Foundayo (orforglipron)

Lilly's Foundayo Cuts Cardiovascular Death Risk 53% in ACHIEVE-4 Trial

Indianapolis – – September 30, 2026 -- Eli Lilly and Company (NYSE: LLY) reported that its oral GLP-1 therapy Foundayo (orforglipron) reduced cardiovascular death risk by 53% and all-cause death risk by 57% compared with insulin glargine in the Phase 3 ACHIEVE-4 trial, the largest and longest study of the medicine in type 2 diabetes to date.

Foundayo meets non-inferiority bar on major cardiovascular events

Among 2,749 participants randomized across 16 countries including the U.S., Germany, India, Brazil and South Korea, Foundayo showed a 16% lower risk of MACE-4 (cardiovascular death, heart attack, stroke or hospitalization for unstable angina) versus insulin glargine, with a hazard ratio of 0.84 (95.0% CI: 0.59 to 1.20), meeting the prespecified non-inferiority threshold. The risk of MACE-3 (cardiovascular death, heart attack or stroke) was 23% lower (hazard ratio: 0.77; 95.0% CI: 0.52 to 1.13).

Lilly's Foundayo Outperforms Oral Semaglutide 25 mg in New Diabetes Data

Indianapolis – September 29, 2026 -- Eli Lilly and Company (NYSE: LLY) reported that its oral GLP-1 drug Foundayo (orforglipron) at 17.2 mg produced 1.5% greater weight loss and 0.3% greater A1C reduction than oral semaglutide 25 mg over 52 weeks in adults with type 2 diabetes, based on an indirect treatment comparison presented at the 62nd Annual Meeting of the European Association for the Study of Diabetes in Milan.

Indirect analysis draws on ACHIEVE-3 and PIONEER PLUS trial data

The comparison, covariate-adjusted for gender, age, baseline A1C and baseline weight, found weight-loss differences ranging from 1.5% to 2.4% and A1C reductions of 0.3% to 0.6% in favor of Foundayo 17.2 mg across multiple statistical methods. The 95% confidence interval for weight loss was -2.7% to -0.2%, and for A1C reduction was -0.6% to -0.1%.

Lilly Sets 2040 Deadline to Equalize Diabetes, Obesity Drug Access

Indianapolis – September 28, 2026 -- Eli Lilly and Company (NYSE: LLY) launched the Lilly Change the Course Commitment on Sept. 28, targeting treatment parity for diabetes and obesity patients between high-income countries and resource-limited settings by 2040. Today, for every four patients in high-income countries who access Lilly's diabetes and obesity medicines, only one patient in low- and middle-income countries (LMICs) can reach them.

Lilly targets registration of GLP-1 medicines across Africa, Latin America and Asia

The initiative rests on three pillars: adapting clinical development for resource-limited settings, accelerating registration of innovative medicines including GLP-1s in more LMICs, and strengthening primary health systems through training and digital tools. Lilly said it will prioritize regulatory filings and access pathways in Africa, Latin America and Asia, working with regulators, NGOs and global health organizations.

Lilly Breaks Ground on $6.5B Houston API Plant for Foundayo

Houston – – September 21, 2026 -- Eli Lilly and Company (NYSE: LLY) has broken ground on a $6.5 billion manufacturing site in Houston, Texas, that will produce active pharmaceutical ingredients for Foundayo (orforglipron), the company's first synthetic oral GLP-1 medicine for weight management.

Houston site becomes Lilly's fifth domestic API facility since 2020

The plant is one of ten U.S. manufacturing sites Lilly has announced since 2020 and the fifth dedicated to producing active pharmaceutical ingredients domestically. The investment falls under Lilly's broader $50 billion initiative to reshore medicine production in the United States and export American-made drugs globally.