FDA clears Wegovy pill, the first oral GLP-1 approved for weight loss

The FDA approved a once-daily pill form of semaglutide, sold under the Wegovy brand, for long-term weight management and for lowering cardiovascular risk in adults who have established heart disease along with obesity or overweight ^[1][2][4]. No GLP-1 pill had been cleared for weight loss before this decision ^[1][4][5].

The 25 mg tablet carries the same active ingredient as injectable Wegovy. Novo Nordisk said the pill will reach US pharmacies in early January 2026 and set the price at $149 a month ^[1]. The weight indication covers adults with obesity, or with overweight plus at least one weight-related condition, as an addition to a reduced-calorie diet and more physical activity ^[2][5]. The heart indication covers cardiovascular death, non-fatal heart attack and non-fatal stroke in adults with established cardiovascular disease who also have obesity or overweight ^[2].

The trial behind the weight indication

OASIS 4 randomized 307 adults without diabetes who had a body mass index of 30 or higher, or 27 or higher with at least one related condition ^[1][4]. About two-thirds received oral semaglutide 25 mg and the rest received placebo, both alongside lifestyle interventions ^[1][4].

After 64 weeks, average body weight fell 13.6% on semaglutide and 2.2% on placebo (95% CI, -13.9% to -9.0%; P < .001) ^[1][4]. The shares of participants reaching 5%, 10%, 15% and 20% weight loss were 79.2% vs 31.1%, 63% vs 14.4%, 50.0% vs 5.6%, and 29.7% vs 3.3% ^[1]. An analysis assuming participants took the drug as assigned estimated a 16.6% average reduction, with placebo at 2.7% ^[4]; Novo Nordisk has said indirect comparisons show results comparable to injectable Wegovy 2.4 mg ^[3][5].

Side effects were common. Gastrointestinal problems, mainly nausea and vomiting, affected 74.0% of the semaglutide group and 42.2% of the placebo group ^[1][4]. Overall, 93.1% of semaglutide participants and 85.3% of placebo participants reported any adverse event, mostly mild or moderate, and the trial reported no permanent discontinuations ^[4]. Like every semaglutide product, the pill carries a boxed warning about thyroid C-cell tumors seen in rodents and is not for people with a personal or family history of medullary thyroid carcinoma or MEN 2 ^[2][3].

Where the heart data comes from

The cardiovascular claim draws partly on earlier work. In October 2025, oral semaglutide 7 mg and 14 mg won a cardiovascular indication for adults with type 2 diabetes at high risk ^[1][4]. The SOUL trial enrolled 9,650 such adults and followed them for a median of about four years; major adverse cardiovascular events occurred in 12.0% of those on semaglutide versus 13.8% on placebo, a 14% relative risk reduction ^[1]. SOUL studied people with diabetes, and it is not clear whether the same benefit extends to patients who have heart disease and obesity without diabetes ^[1].

Why it matters for patients

For years, GLP-1 treatment for weight loss in the US meant a weekly injection. A daily tablet gives people who dislike needles another route, and one investigator said an effective oral option could help patients stay on these medicines long term ^[4].

Taking the pill is not simple. The label directs patients to take it once daily in the morning on an empty stomach with no more than 4 ounces of plain water, then wait at least 30 minutes before food, other drinks or other oral medicines, and to swallow the tablet whole ^[2]. Oral semaglutide is poorly absorbed — bioavailability for the earlier diabetes tablet is under 1% — so those steps matter ^[3]. Tablets come in 1.5 mg, 4 mg, 9 mg and 25 mg strengths, and formulations are not interchangeable milligram for milligram ^[2][3].

Other practical points: semaglutide may harm a fetus, so the label says to stop it at least two months before a planned pregnancy, and breastfeeding is not recommended during tablet treatment ^[2]. People who also take insulin or a sulfonylurea face a higher risk of low blood sugar and may need dose changes ^[2][3]. Delayed gastric emptying is now listed as a labeled adverse event, which matters for planning surgery or procedures ^[3].

Whether insurers will cover the pill, and on what terms, has not been disclosed ^[1][5].

What happens next

The US launch is planned for early January 2026 ^[1][4][5]. Novo Nordisk filed with the European Medicines Agency and other regulators in the second half of 2025, and those decisions have not been announced ^[5]. WeightWatchers said it would offer the oral product through its telehealth service ^[5]. Eli Lilly's oral orforglipron, which can be taken without food or water restrictions, is under FDA review; in the ATTAIN-MAINTAIN trial, patients who switched from semaglutide to orforglipron had a body weight change of -0.1 kg over 24 weeks versus 9.4 kg on placebo ^[4]. Healio later reported that the FDA approved orforglipron under the Foundayo brand for adults with obesity ^[14]. Novo Nordisk also moved its oral semaglutide for type 2 diabetes to a reformulated tablet sold as Ozempic, launched nationwide on May 4, 2026, phasing out Rybelsus in the US ^[3].