Dec 23, 2025 15:16:00

FDA approves Wegovy, the first GLP-1 drug for weight loss in adults

On December 22, 2025 local time,

it was announced that the U.S. Food and Drug Administration (FDA) , which regulates medical products in the United States, had approved Wegovy tablets from Denmark-based pharmaceutical company Novo Nordisk as the first oral obesity treatment ( GLP-1 drug).

FDA approves Novo Nordisk's Wegovy® pill, the first and only oral GLP-1 for weight loss in adults
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

Wegovy tablets are an oral anti-obesity medication that, when used in conjunction with a calorie-restricted diet and increased physical activity, can help obese adults and overweight adults with weight-related health issues maintain weight loss. Wegovy tablets are also suitable for reducing the risk of major adverse cardiovascular events (MACE), including death, heart attack, and stroke, in overweight or obese adults with cardiovascular disease.

Dave Moore, Executive Vice President of Novo Nordisk's Americas division, said, 'Wegovy, launched in 2021, transformed the way obesity is thought about and treated in the United States. Now, Wegovy tablets will provide weight loss benefits on a scale that other GLP-1 drugs (oral obesity treatment candidates) have not been able to achieve in Phase III trials . We are confident that making Wegovy tablets will help treat patients who have never previously sought or received treatment. Wegovy tablets represent a new chapter in our decades of experience in GLP-1 treatment, and the most affordable co-pay price for an obesity treatment GLP-1 to date. Manufacturing is progressing smoothly at our North Carolina facility, and we are preparing for a full-scale launch in the United States in early January 2026.'

The FDA's approval of Wegovy tablets is based on the results of the OASIS 4 Phase III trial, a 64-week medical investigation of 307 non-diabetic adults who were obese or overweight and had one or more weight-related comorbidities.

The results of the study showed that when all patients continued treatment with Wegovy tablets taken once daily, those who combined a low-calorie diet and exercise achieved an average weight loss of 16.6%. Those who took a placebo experienced an average weight loss of 2.7%. When efficacy was examined for all patients, regardless of whether they continued treatment, the average weight loss rate for those taking Wegovy tablets was 13.6% compared to 2.4% for those taking a placebo. Side effects reported included the same side effects seen with Wegovy 2.4mg injection, such as nausea, diarrhea, and vomiting.

Wegovy tablets are approved only in the United States and are scheduled to be released in early January 2026.

GLP-1 drugs are known to be effective in treating alcohol and substance use disorders , dramatically reducing mortality in colorectal cancer patients , and halving the frequency of migraines .

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