Overview
- The FDA approved an oral version of Wegovy on Dec. 22, with Novo Nordisk targeting a U.S. launch in early January 2026.
- The decision makes Wegovy the first FDA-authorized GLP-1 pill for weight loss, giving Novo a head start over Eli Lilly’s pending oral orforglipron.
- Eli Lilly remains the market leader, with Zepbound showing greater average weight loss than Wegovy and generating $9.3 billion in the first nine months of 2025 versus about $9 billion for Wegovy.
- Lilly’s pipeline advances include strong phase 3 results for orforglipron, which is expected by analysts to gain approval in 2026, and retatrutide producing 28.7% mean weight loss at the highest dose in phase 3.
- The approval arrives after a difficult 2025 for Novo that featured trimmed forecasts, pricing pressure, layoffs and leadership changes, with some analysts calling the pill a redemption for investors.