The Fierce Race for FDA Approval in Oral GLP-1 Obesity Drugs

The race to bring the first oral GLP-1 receptor agonist (GLP-1 RA) for obesity to market has intensified, with Eli Lilly and Novo Nordisk locked in a high-stakes contest to secure FDA approval. While Novo Nordisk appears poised to launch its 25 mg oral semaglutide in late 2026, Eli Lilly's orforglipron is quietly positioning itself to outpace its rival through a combination of fast-track regulatory strategies, superior clinical data in diabetes, and a robust market access plan. For investors, the implications of this race extend beyond first-mover advantage, with long-term value hinging on differentiation, scalability, and patient adherence.

Regulatory Race: Fast-Track Designations and Accelerated Timelines

Eli Lilly's orforglipron is targeting a regulatory submission for obesity in late 2025, with the FDA initially setting a decision date of May 20, 2026 according to Nasdaq reports. However, internal discussions suggest the drug could leverage the FDA's Commissioner's National Priority Voucher (CNPV) program to secure a drastically accelerated timeline. According to Reuters, the CNPV allows for a 1- to 2-month review period, potentially pushing the approval date to March 28, 2026. This would outpace Novo Nordisk's oral semaglutide, which is expected to receive a decision by year-end 2025 according to Nasdaq reports.

Novo Nordisk, meanwhile, has already submitted its NDA for 25 mg oral semaglutide and is leveraging the CNPV for a higher-dose injectable Wegovy formulation. While this dual-track strategy strengthens Novo's market presence, Eli Lilly's focus on a single, streamlined submission for orforglipron-combined with its CNPV bid-could allow it to bypass regulatory bottlenecks. According to Reuters, the FDA's internal push to reduce initial filing reviews from 60 days to as little as two weeks further tilts the playing field in Lilly's favor.

Clinical Efficacy: Diabetes as a Differentiator

. While Novo Nordisk's oral semaglutide demonstrated a 13.6% weight loss in the OASIS-4 trial, Eli Lilly's orforglipron has shown superior performance in type 2 diabetes trials. According to CNBC, data from the ACHIEVE-3 trial revealed a 2.2% reduction in A1C levels for orforglipron versus 1.4% for Novo's drug. Additionally, orforglipron achieved a 9.2% weight loss in diabetic patients compared to 5.3% for semaglutide according to CNBC. These results position orforglipron as a dual-purpose therapy for obesity and diabetes, a critical differentiator in a market where comorbidities drive treatment decisions.

Novo's edge in weight loss for non-diabetic patients (12.4% for orforglipron vs. 13.6% for semaglutide) is marginal according to Clinical Trials Arena, but Lilly's drug offers unique advantages. As a small molecule, orforglipron can be taken without dietary restrictions, unlike semaglutide, which requires fasting according to Lilly. This convenience could enhance patient adherence, a key metric in chronic disease management. However, orforglipron's higher gastrointestinal discontinuation rate (9.7% vs. 4.9%) remains a hurdle according to CNBC, underscoring the need for robust post-marketing safety monitoring.

Market Access: Expanding Beyond Obesity

Eli Lilly's strategy extends beyond obesity, with plans to submit orforglipron for type 2 diabetes in early 2026 according to Lilly investor updates. This dual-indication approach taps into a $100 billion diabetes market according to Nasdaq reports, where Lilly already holds a strong presence with its insulin portfolio. By targeting both obesity and diabetes, orforglipron could capture patients in primary care settings who may be hesitant to adopt injectables. Novo's focus on obesity and cardiovascular risk reduction, while valuable, narrows its addressable market.

Lilly's manufacturing scalability further strengthens its position. As a small-molecule drug, orforglipron can be produced at lower costs than semaglutide, which relies on complex peptide synthesis according to Nasdaq reports. This cost advantage could translate into pricing flexibility, a critical factor as payers demand value-based contracts. Additionally, Lilly's partnership with the U.S. government to expand obesity medicine access according to Lilly signals strong public-sector support, mitigating potential reimbursement challenges.

Investor Implications: Long-Term Value in Differentiation

For investors, the race for FDA approval is not merely about speed but about capturing sustainable market share. Novo Nordisk's first-to-market status for oral semaglutide is a strategic asset, but Eli Lilly's fast-track bid and diabetes indication could carve out a distinct niche. The latter's ability to leverage its existing diabetes infrastructure and manufacturing expertise provides a long-term edge in a market projected to grow to $100 billion by 2030 according to Nasdaq reports.

Moreover, Lilly's CNPV-driven timeline-should it secure March 2026 approval-would allow it to launch orforglipron ahead of Novo's oral semaglutide, capitalizing on early demand. Even if Novo secures first approval, Lilly's dual-indication strategy and competitive pricing could erode Novo's market share over time. The key risk lies in regulatory delays or safety concerns, but Lilly's Phase 3 trial data and proactive engagement with the FDA suggest a well-prepared submission.

Conclusion

The battle for oral GLP-1 dominance is far from over. While Novo Nordisk's experience in obesity and injectable GLP-1s gives it a head start, Eli Lilly's fast-track bid, diabetes differentiation, and manufacturing scalability position it as a formidable contender. For investors, the long-term value lies in Lilly's ability to transform orforglipron into a blockbuster across two high-growth therapeutic areas. As the FDA's decision calendar fills in 2026, the company's regulatory agility and clinical data will be critical in determining who emerges as the market leader.