FDA approves Wegovy tablets, the first oral semaglutide for weight management

Drugs@FDA lists Wegovy tablets under a separate application, NDA 218316, approved on 22 December 2025 as a new dosage form. The listed strengths are 1.5 mg, 4 mg, 9 mg and 25 mg oral tablets ^[1]. The injection keeps its own application, NDA 215256, first approved in June 2021 ^[1].

The current US label, which now covers both forms, says Wegovy tablets are indicated alongside a reduced-calorie diet and increased physical activity to reduce excess body weight and maintain weight reduction long term in adults with obesity, or in adults with overweight and at least one weight-related condition. The label also lists a tablet indication to reduce the risk of major adverse cardiovascular events in adults with established cardiovascular disease and obesity or overweight ^[2]. The label states that the tablets have not been studied for weight reduction in adults with type 2 diabetes ^[2].

This is the first time a semaglutide tablet has had a US weight-management label. Until then, the only semaglutide tablets in the US were diabetes products, so questions about oral semaglutide for weight loss in non diabetics had no labelled answer. Semaglutide pills for weight now have an approved product in the US, sold as Wegovy rather than under a new brand name. Our GLP-1 brand names guide explains which brands contain which molecule.

The trial behind the approved 25 mg dose was OASIS 4 (NCT05564117), which the label lists as Study 7. It was published in the New England Journal of Medicine in September 2025. It enrolled 307 adults without diabetes who had a BMI of 30 or more, or 27 or more with at least one obesity-related complication, and randomised them 2:1 to oral semaglutide 25 mg or placebo once daily, alongside lifestyle support, for 64 weeks of treatment ^[3].

Average body weight fell by 13.6% on oral semaglutide and 2.2% on placebo, an estimated difference of 11.4 percentage points (95% CI 9.0 to 13.9). People on the tablet were significantly more likely to lose at least 5%, 10%, 15% and 20% of their starting weight, and to report better physical function on a quality-of-life scale ^[3]. The label reports a 13.6% loss against 2.4% on placebo in its intention-to-treat table. The placebo figure differs slightly between the two sources ^{[2] [3]}.

An earlier trial, OASIS 1, tested a higher 50 mg daily tablet in 667 adults with overweight or obesity and no type 2 diabetes. After 68 weeks, weight fell by 15.1% on oral semaglutide and 2.4% on placebo ^[4]. That 50 mg dose is not on the US label. It showed that a daily semaglutide tablet, taken by people without diabetes, could produce double-digit average weight loss against placebo ^[4].

The label starts Wegovy tablets at 1.5 mg once daily for 30 days, then 4 mg for days 31 to 60 and 9 mg for days 61 to 90, reaching the 25 mg maintenance dose from day 91 ^[2]. It sets strict conditions for absorption: take the tablet on an empty stomach in the morning with up to 4 ounces of water only, swallow it whole, and wait at least 30 minutes before eating, drinking or taking other oral medicines ^[2]. The tablets contain an absorption enhancer, salcaprozate sodium (SNAC) ^[2].

The label also sets out switching. A person on the 2.4 mg weekly injection may start 25 mg tablets one week after the last injection, and a person on 25 mg tablets may start the 2.4 mg injection the day after the last tablet ^[2]. These are label doses, reported here as information. They are not advice, and they do not apply to semaglutide sold as a research peptide, whose content is unverified.

In OASIS 4, gastrointestinal adverse events affected 74.0% of people on oral semaglutide and 42.2% on placebo ^[3]. The label reports that 6.9% of patients on the 25 mg tablet and 5.9% on placebo stopped treatment because of adverse reactions, most often gastrointestinal ^[2]. It also reports severe gastrointestinal reactions in 2% of tablet-treated patients against none on placebo, gallstones in 2.5% against 1%, and dysesthesia, an altered skin sensation, in 5% against none ^[2].

Because semaglutide slows stomach emptying, the label advises monitoring of other oral medicines, and it notes that levothyroxine exposure rose by 33% when taken with the semaglutide tablet in a drug interaction study ^[2]. The tablet carries the same class warnings as the injection, which our semaglutide guide covers in full.

This semaglutide news is a US approval. The MHRA's public guidance on GLP-1 medicines, last updated in February 2026, lists Rybelsus, the diabetes tablet, as licensed for type 2 diabetes but not for weight management, and does not mention a Wegovy tablet ^[5]. The same guidance says legitimate GLP-1 medicines come as prefilled pens or tablets, and that powder in vials for mixing is not authorised ^[5]. Our UK legal status page covers the wider rules.

For readers comparing semaglutide tablets with weekly injections of other drugs, the tirzepatide vs semaglutide comparison sets out the head-to-head evidence. Oral semaglutide weight loss results come from licensed tablets in monitored trials, and they cannot be assumed for unlicensed products.