Novo Nordisk announced that the U.S. Food and Drug Administration has approved the once-daily Wegovy pill, marking the first oral GLP-1 treatment for obesity available in the United States. The pill is intended for adults with obesity or overweight individuals with weight-related health conditions, to be used alongside a reduced-calorie diet and increased physical activity to promote weight loss and maintain it over time. Additionally, Wegovy pill is approved to reduce the risk of major adverse cardiovascular events such as heart attack, stroke, or death in adults with overweight or obesity who have established cardiovascular disease.
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Dave Moore, Executive Vice President of U.S. Operations at Novo Nordisk, stated that the launch of Wegovy in 2021 transformed the treatment landscape for obesity, and the new oral formulation provides a level of weight loss that no other oral GLP-1 therapy has achieved in phase 3 studies. He emphasized that the pill option could help patients who previously may have avoided or declined treatment. Moore also highlighted that Wegovy pill represents the next stage in Novo Nordisk’s decades of GLP-1 experience and will be offered at the most affordable self-pay price for a GLP-1 obesity treatment to date, with a full U.S. launch planned for early January 2026. Manufacturing is already underway at the company’s North Carolina facilities.
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The FDA approval was supported by the OASIS 4 phase 3 trial, which followed 307 adults with obesity or overweight and at least one weight-related comorbidity, excluding diabetes, over 64 weeks. The study showed that patients who stayed on treatment and combined the pill with diet and exercise lost an average of 16.6 percent of their body weight compared with 2.7 percent for those taking a placebo. Across all participants regardless of adherence, average weight loss with Wegovy pill was 13.6 percent compared with 2.4 percent for placebo. Common side effects included nausea, diarrhea, and vomiting, consistent with prior Wegovy injection trials.
Timothy Garvey, MD, professor of medicine and director of the Diabetes Research Center at the University of Alabama at Birmingham, noted that the oral option gives healthcare professionals greater flexibility in tailoring weight management treatments. He said the pill allows providers to meet patients where they are while delivering a powerful and effective GLP-1 therapy in a new method of administration.
The starting dose of 1.5 mg will be available in pharmacies and select telehealth providers in early January 2026 with savings offers starting at $149 per month. Additional information on insurance coverage, savings programs, and support for reducing out-of-pocket costs will also be provided at that time.
Joe Nadglowski, President and CEO of the Obesity Action Coalition, remarked that FDA-approved, rigorously tested treatments are essential for patient safety. He emphasized that having an effective oral option offers patients more flexibility in choosing a GLP-1 therapy that fits their daily routines and personal preferences. Wegovy® pill is currently approved only in the United States, and Novo Nordisk anticipates nationwide availability in early January 2026.
Weight loss results are based on two estimands: the trial product estimand, which reflects estimated efficacy assuming all patients adhered to the treatment without using other weight loss therapies, and the treatment policy estimand, which reflects efficacy regardless of adherence or use of other therapies.
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