FDA Accepts NDA Submission for Oral Semaglutide 25 mg

The US Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) submission for a once-daily 25 mg oral formulation of semaglutide injection (Wegovy) for adults with obesity or overweight.1

Announced by Novo Nordisk on May 2, 2025, the investigational oral formulation of semaglutide is targeted for chronic weight management in patients with obesity or overweight and ≥1 comorbid condition and to reduce the risk of major adverse cardiovascular events (MACE) in those with overweight or obesity and established cardiovascular disease.

“We are entering a new era of obesity care where patients want individualized treatment plans that address their needs and provide choices, including oral formulations," said Anna Windle, PhD, senior vice president of clinical development, medical and regulatory affairs at Novo Nordisk.1

Semaglutide injection 2.4 has received approval to treat adults and children aged ≥12 years with obesity, or some with overweight and weight-related medical problems. Alongside a reduced calorie diet and increased physical activity, the medicine is indicated to help individuals lose excess body weight and lower the risk of MACE, including death, heart attack, or stroke, among those with known heart disease and obesity or overweight.2

The NDA was submitted based on results from the 64-week, Phase 3, randomized, controlled OASIS 4 trial measuring the efficacy and safety of a daily semaglutide 25 mg pill versus placebo in 307 adults with obesity or overweight and ≥1 comorbidity. Obesity and overweight were defined as body mass index (BMI) ≥30 kg/m2 and 27 kg/m2, respectively. Investigators excluded patients with diabetes.1

OASIS 4 involved a 64-week treatment period, including a 12-week dose escalation period and a 7-week off-treatment follow-up period. Participants were randomized 2:1 to daily oral semaglutide 25 mg or placebo, as an adjunct to lifestyle intervention for 64 weeks.

Pending regulatory approval, Novo Nordisk announced that semaglutide could become the first oral formulation of a glucagon-like peptide-1 (GLP-1) indicated for chronic weight management. The action date for the decision on the oral semaglutide NDA is targeted for Q4 2025.

"Novo Nordisk's strong legacy in obesity care and decades of scientific research and innovation have brought us to this moment,” Windle added. “We are pleased that the FDA has accepted our submission and look forward to working with regulatory authorities on what would be the first oral GLP-1 treatment for obesity."1

References

1. FDA accepts filing application for oral semaglutide 25 mg, which if approved, would be the first oral GLP-1 treatment for obesity. Novo Nordisk. May 2, 2025. Accessed May 2, 2025. https://www.novonordisk-us.com/media/news-archive/news-details.html?id=915988&utm_medium=email&utm_source=newsletter&utm_campaign=2025-media-release&utm_content=nni-wegovy-pill-fda-acceptance-sci_inn.

2. Campbell P. Semaglutide (Wegovy) receives FDA label expansion to include cardiovascular risk reduction. HCP Live. March 8, 2024. Accessed May 2, 2025. https://www.hcplive.com/view/semaglutide-wegovy-receives-fda-label-expansion-to-include-cardiovascular-risk-reduction.