Amycretin is an investigational single-molecule GLP-1 and amylin receptor co-agonist from Novo Nordisk, in development as both a subcutaneous injection and an oral tablet for weight management. It is not approved anywhere; a Phase 1b/2a subcutaneous trial reported up to about 24 percent mean weight loss at 36 weeks in the highest-dose group, and Novo Nordisk has moved the program into Phase 3.

Is Amycretin approved for medical use?

Amycretin is investigational: it is being studied in clinical research and is not an approved medicine. United States (FDA): Not approved. Investigational only; in early-to-mid phase clinical development for obesity and not authorized for any indication. European Union (EMA): Not authorized. Investigational; no EU marketing authorisation. Australia (TGA): Not registered on the Australian Register of Therapeutic Goods (ARTG). Investigational; not approved in Australia.

Is Amycretin legal in Australia?

Amycretin in Australia (TGA): Not registered on the Australian Register of Therapeutic Goods (ARTG). Investigational; not approved in Australia.

Is Amycretin banned in sport?

Amycretin under the World Anti-Doping Agency (WADA) code: Not listed on the WADA Prohibited List and not in the 2026 Monitoring Program (which names only markers of semaglutide and tirzepatide).

Unimolecular GLP-1 and amylin receptor co-agonist

Amycretin

Investigationalaka NNC0487-0111

Amycretin is an investigational single-molecule GLP-1 and amylin receptor co-agonist from Novo Nordisk, studied as both a once-weekly subcutaneous injection and a once-daily oral form for weight management. In an early-phase randomized controlled trial of subcutaneous amycretin in adults with overweight or obesity, the highest-dose group lost about 24 percent of body weight at 36 weeks versus roughly 1 percent with placebo, with mostly gastrointestinal side effects. It is not approved anywhere and has entered Phase 3 development.

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Mechanism

In plain terms, amycretin is one molecule that acts on two appetite-regulating targets at once: the GLP-1 receptor, the target of drugs such as semaglutide, and the amylin receptor. Technically it is a unimolecular GLP-1 and amylin receptor agonist engineered for extended activity, developed in subcutaneous and oral formulations.

Regulatory Status by Region

United States (FDA)Not approved. Investigational only; in early-to-mid phase clinical development for obesity and not authorized for any indication.
Australia (TGA)Not registered on the Australian Register of Therapeutic Goods (ARTG). Investigational; not approved in Australia.
European Union (EMA)Not authorized. Investigational; no EU marketing authorisation.
WADANot listed on the WADA Prohibited List and not in the 2026 Monitoring Program (which names only markers of semaglutide and tirzepatide).

See the full regulatory status matrix

Key Studies

Amycretin, unimolecular GLP-1 and amylin receptor agonist administered subcutaneously, Phase 1b/2a RCT (Dahl et al.) (opens in a new tab) (Lancet 2025;406(10499):149-162; DOI 10.1016/S0140-6736(25)01185-7; PMID 40550231; NCT06064006)
Phase 1b/2a subcutaneous amycretin (NNC0487-0111) in overweight or obesity (ClinicalTrials.gov record) (opens in a new tab) (Novo Nordisk; randomized, placebo-controlled, double-blind; 125 participants; NCT06064006)

Related Clinical Trials

Common Questions

What is Amycretin?: Amycretin is an investigational single-molecule GLP-1 and amylin receptor co-agonist from Novo Nordisk, in development as both a subcutaneous injection and an oral tablet for weight management. It is not approved anywhere; a Phase 1b/2a subcutaneous trial reported up to about 24 percent mean weight loss at 36 weeks in the highest-dose group, and Novo Nordisk has moved the program into Phase 3.
Is Amycretin approved for medical use?: Amycretin is investigational: it is being studied in clinical research and is not an approved medicine. United States (FDA): Not approved. Investigational only; in early-to-mid phase clinical development for obesity and not authorized for any indication. European Union (EMA): Not authorized. Investigational; no EU marketing authorisation. Australia (TGA): Not registered on the Australian Register of Therapeutic Goods (ARTG). Investigational; not approved in Australia.
How does Amycretin work?: In plain terms, amycretin is one molecule that acts on two appetite-regulating targets at once: the GLP-1 receptor, the target of drugs such as semaglutide, and the amylin receptor. Technically it is a unimolecular GLP-1 and amylin receptor agonist engineered for extended activity, developed in subcutaneous and oral formulations.
Is Amycretin legal in Australia?: Amycretin in Australia (TGA): Not registered on the Australian Register of Therapeutic Goods (ARTG). Investigational; not approved in Australia.
Is Amycretin banned in sport?: Amycretin under the World Anti-Doping Agency (WADA) code: Not listed on the WADA Prohibited List and not in the 2026 Monitoring Program (which names only markers of semaglutide and tirzepatide).