GLP-1 agonist
Orforglipron
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.
This page has not been individually reviewed by a clinician.
Fact sheet · 6 facts
every row cites its source and its date| Fact | Value | Tier | Checked | Source |
|---|---|---|---|---|
| Also called | Foundayo | primary | dailymed.nlm.nih.gov | |
| Class | glp-1-agonist | primary | dailymed.nlm.nih.gov | |
| Regulatory status | fda-approved | primary | accessdata.fda.gov | |
| Status source read | 2026-10-24 | primary | accessdata.fda.gov | |
| Evidence grade | strong-human | our assessment | peptideindex.ai | |
| Label 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. | primary | dailymed.nlm.nih.gov |
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.
Our assessment, drawn from the sources below.
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].
Many 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].
FDA approved it in April 2026 under the brand name Foundayo [1] [3]. One company makes it [1].
Where it stands legally
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.
The 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].
The 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].
What the evidence shows
Evidence grade: strong-human · our assessment
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].
In 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].
The 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].
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].
What nobody knows yet
- 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].
Legitimate ways to get it
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].
Drugs@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].
Approved product
Approved by FDA and sold with a prescription as a pill taken once a day, for weight loss in adults.
Brand names: Foundayo
Manufacturer: Eli Lilly and Company
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.
Recruiting trials
A listing is not a recommendation. Trials have strict eligibility rules. Talk to your doctor and read the official record.
Snapshot of .clinicaltrials.gov
NCT07790861
A Study of Orforglipron (LY3502970) in Chinese Participants With Obesity or Overweight and Weight-Related Health Problems
Phase: Phase 3 · Sponsor: Eli Lilly and Company · Status: Not yet recruiting
Countries: China
US states: none listed
NCT07729332
Switching to Oral Weight Management Pharmacotherapy to Prevent Weight Regain After GLP-1 Therapy Discontinuation
Phase: Phase 4 · Sponsor: Massachusetts General Hospital · Status: Not yet recruiting
Countries: United States
US states: Massachusetts
NCT07739537
PATHS-T2D: A Recall-by-Genotype Study of Physiologic and Pharmacologic Responses
Phase: Phase 4 · Sponsor: Massachusetts General Hospital · Status: Not yet recruiting
Countries: none listed
US states: none listed
NCT07793019
IBI3042 Study in Healthy Participants and Overweight or Obese Participants
Phase: Phase 1 · Sponsor: Innovent Biologics (Suzhou) Co. Ltd. · Status: Recruiting
Countries: China
US states: none listed
NCT07794579
A Study of Orforglipron in Participants With Overweight at Risk of Development of Obesity-Related Complications or Progression to Class 1 Obesity
Phase: Phase 3 · Sponsor: Eli Lilly and Company · Status: Recruiting
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
NCT07613307
A Study of Orforglipron (LY3502970) in Participants With Type 2 Diabetes Who Observe Ramadan Fasting
Phase: Phase 3 · Sponsor: Eli Lilly and Company · Status: Recruiting
Countries: India, Saudi Arabia, South Africa, United Arab Emirates
US states: none listed
NCT07668336
A Study of Orforglipron (LY3502970) Compared With Dulaglutide in Pediatric Participants With Type 2 Diabetes
Phase: Phase 3 · Sponsor: Eli Lilly and Company · Status: Recruiting
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
NCT07107334
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
Phase: Phase 2 · Sponsor: University of Florida · Status: Recruiting
Countries: United States
US states: Florida
NCT07241390
A Study of Orforglipron (LY3502970) on Cardiovascular Outcomes in Adults With Atherosclerotic Cardiovascular Disease and/or Chronic Kidney Disease (ATTAIN-Outcomes)
Phase: Phase 3 · Sponsor: Eli Lilly and Company · Status: Recruiting
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: none listed
NCT07223593
Efficacy and Safety of Orforglipron in Participants With Peripheral Artery Disease
Phase: Phase 3 · Sponsor: Eli Lilly and Company · Status: Recruiting
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
NCT07202884
A Study of Orforglipron in Female Participants With Stress Urinary Incontinence Who Have Obesity or Overweight
Phase: Phase 3 · Sponsor: Eli Lilly and Company · Status: Recruiting
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
NCT06672939
A Study of Orforglipron (LY3502970) in Adolescent Participants With Obesity, or Overweight With Related Comorbidities
Phase: Phase 3 · Sponsor: Eli Lilly and Company · Status: Recruiting
Countries: United States, Israel, Italy, Japan, Poland, United Kingdom
US states: California, Connecticut, Georgia, Illinois, Louisiana, Missouri, North Carolina, Pennsylvania, Tennessee, Texas
NCT06672549
A Platform Trial for Pediatric Participants With Obesity or Overweight (LY900040)
Phase: Phase 3 · Sponsor: Eli Lilly and Company · Status: Recruiting
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
How people are getting it anyway
This section describes what happens and is not a recommendation.
