The FDA has approved the first pill version of Wegovy, expanding access to one of the most popular and effective weight-loss medications in the U.S.
The once-daily tablet offers a needle-free alternative to the injectable drug that has helped millions lose weight and reduce obesity-related health risks.
Experts say the approval could significantly reshape the obesity treatment market, making GLP-1 medications easier for patients to start and maintain.
In a decision that could change how obesity is treated in the United States, the U.S. Food and Drug Administration has approved a pill form of Wegovy, the popular weight-loss drug previously available only as a weekly injection.
The new oral medication contains semaglutide, the same active ingredient used in injectable Wegovy, and works by mimicking a hormone that regulates appetite and blood sugar. By slowing digestion and increasing feelings of fullness, the drug helps patients eat less and lose weight over time.
Novo Nordisk, the drug’s manufacturer, said the pill was shown in clinical trials to produce significant weight loss when combined with diet and exercise. While average weight loss was slightly lower than that seen with the injectable version, researchers found the pill to be highly effective and well tolerated, with nausea, vomiting, and diarrhea remaining the most common side effects.
Removing a significant obstacle
Health experts say the pill format could remove a major psychological and practical barrier for many patients who are reluctant to self-inject medication.
Obesity affects more than 40% of U.S. adults and is linked to heart disease, diabetes, stroke, and certain cancers. Demand for GLP-1 medications like Wegovy has surged in recent years, fueling shortages, high prices, and intense debate over insurance coverage.
The pill version of Wegovy is expected to face similar coverage challenges. Many insurers still limit reimbursement for weight-loss drugs, although employer plans and Medicare policymakers are increasingly reevaluating those restrictions as evidence grows that treating obesity can lower long-term health costs.
Novo Nordisk said it plans to launch the oral Wegovy within the next few months, with pricing details to be announced closer to release. Analysts predict the pill could dramatically expand the market, intensifying competition with rival drugmakers racing to develop their own oral obesity treatments.