{"shortAnswer":"Orforglipron is FDA-approved as Foundayo, a daily pill for weight loss, with a prescription. The evidence grade is strong-human for weight loss in adults. It is not approved for diabetes, and its long-term effects are not known.","url":"https://peptideindex.ai/compound/orforglipron","status":"fda-approved","statusCheckedAt":"2026-10-25T06:22:41.170Z","statusStale":false,"regulatoryAsOf":"2026-10-24","verified":"2026-10-25T17:34:42.327Z","primarySourceUrl":"https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=220934","clinicallyReviewed":false,"notice":"Information, not medical advice.","id":"de850695-ff57-41b1-97ca-ef75d88c88b8","object":"compound","slug":"orforglipron","name":"Orforglipron","attrs":{"name":"Orforglipron","class":"glp-1-agonist","access":[{"type":"approved-product","detail":"Approved by FDA and sold with a prescription as a pill taken once a day, for weight loss in adults.","indication":"With a lower-calorie diet and more exercise, to lose excess weight and keep it off in adults with obesity, or adults with overweight and at least one weight-related health problem.","source_url":"https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=8ac446c5-feba-474f-a103-23facb9b5c62","brand_names":["Foundayo"],"manufacturer":"Eli Lilly and Company"}],"dosing":"From the Foundayo label. One tablet by mouth once a day, with or without food. It starts at 0.8 mg a day. After at least 30 days it goes to 2.5 mg, and after 30 more days to 5.5 mg. It may then go up to 9 mg, 14.5 mg or 17.2 mg, with at least 30 days at each step. The most is 17.2 mg a day, or 9 mg a day with some drugs that slow how the body breaks it down. The prescriber sets the dose.","trials":[{"nct":"NCT07790861","url":"https://clinicaltrials.gov/study/NCT07790861","phase":"Phase 3","title":"A Study of Orforglipron (LY3502970) in Chinese Participants With Obesity or Overweight and Weight-Related Health Problems","status":"not-yet-recruiting","sponsor":"Eli Lilly and Company","countries":["China"],"us_states":[]},{"nct":"NCT07729332","url":"https://clinicaltrials.gov/study/NCT07729332","phase":"Phase 4","title":"Switching to Oral Weight Management Pharmacotherapy to Prevent Weight Regain After GLP-1 Therapy Discontinuation","status":"not-yet-recruiting","sponsor":"Massachusetts General Hospital","countries":["United States"],"us_states":["Massachusetts"]},{"nct":"NCT07739537","url":"https://clinicaltrials.gov/study/NCT07739537","phase":"Phase 4","title":"PATHS-T2D: A Recall-by-Genotype Study of Physiologic and Pharmacologic Responses","status":"not-yet-recruiting","sponsor":"Massachusetts General Hospital","countries":[],"us_states":[]},{"nct":"NCT07793019","url":"https://clinicaltrials.gov/study/NCT07793019","phase":"Phase 1","title":"IBI3042 Study in Healthy Participants and Overweight or Obese Participants","status":"recruiting","sponsor":"Innovent Biologics (Suzhou) Co. Ltd.","countries":["China"],"us_states":[]},{"nct":"NCT07794579","url":"https://clinicaltrials.gov/study/NCT07794579","phase":"Phase 3","title":"A Study of Orforglipron in Participants With Overweight at Risk of Development of Obesity-Related Complications or Progression to Class 1 Obesity","status":"recruiting","sponsor":"Eli Lilly and Company","countries":["United States","Argentina","China","Czechia","Germany","India","Japan","Mexico","Puerto Rico","South Korea","Spain","Taiwan"],"us_states":["Alabama","Arizona","California","Connecticut","Florida","Georgia","Idaho","Illinois","Iowa","Kansas","Kentucky","Louisiana","Maryland","Massachusetts","Michigan","Minnesota","Missouri","Nevada","New Jersey","New York","North Carolina","North Dakota","Ohio","Oklahoma","Oregon","Pennsylvania","South Carolina","Tennessee","Texas","Virginia","West Virginia"]},{"nct":"NCT07613307","url":"https://clinicaltrials.gov/study/NCT07613307","phase":"Phase 3","title":"A Study of Orforglipron (LY3502970) in Participants With Type 2 Diabetes Who Observe Ramadan Fasting","status":"recruiting","sponsor":"Eli