FDA Approves Oral Semaglutide as First GLP-1 Pill for Weight Loss

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The FDA has approved the first oral glucagon-like peptide-1 (GLP-1) receptor agonist for weight loss and to reduce the risk of major adverse cardiovascular events (MACE).1 Novo Nordisk plans to launch the once-daily oral semaglutide (Wegovy) 25 mg in the US in early January 2026.

The approval is based on results from the OASIS clinical trials and the SELECT trial. OASIS 4 showed a mean weight loss of 13.6% at 64 weeks.2 The study evaluated the efficacy and safety of once-daily oral semaglutide compared with placebo.

“The pill is here. With today's approval of the Wegovy pill, patients will have a convenient, once-daily pill that can help them lose as much weight as the original Wegovy injection,” Mike Doustdar, president and CEO of Novo Nordisk, said in a statement.1 “As the first oral GLP-1 treatment for people living with overweight or obesity, the Wegovy pill provides patients with a new, convenient treatment option that can help patients start or continue their weight loss journey.”

Clinical Efficacy: The OASIS 4 Trial

The OASIS 4 trial enrolled 307 adults with obesity or overweight who received either oral semaglutide (n = 205) or placebo (n = 102). The coprimary end points were the percent change in body weight and a reduction of 5% or more in body at week 64.

Oral GLP-1 Competition on the Horizon

The FDA decision gives oral semaglutide an edge in a competitive weight loss market, with Eli Lilly having submitted its own oral GLP-1, orforglipron, to the FDA for review.3 Orforglipron is an investigational, non-peptide, once-daily oral GLP-1 receptor agonist that can be taken without restrictions on food or water intake.

References

1. Novo Nordisk A/S: Wegovy pill approved in the US as first oral GLP-1 for weight management. News release. Novo Nordisk. December 22, 2025. Accessed December 22, 2025. https://www.novonordisk.com/news-and-media/news-and-ir-materials/news-details.html?id=916472

2. Wharton S, Lingvay I, Bogdansi P, et al; OASIS 4 study group. Oral semaglutide at a dose of 25 mg in adults with overweight or obesity. N Engl J Med. 2025;393(11):1077-1087. doi:10.1056/NEJMoa2500969

3. Jennings S. Phase 3 data support oral orforglipron for weight maintenance after GLP-1–based weight loss. Patient Care®. December 19, 2025. Accessed December 22, 2025. https://www.patientcareonline.com/view/phase-3-data-support-oral-orforglipron-for-weight-maintenance-after-glp-1-based-weight-loss