FDA approves first GLP-1 pill for obesity from Wegovy maker Novo Nordisk

The U.S. Food and Drug Administration on Monday approved Wegovy maker’s first GLP-1 anti-obesity pill Novo NordiskIt’s a landmark decision that health experts say could open access to treatment to more patients.

Novo Nordisk said it expects to launch the pill in early 2026. The Danish drugmaker said the 1.5-milligram starting dose will be available in pharmacies and through select telehealth providers starting in early January for $149 per month.

Novo Nordisk did not say how much higher doses of the drug would cost, but said additional information on insurance coverage and savings options for eligible patients will be available at that time.

Shares of Novo Nordisk gained nearly 9% in extended trading on Monday.

Approval gives Novo Nordisk an advantage over its chief rival Eli Lilly, The company that is currently the dominant player in the market and is racing to launch its own obesity pill. Pills are the next battleground for the two drugmakers that make up the fast-growing GLP-1 space, which some analysts say could be worth nearly $100 billion by the 2030s.

Wall Street thinks there’s plenty of room for pills in the market, with a Goldman Sachs analyst saying in August that pills could take 24% (or about $22 billion) of the 2030 global weight-loss drug market.

“What we’ve learned from years of research is that having the oral option really opens up, mobilizes and motivates diverse populations to seek treatment,” Dave Moore, vice president of U.S. operations for Novo Nordisk, told CNBC before the approval. “Having that conversation with their doctor to see if this is the right thing for them.”

“We’re excited to be able to give people a choice and make sure we have access and ease of access like we do with our injections,” he continued.

The FDA’s approval also validates the pill’s use in adults with obesity and established cardiovascular disease to reduce the risk of major cardiovascular events such as death, heart attack or stroke, according to Novo Nordisk. This is consistent with the approval label for the company’s blockbuster weight-loss drug Wegovy, which shares the same active ingredient, semaglutide.

The approval is based on a phase three trial that followed more than 300 adults who did not have diabetes but had obesity.

In that study, a 25-milligram dose of Novo Nordisk’s oral dose of semaglutide helped patients lose weight by an average of 16.6% after 64 weeks, according to trial results presented at a medical conference in 2024. When the company analyzed all patients, whether they had stopped the drug or not, that weight loss was 13.6%.

The pill appears to be slightly more effective than Eli Lilly’s experimental oral drug, which is still awaiting FDA approval.

But unlike Novo Nordisk’s pill, Eli Lilly’s treatment is not a peptide drug. This means it is more easily absorbed by the body and does not require dietary restrictions. People taking the Novo Nordisk pill must wait 30 minutes before eating or drinking each day.

Pill prices have brought costs closer to what some people pay for unapproved, compounded versions of brand-name GLP-1s, some of which are still illegally mass-marketed and sold in the United States, Moore said.

When Ozempic and Wegovy were in short supply or lacked insurance coverage for expensive treatments due to rapidly increasing demand over the past two years, patients flocked to cheaper imitators. During FDA-declared shortages, pharmacists can legally produce compounded versions of brand-name drugs. But the agency determined earlier this year that the semaglutide shortage was over, and in most cases the application was blocked.

“This remains concerning and troubling to us,” Moore told CNBC, referring to illegitimate ingredients illegally imported into the United States and used by some pharmacies to create counterfeit versions of GLP-1s.

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