Novo Nordisk Submits NDA for Oral Semaglutide for Chronic Weight Management to FDA

Apr 23, 2025 15:32 CST Updated 15:32

Novo Nordisk

Insulin Developer and Manufacturer

Local time on April 22, according to foreign media reports, Novo NordiskSubmitted Oral Semaglutide Weight Loss Indication to FDAMarketing Application. This is two years after the company first announced the success of the pivotal Phase III trial for oral semaglutide in weight management.

Source: Foreign media official website

In May 2023, Novo NordiskPublishedOral Semaglutide 50mgResults from the Phase III OASIS 1 clinical trial for the treatment of obesity. This was a 68-week efficacy and safety trial comparing the weight management effects of once-daily oral semaglutide 50 mg versus placebo in 667 adults with obesity or overweight and accompanied by one or more comorbidities. Both treatment groups were combined with lifestyle interventions.

The results showed that oral semaglutide at Week 68Statistically significant and better weight loss, achieving its primary endpoint. The treatment group achieved an average weight loss of 15.1% at 68 weeks, compared to 2.4% in the placebo group; additionally, 85% of patients in the oral semaglutide group had a weight loss of ≥ 5% at 68 weeks, compared to only 26% in the placebo group.

Source: Insight Database

In November 2024, Novo Nordisk announcedOral Semaglutide 25mgPhase III for the Treatment of Overweight or ObesityOASIS 4 Study Results. The study enrolled 307 subjects who were randomly assigned in a 2:1 ratio to receive either oral semaglutide or placebo for 64 weeks, along with lifestyle intervention.

The results showed that the treatment group lost an average of 13.6% of their weight, compared to 2.2% in the placebo group.Compared with the placebo group, more subjects in the oral semaglutide group achieved ≥5% weight loss (79.2% vs 31.1%), ≥10% weight loss (63.0% vs 14.4%), ≥15% weight loss (50.0% vs 5.6%), and ≥20% weight loss (29.7% vs 3.3%).

Source: Insight Database

In mid to late April this year, Eli Lilly just announced the success of the first Phase III clinical trial of its oral GLP-1 orforglipron.Expected to submit to global regulatory authorities by the end of this yearOrforglipron for weight management is expected to file for marketing approval for the treatment of type 2 diabetes in 2026.

To seize the first-mover advantage in the oral weight loss market, Novo Nordisk has submitted to the FDAThe marketing application for a new indication of oral semaglutide.

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