Facing added pressure from Eli Lilly, Novo Nordisk submits for FDA approval of oral GLP-1 obesity drug
Title
Novo Nordisk Seeks FDA Approval for Oral Semaglutide as Competition with Eli Lilly Intensifies in Obesity Drug Market
Keywords
- Novo Nordisk
- Eli Lilly
- Oral GLP-1
- Semaglutide
- Obesity drug
- FDA approval
- Weight loss medication
- Orforglipron
- Pharmaceutical competition
- Market pressure
Key Facts
- Novo Nordisk has submitted an application to the U.S. Food and Drug Administration (FDA) for the approval of an oral formulation of semaglutide, its GLP-1-based medication for obesity4.
- Semaglutide, already marketed as Wegovy in an injectable form for obesity and Ozempic for diabetes, showed in Phase 3 trials that the oral version can help patients lose about 15% of their body weight over 64 weeks at the highest dose4.
- The move by Novo Nordisk comes as direct competition with Eli Lilly intensifies. Eli Lilly recently reported strong clinical results for its own oral GLP-1 drug, orforglipron, and has received FDA approval for Zepbound, another obesity medication, further increasing market pressure on Novo Nordisk245.
- The global obesity drug market is expected to surpass $100 billion annually within the next decade, making the development of oral, effective, and convenient weight loss drugs a key strategic priority for major pharmaceutical companies4.
- Novo Nordisk initially delayed seeking approval for oral semaglutide to focus on enhancing its injectable portfolio, but rising competitive threats from Lilly’s pipeline have prompted a pivot in strategy45.
- Stock prices for Novo Nordisk have responded negatively amid these competitive pressures and positive news from Lilly’s oral GLP-1 pill studies5.
- Both Novo Nordisk and Eli Lilly are deeply invested in expanding their share of the lucrative obesity drug market by developing innovative oral therapies that can be both effective and appealing to patients45.
Sources:
2. https://www.investopedia.com/lilly-rises-on-fda-approval-of-weight-loss-drug-zepbound-for-sleep-apnea-8765683
4. https://www.biopharmadive.com/news/novo-oral-semaglutide-fda-approval-application-obesity/745882/
5. https://fortune.com/europe/2025/04/22/novo-nordisk-slides-pressure-eli-lilly-pill-study-ozempic-wegovy/