Orforglipron

The opinion will now be sent to the European Commission (EC) for a final decision on marketing authorisation. Credit: Below the Sky/Shutterstock.com. A European Medicines Agency (EMA) panel has backed Eli Lilly’s Foundayo (orforglipron) for approval, helping the drugmaker close the gap on Novo Nordisk in the obesity pill arena. The agency’s human medicines committee (CHMP) endorsed Foundayo for both weight loss and type 2 diabetes. As with other glucagon-like peptide-1 receptor agonists (GLP-1RAS), the therapy is intended for use alongside a healthy diet and physical activity. The backing means Foundayo is likely to become the second oral GLP-1RA approved in the EU after Novo Nordisk’s oral Wegovy (semaglutide). The Danish drugmaker has raced ahead in the oral GLP-1RA space, with Lilly second to market in the US , UK, and Europe. However, Novo’s pill is approved in these territories for weight management only. Alongside facing off against oral Wegovy in obesity, Foundayo will now directly compete with Novo’s Rybelsus brand of oral semaglutide in type 2 diabetes. The pill remained a blockbuster drug in 2025 despite increased competition. Rybelsus comes in lower doses tailored for blood sugar control. Lilly’s ATTAIN-1 (NCT05869903) and ATTAIN-2 (NCT05872620) studies, both Phase III trials, demonstrated that adults with obesity on the highest dose of the pill lost up to 11.2% of their body weight, compared to a ceiling of 2.5% in the placebo group. The ACHIEVE programme, which evaluated Foundayo in type 2 diabetes patients, reported significant improvements in blood sugar control and body weight. Novo’s pivotal OASIS programme (NCT05035095, NCT05564117) revealed that the highest dose of its tablet led to weight loss of around 13.6%. Given its first-mover advantage, oral Wegovy is currently leading GLP-1RA pill revenue. It generated around $850m in sales worldwide in the first half of this year, while Foundayo generated just shy of $100m, solely in Q2 following its later launches. Foundayo’s advantage over oral semaglutide is that it does not have meal restrictions with administration. Novo’s compound, on the other hand, must be taken on an empty stomach each morning. Analysts remain unsure whether this convenience will translate to stronger adoption than oral Wegovy. While the approval of oral GLP-1RAs are transforming the cardiometabolic arena, injectables still retain a dominant position. In Q2, Lilly’s performance was fuelled by tirzepatide brands Mounjaro and Zepbound, with the type 2 diabetes and obesity drugs accounting for around 64% of revenue. Mounjaro sales spiked 91% to hit $9.9bn, while Zepbound grew 44% to $4.9bn. This far out-performed Novo’s injectable semaglutide franchise, which brought in $7.8bn globally. Indeed, analysis by GlobalData says that tirzepatide holds the potential to outperform oral and injectable semaglutide in type 2 diabetes patients. Real-world data presented at the European Association for the Study of Diabetes (EASD) Annual Meeting 2026 showcased the drug’s higher effectiveness in helping patients achieve glycaemic and weight-loss targets. GlobalData pharma analyst Maria Alexandrovich said: “In an increasingly competitive incretin market, these data could help differentiate tirzepatide from semaglutide. Its benefits across both glycaemic control and weight loss may increase its relevance as treatment decisions increasingly consider outcomes beyond HbA1c alone.”

