FDA Approves Oral Semaglutide Pill for Chronic Weight Management

The FDA has approved a once-daily oral semaglutide pill for chronic weight management in adults with obesity or overweight and at least one weight-related comorbidity. The indication also includes reduction of major adverse cardiovascular events in adults with overweight or obesity and established cardiovascular disease, when used alongside diet and physical activity.

The approval was based on results from the phase 3 OASIS 4 trial, a 64-week, randomized, double-blind, placebo-controlled study that enrolled 307 adults with obesity or overweight and at least one weight-related comorbidity, excluding diabetes. Participants receiving once-daily oral semaglutide 25 mg achieved a mean weight reduction of 16.6% at week 64 if all patients remained on treatment, compared with 2.7% with placebo. When analyzed regardless of treatment discontinuation, mean weight loss was 13.6% with oral semaglutide versus 2.4% with placebo.

“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,” Joe Nadglowski, president and chief executive officer of the Obesity Action Coalition, said in a press release. “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.”

According to the manufacturer, the oral semaglutide pill is expected to launch in the United States in early January 2026. The starting dose of 1.5 mg is anticipated to be available through retail pharmacies and select telehealth providers, with a self-pay price of $149 per month offered through savings programs. Additional information on insurance coverage and patient assistance is expected at launch.

The most reported adverse events were gastrointestinal and included nausea, diarrhea, and vomiting. The prescribing information includes warnings for potential thyroid C-cell tumors, pancreatitis, gallbladder disease, hypoglycemia when used with certain diabetes medications, kidney injury related to dehydration, and psychiatric adverse effects, among others. Oral semaglutide is contraindicated in patients with a personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome type 2.

Reference
Novo Nordisk Inc. FDA approves Novo Nordisk’s Wegovy® pill, the first and only oral GLP-1 for weight loss in adults [press release]. PR Newswire. December 22, 2025. Accessed December 23, 2025. https://www.prnewswire.com/news-releases/fda-approves-novo-nordisks-wegovy-pill-the-first-and-only-oral-glp-1-for-weight-loss-in-adults-302648344.html