U.S. Food and Drug Administration (FDA)
Is Amycretin legal in United States?
Not approvedNo FDA approval or filing; Novo Nordisk now calls it zenagamtide and has started Phase 3 trials
Not approved as a medicine here.
Amycretin is an investigational Novo Nordisk medicine that is not approved anywhere in the US and has no application under FDA review. Novo's February 2026 report refers to it as zenagamtide (previously amycretin) after a completed phase 2 trial in type 2 diabetes, and its August 2026 report says the AMAZE phase 3 programme has started, including a heart failure outcomes trial (HF-POLARIS). Any product sold as amycretin outside a clinical trial would be an unapproved new drug under FDA rules.
Last verified 2026-09-29 · how we verify
Amycretin elsewhere
Sources (3)
- 01Novo Nordisk financial report for 2025 (Form 6-K, company announcement)Novo Nordisk A/S (SEC filing) · 2026-02-03 · accessed 2026-09-29
- 02Novo Nordisk financial report for the period 1 January to 30 June 2026 (Form 6-K)Novo Nordisk A/S (SEC filing) · 2026-08-04 · accessed 2026-09-29
- 03Development & Approval Process | DrugsU.S. Food and Drug Administration · 2022-08-08 · accessed 2026-09-29