The American Food and Drug Administration (FDA) has just approved the orally given Semaglutide, being sold under the brand name of Wegovy, Novo Nordisk, for the treatment of obesity and maintain weight reduction long term and to reduce the risk of major adverse cardiovascular events, as the first GLP-1 agonist pill.
According to the drug company, this approval was based on the following clinical trials: OASIS trial programme and the SELECT trial. In the OASIS 4 trial, it was observed that once daily orally given Semaglutide 25 mg showed a mean weight loss at 16.6% when treatment was adhered to in adult participants with obesity or overweight with one or more comorbidities. This weight loss achieved with the use of Wegovy pill is almost as same as that of injectable Wegovy 2.4 mg. Moreoever, one in three people have seen a 20% or more weight loss in the OASIS 4 trial. The well-known safety and tolerability profile of semaglutide was reaffirmed with the Wegovy® pill in the OASIS-4 trial, which was comparable to previous trials with semaglutide for weight management.
The company, Novo Nordisk, is planning to launch its orally given Wegovy pill in the US as early as January 2026. Novo Nordisk has submitted oral semaglutide 25 mg once-daily for obesity to the European Medicines Agency (EMA) and other regulatory authorities during the second half of 2025.
References:
- FDA Okays Oral Semaglutide 25 mg for Weight Management - Medscape - December 23, 2025.
- News Details. (n.d.). Novo Nordisk. https://www.novonordisk.com/content/nncorp/global/en/news-and-media/news-and-ir-materials/news-details.html?id=916472