Is MOTS-c available in Australia? TGA, FDA and WADA records

Is MOTS-c available in Australia?

The regulator documents checked on 14 October 2026 did not identify an approved medicine that contains MOTS-c, and the TGA's peptide advisory of 13 April 2026 does not mention MOTS-c by name. The TGA says peptide products are regulated as therapeutic goods under the Therapeutic Goods Act 1989 and that unapproved peptide products are goods not included in the Australian Register of Therapeutic Goods (ARTG), the national list of approved medicines and devices (TGA advisory, 13 April 2026). Its examples are BPC-157, GHK-Cu, TB-500, retatrutide and CJC-1295. The TGA also says how a peptide product is regulated depends on what it contains, how it is promoted and what it is intended to do (TGA, Peptide products, last updated 23 September 2026). Whether any specific product is on the ARTG is answered by the register's own search, which this page does not replace.

Availability and lawfulness are different questions. Sellers print research-use-only labels on vials and listings. According to the TGA, such a disclaimer alone does not make supply lawful, change a product's regulatory status, permit importation or remove advertising or supply obligations (TGA advisory, 13 April 2026). The TGA adds that state and territory laws may impose additional controls on the sale, supply and possession of unapproved peptide products. The Australian peptide law guide and the Western Australian law guide set those layers out.

The site catalogue lists MOTS-C reference material as freeze-dried laboratory material, with current certification unverified. A catalogue listing records what a supplier sells. It does not establish that any person may lawfully possess or use the material, and the material is not for human or animal use.

The register itself is searchable on the TGA's ARTG page. A search there answers the question for a named product; this page records published statements, not a product-level register search.

Is MOTS-c listed in the Australian Poisons Standard?

A text search of the October 2026 Poisons Standard, instrument F2026L01327, run on 14 October 2026, found no named entry for MOTS-c. The search covered the authorised version registered on 30 September 2026 and found no occurrence of MOTS-c, its spelled-out name or the word mitochondrial, while named entries for BPC-157 and CJC-1295 are present. The Poisons Standard is the national schedule that sorts medicines and poisons into classes, such as Schedule 4 for prescription-only medicines. A missing entry is not permission, because group headings and derivative provisions can reach substances that are not named.

A search by the site's research team on 1 October 2026 (UTC) reached the same result for the names 'mots-c', 'mots c', 'motsc' and 'mitochondrial-derived peptide'. What Schedule 4 and Appendix D mean explains the entries that do exist, and MOTS-c in Perth records the same search beside the peptide's identity details.

The point of the check is narrow. It finds named entries, and nothing more. Whether a group heading reaches MOTS-c is a legal question that this page leaves open.

Has the TGA issued a warning about MOTS-c?

The TGA has issued two 2026 safety advisories about unapproved peptide products as a group, and the texts read on 14 October 2026 do not name MOTS-c. The 13 April 2026 advisory says unapproved peptide products have not been assessed by the TGA for safety, quality or effectiveness, and that research-use-only disclaimers alone do not make supply lawful. The 7 May 2026 warning says vials that do not meet importation requirements through poor or unclear labelling will not be released under the Personal Importation Scheme, and that the TGA will notify the Australian Border Force to seize and destroy such products when they are intercepted at the border.

The 13 April advisory lists adverse events and concerns the TGA received for unapproved peptide products generally: severe allergic reactions needing hospital care, systemic inflammatory response syndrome, full-body itching and palpitations, insomnia, blurred vision, extreme tiredness, flu-like illness, joint pain, skin sensitivity, musculoskeletal injuries and poor product quality. The list does not attribute any of them to MOTS-c.

The TGA also says that advertising or promoting unapproved peptide products, particularly through social media or influencer channels, is likely to breach Australian therapeutic goods advertising laws (TGA advisory, 13 April 2026). The TGA topic page Peptide products, last updated on 23 September 2026 and read on 14 October 2026, does not name MOTS-c either.

Has the FDA approved MOTS-c?

The FDA states that MOTS-c (free base) and MOTS-c acetate have no applicable United States Pharmacopeia monograph and that neither is a component of an FDA-approved drug (FDA briefing document, 11 May 2026). In the same document, FDA reviewers who consulted PubMed, Embase, the Cochrane Library, FAERS and ClinicalTrials.gov wrote that they did not identify any clinical studies or human exposure data for MOTS-c. USADA says MOTS-c is not approved by the FDA for use in humans or in compounded medications (USADA, page read 14 October 2026). The registry lists a Phase 2a trial of MOTS-c, NCT07505745, as recruiting on 14 October 2026.

