FDA approves oral semaglutide 25 mg for weight management

The US Food and Drug Administration approved Novo Nordisk's Wegovy pill — once-daily oral semaglutide 25 mg — for chronic weight management and to reduce the risk of major adverse cardiovascular events (MACE) in adults with obesity or overweight and established cardiovascular disease ^[4][5]. It is the first oral GLP-1 receptor agonist approved anywhere for weight management ^[5]. Novo Nordisk said the pill would launch in the US in early January 2026 at $149 per month, according to the manufacturer ^[1][4].

What the trial showed

The weight-management approval rests mainly on OASIS 4, a phase 3 trial of 307 adults with obesity (BMI of 30 or higher) or overweight (BMI of 27 or higher with at least one weight-related condition), all without diabetes ^[4]. Participants were randomized 2:1 to oral semaglutide 25 mg (205 people) or placebo (102 people), with lifestyle counseling for both groups ^[1][4].

At week 64, average body weight fell 13.6% with oral semaglutide versus 2.2% with placebo ^[4]. When researchers estimated the effect among people who stayed on treatment as assigned, average loss was 16.6% ^[3][4]. Roughly one in three people on treatment lost 20% or more of their body weight ^[3][5]. In the main analysis, 79.2% of the semaglutide group lost at least 5% of body weight versus 31.1% on placebo; 63% versus 14.4% lost at least 10%; 50.0% versus 5.6% lost at least 15%; and 29.7% versus 3.3% lost at least 20% ^[1]. Researchers also reported improvements in waist circumference, fasting glucose, triglycerides, C-reactive protein and physical function scores ^[1]. Sources describe OASIS 4 slightly differently — one calls it a 71-week trial, others a 64-week trial — though all report the primary results at week 64 ^[1][3][4].

Side effects were typical for the drug class. Adverse events occurred in 93.1% of the semaglutide group and 85.3% of the placebo group, and were mostly mild or moderate ^[4]. Gastrointestinal problems, especially nausea and vomiting, were more common with semaglutide (74.0% versus 42.2%) ^[1][4].

Novo Nordisk says the approval also draws on the SELECT cardiovascular outcomes trial ^[4][5]. One clinical outlet noted that the earlier SOUL trial of oral semaglutide, which enrolled 9,650 adults with type 2 diabetes and found MACE in 12.0% on semaglutide versus 13.8% on placebo over a median of about four years, supported cardiovascular claims only in people with diabetes ^[1].

How the pill is taken

The Wegovy label lists tablets in 1.5 mg, 4 mg, 9 mg and 25 mg strengths ^[2]. Tablets are taken once daily on an empty stomach in the morning with no more than 4 ounces of plain water, swallowed whole, with at least a 30-minute wait before other food, drinks or oral medicines ^[2][3]. Treatment starts at 1.5 mg once daily for 30 days, then steps up every 30 days toward the maintenance dose ^[2]. Semaglutide products carry a boxed warning about thyroid C-cell tumors in rodents and are contraindicated in people with a personal or family history of medullary thyroid carcinoma or MEN 2 ^[2]. The label says using Wegovy tablets alongside other semaglutide products or any other GLP-1 receptor agonist is not recommended ^[2].

Why it matters for patients

Until now, every GLP-1 approved for weight loss in the US required an injection. A pill removes needles from the equation, which Novo Nordisk and outside researchers have argued could help more people start and stay on treatment ^[4][5]. But the pill comes with strict timing rules — morning, empty stomach, limited water — that injections do not have, and pharmacists have flagged that oral semaglutide may carry a modestly higher gastrointestinal burden than the injection ^[3].

Cost and coverage are separate questions. The $149 monthly figure cited is a manufacturer price, not an insurance benefit ^[1]. What commercial plans, Medicare or Medicaid will pay is not stated in these sources.

What happens next

The pill was slated for US pharmacies in early January 2026 ^[4][5], with telehealth company WeightWatchers saying it planned to offer it ^[5]. Novo Nordisk filed for approval with the European Medicines Agency and other regulators in the second half of 2025 ^[5]. Competition followed: Eli Lilly's orforglipron was under FDA review at the time of this approval ^[4] and was later approved as Foundayo for adults with obesity ^[14]. Separately, Novo Nordisk launched a reformulated oral semaglutide under the Ozempic brand for type 2 diabetes on May 4, 2026, phasing out Rybelsus in the US ^[3].