By Peter Loftus
U.S. regulators approved the first GLP-1 weight-loss pill -- a tablet formulation of Novo Nordisk's Ozempic and Wegovy -- ushering in a new era of the obesity-drugs revolution that is expected to broaden their use.
Novo Nordisk said Monday it plans to start selling the new pill in the U.S. in early January , with a cash price of $149 a month for the starting dose.
The Food and Drug Administration approval is a milestone because weekly shots such as Wegovy and Eli Lilly's Zepbound have dominated the anti-obesity market to date. Yet many people with excess weight don't take the shots due to cost, spotty insurance coverage and fear of needles.
Drug companies and analysts say pills will tap in to demand from people who don't want an injection or would prefer the cadence of a daily dose. Pills also offer the prospect of lower prices and better health-insurance coverage than injections, because pills cost less to make.
Eli Lilly also plans to introduce a new weight-loss pill, potentially within weeks or months.
"We now have injectable-like efficacy in a once-daily pill," said David Moore, executive vice president of Novo Nordisk's U.S. operations. "And that's a change from where we've been in terms of treating obesity.
The FDA also approved the Wegovy pill to reduce the risk of heart attacks and strokes in people with established cardiovascular disease, a use already approved for the Wegovy shot.
Leerink Partners analyst David Risinger estimates that pills will eventually make up about 25% of the projected $150 billion total obesity-drug market.
For Novo Nordisk, the new drug approval is a chance for the company to turn things around following a difficult year. It lost its lead in the obesity-drug market to Eli Lilly, and some investors think Lilly's pipeline of potential new weight-loss drugs has bigger market potential than Novo Nordisk's.
The challenges led to the ouster of Novo Nordisk's chief executive and a shake-up of its board of directors. Novo Nordisk also recently lost out to Pfizer in a bidding war to acquire an obesity-drug startup, Metsera.
Novo Nordisk's new drug, which the company plans to call Wegovy pill, has the main ingredient semaglutide, which is the same ingredient in its injected diabetes drug Ozempic and weight-loss drug Wegovy. Novo Nordisk has been selling a pill formulation of semaglutide, Rybelsus, that is approved specifically for Type 2 diabetes and not weight loss.
Semaglutide is a GLP-1 drug, which works by mimicking a gut hormone to reduce appetite, make people feel full sooner when eating and slow the rate of food leaving the stomach for the intestine.
In a study of 205 people with excess weight, those taking Novo Nordisk's pill for 64 weeks lost an average of 16.6% of their body weight.
The Wegovy pill could generate sales of nearly $2 billion in 2030, TD Cowen analysts estimate.
Eli Lilly's GLP-1 pill is called orforglipron, and in a study of 3,127 patients its highest dose helped people lose an average of 12.4% of body weight at 72 weeks.
Both drugs can cause side effects including gastrointestinal disorders such as nausea.
Lilly has said it would submit its pill for regulatory approval by the end of 2025. It is seeking an expedited FDA review that could result in approval in early 2026.
Lilly plans to charge $149 a month for the lowest starting dose of its pill, well below the $1,086 list price of Zepbound weight-loss treatment. TD Cowen analysts estimate orforglipron will generate sales of about $5.6 billion in 2030.
Lilly's pill has no restrictions on how patients take it, whereas people are supposed to take Novo Nordisk's pill on an empty stomach in the morning and then wait a half-hour before eating.
Novo Nordisk's Moore said the restriction on waiting to eat hasn't been an impediment to people taking Rybelsus, the pill for diabetes with the same main ingredient.
Write to Peter Loftus at Peter.Loftus@wsj.com
(END) Dow Jones Newswires
December 22, 2025 18:38 ET (23:38 GMT)
Copyright (c) 2025 Dow Jones & Company, Inc.
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