Danish pharmaceutical giant Novo Nordisk has confirmed its submission of a regulatory application to the U.S. Food and Drug Administration for an oral version of its successful weight loss medication. The company is seeking approval for a pill form of semaglutide, the active ingredient in its injectable drugs Wegovy and Ozempic.
The submission marks a significant step in expanding treatment options for obesity, following successful Phase 3 trial results reported in 2023. During those trials, participants taking the highest dose of oral semaglutide experienced approximately 15% reduction in body weight over a 64-week period.
Despite initially indicating plans to file for approval in 2023, Novo Nordisk delayed the submission due to manufacturing considerations and portfolio prioritization decisions. The oral formulation presents unique production challenges, as semaglutide is a peptide-based drug requiring more complex manufacturing processes compared to traditional small molecule medications.
The timing of this regulatory submission coincides with intensifying competition in the obesity treatment market, particularly from Eli Lilly. Just last week, Lilly announced positive results from a large-scale diabetes trial for its oral GLP-1 drug candidate, orforglipron. Lilly’s plans to seek regulatory approval hinge on the success of an ongoing obesity trial.
The obesity drug market has attracted significant attention, with analysts projecting it could exceed $100 billion in annual value by the mid-2030s. Oral medications represent a crucial segment of this market, potentially offering patients a more convenient alternative to injectable treatments.
Manufacturing capacity has been a persistent challenge for Novo Nordisk. While the company has recently managed to address supply shortages for Wegovy through various investments, the oral semaglutide formulation poses new production hurdles. The daily dosage requirement of 25 milligrams is substantially higher than Wegovy’s highest dose, representing approximately 70 times more active ingredient.
Recent setbacks in Novo’s obesity drug pipeline have influenced its strategic focus. The company’s combination therapy CagriSema encountered disappointing study results, necessitating a revised development strategy. Another oral drug candidate in development also failed to meet expectations.
The timing of the FDA submission follows several strategic
developments in Novo’s obesity treatment portfolio. The company has recently implemented manufacturing improvements that have helped resolve long-standing supply constraints for Wegovy. However, the substantial daily dosage required for the oral formulation could potentially create new production challenges.
Further details about the approval application are expected to be disclosed during Novo Nordisk’s first quarter earnings presentation scheduled for May 7, according to a company spokesperson. The submission represents a significant milestone in the company’s efforts to expand its obesity treatment options and maintain its position in the increasingly competitive weight loss drug market.
The development comes amid broader industry movements in obesity treatment, with various pharmaceutical companies pursuing both oral and injectable therapies. The race to develop effective weight loss medications has intensified as healthcare providers and patients seek more accessible and convenient treatment options. Novo Nordisk’s latest submission demonstrates the company’s commitment to maintaining its leadership position in this rapidly evolving therapeutic area, while addressing the growing demand for oral alternatives to injectable weight loss medications.