Lilly and Company","countries":["India","Saudi Arabia","South Africa","United Arab Emirates"],"us_states":[]},{"nct":"NCT07668336","url":"https://clinicaltrials.gov/study/NCT07668336","phase":"Phase 3","title":"A Study of Orforglipron (LY3502970) Compared With Dulaglutide in Pediatric Participants With Type 2 Diabetes","status":"recruiting","sponsor":"Eli Lilly and Company","countries":["United States","Belgium","Brazil","India","Italy","Japan","Mexico","South Korea","Spain","Taiwan","United Kingdom"],"us_states":["California","Connecticut","Georgia","Idaho","Kansas","New York","Oklahoma","Pennsylvania","Tennessee","Texas"]},{"nct":"NCT07107334","url":"https://clinicaltrials.gov/study/NCT07107334","phase":"Phase 2","title":"A Study to Estimate Early Clinical Efficacy Signals of GLP-1 Agonist Administration in Conjunction With Levonorgestrel Intrauterine Device in Obese Patients With Endometrioid Intraepithelial Neoplasia","status":"recruiting","sponsor":"University of Florida","countries":["United States"],"us_states":["Florida"]},{"nct":"NCT07241390","url":"https://clinicaltrials.gov/study/NCT07241390","phase":"Phase 3","title":"A Study of Orforglipron (LY3502970) on Cardiovascular Outcomes in Adults With Atherosclerotic Cardiovascular Disease and/or Chronic Kidney Disease (ATTAIN-Outcomes)","status":"recruiting","sponsor":"Eli Lilly and Company","countries":["Argentina","Australia","Austria","Belgium","Brazil","Bulgaria","Canada","China","Colombia","Czechia","Estonia","France","Germany","Greece","Hungary","India","Israel","Italy","Japan","Lithuania","Malaysia","Mexico","Netherlands","New Zealand","Philippines","Poland","Romania","Serbia","Slovakia","South Africa","South Korea","Spain","Taiwan","Thailand","Tunisia","Turkey (Türkiye)","Ukraine","United Kingdom"],"us_states":[]},{"nct":"NCT07223593","url":"https://clinicaltrials.gov/study/NCT07223593","phase":"Phase 3","title":"Efficacy and Safety of Orforglipron in Participants With Peripheral Artery Disease","status":"recruiting","sponsor":"Eli Lilly and Company","countries":["United States","Argentina","Australia","Brazil","Canada","China","France","Greece","India","Israel","Japan","Netherlands","Poland","Puerto Rico","Slovakia","South Korea","Taiwan","United Kingdom"],"us_states":["Alabama","Arizona","California","Colorado","Florida","Indiana","Maryland","Michigan","Pennsylvania","Tennessee","Texas","Utah","Virginia","Washington"]},{"nct":"NCT07202884","url":"https://clinicaltrials.gov/study/NCT07202884","phase":"Phase 3","title":"A Study of Orforglipron in Female Participants With Stress Urinary Incontinence Who Have Obesity or Overweight","status":"recruiting","sponsor":"Eli Lilly and Company","countries":["United States","Canada","China","Czechia","India","Japan","Mexico","Poland","Romania","South Korea"],"us_states":["Alabama","Arizona","California","Colorado","Florida","Georgia","Michigan","Pennsylvania","Texas","Virginia","Washington"]},{"nct":"NCT06672939","url":"https://clinicaltrials.gov/study/NCT06672939","phase":"Phase 3","title":"A Study of Orforglipron (LY3502970) in Adolescent Participants With Obesity, or Overweight With Related Comorbidities","status":"recruiting","sponsor":"Eli Lilly and Company","countries":["United States","Israel","Italy","Japan","Poland","United Kingdom"],"us_states":["California","Connecticut","Georgia","Illinois","Louisiana","Missouri","North Carolina","Pennsylvania","Tennessee","Texas"]},{"nct":"NCT06672549","url":"https://clinicaltrials.gov/study/NCT06672549","phase":"Phase 3","title":"A Platform Trial for Pediatric Participants With Obesity or Overweight (LY900040)","status":"recruiting","sponsor":"Eli Lilly and Company","countries":["United States","Belgium","Brazil","China","Israel","Italy","Japan","Mexico","Poland","Portugal","South Korea","Spain","United Kingdom"],"us_states":["Arizona","California","Colorado","Connecticut","Florida","Georgia","Illinois","Indiana","Kentucky","Louisiana","Maryland","Massachusetts","Michigan","Minnesota","Mississippi","Missouri","Nebraska","New