The FDA approved Eli Lilly's Foundayo, a once-daily GLP-1 pill for weight loss that needs no food or water restrictions, with direct-to-consumer sales from April 6.
The FDA approved Eli Lilly's Foundayo (orforglipron) on 1 April 2026 for adults with obesity, or overweight with weight-related medical problems, used with a reduced-calorie diet and increased physical activity[2][3]; the approval letter for NDA 220934 is signed by Lisa B. Yanoff, MD, Deputy Director of the Office of Cardiology, Hematology, Endocrinology and Nephrology, with an electronic signature timestamp of 04/01/2026 09:10:30 AM[4]
The application was received on January 20, 2026, and was "not referred to an FDA advisory committee because there were no controversial issues that would benefit from advisory committee discussion"[4]
It is the only GLP-1 pill for weight loss that can be taken any time of day without food or water restrictions, a once-daily small molecule (non-peptide) GLP-1 receptor agonist[3]
Prescriptions are accepted immediately through LillyDirect with shipping beginning April 6, followed shortly by broad availability through U.S. retail pharmacies and telehealth providers[2][3]; Yahoo Finance frames the same launch as Lilly expecting to launch on its direct-to-consumer channel "by 6 April"[1]
In ATTAIN-1, adults on the highest dose who stayed on treatment lost an average of 27.3 pounds (12.4%) against 2.2 pounds (0.9%) with placebo, the efficacy estimand over 72 weeks; regardless of trial completion the average was 25 pounds (11.1%) against 5.3 pounds (2.1%)[3]. EMJ GOLD gives the same trial as "more than 12%" versus around 1%, and "more than 10%" versus approximately 2%[2], and Yahoo Finance cites the 12.4% figure[1]
Foundayo also reduced markers of cardiovascular risk - waist circumference, non-HDL cholesterol, triglycerides and systolic blood pressure - across all doses[2][3]
The ATTAIN Phase 3 programme enrolled more than 4,500 people across two registration trials: ATTAIN-1 (NCT05869903) randomized 3,127 participants in ten countries and territories, and ATTAIN-2 (NCT05872620) over 1,600 participants with type 2 diabetes[3]
Pricing: as little as $25 a month with the savings card for eligible people with commercial insurance, self-pay from $149 a month for the lowest dose, and $50 a month for eligible Medicare Part D individuals "beginning as soon as July 1, 2026"[3]
The tablets come in 0.8 mg, 2.5 mg, 5.5 mg, 9 mg, 14.5 mg and 17.2 mg strengths, starting at 0.8 mg, swallowed whole with or without food, and are not to be used with another GLP-1[2][3]
Orforglipron was discovered by Chugai Pharmaceutical Co., Ltd. and licensed by Lilly in 2018; it is Lilly's second FDA-approved obesity medicine and is also being studied for type 2 diabetes, obstructive sleep apnea, osteoarthritis knee pain, hypertension, peripheral artery disease and stress urinary incontinence[3]
Lilly has submitted orforglipron for weight management and/or type 2 diabetes in more than 40 countries and plans to launch in each shortly after approval[2][3]
Yahoo Finance reports it as "the first new molecular entity (NME) approved under the FDA's national priority voucher (CNPV) programme" launched by Commissioner Marty Makary, which GlobalData analyst Shehroz Mahmood says "has led to the fastest new molecular entity approval since 2002"[1]; the FDA letter itself says only that "New molecular entities qualify for a post approval feedback meeting" and does not mention the voucher[4]
The approval ends Novo Nordisk's first-mover advantage in the US after three months, Wegovy's pill (semaglutide) having launched there in January 2026; Foundayo has no meal restrictions where oral Wegovy must be taken on an empty stomach each morning, and as a small molecule is easier to manufacture and scale[1]
No head-to-head trials have been run, but the Wegovy pill on average leads to 2.2% better weight loss[1]
The label carries a boxed-style warning that Foundayo may cause thyroid tumors including thyroid cancer, and it is contraindicated with a personal or family history of medullary thyroid carcinoma or with MEN 2; other serious risks listed are pancreatitis, severe stomach problems, dehydration and kidney problems, hypoglycemia, allergic reactions, diabetic retinopathy changes, gallbladder problems and aspiration under anesthesia[3]
The commonest side effects are nausea, constipation, diarrhea, vomiting, indigestion, abdominal pain, headache, swollen belly, fatigue, belching, heartburn, gas and hair loss; birth control pills may not work as well, so another method is advised for 30 days after starting and after each dose increase[3]
The FDA attached a long list of postmarketing requirements under 505(o), including a pediatric obesity registry cohort study of at least 10 years, two pregnancy studies, a medullary thyroid carcinoma registry case series of at least 15 years running to a final report in August 2043, the ACHIEVE-4 cardiovascular outcomes trial with adjudicated MACE and drug-induced liver injury assessment, a gastric-emptying clinical pharmacology trial and a milk-only lactation study[4]
Pediatric studies were waived for ages under 6 and deferred for ages 6-11 and 12-17, with the adolescent trial J4M-MC-PW01 (ADVANCE-ATTAIN-ADOLESCENTS) due to complete in March 2028 and report in December 2028[4]
The FDA also requested enhanced pharmacovigilance for five years after approval, with 15-day "Alert reports" for serious unexpected cases of drug-induced liver injury causing jaundice, liver failure, transplant or death[4]
The approved expiry dating period is 24 months from manufacture when stored at 20°C to 25°C[4]
Lilly's CEO David A. Ricks framed the launch around access: "Today, fewer than 1 in 10 people who could benefit from a GLP-1 are taking one, held back by access, stigma, perceived complexity or the belief that their condition isn't serious enough for treatment"[2][3]
Buoyed by obesity drug sales, Lilly's growth rose 45% in 2025, and Citi analysts expect Foundayo's lack of fasting requirements to put it "in pole position to continue Lilly's cardiometabolic dominance"[1]
预估延期3个月可信度 77%189天后Lilly "plans to subsequently submit retatrutide in Q1 2027 for U.S. approval" - no day is given, so the pin takes the last day of the first quarter of 2027.[1]
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预估可信度 50%1.8年后ClinicalTrials.gov[1] lists 2028-07-24 as the estimated primary completion date; a sponsor's estimate, and trials of this size routinely slip.
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预估可信度 50%1.9年后ClinicalTrials.gov[1] lists 2028-08-11 as the estimated primary completion date; a sponsor's estimate, and trials of this size routinely slip.
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