Novo Nordisk Secures FDA Approval for Oral Wegovy Pill, Intensifying GLP-1 Market Battle with Eli Lilly

FDA Approves First Oral GLP-1, Novo Nordisk’s Wegovy Pill

The U.S. Food and Drug Administration (FDA) has approved the once-daily Wegovy® pill from Novo Nordisk A/S (NYSE:NVO), establishing it as the first oral GLP-1 medicine indicated for the treatment of obesity. This landmark approval is based on robust clinical data, including the OASIS 4 trial, which demonstrated a mean weight loss of 16.6% among participants, offering a highly effective and convenient alternative to existing injectable therapies.

The approval of the tablet formulation of semaglutide, the active ingredient in both Wegovy and Ozempic, is expected to significantly reshape the weight-loss market. Novo Nordisk plans to begin selling the new pill in the U.S. soon after the new year. The company has set an aggressive entry price for the starting dose, with a cash price of $149 a month, aiming to capture market share quickly by offering a more accessible option than many current injectable treatments.

The Race for Oral Dominance Heats Up

While Novo Nordisk has secured the first-mover advantage in the oral GLP-1 space, the competitive landscape remains intense, primarily driven by rival Eli Lilly (NYSE:LLY). Lilly is rapidly advancing its own portfolio, challenging Novo Nordisk’s dominance in the overall obesity treatment sector.

Lilly’s injectable dual agonist, Zepbound, has already demonstrated superior efficacy compared to Novo Nordisk’s injectable Wegovy in head-to-head trials. In a Phase 3 trial, Zepbound patients achieved an average weight loss of 20.2% over 72 weeks, significantly outpacing the 13.7% average weight loss recorded for Novo Nordisk’s injectable Wegovy.

The battle for oral market leadership is also poised to escalate. Eli Lilly has submitted a New Drug Application (NDA) to the FDA for its investigational once-daily oral GLP-1 receptor agonist, orforglipron. Both Lilly’s orforglipron and Novo Nordisk’s higher-dose oral semaglutide are anticipated to reach the U.S. market in 2026. If approved, orforglipron could solidify Lilly’s position by offering a convenient oral maintenance therapy, accelerating its overall market share in the obesity space.

The approval of the Wegovy pill is a pivotal moment, offering patients a highly effective, non-injectable option. However, the market will soon face intense competition from Eli Lilly’s pipeline, particularly as both companies race to launch their next-generation oral treatments in 2026.

Pipeline Expansion and Future Strategies

In addition to launching the oral Wegovy, Novo Nordisk is simultaneously strengthening its injectable pipeline. On December 18, 2025, the company announced the submission of an NDA for once-weekly CagriSema (cagrilintide 2.4 mg and semaglutide 2.4 mg) injection. CagriSema is a fixed-dose combination of a long-acting amylin analogue and a GLP-1 receptor agonist.

If approved, CagriSema would represent the first injectable combination treatment pairing a GLP-1 receptor agonist and an amylin analogue, intended to reduce excess body weight and maintain long-term weight reduction in adults with obesity or overweight and at least one weight-related comorbid condition. This filing demonstrates Novo Nordisk’s strategy to compete across multiple modalities—oral convenience and enhanced injectable efficacy—to maintain its leadership position against Eli Lilly’s multi-pronged attack.

• Novo Nordisk’s Oral Entry: The Wegovy pill is the first oral GLP-1 approved for obesity, offering a mean weight loss of 16.6% in trials.
• Pricing Strategy: The starting dose will be priced at $149 per month cash, signaling an attempt to maximize patient access and adoption immediately following the new year launch.
• Lilly’s Efficacy Edge: Eli Lilly’s Zepbound has shown superior weight loss (20.2%) compared to Novo Nordisk’s injectable Wegovy (13.7%).
• Future Oral Competition: Both companies expect their next-generation oral GLP-1 treatments (Novo Nordisk’s higher-dose oral semaglutide and Lilly’s orforglipron) to enter the U.S. market in 2026.