24, 2026. The vote is advisory and is not an approval. [1] [2] [3]

What is the FDA status of MOTS-c in 2026?

Under FDA review. As of September 2026 FDA has not published a final rule adding MOTS-c to the 503A bulks list, so a 503A pharmacy has no federal basis to compound it from bulk, and pharmacies and state boards vary in whether they will fill it. It is not eligible for 503B outsourcing. [2] [3]

Is MOTS-c banned by WADA?

Yes. MOTS-c is named on the WADA Prohibited List under section S4.4 (metabolic modulators) as an activator of AMP-activated protein kinase, and it is prohibited at all times, in and out of competition. [4]

How has the status of MOTS-c changed over time?

  1. WADA

    WADA publishes the 2027 Prohibited List

    WADA published the 2027 Prohibited List on September 21, 2026, and it takes effect January 1, 2027. The S2 peptide hormone and growth factor classes are unchanged. BPC-157 is still named under S0, and MOTS-c is still named under S4.4 as an activator of AMP-activated protein kinase. WADA added a note that many peptides without approval for human use fall under S0 or another section, and that a peptide not named on the list may still be prohibited. GLP-1 receptor agonists such as semaglutide and tirzepatide are still not on the list.

    Source: WADA 2027 Prohibited List
  2. PCAC

    PCAC recommends six peptides for the 503A bulks list

    At its July 23 to 24, 2026 meeting, FDA's Pharmacy Compounding Advisory Committee voted to recommend that BPC-157, KPV, TB-500, MOTS-c, semax, and epitalon be added to the 503A bulk drug substances list. A committee recommendation is advisory; FDA must still issue a rule before the substances are formally listed.

    Regulatory: Under FDA reviewSource: Pharmacy Compounding Advisory Committee
  3. FDA

    FDA lists BPC-157 and 16 other peptides as withdrawn from 503A Category 2

    FDA's Category 2 page, revised in April 2026 and current as of April 22, 2026, moved BPC-157, AOD-9604, CJC-1295, dihexa, DSIP, epitalon, injectable GHK-Cu, ipamorelin, KPV, LL-37, melanotan II, MOTS-c, PEG-MGF, selank, semax, thymosin alpha-1, and thymosin beta-4 fragment (TB-500) to a list of bulk drug substances nominated but withdrawn by their nominators. A withdrawn substance is no longer in 503A Category 2, but withdrawal is not an approval and does not place a substance on the 503A bulks list; a 503A pharmacy still needs a listing before it may compound it. Ipamorelin acetate remains in 503B Category 2. Seven of the withdrawn peptides (BPC-157, KPV, TB-500, MOTS-c, semax, epitalon, and DSIP) were taken to the Pharmacy Compounding Advisory Committee in July 2026.

    Regulatory: Removed from Category 2 (Apr 2026)Source: FDA: Certain bulk drug substances for use in compounding may present significant safety risks (503A and 503B Category 2 lists and withdrawn nominations, content current as of April 22, 2026)
  4. WADA

    WADA 2026 Prohibited List takes effect

    The 2026 WADA Prohibited List took effect on January 1, 2026 and continues to prohibit the S2 peptide hormone and growth factor classes (GHRH analogs, growth hormone secretagogues, GH fragments, IGF-1 and analogs, MGF, thymosin beta-4 and derivatives, hCG and GnRH-class releasing factors in males), myostatin inhibitors, insulin and the AMPK activator MOTS-c under S4, desmopressin under S5, and BPC-157 under S0. GLP-1 receptor agonists such as semaglutide and tirzepatide are not on the list.

    Source: WADA Prohibited List
  5. FDA

    FDA places a batch of nominated peptides in 503A Category 2

    In September 2023 FDA updated its 503A bulk drug substances category lists to place a group of nominated peptides in Category 2, which means FDA identified significant safety risks and the substances may not be used in 503A compounding while the evaluation continues. Kisspeptin-10 and ibutamoren (MK-677) were added on September 29, 2023 and remain in Category 2 on the FDA page current as of April 22, 2026. BPC-157, CJC-1295, ipamorelin, AOD-9604, dihexa, DSIP, epitalon, KPV, MOTS-c, selank, semax, melanotan II, LL-37, thymosin alpha-1, and thymosin beta-4 fragment (TB-500) were also placed in Category 2 under the 503A interim policy; that same page now lists them as nominated but withdrawn (see the April 2026 event). Hexarelin, PNC-27, and 5-amino-1MQ have never appeared on the FDA category lists.

    Regulatory: Not eligible for compoundingSource: FDA: Certain bulk drug substances for use in compounding may present significant safety risks (503A and 503B Category 2 lists and withdrawn nominations, content current as of April 22, 2026)

Sources

Numbered citations in the answers above point here, followed by the regulatory sources on record for MOTS-c and the source of each dated event.

  1. [1]FDA: Certain bulk drug substances for use in compounding that may present significant safety risks (503A Category 2 list and nominated but withdrawn substances, current as of April 22, 2026)FDA, 2026
  2. [2]FDA Pharmacy Compounding Advisory Committee meetings (July 2026 meeting on peptide nominations)FDA, 2026
  3. [3]FDA: Bulk drug substances used in compounding under section 503A of the FD&C Act (links to the Category 1, 2, and 3 lists and the bulks list)FDA, 2026
  4. [4]WADA Prohibited List, section S4.4 metabolic modulatorsWADA, 2026
  5. [5]WADA 2027 Prohibited List (published September 21, 2026, in force January 1, 2027)WADA, 2026

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