FDA Approves Novo’s Wegovy® Pill as First Oral GLP-1 Weight Loss Therapy
Novo Nordisk A/S has announced that the US Food and Drug Administration (FDA) has approved the Wegovy® pill (once-daily oral semaglutide 25 mg) for the reduction of excess body weight and the long-term maintenance of weight loss, as well as for reducing the risk of major adverse cardiovascular events in eligible adults.
The approval makes Wegovy® the first oral glucagon-like peptide-1 (GLP-1) receptor agonist authorised by the FDA for weight management, marking a significant development in the treatment landscape for obesity and overweight, where GLP-1 therapies have until now largely been available as injectable medicines.
Clinical Evidence Supporting Approval
The FDA decision is based on data from the OASIS clinical trial programme and the SELECT trial. In the phase 3b OASIS 4 study, once-daily oral semaglutide 25 mg demonstrated a mean weight loss of 16.6% over 64 weeks in adults with obesity or overweight and at least one comorbidity, when treatment adherence was maintained. One in three participants achieved weight loss of 20% or greater.
Novo Nordisk reported that the weight loss achieved with the Wegovy® pill was comparable to that observed with the once-weekly injectable Wegovy® 2.4 mg. The safety and tolerability profile of oral semaglutide in OASIS 4 was consistent with previous semaglutide trials for weight management.
The global phase 3 OASIS programme comprised four trials enrolling approximately 1,300 adults with obesity or overweight and one or more comorbidities, evaluating once-daily oral semaglutide doses of 25 mg and 50 mg.
Significance of Introducing an Oral GLP-1 Option
Commenting on the FDA approval, Novo Nordisk highlighted the significance of introducing an oral GLP-1 option for people living with obesity or overweight.
Mike Doustdar, President and CEO, Novo Nordisk, said:
“The pill is here. With today’s 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 living with overweight or obesity, the Wegovy® pill provides patients with a new, convenient treatment option that can help patients start or continue their weight loss journey. No other current oral GLP-1 treatment can match the weight loss delivered by the Wegovy® pill, and we are very excited for what this will mean for patients in the US”.
Novo Nordisk has also described the once-daily pill as a “convenient option” compared with injectable therapy and stated that it would provide the same weight loss as the injection.
Regulatory Scope and Indication
In the US, Wegovy® is approved to reduce excess body weight and help maintain long-term weight reduction in adults with obesity or overweight and at least one weight-related medical condition. The FDA has also approved Wegovy® to reduce the risk of major adverse cardiovascular events, including death, heart attack or stroke, in adults with known heart disease and either obesity or overweight.
Wegovy® is now approved by the FDA in two formulations: a once-daily oral tablet (25 mg) and a once-weekly injectable formulation (2.4 mg). The injectable version is approved by the European Medicines Agency (EMA) and other regulatory authorities globally, while the Wegovy® pill is currently under review by the EMA and other regulators following submissions made in the second half of 2025.
Market Reaction and Outlook
The approval comes amid heightened competition in the weight-loss market, including from rival drugmakers such as Eli Lilly. Novo Nordisk has faced pressure during the year after warning over profits, but investor reaction to the approval was positive, with the company’s shares rising by almost 10% in after-hours trading in New York.
Novo Nordisk expects to launch the Wegovy® pill in the US in early January 2026, expanding treatment options for adults who prefer an oral therapy over injectable weight-management medicines.
