Novo Nordisk and Eli Lilly Race to Dominate Oral Obesity Drug Market

Novo Nordisk has filed for U.S. Food and Drug Administration (FDA) approval of an oral formulation of its blockbuster weight loss drug semaglutide, intensifying the competition with rival Eli Lilly in the rapidly expanding obesity treatment market. This development marks a significant milestone in the pharmaceutical industry's efforts to provide more convenient and accessible options for patients struggling with obesity.

Novo Nordisk's Oral Semaglutide Filing

Novo Nordisk confirmed that it submitted an application for a 25-mg oral formulation of semaglutide to the FDA "earlier this year" for the treatment of overweight or obesity. This filing represents the first potential approval of a GLP-1 receptor agonist in pill form specifically for weight loss. The Danish pharmaceutical giant already markets semaglutide as Ozempic for type 2 diabetes and Wegovy for obesity, both administered as subcutaneous injections.

The company's decision to pursue an oral formulation follows promising clinical trial results. In May 2023, Novo Nordisk reported that a 50-mg dose of oral semaglutide led to approximately 15% body weight reduction over 68 weeks compared to placebo. The current filing for the 25-mg dose suggests a strategic balance between efficacy and potential manufacturing considerations.

Eli Lilly's Orforglipron Advances

Meanwhile, Eli Lilly is making significant strides with its oral obesity candidate, orforglipron. The company recently released Phase III data demonstrating the drug's efficacy in patients with type 2 diabetes. A once-daily 36-mg dose of orforglipron reduced blood glucose levels by 1.5% at 40 weeks, compared to 0.1% in the placebo group. Additionally, body weight decreased by 7.9% over the same period, versus 1.6% in placebo comparators.

Lilly CEO David Ricks announced plans to file for approval of orforglipron for chronic weight management "by the end of the year," with a potential launch in 2026. The company is also preparing for large-scale production, constructing what Ricks described as the "largest" active pharmaceutical manufacturing factory "in history in the country" to ensure a smooth global launch without supply interruptions.

Market Implications and Future Outlook

The race between Novo Nordisk and Eli Lilly to dominate the oral obesity drug market underscores the immense potential of this therapeutic area. Analysts project that the obesity treatment market could exceed $100 billion annually by the next decade, driving intense competition and innovation among pharmaceutical companies.

Both companies are pursuing additional research to expand the applications of their respective drugs. Novo Nordisk is developing a next-generation weight-loss pill, a long-acting agonist of the GLP-1 and amylin receptors, which has shown promising early results. Eli Lilly plans to study orforglipron in "dozens" of other indications, including inflammation and joint pain.

As these developments unfold, the pharmaceutical industry eagerly anticipates the potential approval and launch of these oral obesity medications, which could revolutionize treatment options for millions of patients worldwide.