Overview
- The approval covers adults with obesity or overweight and includes a labeled use to reduce major cardiovascular events in patients with established cardiovascular disease.
- Novo Nordisk plans a U.S. launch in January 2026 with an introductory $149 per month cash price for the 1.5 mg starting dose, with higher-dose pricing to be detailed later.
- Phase 3 data reported average weight loss of about 16–17% over 64 weeks at target dosing versus roughly 2–3% with placebo, with 7% discontinuing due to side effects.
- The once-daily tablet must be taken on an empty stomach with a small amount of water, with no food, drink, or other medicines for 30 minutes after dosing.
- Novo Nordisk says it has increased production ahead of launch, while Eli Lilly’s oral rival orforglipron remains under FDA review for a decision expected in the coming months.