Novo Nordisk has received approval from the US Food and Drug Administration (FDA) for its once-daily Wegovy pill, marking it as the first oral GLP-1 medication for obesity available in the United States. The company, based in Plainsboro, developed the pill to be used alongside a reduced calorie diet and increased physical activity for adults with obesity or overweight who also have weight-related health conditions. The medication is also indicated to lower the risk of major adverse cardiovascular events such as death, heart attack, or stroke in adults with established cardiovascular disease.
Dave Moore, executive vice president of US Operations at Novo Nordisk, commented on the development: “The launch of Wegovy in 2021 changed how obesity was viewed and treated in the US. Now, with Wegovy pill, we are offering a magnitude of weight loss that no other oral GLP-1 obesity candidate has been able to duplicate in phase 3 trials. We 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 our decades-long GLP-1 experience—supported by the most affordable self-pay price to date in a GLP-1 for obesity. We are prepared for a full US launch in early January 2026, with manufacturing well underway in our North Carolina facilities.”
The FDA’s decision was supported by results from the OASIS 4 phase 3 clinical trial involving 307 adults who were obese or overweight with at least one related comorbidity but did not have diabetes. Over a period of 64 weeks, participants taking Wegovy pill daily along with dietary and exercise changes achieved an average weight loss of about 17% if they remained on treatment throughout, compared to roughly 3% for those on placebo. When considering all enrolled participants regardless of whether they completed treatment, average weight loss was about 14% for those on Wegovy versus around 2% for placebo.
Common side effects observed were similar to those previously reported with injectable semaglutide treatments and included nausea, diarrhea, and vomiting.
Timothy Garvey, MD, professor of medicine and director of the Diabetes Research Center at University of Alabama at Birmingham stated: “With more choices, HCPs are better equipped to tailor treatment approaches and support patients who want to gain control of their weight, and this milestone approval underscores exactly that kind of choice. The availability of Wegovy pill expands the possibilities for weight management with semaglutide, giving healthcare professionals a powerful, efficacious medicine in a new method of delivery, allowing the ability to help meet more patients where they are.”
The initial dose will be available through pharmacies and select telehealth providers starting early January at $149 per month. Novo Nordisk plans to offer additional savings programs and resources aimed at reducing out-of-pocket costs for eligible patients.
Joe Nadglowski, president and CEO of the Obesity Action Coalition said: “After many years advocating for people living with obesity, one thing has always been clear: patient safety has to come first. That’s why it’s critical we rely on treatments that are rigorously tested and FDA-approved. A brand new effective pill for weight loss gives people greater flexibility to choose a GLP-1 treatment that can fit in their daily routine and preferences.”
Currently approved only in the US market, Novo Nordisk expects full commercial availability starting January 2026.
