Is PT-141 legal in Australia?

Is PT-141 available in Australia?

No single record answers whether PT-141 is available in Australia. The TGA, Australia's medicines regulator, says peptide products are regulated as therapeutic goods under the Therapeutic Goods Act 1989. Therapeutic goods is the legal term for medicines and medical products. The TGA says unapproved peptide products are goods not included in the Australian Register of Therapeutic Goods (ARTG), the national list of approved medicines and devices. That advisory is dated 13 April 2026. Its text, read on 16 October 2026, does not name bremelanotide or PT-141. A keyword search of the ARTG that day did not confirm a registered bremelanotide product.

Availability and lawfulness are different questions. The TGA states that a research-use-only disclaimer does not make supply lawful. The TGA says such a disclaimer also does not change a product's regulatory status, permit importation, or remove advertising or supply obligations. State and territory laws may add further controls, the TGA adds. The Australian peptide law guide sets those layers out.

The register's own search page answers the question for a named product. It is on the TGA's ARTG page. This page records published statements and a keyword search, not a product-level check.

Is PT-141 listed in the Australian Poisons Standard?

The text of the October 2026 Poisons Standard does not mention PT-141 or bremelanotide by name. The Poisons Standard is Australia's national list that sorts medicines and poisons into classes, such as Schedule 4 for prescription-only medicines. A text search of instrument F2026L01327, run on 16 October 2026 on the version registered on 30 September 2026, found no match for bremelanotide, PT-141 or melanocortin. A missing name is not an exemption. The instrument also has group headings and general rules that can reach substances it does not name. Whether any of them reaches bremelanotide is a legal question this page leaves open.

The same instrument does list Melanotan II by name in Schedule 4, with a cross-reference to alpha-melanocyte-stimulating hormone. Melanotan II is a different molecule, so its row does not stand in for bremelanotide. What Schedule 4 and Appendix D mean explains how these entries work.

This page does not say that PT-141 is unscheduled. It does not say that PT-141 is in Schedule 4 either. The search finds named entries and nothing more.

What has the TGA said about peptide products like PT-141?

The TGA has written about unapproved peptide products as a group, not about PT-141 by name. Its safety advisory of 13 April 2026 says the TGA has not assessed unapproved peptide products for safety, quality or effectiveness. It adds that important information about these products remains unknown. A separate TGA blog, dated 24 January 2025, covers melanotans. It says melanotans are lab-made peptides that make the skin produce more melanin, the pigment that darkens skin. It also says they are not approved for sale or use as a tanning agent in Australia. That blog is about melanotan products, not about bremelanotide.

Neither TGA text read for this page names bremelanotide or PT-141. Silence in a general warning is not a finding about one substance, so this page draws no conclusion from it.

Is bremelanotide approved by the FDA?

Yes, for one product and one group of people. The FDA approved Vyleesi (bremelanotide) in 2019 for premenopausal women with acquired, generalised hypoactive sexual desire disorder. The label states that Vyleesi is not indicated, meaning not approved, in postmenopausal women or in men. An FDA approval covers one named product made to a stated specification, a fixed description of what the product must be. It does not approve other material that carries the same molecule name. It is also not an Australian approval. The side-effects page sets out what the label records about safety.

The label was revised in June 2019, and the document itself says it may not be the latest version. The current record sits in Drugs@FDA, the FDA's online drug database, under application number NDA 210557. This page opened no European Medicines Agency record, so it makes no statement about Europe. The two trials behind the approval are reported in a 2019 paper by Kingsberg and colleagues in Obstetrics & Gynecology.

Is PT-141 banned by WADA?

The WADA 2026 Prohibited List does not name bremelanotide or PT-141 in its text, searched on 16 October 2026. WADA, the World Anti-Doping Agency, lists the substances banned in sport, and this List has been in force since 1 January 2026. Its class S0 covers any pharmacological substance, meaning a substance with a drug action, that no later section addresses and that has no current approval by any government health authority for human therapeutic use. The FDA label records Vyleesi's first US approval in 2019, but that label is not an anti-doping ruling. A missing name cannot settle whether another class applies.

An athlete needs a product-specific status check through the relevant anti-doping organisation. In Australia, that organisation is Sport Integrity Australia.

The List also has classes for peptide hormones and for hormone and metabolic modulators. A name that is missing from the examples can still be reached by a class description, and only the anti-doping organisation can say. Do peptides show up on drug tests? covers testing in general.

Evidence limits

What do these records not show?

Each record answers its own question, and no record answers another's. A name in a schedule, a name on a register, an approval in another country and a sport ruling are four separate facts.