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Metabolic & Weight Management

Survodutide

Also known as BI 456906 · BI-456906

Emerging researchSubcutaneous injectionInvestigational; not approved by the FDA, EMA, or other major regulators for any indication as of mid-2026, with Phase 3 trials ongoing/reporting. Received US FDA Breakthrough Therapy designation (September 2024) for non-cirrhotic MASH with fibrosis, which expedites development but is not approval. As an unapproved investigational new drug it is not a legitimate compounding ingredient under 503A/503B; following the resolution of GLP-1 shortages, FDA enforcement discretion for compounded GLP-1 drugs ended in 2025, and compounded "research" versions are not FDA-evaluated. For athletes, GLP-1 receptor agonists are not on the WADA Prohibited List but appear on WADA's 2026 Monitoring Program.

Survodutide (BI 456906) is an investigational, oxyntomodulin-derived peptide developed by Boehringer Ingelheim in partnership with Zealand Pharma. It acts as a dual agonist at both the glucagon-like peptide-1 receptor (GLP-1R) and the glucagon receptor (GCGR); researchers describe GLP-1R activity as influencing appetite and energy intake while GCGR activity is associated with energy expenditure and hepatic metabolism. It has been evaluated in randomized, placebo-controlled human trials, including Phase 2 studies and the Phase 3 SYNCHRONIZE program for overweight/obesity and trials in metabolic dysfunction-associated steatohepatitis (MASH/NASH). As of mid-2026 it remains investigational and is not approved by the FDA or other major regulators, with key Phase 3 obesity readouts reported during 2026. The research base is built on human RCTs, but no regulatory body has cleared it for clinical use, and the evidence is still developing.

Studied / used for

  • Investigated for weight reduction in adults with overweight or obesity without type 2 diabetes
  • Studied for weight management in people with overweight or obesity and type 2 diabetes
  • Investigated for metabolic dysfunction-associated steatohepatitis (MASH/NASH) and associated liver fibrosis
  • Studied for cardiometabolic parameters associated with obesity

Commonly reported side effects

  • Nausea, commonly reported in trials, particularly during the dose-escalation phases of trials
  • Vomiting, commonly reported in trials
  • Diarrhea, commonly reported in trials
  • Constipation, commonly reported in trials
  • Decreased appetite and other gastrointestinal disturbances, commonly reported in trials
Emerging research. Active research; human evidence still developing. This reflects the strength of the research base, not effectiveness or a recommendation.

Not medical advice.

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