The era of GLP-1 drugs has reached a new milestone: The U.S. Food and Drug Administration has approved Novo Nordisk’s once-daily oral semaglutide tablets to treat patients at high risk of cardiovascular events such as heart attack and stroke.
Rybelsus (semaglutide) is currently approved for use in adult patients with type 2 diabetes mellitus who are at increased risk of major cardiovascular events (CVEs), such as cardiovascular death, myocardial infarction, or stroke. First released in 2019, the drug is designed to improve glycemic control in adults with diabetes. Rybelsus is an oral GLP-1 receptor agonist available in 7 mg and 14 mg dosages.
”As the only FDA-approved GLP-1-based drug in tablet form with proven cardiovascular benefits, it sets a new standard for future innovation in oral medications,” said Dave Moore, executive vice president of U.S. operations at Novo Nordisk. “Semaglutide continues to demonstrate high efficacy in numerous large-scale studies, further confirming its proven effectiveness for patients with cardiovascular disease.”
The approval was based on results from the Phase 3b SOUL clinical trial, which evaluated the efficacy of a 14 mg dose in reducing the risk of developing MACE in high-risk adult diabetic patients. Ultimately, oral semaglutide at a dose of 14 mg significantly reduced the risk of developing MACE by 14% over four years compared to placebo. These results build on earlier positive results: the drug achieved the Phase 3 milestone, which was sufficient for Novo Nordisk to submit an application for FDA approval.
”Adults with type 2 diabetes face an increased risk of cardiovascular events, even without a history of heart attack or stroke, highlighting the need for treatments that go beyond glycemic control,” said John B. Buse, MD, director of the University of North Carolina Diabetes Center and co-chair of the SOUL trial steering committee. “The fact that oral GLP-1 therapy can improve glycemic control is groundbreaking. This new indication, based on data from the SOUL trial, marks further progress, demonstrates the versatility of semaglutide, and expands treatment options for millions of patients.”
Currently, there are no oral GLP-1-based medications specifically designed for the treatment of obesity. However, Novo Nordisk has submitted a separate application to the FDA for approval of its once-daily oral drug semaglutide (Wegovy). The regulator is expected to make a decision by the end of 2025.
Those looking for diet pills should keep in mind that they are unlikely to be much cheaper than injectable GLP-1 medications. While injectable GLP-1 medications eliminate the need for needles, Novo Nordisk has increased the concentration of the active ingredient, allowing it to persist after passing through the stomach. Its competitor, Eli Lilly and Company (the maker of Mounjaro), plans to submit an application to the US Food and Drug Administration (FDA) by the end of this year for the registration of its long-lasting oral medication, Orforglipron.
Notably, the oral obesity drug will be available in a higher dosage—one Novo Nordisk tablet will contain 25 mg, more than double the dosage of the highest-dose Rybelsus tablet.
Post time: Oct-22-2025