Overview
- The once-daily semaglutide tablet is cleared for chronic weight management and for reducing major cardiovascular events.
- Novo Nordisk says U.S. availability begins in early January 2026, with pricing for higher doses and insurance coverage still to be detailed.
- Pivotal trials reported roughly 13%–17% average weight loss over 64 weeks versus about 2%–3% on placebo, with mainly gastrointestinal side effects.
- Patients must take the pill on an empty stomach with a sip of water and wait about 30 minutes before eating or drinking.
- The approval gives Novo an early lead over Eli Lilly’s orforglipron, which remains under FDA review and is reported to lack food‑timing restrictions.