Novo Nordisk announced that the FDA has approved the Wegovy® pill, which is the first oral GLP-1 medicine for treating obesity in the U.S. The Wegovy® pill is used along with a reduced-calorie diet and increased physical activity to help adults with obesity or those who are overweight and have weight-related health issues lose weight and keep it off. It can also help reduce the risk of serious heart problems, like heart attacks and strokes, for people with overweight or obesity and existing heart disease.
The approval was based on results from a 64-week study (called OASIS 4) with 307 adults who had obesity or were overweight with health problems but didn’t have diabetes. The study showed that people taking the Wegovy® pill once a day, along with diet and exercise, lost about 17% of their weight, compared to just 3% for those taking a placebo.
Common side effects in the study were nausea, diarrhea, and vomiting, similar to those seen with the injectable version of Wegovy®.
The starting dose of 1.5 mg will be available in pharmacies and through some telehealth providers starting in early January. The pill will cost USD 149 per month, with savings options to help lower costs for eligible patients.
Executive Statement
According to Dave Moore, executive vice president, US Operations at Novo Nordisk, the launch of Wegovy® in 2021 changed how obesity was viewed and treated in the US. Now, with Wegovy® pill, they are offering a magnitude of weight loss that no other oral GLP-1 obesity candidate has been able to duplicate in phase 3 trials. They are confident that the expansion of Wegovy® to a pill will help patients who may have not sought or accepted treatment before. Wegovy® pill is the next chapter in their decades-long GLP-1 experience—supported by the most affordable self-pay price to date in a GLP-1 for obesity. They are prepared for a full US launch in early January 2026, with manufacturing well underway in their North Carolina facilities.