Is MOTS-c legal? US, UK and Australia status (2026)

The short answer

MOTS-c is not an approved medicine in the US, UK or Australia and is not a controlled drug in the US or UK. An FDA advisory committee recommended it for pharmacy compounding by a narrow 7-5 vote in July 2026, but it was not yet on the 503A bulks list in October 2026, and WADA names it explicitly as a prohibited metabolic modulator.

MOTS-c (mitochondrial open reading frame of the 12S rRNA type-c) is a 16-amino-acid peptide encoded in mitochondrial DNA. It was first described in a 2015 study in cell and mouse models of metabolism. Human data remain limited.

MOTS-c status at a glance (October 2026)

United States

The FDA placed MOTs-C in 503A Category 2 on 29 September 2023, saying compounded drugs containing it may pose a significant risk of immunogenicity for some routes of administration and may have complexities with peptide-related impurities. It was moved off Category 2 on 22 April 2026 after its nominators withdrew.

On 23 July 2026 the Pharmacy Compounding Advisory Committee voted 7-5 with two abstentions to recommend MOTS-c free base and acetate for the 503A bulks list. As with the other peptides voted on that day, FDA staff had recommended against, the vote is not binding, and the FDA must complete rulemaking before MOTS-c can be lawfully compounded. MOTS-c is not a controlled substance.

United Kingdom

MOTS-c is not controlled under the Misuse of Drugs Act 1971 and holds no UK marketing authorisation. If it is presented as treating a condition or supplied to modify physiological function in people, it is a medicinal product under the Human Medicines Regulations 2012, and the MHRA's 2026 position on peptide clinic claims applies. There has been no UK announcement specific to MOTS-c, and the US advisory vote has no legal effect in the UK, so the UK position is unchanged by events at the FDA.

Australia

We could not find a named Poisons Standard entry for MOTS-c. It is not on the Australian Register of Therapeutic Goods, so supplying it for human use makes it an unapproved therapeutic good, and the TGA has said it is unlawful to import, advertise, manufacture or supply unapproved peptide products in Australia. Its 2026 compliance priority covers unapproved peptides generally, not only those it named.

Sport

MOTS-c is one of the few research peptides named outright on the WADA Prohibited List. The 2026 List names it under S4.4.1, metabolic modulators, as an example of an activator of AMP-activated protein kinase (AMPK), alongside AICAR. S4.4 substances are prohibited in and out of competition and are non-Specified, which carries higher default sanctions than S0.

Why the sport and compounding positions differ

MOTS-c shows how the same peptide can be treated differently by different bodies. The FDA advisory committee was asked a narrow question: whether licensed pharmacies should be able to compound it for individual patients under prescription. WADA asks a different one: whether a substance could enhance performance, poses a health risk or breaches the spirit of sport. Because MOTS-c has been studied as an activator of AMPK, a central regulator of cellular energy metabolism, WADA lists it in the same group as AICAR.

A favourable FDA rulemaking outcome would not change MOTS-c's WADA status. Even if it joins the 503A bulks list, athletes would still face a prohibited at all times listing unless WADA removes it.

What to watch next

For MOTS-c the next formal step is the FDA's decision on the July 2026 recommendation, which would appear as a proposed rule or an FDA list update. Its narrow 7-5 margin, with two abstentions, makes it the recommendation most worth watching. We record any change in our peptide regulation tracker.

Where Celyfe fits

Celyfe does not supply MOTS-c. Its four research pens contain NAD+, BPC-157, TB-500, GHK-Cu and KPV. This page is included because MOTS-c was one of the four peptides voted on at the FDA's July 2026 advisory committee meeting, and its legal position is often confused with theirs.

Sources

Checked 8 October 2026:

• FDA: Certain bulk drug substances for use in compounding that may present significant safety risks (MOTs-C entry dated 29 Sep 2023; current page as of 22 Apr 2026), fda.gov
• FDA: July 23-24, 2026 meeting of the Pharmacy Compounding Advisory Committee, fda.gov
• The FDA Law Blog: PCAC approves four bulk drug substances for the 503A list, 24 Jul 2026
• AJMC: FDA panel backs 6 peptides for compounding, 31 Jul 2026
• TGA media releases on unapproved peptide products, June to August 2026, tga.gov.au
• WADA: Prohibited List 2026 (S4.4.1), wada-ama.org
• Lee C et al. The mitochondrial-derived peptide MOTS-c promotes metabolic homeostasis and reduces obesity and insulin resistance. Cell Metabolism, 2015. PMID 25738459

Research use only

Celyfe supplies research peptides for laboratory and research use only. Nothing on this page is guidance on use in humans or animals. This is general information, not legal advice. Rules in all three countries changed several times in 2026, so check the regulator's current publications or speak to a qualified adviser before relying on anything here.