MOTS-c is a 16-amino-acid peptide first described in cell and mouse experiments, which do not establish effects in people (Lee et al., Cell Metabolism, 2015), and the MOTS-c research guide covers the first papers. The FDA also notes that MOTS-c is a common name and not a United States Adopted Name, a unique nonproprietary name for a drug sold in the United States, and that it has encountered multiple salts and derivatives sold commercially under the same common name (FDA briefing document, 11 May 2026).

A 2026 narrative review of 12 marketed peptides, MOTS-c among them, describes a parallel gray market of unapproved compounds operating largely outside regulatory oversight and reports that rigorous human safety data for unapproved peptides are scarce; as a review, it gathers published reports and tests nothing itself (Mendias and Awan, Sports Medicine, 2026).

Has the FDA warned about MOTS-c?

The FDA has published safety concerns about MOTS-c rather than an approval. On its page of bulk drug substances that may present significant safety risks, content current to 22 April 2026, the FDA lists MOTS-c among substances whose nominations were withdrawn after placement in category 2, and says compounded drugs containing it may pose a significant risk of immunogenicity (an immune reaction against the peptide), with a route qualifier stated on that page. The FDA adds that it has not identified any human exposure data on drug products containing MOTS-c and lacks important information on whether it would cause harm in humans. Its 11 May 2026 briefing document reports that searches of FDA's adverse event database retrieved no MOTS-c reports through 9 March 2025.

Category 2 is a label in the FDA's interim policy for nominated bulk drug substances that raise significant safety concerns. MOTS-c sits in the table of 'nominated but withdrawn' substances because the nominator withdrew its nomination, and the FDA then chose to evaluate MOTS-c on its own initiative (FDA safety-risk page, content current to 22 April 2026; FDA briefing document, 11 May 2026).

The briefing document gives its reasons for concern. FDA wrote that there is a lack of information to assess the immunogenic safety risk of MOTS-c and that the potential safety risks of MOTS-c in humans are unknown (FDA briefing document, 11 May 2026). The document is a safety assessment for the committee, not a warning letter.

What did the FDA advisory committee decide about MOTS-c in July 2026?

The FDA's Pharmacy Compounding Advisory Committee met on 23 July 2026 to advise whether MOTS-c should join the 503A bulks list, a US list of ingredients that state-licensed pharmacies may use in compounding. FDA staff proposed that MOTS-c (free base) and MOTS-c acetate not be included (FDA briefing document, 11 May 2026). The committee voted 7 to 5, with 2 abstentions, to recommend each form for inclusion, according to Healio, 24 July 2026. AJMC, 31 July 2026 reported that the recommendations are nonbinding and that legal compounding remains prohibited unless FDA accepts them and completes rulemaking.

AJMC reported that the FDA must still decide whether to accept the committee's nonbinding recommendations and, if it does, proceed through notice-and-comment rulemaking before compounding pharmacies could legally prepare the substances (AJMC, 31 July 2026).

The vote concerns US pharmacy compounding. It does not approve MOTS-c as a medicine, and it sits apart from Australian law. The two news reports quoted here, Healio and AJMC, are secondary sources, because the FDA meeting page read on 14 October 2026 listed no minutes of the meeting.

Is MOTS-c banned in sport?

The WADA 2026 Prohibited List names MOTS-c under S4.4.1, activators of the AMPK enzyme, within the hormone and metabolic modulators class that is prohibited at all times, and the list took effect on 1 January 2026 (WADA Prohibited List 2026). Sport Integrity Australia lists MOTS-c among common examples of prohibited unapproved peptides (Sport Integrity Australia, Peptides explained, page read 14 October 2026). USADA says a Therapeutic Use Exemption for MOTS-c is highly unlikely because it has no approved therapeutic use (USADA, page read 14 October 2026).

Sport Integrity Australia says that possession or use of prohibited peptide products by athletes can result in anti-doping rule violations and bans, and it points athletes to the Global DRO site to check the status of a substance (Sport Integrity Australia, Peptides explained, read 14 October 2026). A sports-testing laboratory reported validating a mass-spectrometry method for measuring MOTS-c in plasma against WADA's International Standard for Laboratories, a laboratory method tested with plasma samples that gives no detection window for any person (Knoop et al., Rapid Communications in Mass Spectrometry, 2019).

WADA publishes a new list each year, so a later list may differ from the 2026 text quoted here. The sport rules are separate from the Poisons Standard and from TGA approval.

Evidence limits

What do these records not settle?

A missing approval and a missing schedule entry are different facts, and a seller's label is a third. The research-use-only wording on a vial is the seller's statement about intent, and the TGA has said that such wording alone does not change regulatory status (TGA advisory, 13 April 2026).