York","North Carolina","Ohio","Oklahoma","Pennsylvania","South Carolina","Tennessee","Texas","Utah","Virginia","Washington"]}],"aliases":["Foundayo"],"summary":"A daily pill that acts on the body's GLP-1 receptor. It is a small molecule, not a peptide. FDA approved it as Foundayo for weight loss in 2026.","citations":[{"n":1,"url":"https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=220934","tier":"primary","type":"regulatory","title":"Drugs@FDA: Foundayo tablets, application 220934"},{"n":2,"url":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/220934Orig1s000ltr.pdf","tier":"primary","type":"regulatory","title":"FDA approval letter for Foundayo, 1 April 2026"},{"n":3,"url":"https://www.fda.gov/news-events/press-announcements/fda-approves-first-new-molecular-entity-under-national-priority-voucher-program","tier":"primary","type":"regulatory","title":"FDA: first new molecular entity approved under the national priority voucher program, 1 April 2026"},{"n":4,"url":"https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=8ac446c5-feba-474f-a103-23facb9b5c62","tier":"primary","type":"label","title":"DailyMed: Foundayo tablets prescribing information, revised July 2026"},{"n":5,"url":"https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/220934s003lbl.pdf","tier":"primary","type":"label","title":"FDA: Foundayo prescribing information, supplement approved 4 August 2026"},{"n":6,"url":"https://www.accessdata.fda.gov/CMS_IA/importalert_1186.html","tier":"primary","type":"regulatory","title":"FDA Import Alert 66-80: GLP-1 drug ingredients, published 9 October 2026"},{"n":7,"url":"https://clinicaltrials.gov/study/NCT05869903","tier":"primary","type":"human-trial","title":"ClinicalTrials.gov NCT05869903: ATTAIN-1, orforglipron in adults with obesity"},{"n":8,"url":"https://clinicaltrials.gov/study/NCT05872620","tier":"primary","type":"human-trial","title":"ClinicalTrials.gov NCT05872620: ATTAIN-2, orforglipron in adults with obesity and type 2 diabetes"},{"n":9,"url":"https://clinicaltrials.gov/study/NCT05971940","tier":"primary","type":"human-trial","title":"ClinicalTrials.gov NCT05971940: ACHIEVE-1, orforglipron in early type 2 diabetes"},{"n":10,"url":"https://clinicaltrials.gov/study/NCT05803421","tier":"primary","type":"human-trial","title":"ClinicalTrials.gov NCT05803421: orforglipron versus insulin glargine and heart risk"},{"n":11,"url":"https://www.thefdalawblog.com/2025/11/fda-accelerates-again-the-second-cnpv-cohort/","tier":"legal-analysis","type":"legal-analysis","title":"FDA Law Blog: FDA names the second national priority voucher cohort, November 2025"},{"n":12,"url":"https://www.lachmanconsultants.com/2026/04/first-nme-approved-through-commissioners-national-priority-voucher-cnpv-program/","tier":"legal-analysis","type":"legal-analysis","title":"Lachman Consultants: first new molecular entity approved through the voucher program"},{"n":13,"url":"https://pubmed.ncbi.nlm.nih.gov/40960239/","tier":"peer-reviewed","type":"rct","title":"ATTAIN-1: oral orforglipron in adults with obesity, 2025"},{"n":14,"url":"https://pubmed.ncbi.nlm.nih.gov/41275875/","tier":"peer-reviewed","type":"rct","title":"ATTAIN-2: orforglipron in adults with obesity and type 2 diabetes, 2025"},{"n":15,"url":"https://pubmed.ncbi.nlm.nih.gov/40544435/","tier":"peer-reviewed","type":"rct","title":"ACHIEVE-1: orforglipron in early type 2 diabetes, 2025"},{"n":16,"url":"https://pubmed.ncbi.nlm.nih.gov/42815506/","tier":"peer-reviewed","type":"rct","title":"Orforglipron versus insulin glargine and heart outcomes in type 2 diabetes, 2026"},{"n":17,"url":"https://pubmed.ncbi.nlm.nih.gov/42120723/","tier":"peer-reviewed","type":"rct","title":"ATTAIN-MAINTAIN: orforglipron to keep weight off after weekly shots, 2026"},{"n":18,"url":"https://pubmed.ncbi.nlm.nih.gov/41296780/","tier":"peer-reviewed","type":"systematic-review","title":"Review and meta-analysis of orforglipron in adults with