In a landmark decision that could reshape the landscape of metabolic health, the U.S. Food and Drug Administration (FDA) approved a pill version of the blockbuster drug Wegovy on December 22, 2025.
For years, the gold standard for GLP-1 therapy has been weekly injections, such as the original Wegovy and Eli Lilly’s Zepbound. While highly effective, the “needle factor” and strict cold-chain storage requirements have remained barriers for many. The approval of the Wegovy pill—containing 25 mg of semaglutide—aims to broaden access for the nearly 100 million American adults living with obesity.
Clinical Efficacy and Patient Impact
The FDA’s green light was primarily based on the results of the OASIS 4 phase 3 clinical trial. The study followed 307 adults with obesity or overweight who had at least one weight-related comorbidity. The results were striking:
- Weight Loss: Participants who strictly adhered to the daily pill regimen achieved an average weight loss of 16.6% over 64 weeks.
- Comparison: Even when accounting for those who missed doses, the average weight loss remained a robust 13.6%, compared to just 2.2% in the placebo group.
- Cardiovascular Benefits: Like its injectable predecessor, the pill is also approved to reduce the risk of major adverse cardiovascular events (MACE), such as heart attack and stroke, in adults with established heart disease.
“The pill is here,” said Mike Doustdar, President and CEO of Novo Nordisk, in a company statement. “With today’s approval, patients will have a convenient, once-daily option that can help them lose as much weight as the original injection.”
Market Shifts and Accessibility
The timing of the approval gives Novo Nordisk a significant competitive advantage over Eli Lilly, whose oral candidate, orforglipron, is still undergoing regulatory review. To ensure a rapid foothold, Novo Nordisk announced that the pill will be available in U.S. pharmacies as early as January 2026.
Price and insurance coverage have long been the Achilles’ heel of GLP-1 drugs. In a move to improve affordability, Novo Nordisk revealed that the starting dose of 1.5 mg will be available for a self-pay price of $149 per month through select telehealth providers and savings offers. This is a substantial reduction compared to the typical $1,000-plus list prices for injectable versions.
Safety Profile
Medical experts noted that the side effect profile of the tablet is consistent with other semaglutide products. Most reported issues were gastrointestinal, including nausea, vomiting, and diarrhea, which typically subside as the body adjusts to the medication. Doctors emphasize that the pill must be taken on an empty stomach with a small sip of water to ensure proper absorption.
As the “needle-free” era of obesity treatment begins, the medical community looks toward a future where metabolic health is managed as a chronic, accessible condition rather than a specialized surgical or injectable luxury.
Sources:
- CBS News: FDA approves Wegovy pill for weight loss
- Novo Nordisk Official News: Wegovy pill approved in the US
- AJMC: FDA Approves Oral Semaglutide as First GLP-1 Pill for Weight Loss
- Associated Press: US regulators approve Wegovy pill for weight loss
- PR Newswire: Novo Nordisk’s Wegovy pill, the first and only oral GLP-1 for weight loss
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