Oct 15, 2026 View: 105 Leave a message In post-hoc analyses of ATTAIN-1, Foundayo 17.2 mg was associated with a predicted 57% and 18% reduction in risk of type 2 diabetes and cardiovascular disease vs. placebo Combined with recent research on the savings tied to weight loss, these findings suggest Foundayo could help reduce long-term spending for patients and healthcare systems INDIANAPOLIS, Oct. 1, 2026 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY), the maker of Zepbound (tirzepatide), today announced results from post-hoc analyses of ATTAIN-1 showing that Foundayo was associated with significant reductions in predicted 10-year risk of type 2 diabetes and cardiovascular disease in adults with obesity or overweight with a weight-related medical problem. Obesity is strongly associated with an increased risk of developing both cardiovascular disease and type 2 diabetes.1 Through its proven benefit in weight loss and its ability to improve certain cardiovascular risk factors like blood sugar, blood pressure and cholesterol, Foundayo may be a meaningful treatment option for the more than 100 million U.S. adults living with obesity.2 The findings of these analyses were published in Diabetes, Obesity and Metabolism. "For many people living with obesity or overweight, the concern isn't just what the scale says today, it's whether their future could include type 2 diabetes or heart disease," said Thomas Seck, M.D., senior vice president of product development, Lilly Cardiometabolic Health. "These additional analyses of ATTAIN-1 show that Foundayo was associated with a lower predicted long-term risk of both conditions, in addition to meaningful weight loss. We've also seen evidence that treating obesity and reducing the risk of its downstream consequences, like cardiovascular disease and type 2 diabetes, can meaningfully lower healthcare costs.3,4,5 That gives us real optimism about what long-term Foundayo use could mean, both for patients and for the broader healthcare system." In these analyses, modeling showed that Foundayo was associated with clinically meaningful improvements in predicted 10-year risk of type 2 diabetes and cardiovascular disease across all three doses.6 At 72 weeks, participants taking Foundayo 5.5 mg, 9 mg and 17.2 mg showed an estimated 45.0%, 50.0% and 57.0% reduction, respectively, in predicted type 2 diabetes risk versus placebo.7,8 Participants taking Foundayo 17.2 mg also showed an estimated 18.0% reduction in predicted cardiovascular disease risk versus placebo. ATTAIN-1 Post-Hoc Analyses: Change in Predicted 10-Year Cardiometabolic Risk at 72 Weeks Foundayo 5.5 mg Foundayo 9 mg Foundayo 17.2 mg Placebo Predicted 10-year type 2 diabetes risk at baseline 16.4 % 16.0 % 17.1 % 17.3 % Change in predicted 10-year type 2 diabetes risk at 72 weeks -8.0 % -8.8 % -9.8 % -1.7 % Estimated type 2 diabetes risk reduction vs. placeboii 45% (HR = 0.55) (95% CI 0.52, 0.60) 50% (HR = 0.50) (95% CI 0.47, 0.54) 57% (HR = 0.43) (95% CI 0.40, 0.47) – Predicted 10-year cardiovascular disease risk at baseline 8.5 % 8.5 % 8.7 % 8.9 % Change in predicted 10-year cardiovascular disease risk at 72 weeks -0.6 % -0.7 % -1.0 % 0.6 % Estimated cardiovascular disease risk reduction vs. placeboii 13% (HR = 0.87) (95% CI 0.83, 0.90) 15% (HR = 0.85) (95% CI 0.82, 0.89) 18% (HR = 0.82) (95% CI 0.79, 0.86) – iType 2 diabetes risk was estimated using the Cardiometabolic Disease Staging (CMDS) risk engine. iiEstimated risk reduction versus placebo is approximated based on the model-based hazard ratio (HR); placebo was the reference group. iiiCardiovascular disease risk was estimated using the BMI-based Framingham risk engine. About Foundayo Foundayo (orforglipron) is FDA-approved for adults with obesity, or some adults with overweight who also have weight-related medical problems to reduce excess body weight and maintain weight reduction long term, alongside a reduced-calorie diet and increased physical activity. Foundayo is a once-daily small molecule (non-peptide) oral glucagon-like peptide-1 receptor agonist that can be