obesity, 2025"},{"n":19,"url":"https://pubmed.ncbi.nlm.nih.gov/41465949/","tier":"peer-reviewed","type":"systematic-review","title":"Review of stomach and gut problems with pill-form GLP-1 drugs, 2025"},{"n":20,"url":"https://www.fiercepharma.com/pharma/lilly-answers-novos-glp-1-pill-highly-anticipated-fda-nod-foundayo","tier":"established-news","type":"reference","title":"Fierce Pharma: FDA approves Lilly's GLP-1 pill Foundayo"},{"n":21,"url":"https://abc30.com/post/fda-grants-speedy-approval-eli-lillys-weight-loss-glp-1-pill-foundayo-obesity/18823509/","tier":"established-news","type":"reference","title":"Associated Press via ABC30: FDA grants speedy approval to the weight-loss pill Foundayo"}],"known_risks":["The most common problems are nausea, constipation, diarrhea, vomiting, indigestion and belly pain [^4]. A 2025 review of early trials found nausea was the most common problem [^19]. In the two main trials, 8% of people on it stopped because of unwanted effects, against 3% on a dummy pill [^4].","Serious stomach and gut problems were about three times as common as with a dummy pill [^4].","The label warns of a swollen pancreas and gallbladder disease [^4]. It also warns of kidney harm from losing fluids, and of bad allergic reactions [^4].","Taken with insulin or some diabetes pills, it can push blood sugar too low [^4]. In the trial of people with diabetes, low blood sugar was more common on it than on a dummy pill [^4].","It slows how fast the stomach empties, so birth control pills may work less well. The label advises another method for 30 days after starting and after each dose increase [^4].","The label carries a boxed warning about thyroid tumors. People with a rare type of thyroid cancer in the family should not take it [^4]."],"short_answer":"Orforglipron is FDA-approved as Foundayo, a daily pill for weight loss, with a prescription. The evidence grade is strong-human for weight loss in adults. It is not approved for diabetes, and its long-term effects are not known.","evidence_grade":"strong-human","open_questions":["Nobody knows if it raises the risk of thyroid cancer in people. It does not act on the rat or mouse receptor, so animal studies could not test that risk [^4].","The main weight trials lasted 72 weeks, so they do not show what many years of use do [^4] [^13].","In a 2-year heart trial of 2,749 adults with diabetes, heart attacks, strokes and heart deaths were not more common on it than on insulin. The trial did not show that it lowers heart risk [^16].","Nobody knows how well it keeps weight off past one year after people switch from a weekly shot [^17].","No trial has compared it head to head with the Wegovy pill, another GLP-1 pill [^20]."],"section_routes":"The legal way to get orforglipron is a prescription for Foundayo [^1] [^4]. It is approved by FDA for weight loss in adults [^1] [^2]. The label says who it is for and how it is taken [^4].\n\nDrugs@FDA lists Foundayo tablets as the approved product [^1]. FDA also watches the raw drug ingredient that comes into the country. Shipments from makers not on an FDA list may be held at the border [^6].","regulatory_as_of":"2026-10-24","section_channels":"No FDA page we found names orforglipron in a warning letter or a fake-product alert. That may change as the pill becomes more common. The one FDA record that names it is about raw drug ingredient brought in from other countries [^6].\n\nFDA lets its border staff hold shipments of GLP-1 drug ingredient from other countries without first testing them [^6]. Only makers on an FDA list are exempt. FDA added orforglipron ingredient from three makers to that list [^6]. FDA says it checked 48 makers of GLP-1 ingredient and found 21% did not follow its manufacturing quality rules [^6]. FDA treats ingredient made outside these rules as adulterated, which means unfit under the law [^6]. Pharmacies that mix drugs do not have to test the ingredient for strength or impurities [^6].","section_evidence":"The evidence grade is strong-human for weight loss: two large 72-week trials in people found more weight loss than a dummy pill [^13] [^14]. In a trial of 3,127 adults with obesity and no diabetes, people on the highest dose lost about 11% of their weight. People on the dummy pill lost about 2% [^13]. In a trial of 1,613 adults with overweight and type 2 diabetes, people on the highest dose lost about 10%. People on the dummy pill lost about 2.5% [^14]. A 2025 review of five trials with 4,410 people found the same pattern [^18].