On Monday, the U.S. Food and Drug Administration gave the green light to a pill version of Wegovy, the first daily oral medication to treat obesity.
FDA Approval Marks a Milestone in Obesity Treatment
The approval gives Novo Nordisk a competitive edge over rival Eli Lilly, whose oral drug orforglipron remains under review. Both drugs belong to the GLP-1 class, which mimic a natural hormone that controls appetite and fullness.
Drug Details and Clinical Results
The Wegovy pill contains 25 milligrams of semaglutide, the same ingredient found in the injectable Wegovy, Ozempic, and the 2019 diabetes pill Rybelsus. In a clinical trial, participants who took oral Wegovy lost an average of 13.6 percent of their total body weight over about 15 months, compared with a 2.2 percent loss for those who took a placebo. That result is nearly the same as the 15 percent weight loss seen with injectable Wegovy.
Chris Mertens, a 35-year-old pediatric lung doctor from Menomonee Falls, Wisconsin, joined the Novo Nordisk trial in 2022. He reported losing about 40 pounds while taking the Wegovy pill. He said the daily medication helped reduce his appetite and intrusive thoughts of food. “If there were days where I missed a meal, I almost didn’t realize it,” Mertens said.
Lilly’s Oral Candidate and the Competitive Landscape
Participants who took the highest dose of Lilly’s orforglipron lost 11.2 percent of their total body weight on average over nearly 17 months, compared with a 2.1 percent loss for those on a placebo. Both oral drugs produced less weight loss than Lilly’s injectable Zepbound, which targets GLP-1 and GIP and achieved a 21 percent average weight loss.
All GLP-1 drugs, whether oral or injectable, share similar side effects such as nausea and diarrhea. The Wegovy pill must be taken with a sip of water on an empty stomach, followed by a 30-minute break before eating or drinking. This schedule helps the drug avoid breakdown in the stomach and improves absorption. In contrast, Lilly’s orforglipron has no dosing restrictions. The drug is being considered under the FDA’s new priority voucher program, with a decision expected by spring.
Practical Considerations and Pricing
Producing pills is generally cheaper than making injectable drugs, which could lower the cost of the new oral medications. The Trump administration earlier this year said officials had worked with drugmakers to negotiate lower prices for GLP-1 drugs, which can cost upwards of $1,000 a month. Novo Nordisk said the starting dose of the Wegovy pill would be available for $149 per month from some providers. Additional cost information will be released in January.
About one in eight Americans have used injectable GLP-1 drugs, according to a survey from KFF, a nonprofit health policy research group. Many more people struggle to afford the costly shots. “There’s an entire demographic that can benefit from the pills,” said Dr. Fatima Cody Stanford, a Massachusetts General Hospital obesity expert. “For me, it’s not just about who gets it across the finish line first. It’s about having these options available to patients.”
It remains unclear whether patients will prefer daily pills or weekly injections. Some patients dislike needles, while others do not mind the weekly injections. Mertens turned to injectable Zepbound after he regained weight once the Wegovy pill trial ended. He said he liked the discipline of the daily pill: “It was a little bit of an intentional routine and a reminder of today I’m taking this so that I know my choices are going to be affected for the day.”
Dr. Angela Fitch, an obesity expert and chief medical officer of knownwell, said whatever the format, the biggest benefit will be in making weight-loss medications more widely accessible and affordable. “It’s all about the price,” she said. “Just give me a drug at $100 a month that is relatively effective.”
Key Takeaways
- FDA approves the first oral Wegovy pill, giving Novo Nordisk a lead over Lilly.
- The 25-mg semaglutide pill achieves weight loss similar to injectable Wegovy, with a 13.6 percent average reduction.
- Pricing starts at $149 per month, potentially lower than the $1,000-plus cost of injectable GLP-1 drugs.
The approval signals a significant shift in obesity treatment, offering a convenient and potentially more affordable option for millions of Americans who currently face barriers to accessing injectable therapies.