taken any time of the day without restrictions on food and water intake. Orforglipron was discovered by Chugai Pharmaceutical Co., Ltd. and licensed by Lilly in 2018. In addition to chronic weight management, orforglipron is being studied as a potential treatment for type 2 diabetes, obstructive sleep apnea, osteoarthritis knee pain, hypertension, peripheral artery disease and stress urinary incontinence. About ATTAIN-1 and the ATTAIN clinical trial program ATTAIN-1 (NCT05869903) is a Phase 3, 72-week, randomized, double-blind, placebo-controlled trial comparing the efficacy and safety of Foundayo 5.5 mg, 9 mg and 17.2 mg as a monotherapy to placebo in adults with obesity, or overweight with at least one of the following comorbidities: hypertension, dyslipidemia, obstructive sleep apnea or cardiovascular disease, who did not have diabetes. The trial is the first Phase 3 study of this patient population in which treatment was evaluated as an adjunct to exercise and a balanced, healthy diet rather than a reduced-calorie diet. The trial randomized 3,127 participants across the U.S., Brazil, China, India, Japan, South Korea, Puerto Rico, Slovakia, Spain and Taiwan in a 3:3:3:4 ratio to receive either 5.5 mg, 9 mg or 17.2 mg Foundayo or placebo. The primary objective of the study was to demonstrate that Foundayo (5.5 mg, 9 mg or 17.2 mg) is superior to placebo in body weight reduction from baseline after 72 weeks in people with a BMI ≥30.0 kg/m² or a BMI ≥27.0 kg/m² with at least one weight-related comorbidity and a history of at least one self-reported unsuccessful dietary effort to lose body weight. All participants in the Foundayo treatment arms started the study at a dose of Foundayo 0.8 mg once-daily and then increased the dose in a step-wise approach at four-week intervals to their final randomized maintenance dose of 5.5 mg (via steps at 0.8 mg and 2.5 mg), 9 mg (via steps at 0.8 mg, 2.5 mg and 5.5 mg) or 17.2 mg (via steps at 0.8 mg, 2.5 mg, 5.5 mg, 9 mg and 14.5 mg). The trial was conducted using an investigational formulation of Foundayo at dosages equivalent to Foundayo tablets. The ATTAIN Phase 3 global clinical development program for orforglipron enrolled more than 4,500 people with obesity or overweight across two global registration trials (ATTAIN-1 & ATTAIN-2). Endnotes and References 1,Jensen MD, Ryan DH, Apovian CM, et al. 2013 AHA/ACC/TOS guideline for the management of overweight and obesity in adults. Circulation. 2014;129(25 Suppl 2):S102-S138. 2,Centers for Disease Control and Prevention. Adult Obesity Facts. https://www.cdc.gov/obesity/adult-obesity-facts/index.html. 3,Bjornson AM, Szabo SM, Donato BMK, Gardner M, Kuti E. Costs of obesity, obesity-related complications, and weight loss in the United States: A systematic literature review. J Manag Care Spec Pharm. 2025;31(9):851-861. 4,Xue J, Anderson J, Huang A, Gou R, Sun H, Zhao J, Allende C, Hua H, Hohlbauch A, Chinthammit C. Clinical and Economic Burden of Obesity and Cardiovascular Disease Among Medicare Fee-For-Service Beneficiaries. Diabetes Obes Metab. 2026. 5,Boye KS, Lage MJ, Terrell K. Healthcare outcomes for patients with type 2 diabetes with and without comorbid obesity. J Diabetes Complications. 2020;34(12):107730. 6,D'Agostino Sr RB, Vasan RS, Pencina MJ, Wolf PA, Cobain M, Massaro JM, Kannel WB. General cardiovascular risk profile for use in primary care: the Framingham Heart Study. Circulation. 2008;117(6):743-53. 7,Guo F, Garvey WT. Development of a weighted cardiometabolic disease staging (CMDS) system for the prediction of future diabetes. The Journal of Clinical Endocrinology & Metabolism. 2015;100(10):3871-7. 8,Wilkinson L, Yi N, Mehta T, Judd S, Garvey WT. Development and validation of a model for predicting incident type 2 diabetes using quantitative clinical data and a Bayesian logistic model: a nationwide cohort and modeling study. PLoS medicine. 2020;17(8):e1003232. GenoHope Biotech Ltd. A leading manufacturer of GLP-1 API Approal by FDA Welcome any Inquiry WhatsApp/Tel:+8613833133635 Email:info@genohopebio.com Send Inquiry