Analysis: Novo Nordisk’s Oral GLP-1 Pill FDA Approval – Competitive Impact and Valuation

The FDA’s December 22, 2025, approval of Novo Nordisk’s oral Wegovy (semaglutide) for obesity treatment—making it the first oral GLP-1 drug for this indication in the U.S.—represents a pivotal milestone for the company’s competitive positioning [1]. Clinical trials showed the pill delivered 16.6% mean weight loss, comparable to its 2.4mg injectable counterpart [1]. Novo Nordisk plans to launch the oral Wegovy in January 2026, six months ahead of rival Eli Lilly’s oral GLP-1 candidate (orforglipron), granting a critical first-mover advantage in the oral GLP-1 segment [3]. This segment is projected to capture 24% ($22B) of the $95B global weight loss market by 2030, providing a significant growth opportunity [4].

Novo Nordisk had lost U.S. market share to Eli Lilly’s injectable Zepbound in 2025, but the oral Wegovy’s approval—combined with its superior efficacy (16.6% vs. Lilly’s orforglipron’s 12.4% at the highest dose [4])—positions the company to reverse this trend. Concurrently, the U.S. Centers for Medicare & Medicaid Services (CMS) announced a voluntary program to cover GLP-1 drugs, including oral Wegovy, for Medicare/Medicaid beneficiaries, enhancing patient access and market potential [2]. Market data shows NVO’s stock opened 9.5% higher ($52.67) on December 23, following the after-hours approval news, with a current TTM P/E ratio of 14.46 and a market cap of $235.25B as of December 24 [0]. The stock was down ~38% YTD prior to the rally, likely due to earlier market share losses and supply issues [3].

1. Dual Competitive Edge
   : Novo Nordisk’s first-mover status in the oral GLP-1 segment, paired with its pill’s superior efficacy compared to Eli Lilly’s upcoming candidate, creates a differentiated market position that could capture a large share of the growing oral GLP-1 market [3][4].
2. Accessibility-Driven TAM Expansion
   : The oral formulation addresses a key barrier (injectable hesitancy) for many patients, while concurrent CMS coverage expands access to a broader patient base, potentially increasing the total addressable market for Novo Nordisk’s obesity treatments [1][2].
3. Valuation Re-rating Potential
   : The approval, combined with the stock’s historical underperformance (52-week high of $93.80 vs. current ~$52.98 [0]), suggests that upward revisions to revenue projections could drive a valuation re-rating, especially given the pill’s projected market share in the $22B oral segment [4].

• Capture a leading share of the $22B global oral GLP-1 obesity market by 2030 [4].
• Reverse U.S. market share losses incurred to Eli Lilly’s Zepbound in 2025 [5].
• Diversify its GLP-1 franchise beyond injectables (Wegovy/Ozempic), strengthening its competitive moat [1].

• Eli Lilly’s mid-2026 launch of orforglipron and pipeline triple agonist (retatrutide) could erode Novo Nordisk’s first-mover advantage [1][4].
• CMS coverage programs and regulatory price controls may limit revenue potential despite broader access [2].
• Long-term data on the oral formulation’s weight maintenance and safety are still emerging, creating uncertainty [1].
• Supply chain scaling challenges could hinder the company’s ability to meet expected demand post-launch [0].

Novo Nordisk’s FDA approval of oral Wegovy on December 22, 2025, marks the first GLP-1 pill for obesity treatment in the U.S. The company will launch the product in January 2026, six months ahead of Eli Lilly’s competing pill, with superior clinical efficacy (16.6% weight loss). NVO’s stock rallied 9.5% on December 23, 2025, to $52.67, with a current market cap of $235.25B and TTM P/E of 14.46. Concurrent CMS coverage expansions enhance patient access, while the oral segment is projected to reach $22B by 2030. The approval presents significant growth opportunities, but risks include upcoming competition, pricing pressures, and long-term efficacy data gaps.