The Food and Drug Administration on Monday approved a pill version of Wegovy, Novo Nordisk's blockbuster weight-loss drug—marking a potential turning point in the obesity treatment market. The Wegovy pill becomes the first oral GLP-1 medication cleared specifically for weight management, offering an alternative to the injections that have dominated the category.
What the FDA Approved
The approval covers oral semaglutide in tablet form for chronic weight management in adults with obesity (BMI of 30 or higher) or overweight (BMI of 27 or higher) with at least one weight-related condition such as high blood pressure, type 2 diabetes, or high cholesterol.
Critically, the FDA also cleared the pill to reduce the risk of major cardiovascular events—death, heart attack, or stroke—in adults with obesity and established cardiovascular disease. This matches the cardiovascular indication already held by injectable Wegovy.
The Clinical Data
Phase 3 trial results published in the New England Journal of Medicine showed impressive efficacy:
- Weight loss: Patients taking the highest dose lost 16.6% of their body weight on average after 64 weeks, compared to 2.2% in the placebo group
- Comparable to injections: The weight loss achieved matches that of injectable Wegovy 2.4 mg
- Cardiovascular benefits: Significant reduction in major adverse cardiovascular events
The pill must be taken on an empty stomach with a small amount of water. Patients cannot eat, drink, or take other medications for 30 minutes afterward—a requirement that may limit convenience compared to once-weekly injections.
Pricing and Availability
Novo Nordisk announced aggressive pricing in partnership with the Trump administration:
- Starting dose (1.5 mg): Available in early January at pharmacies and select telehealth providers
- Out-of-pocket price: $149 per month with savings offers for cash-paying customers
- Higher doses: Will follow as supply ramps up throughout 2025
The $149 price point represents a significant discount from the list price of injectable Wegovy (approximately $1,300/month) and reflects a November deal between Novo Nordisk and the administration to provide affordable access in exchange for tariff relief.
Competitive Implications
The approval gives Novo Nordisk a meaningful head start over chief rival Eli Lilly, which is racing to launch its own obesity pill called orforglipron. That drug is expected to receive FDA clearance by summer 2025.
The oral format could expand the addressable market significantly. Many patients who are reluctant to self-inject may find a daily pill more acceptable, despite the dosing requirements. The lower initial price point could also improve access for patients without comprehensive insurance coverage.
What It Means for Investors
Novo Nordisk shares jumped in premarket trading on the news. The company's obesity franchise—which includes both Wegovy and Ozempic—has been the primary driver of its stock performance over the past two years.
Key considerations:
- Manufacturing capacity: Novo Nordisk has struggled with supply constraints for injectable Wegovy. The pill uses different production processes that could help address shortages.
- Pricing pressure: The $149 price point suggests willingness to trade margin for volume and market share.
- Competition timeline: Lilly's orforglipron, if approved, could intensify competition by mid-2025.
The Bottom Line
The approval of the Wegovy pill marks a new chapter in obesity treatment. For the first time, an effective GLP-1 medication is available in pill form at a price point that approaches accessibility. Whether this translates into the mass-market adoption that Novo Nordisk hopes for depends on supply execution, insurance coverage, and how patients respond to the dosing requirements. But the direction is clear: effective obesity treatment is becoming more accessible, and that's a development with implications far beyond any single drugmaker's stock price.
