Novo Nordisk’s 25 mg oral dosage form of smeglutide has been accepted by the FDA and may become the first oral drug for long-term weight management

On May 2, 2025, Novo Nordisk announced that the U.S. Food and Drug Administration (FDA) has Officially accepted the new drug application (NDA) for its Semaglutide) 25mg oral formulation. Targeted for adults who are obese or overweight and have at least one associated comorbidity, the drug is designed to achieve long-term weight control while reducing the risk of major adverse cardiovascular events in patients with established cardiovascular disease. FDA is expected to complete its review of the new drug in the fourth quarter of 2025. This progress indicates that the application of oral GLP-1 drugs in the field of weight management will enter a new stage.

Semaglutide is a glucagon-like peptide-1 (GLP-1) receptor agonist that regulates blood sugar by stimulating insulin secretion and inhibiting glucagon release. In addition, it can effectively suppress appetite and reduce food intake, thereby helping patients control their weight. If this oral dosage form is approved, semaglutide will become the first oral GLP-1 receptor agonist on the market specifically for long-term weight management, which is of great significance to improving patient medication compliance and quality of life.

Looking back at the history of semaglutide, the drug was originally approved by the FDA under the trade name Ozempic for the treatment of patients with type 2 diabetes. 2021In June , FDA expanded its approval of its injection form (trade name Wegovy) for weight management of ordinary obese or overweight patients. In March 2024, Wegovy injection was further approved to reduce cardiovascular mortality and the risk of heart attacks and strokes in adults with obesity and cardiovascular disease. It is worth mentioning that the oral version of semaglutideRybelsus was approved as early as 2019 for the treatment of 2 type 2 diabetes, but this time it is the first application for a 25 high-dose oral formulation for weight management.

The main basis for this new drug application comes from Phase 3 clinical trialsOASIS 4 (NCT05564117), this is a 64 weeks randomized double-blind controlled study. On the basis of lifestyle intervention, participants 2:1 ratio to receive oral semaglutide 25 mg (205 cases) or placebo (102 cases). The primary endpoints of the study included relative change in body weight and the proportion of patients who lost at least 5% of their weight. The results showed that the average weight loss of patients taking semaglutide was 13.6%, which was much higher than the 2.2% of the placebo group, and was as high as < span>79.2%of patients achieved weight loss of 5% or more, which was significantly better than the 31.1% of the control group. At the same time, the semaglutide group also showed significant improvements in cardiometabolic risk indicators, demonstrating its positive effect on cardiovascular health.

In terms of safety, The tolerability of 25 mg oral semaglutide is consistent with the known characteristics of GLP-1 receptor agonist drugs. The most common side effects are gastrointestinal reactions, such as nausea, diarrhea, etc., and most symptoms are mild to moderate, and patients can usually tolerate it. Taken together, if the oral formulation of semaglutide 25 is approved, it will bring a convenient and effective new weight management solution to obese and overweight patients, especially those at risk of cardiovascular disease, and will greatly promote the treatment of obesity into a new era of oral drugs.

References:FDA accepts filing application for oral semaglutide 25 mg, which if approved, would be the first oral GLP-1 treatment for obesity. News release. Novo Nordisk. May 2, 2025.