\n\nIn a 40-week trial of 559 adults with early type 2 diabetes, it lowered blood sugar more than a dummy pill [^15]. Diabetes is not an approved use [^4]. In a heart trial of 2,749 adults with diabetes and heart or kidney disease, it was compared with insulin. Heart attacks, strokes and heart deaths were about as common with both [^16]. In a one-year trial, people who had lost weight on a weekly shot kept off more of it on orforglipron than on a dummy pill [^17].\n\nThe maker paid for the main weight trial and the early diabetes trial [^13] [^15]. The trials used an earlier test form of the pill. The label treats that form as matching the approved tablets [^4]. Most people who stopped because of unwanted effects had stomach or gut problems [^4].","regulatory_status":"fda-approved","section_what_it_is":"Orforglipron is a prescription pill taken once a day [^4]. It acts on the GLP-1 receptor in the body [^4]. GLP-1 is a gut hormone that helps control hunger and how much people eat [^4].\n\nMany GLP-1 drugs are peptides, which are short chains of protein building blocks [^16] [^21]. Orforglipron is not. It is a small molecule [^13] [^15]. It can be taken with or without food [^4]. The body clears half of a dose in about 29 to 49 hours [^4].\n\nFDA approved it in April 2026 under the brand name Foundayo [^1] [^3]. One company makes it [^1].","section_is_it_legal":"Orforglipron is FDA-approved: FDA approved it as Foundayo on 1 April 2026 [^1] [^2] [^3]. That covers the brand pill, with a prescription, for the use on its label. It does not make any other version approved. Checked 24 October 2026.\n\nThe approved use is weight loss and keeping weight off. It is for adults with obesity, or adults with overweight and at least one related health problem [^2] [^4]. It is to be used with a lower-calorie diet and more exercise [^4]. The label does not list type 2 diabetes as a use, though several trials tested it in people with diabetes [^4] [^15].\n\nThe approval was fast. FDA gave the company a national priority voucher in November 2025, before the drug was approved [^11]. The voucher program aims to speed up reviews [^3] [^11]. FDA approved the drug 50 days after the application was filed [^3]. FDA did not send it to an advisory committee, a panel of outside experts [^2]. Some observers have questioned how the program picks drugs [^12].","unofficial_channels":[{"type":"overseas-or-import","what_it_is":"Raw GLP-1 drug ingredient made in other countries and shipped to the US, including orforglipron ingredient.","enforcement":[{"date":"2026-10-09","text":"FDA published a revised import alert on GLP-1 drug ingredient. It added orforglipron ingredient from three makers to the list exempt from being held.","source_url":"https://www.accessdata.fda.gov/CMS_IA/importalert_1186.html"}],"legal_position":{"text":"FDA lets border staff hold GLP-1 ingredient shipments without testing them, unless the maker is on FDA's list of makers that follow the rules.","source_url":"https://www.accessdata.fda.gov/CMS_IA/importalert_1186.html"},"documented_risks":[{"text":"FDA checked 48 makers of GLP-1 ingredient and found 21% did not follow FDA's manufacturing quality rules, or did not answer FDA.","source_url":"https://www.accessdata.fda.gov/CMS_IA/importalert_1186.html"},{"text":"FDA says pharmacies that mix drugs do not have to test the ingredient for strength or impurities, so a problem may not be 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