The U.S. Food and Drug Administration – FDA on December 22, 2025, gave an approval to the first GLP-1 pill for obesity from Novo Nordisk, the Wegovy maker. This can surely be called a landmark decision, which, as per health experts, could open up treatment access to more patients.
Novo Nordisk said it anticipates the first GLP-1 pill for obesity to be launched in early 2026. The Danish drugmaker said that starting in early January 2026, the starting dose of 1.5 milligrams is going to be made available in pharmacies and also through select telehealth providers having savings offers for $149 a month.
This is indeed the same price that cash-paying patients can go ahead and access the starting dose of the pill on the direct-to-consumer website, TrumpRx, by President Donald Trump under a deal that Novo Nordisk struck with his administration in November 2025. Apparently, Trump’s site also launches in January 2026.
Although Novo Nordisk did not say how much higher doses of the drug are going to cost, the additional information pertaining to coverage and savings options in terms of eligible patients is going to be made available at that time too.
It is well to be noted that shares of Novo Nordisk gained around 10% in the extended trading on December 22.
The approval by the FDA also clears the pill for usage to reduce the risk of major cardiovascular events like death, heart attack, or stroke in adults having obesity and established cardiovascular disease, says Novo Nordisk.
That is indeed consistent with the approval label of the blockbuster weight loss drug of the company called Wegovy, which goes on to share the same active ingredient as semaglutide. Both work through mimicking the gut hormone GLP-1 in order to suppress appetite.
It is unclear exactly how many people are making use of GLP-1s in the U.S., specifically when it comes to obesity. But almost 1 in 8 adults said that they were taking a GLP-1 drug so as to lose weight or maybe treat another chronic condition as of November 2025, as per a poll from KFF, the health policy research organization.
The approval goes on to give Novo Nordisk a head start over Eli Lilly, its chief rival, which is at present the dominant player in the market and is also racing to launch its own obesity pill. Apparently, pills can indeed be referred to as the next battleground for the drugmakers, who went on to establish the booming GLP-1 space that some analysts say could as well be worth around $100 billion by the end of the decade.
In a note on December 22, Evan Seigerman, the BMO Capital Markets analyst, said that the approval of the pill from Novo Nordisk goes on to give the company a much-required win in light of the recent challenges in maintaining its incretin market share dominance.
Incretins are treatments that mimic the gut hormones like GLP-1. Eli Lilly earlier in 2025 had gained the majority share of the market, all thanks to Zepbound, its blockbuster obesity injection, which has been demonstrated to be more effective as compared to Wegovy from Novo Nordisk.
Seigerman says that Novo is most likely to benefit from the first-mover advantage, capturing the patients with a preference in terms of convenience as well as comfort, which is provided by an oral dosing regimen. However, he also noted that the market is indeed fast-evolving with competitive assets in development, and an approval for orforglipron, Eli Lilly’s pill, is also just around the corner.
What is the Wegovy pill?
The approval for Wegovy is based on a phase three trial that followed over 300 adults with obesity but not diabetes.
In that study, a 25-milligram dose of oral semaglutide by Novo Nordisk helped patients lose almost 16.6% of their weight on average post 64 weeks, as per a result from the trial presented at a medical conference in 2024. Notably, that weight loss was 13.6% when the company evaluated all patients, in spite of whether they stopped the drug.
The pill looks to be slightly more effective as compared to the experimental oral drug from Eli Lilly, which is still awaiting its FDA approval.
However, unlike the pill from Novo Nordisk, Eli Lilly’s treatment isn’t a peptide medication, which means it is absorbed way more easily by the body and does not need any sort of dietary restrictions. People who go on to take the pill from Novo Nordisk have to wait 30 minutes prior to eating or drinking every day.
Notably, patients flocked to the cheaper copycats when Ozempic as well as Wegovy were in short supply in the last two years because of skyrocketing demand, or if they did not have insurance coverage for those costly treatments. At the time of FDA-declared shortages, pharmacists can legally go on to make compounded versions when it comes to brand-name medications. However, the agency earlier in 2025 went on to determine that the shortage of semaglutide is indeed way past, barring this practice in numerous cases.
