U.S. Food and Drug Administration (FDA)
Is Survodutide legal in United States?
Not approvedInvestigational; Boehringer Ingelheim has US Phase 3 trials running and no FDA approval exists
Not approved as a medicine here.
Survodutide (BI 456906) is a Boehringer Ingelheim glucagon and GLP-1 receptor dual agonist under study for obesity and liver disease. US-registered Phase 3 trials include LIVERAGE for MASH with fibrosis (recruiting) and the SYNCHRONIZE programme for obesity. No FDA approval exists, so it is classed as not approved, and any product sold as survodutide outside trials is an unapproved drug. FDA says it has warned companies that illegally sold survodutide falsely labelled 'for research purposes' or 'not for human consumption'.
Last verified 2026-09-29 · how we verify
Survodutide elsewhere
Sources (4)
- 01LIVERAGE: A Study to Test Whether Survodutide Helps People With a Liver Disease Called NASH/MASH Who Have Moderate or Advanced Liver Fibrosis, NCT06632444U.S. National Library of Medicine (ClinicalTrials.gov) · 2026-09 · accessed 2026-09-29
- 02A Study to Test Whether Survodutide Helps People Living With Obesity or Overweight and With NASH to Reduce Liver Fat and to Lose Weight (SYNCHRONIZE-MASLD), NCT06309992U.S. National Library of Medicine (ClinicalTrials.gov) · 2026-04 · accessed 2026-09-29
- 03Development & Approval Process | DrugsU.S. Food and Drug Administration · 2022-08-08 · accessed 2026-09-29
- 04FDA's Concerns with Unapproved GLP-1 Drugs Used for Weight LossU.S. Food and Drug Administration · 2026-09-01 · accessed 2026-09-29