The U.S. Food and Drug Administration has given the green light to Novo Nordisk’s first oral version of its popular Wegovy weight-loss pill, marking a historic first for an oral GLP-1 medication.
In a Tuesday press release, the company explained that the pill is designed for once-daily dosing and aims to reduce excess body weight, help maintain weight loss over the long term, and lower the risk of major adverse cardiovascular events.
Novo Nordisk plans to bring the product to market in the United States in early 2026, according to the company’s announcement.
The FDA’s approval follows a prior August clearance of the Wegovy injection, which the agency authorized for the treatment of metabolic-associated steatohepatitis in adults with significant liver scarring.
Mike Doustdar, Novo Nordisk’s president and CEO, said the new oral pill “provides patients with a new, convenient treatment option that can help patients start or continue their weight loss journey.”
Earlier this year, the Trump administration highlighted agreements with Novo Nordisk and Eli Lilly to offer GLP-1 drugs at reduced prices under its Most Favored Nation policy.
Under the agreement, oral GLP-1s that were still under review are slated to be sold at a starting price of $149 per month for individuals enrolled in Medicare and Medicaid, as well as those who will use the TrumpRX platform that is set to launch in January.
Health and Human Services Secretary Robert F. Kennedy Jr. described the move as a “lifesaver” for people who cannot afford the medications, adding that his department will also tackle the “root causes of chronic disease.”
A November survey conducted by the health-policy research group KFF found that 12 percent of respondents were currently taking GLP-1 drugs for weight loss, yet more than half reported that the medications were difficult to afford.
Novo Nordisk lists nausea, gastrointestinal problems, vomiting, fatigue, dizziness, and low blood sugar in people with type 2 diabetes as the most common side effects of Wegovy.
The oral formulation could broaden access for patients who prefer pills over injections, potentially increasing adherence and weight-loss outcomes across a wider population.
Because the pill is expected to launch in 2026, patients who need immediate treatment may still rely on the injection or other weight-loss therapies until the oral version becomes available.
The FDA’s approval also underscores the growing regulatory acceptance of GLP-1 medications for weight management, a class that has expanded rapidly in recent years.
Novo Nordisk’s strategy to price the oral pill at $149 per month for Medicare and Medicaid beneficiaries aligns with the Trump administration’s broader effort to make high-cost drugs more affordable for vulnerable groups.
The company’s decision to launch the pill in early 2026 suggests a phased approach, allowing time for clinical data collection and market preparation before the product reaches consumers.
Health policy analysts note that the price point may still pose a barrier for many patients, despite the lower cost compared to the injection, which can exceed $1,000 per month.
The announcement also highlights the importance of monitoring side-effect profiles, as patients with type 2 diabetes may experience hypoglycemia when taking Wegovy.
As the market for GLP-1 drugs continues to grow, Novo Nordisk’s entry into the oral segment could intensify competition among manufacturers seeking to capture the expanding weight-loss market.
The FDA’s decision to approve the oral Wegovy may also influence other pharmaceutical companies to develop oral formulations of their GLP-1 products, potentially reshaping the therapeutic landscape.
In summary, the FDA’s approval of Novo Nordisk’s oral Wegovy marks a significant milestone in weight-loss treatment, offering a new, convenient option for patients while setting the stage for broader access and continued innovation in the GLP-1 space.
Key Takeaways
- FDA approves first oral Wegovy, slated for 2026 launch.
- Oral GLP-1s will start at $149/month for Medicare/Medicaid under Trump’s policy.
- 12% of surveyed adults use GLP-1 drugs for weight loss, yet affordability remains a challenge.
- The approval paves the way for broader access and competition in the weight-loss medication market.
With the oral Wegovy on the horizon, patients and clinicians alike will watch closely to see how the new formulation performs in real-world settings and whether it can help more people achieve sustainable weight loss.
