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FDA reviews oral GLP-1 semaglutide for obesity
Novo Nordisk is pursuing FDA approval for the first oral GLP-1 semaglutide, aiming to expand Wegovy's indication for chronic obesity and weight management.
On May 2, Novo Nordisk announced that the FDA accepted its New Drug Application for an investigational, once-daily, 25 mg oral formulation of Wegovy. If approved, this would become the first oral glucagon-like peptide-1 receptor agonist indicated for chronic weight management in adults with obesity or who are overweight with one or more comorbidities.
Submission of Novo Nordisk's New Drug Application follows positive outcomes from the Phase 3 OASIS 4 trial, which demonstrated significant weight loss and safety in adults with obesity or overweight conditions, excluding those with diabetes.
The placebo-controlled trial included a 12-week dose escalation phase, followed by 64 weeks of treatment and a 7-week off-treatment follow-up period.
"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," Anna Windle, PhD, Senior Vice President, Clinical Development, Medical & Regulatory Affairs at Novo Nordisk Inc., said in the press release. "Novo Nordisk's strong legacy in obesity care and decades of scientific research and innovation have brought us to this moment."
Expanding market reach
Oral semaglutide could significantly transform obesity care by offering a convenient, needle-free alternative. This would likely enhance patient adherence and expand market reach.
Wegovy (semaglutide 2.4 mg injection) is currently approved for weight management in adults and adolescents aged 12 and older and will be the preferred glucagon-like peptide-1 (GLP-1) receptor agonist on the template formularies of CVS Caremark -- one of the top U.S. pharmacy benefit managers -- beginning July 1, 2025.
The application's acceptance is a significant step for Novo Nordisk amid increasing competition within the rapidly growing GLP-1 market.
However, Novo Nordisk confirmed its prominence in the GLP-1 market by announcing a $1.09 billion investment to scale up its Brazilian manufacturing site to meet the growing demand for GLP-1-based treatments.
Fueled by unprecedented consumer interest and media attention toward GLP-1 treatments, oral alternatives that rival the efficacy of GLP-1 injections could begin the next wave of innovative GLP-1 therapies.
Broader clinical benefits of semaglutide
Ongoing studies suggest that semaglutide offers broad therapeutic benefits for those struggling with weight management.
For example, a study found that semaglutide effectively reduced weight in patients who previously experienced insufficient weight loss following bariatric surgery, positioning it as a viable alternative to surgical interventions.
Another trial demonstrated semaglutide's effectiveness in significantly improving heart failure symptoms in obese patients with heart failure with preserved ejection fraction, showcasing the drug’s versatility in addressing obesity-related cardiovascular complications.
Currently, obesity affects approximately 40% of U.S. adults, substantially contributing to chronic health conditions and escalating healthcare costs. The FDA is expected to announce its decision on oral Wegovy by the fourth quarter of 2025.
Alivia Kaylor is a scientist and the senior site editor of Pharma Life Sciences.
