First daily pill for obesity treatment approved in the U.S.

The U.S. Food and Drug Administration has approved Novo Nordisk’s Wegovy pill, making it the first oral GLP 1 medicine cleared for chronic weight management in adults, Qazinform News Agency correspondent reports.

photo: QAZINFORM

The once daily tablet is approved for use alongside a reduced calorie diet and increased physical activity in adults with obesity, or in adults who are overweight and have at least one weight related medical condition.

The approval also covers a cardiovascular benefit. Wegovy pill is indicated to reduce the risk of major adverse cardiovascular events, including death, heart attack and stroke, in adults with overweight or obesity who have established cardiovascular disease.

Novo Nordisk said the Wegovy pill will be produced in the United States and that supply is ready for launch. A starting dose of 1.5 mg is expected to be available in pharmacies and through select telehealth providers in early January 2026, with savings offers that bring the monthly self-pay price to 149 dollars. The company said additional information on coverage and patient assistance programs will be released at launch.

Novo Nordisk said the decision was based on results from the OASIS 4 phase 3 clinical trial, a 64 week randomized, double blind, placebo controlled study involving 307 adults without diabetes. Participants received once daily oral semaglutide at a dose of 25 mg or placebo, together with lifestyle intervention.

In the trial, patients who remained on treatment throughout the study achieved an average weight loss of about 17%, compared with about 3% in the placebo group. When all participants were included regardless of whether they stayed on treatment, average weight loss was about 14% with the Wegovy pill versus about 2% with placebo. Based on baseline body weight, 76% of patients taking the pill achieved at least 5% weight loss, compared with 31% of those receiving placebo.

Common side effects reported in OASIS 4 were consistent with those seen with injectable semaglutide and included nausea, diarrhea and vomiting, according to the company.

Earlier, Qazinform News Agency reported that Ozempic may reduce health risks in schizophrenia.