Eli Lilly And Co
FDA approved orforglipron (Foundayo, Eli Lilly) for type 2 diabetes -- a once-daily oral small-molecule GLP-1 receptor agonist. Orforglipron is the first non-peptide oral GLP-1 approved in the US; oral semaglutide (Rybelsus, Novo Nordisk) has been approved for T2D since 2019 and expanded to obesity in January 2026. Unlike Rybelsus, orforglipron requires no fasting or water volume restrictions before dosing.
FDA action: Approved | Decision type: New Drug Approval (NDA/BLA) | Drug: Foundayo | Generic name: Orforglipron | Brand name: Foundayo | Application: NDA220934 (ORIG) | Submission class: TYPE 1 | Sponsor: Eli Lilly And Co | Action date: April 01, 2026 | Geography: United States (FDA)
Phase 3 SURMOUNT-1 tests once-weekly tirzepatide at three doses versus placebo in adults without type 2 diabetes who have obesity or are overweight with comorbidities. The randomized, double-blind trial targets 2,539 participants with primary efficacy assessment at 72 weeks. This represents tirzepatide's pivotal obesity trial against placebo, potentially supporting Eli Lilly's bid to compete directly with Wegovy in the non-diabetic obesity market. A prediabetes subgroup continues long-term to assess diabetes prevention.
Phase 3 trial evaluates semaglutide versus placebo in adults with non-cirrhotic NASH, measuring steatohepatitis resolution, fibrosis improvement, and cirrhosis-free survival over approximately 5 years. The study enrolled 1,205 adults and is active but not recruiting, with completion expected in 2029. This represents Novo Nordisk's push into NASH, a major unmet need with no approved GLP-1 therapies despite strong preclinical rationale. The trial's dual primary endpoints and 5-year duration suggest preparation for a pivotal regulatory filing in this large addressable market.
Phase 3 trial evaluating retatrutide for chronic low back pain in people with obesity or overweight, targeting dual primary endpoints of pain intensity reduction and weight loss. 586-person placebo-controlled study expected to complete September 2027, investigating a novel indication beyond traditional metabolic endpoints. Eli Lilly is exploring pain management as a potential expansion for their triple agonist, representing the first major trial of a GLP-1-based therapy specifically for chronic pain conditions.
Phase 3 cardiovascular outcomes trial testing orforglipron versus placebo in people with established atherosclerotic cardiovascular disease and/or chronic kidney disease. Event-driven study enrolling 7,140 participants with expected completion in August 2031, approximately 5 years duration. This positions Eli Lilly to compete directly with Novo Nordisk's cardiovascular claims for semaglutide by establishing orforglipron as the first small-molecule oral GLP-1 with proven cardiovascular benefits. The trial targets a high-risk population already established for GLP-1 cardiovascular benefit validation.
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