Written By: Pharmacally Medical News Desk
Novo Nordisk A/S has secured US FDA approval for its oral formulation of Wegovy, marking the first oral GLP-1 receptor agonist approved in the US for chronic weight management. The once-daily pill is indicated for adults with obesity or overweight who have at least one weight-related comorbidity, to be used alongside diet and physical activity.
This approval expands the GLP-1 landscape beyond injections, offering a pill-based option that may appeal to patients who prefer oral therapy or have difficulty with injectable treatments.
Clinical Evidence: OASIS and SELECT Trial Programmes
The FDA decision is based on data from the Phase 3 OASIS clinical development program (NCT05564117) and supportive evidence mainly related to cardiovascular risk reduction from the SELECT trial (NCT03574597). OASIS evaluated once-daily oral semaglutide at 25 mg and 50 mg doses in adults with obesity or overweight with one or more comorbidities.
The global Phase 3 OASIS program comprised four trials and enrolled approximately 1,300 participants. These studies were designed to assess both the efficacy and long-term safety of oral semaglutide as a chronic weight-management therapy.
OASIS 4: Key Efficacy and Safety Results
OASIS 4 was a 64-week, Phase 3b, randomized efficacy and safety trial comparing oral semaglutide 25 mg once daily with placebo in 307 adults with obesity or overweight and at least one comorbidity.
Key findings from OASIS 4 include:
- 16.6% mean weight loss among participants who adhered to treatment
- One in three participants achieved 20% or greater weight loss, a level typically associated with bariatric-scale outcomes
- Clinically meaningful weight reduction observed across a broad patient population with obesity-related conditions
These results highlight that the oral formulation delivers substantial weight loss, approaching outcomes previously associated mainly with injectable GLP-1 therapies.
Safety Profile: In Line with Known Semaglutide Data
The safety profile of oral Wegovy in the OASIS program was consistent with the established GLP-1 receptor agonist class. The most common adverse events were gastrointestinal, including nausea, vomiting, diarrhea, and constipation, most frequently occurring during dose escalation.
Labeling includes known class warnings and precautions, including risks of pancreatitis and gallbladder disease, as well as a boxed warning for thyroid C-cell tumors based on animal studies. No new safety concerns unique to the oral formulation were identified.
Commenting on the approval, Mike Doustdar, President and CEO of Novo Nordisk, emphasized that the availability of an oral GLP-1 option represents an important step toward meeting diverse patient needs in obesity care. He noted that many patients delay or avoid injectable therapies, and a pill-based alternative could close that gap while maintaining strong clinical efficacy.
Novo Nordisk expects to launch the Wegovy pill in the US in early January 2026. Beyond the US, the company has already submitted oral semaglutide 25 mg once daily for the treatment of obesity to the European Medicines Agency and other regulatory authorities during the second half of 2025.
With injectable and oral GLP-1 options now in development and approved, Novo Nordisk continues to build a broad obesity treatment portfolio aimed at long-term disease management rather than short-term weight loss alone.
Reference
Novo Nordisk A/S: Wegovy® pill approved in the US as first oral GLP-1 for weight management, 23 December 2025, https://www.novonordisk.com/content/nncorp/global/en/news-and-media/news-and-ir-materials/news-details.html?id=916472
Can oral Semaglutide (Wegovy) 25 mg replace the Once-Weekly 2.4 mg Injection for Obesity?, 25 September 2025, https://pharmacally.com/can-oral-semaglutide-wegovy-25-mg-replace-the-once-weekly-2-4-mg-injection-for-obesity/
Research Study Looking at How Well Semaglutide Tablets Taken Once Daily Work in People Who Have a Body Weight Above the Healthy Range (OASIS 4), ClinicalTrials.gov ID NCT05564117, https://clinicaltrials.gov/study/NCT05564117
Wharton S, Lingvay I, Bogdanski P, Duque do Vale R, Jacob S, Karlsson T, Shaji C, Rubino D, Garvey WT; OASIS 4 Study Group. Oral Semaglutide at a Dose of 25 mg in Adults with Overweight or Obesity. N Engl J Med. 2025 Sep 18;393(11):1077-1087. Doi: 10.1056/NEJMoa2500969. PMID: 40934115.
Semaglutide Effects on Heart Disease and Stroke in Patients with Overweight or Obesity (SELECT), ClinicalTrials.gov ID NCT03574597, https://clinicaltrials.gov/study/NCT03574597
Long-Term SELECT Trial: Semaglutide Cuts Cardiovascular Events by 20% beyond Weight Loss, 26 October 2025, https://pharmacally.com/long-term-select-trial-semaglutide-cuts-cardiovascular-events-by-20-beyond-weight-loss/