Novo Nordisk filed for approval of its oral semaglutide with the FDA earlier this year, the company confirmed to media sources.
The drugmaker has already filed for approval of semaglutide 25 mg for overweight and obesity, marking first application and potential approval of a GLP-1 pill specifically for weight loss. Novo said additional details and timing will be shared with its quarterly results on May 7.
Novo reported results from a phase 3 study comparing once-daily oral semaglutide 50 mg for weight management to placebo back in May 2023. In the trial, patients treated with oral semaglutide achieved a statistically significant weight loss of 17.4% after 68 weeks compared to a 1.8% reduction with placebo. Novo already markets Rybelsus, an oral semaglutide treatment for diabetes, which comes in 7 mg and 14 mg doses.
The reveal comes days after Eli Lilly announced positive topline results from a phase 3 trial evaluating the safety and efficacy of its oral small molecule GLP-1 receptor agonist, orforglipron, in adults with type 2 diabetes and inadequate glycemic control with diet and exercise alone.
Last week, Pfizer said it will discontinue development of its oral GLP-1, danuglipron, after a single participant in one of the dose-optimization studies experienced a potential drug-induced liver injury which resolved after discontinuation of the drug.