Novo Nordisk’s Wegovy (semaglutide) pill has been approved by the US FDA as an oral weight loss medication.
In addition to its use for weight loss and weight loss maintenance, the oral medication can also reduce the risk of major adverse cardiovascular events in adults who are overweight or obese and have heart disease.
Wegovy is a glucagon-like peptide-1 (GLP-1) receptor agonist treatment and the pill is the first oral version to be approved for weight management.
Data from two trials, the OASIS clinical trial and the SELECT trial, was submitted for the approval.
Data reported from the OASIS 4 trial showed that taking oral semaglutide 25 mg once a day resulted in a 16.6% weight loss for those who were overweight or obese and had one or more comorbidities. Of those taking part in the trial, one in three had a higher weight loss of 20% or more. Those taking the 25mg pill lost a similar amount of weight as those using injectable Wegovy 2.4 mg.
The oral medication trials showed comparable safety and tolerability profiles to those confirmed in previous trials for the injected medication.
Wegovy is already approved by the FDA as a once-weekly injection.
Following the FDA’s approval, Novo Nordisk expects to launch the Wegovy pill in the US in January 2026. In the last six months of 2025, the oral medication was also submitted to the European Medicines Agency (EMA) and other regulatory authorities for approval.
Mike Doustdar, president and CEO of Novo Nordisk, said: “The pill is here. With the approval of the Wegovy pill, patients will have a convenient, once-daily pill that can help them lose as much weight as the original Wegovy injection.
“As the first oral GLP-1 treatment for people [who are] overweight or obese, the Wegovy pill provides patients with a new, convenient treatment option that can help patients start or continue their weight loss journey.”