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].
FDA 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].
Overseas or import
Raw GLP-1 drug ingredient made in other countries and shipped to the US, including orforglipron ingredient.
The lawFDA 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.accessdata.fda.gov
Documented riskFDA checked 48 makers of GLP-1 ingredient and found 21% did not follow FDA's manufacturing quality rules, or did not answer FDA.accessdata.fda.gov
Documented riskFDA says pharmacies that mix drugs do not have to test the ingredient for strength or impurities, so a problem may not be caught.accessdata.fda.gov
Enforcement 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.accessdata.fda.gov
Sources
- [1]Drugs@FDA: Foundayo tablets, application 220934Regulatory · primary
- [2]FDA approval letter for Foundayo, 1 April 2026Regulatory · primary
- [3]FDA: first new molecular entity approved under the national priority voucher program, 1 April 2026Regulatory · primary
- [4]DailyMed: Foundayo tablets prescribing information, revised July 2026Label · primary
- [5]FDA: Foundayo prescribing information, supplement approved 4 August 2026Label · primary
- [6]FDA Import Alert 66-80: GLP-1 drug ingredients, published 9 October 2026Regulatory · primary
- [7]ClinicalTrials.gov NCT05869903: ATTAIN-1, orforglipron in adults with obesityHuman trial · primary
- [8]ClinicalTrials.gov NCT05872620: ATTAIN-2, orforglipron in adults with obesity and type 2 diabetesHuman trial · primary
- [9]ClinicalTrials.gov NCT05971940: ACHIEVE-1, orforglipron in early type 2 diabetesHuman trial · primary
- [10]ClinicalTrials.gov NCT05803421: orforglipron versus insulin glargine and heart riskHuman trial · primary
- [11]FDA Law Blog: FDA names the second national priority voucher cohort, November 2025Legal analysis · legal-analysis
- [12]Lachman Consultants: first new molecular entity approved through the voucher programLegal analysis · legal-analysis
- [13]ATTAIN-1: oral orforglipron in adults with obesity, 2025Rct · peer-reviewed
- [14]ATTAIN-2: orforglipron in adults with obesity and type 2 diabetes, 2025Rct · peer-reviewed
- [15]ACHIEVE-1: orforglipron in early type 2 diabetes, 2025Rct · peer-reviewed
- [16]Orforglipron versus insulin glargine and heart outcomes in type 2 diabetes, 2026Rct · peer-reviewed
- [17]ATTAIN-MAINTAIN: orforglipron to keep weight off after weekly shots, 2026Rct · peer-reviewed
- [18]Review and meta-analysis of orforglipron in adults with obesity, 2025Systematic review · peer-reviewed
- [19]Review of stomach and gut problems with pill-form GLP-1 drugs, 2025Systematic review · peer-reviewed
- [20]Fierce Pharma: FDA approves Lilly's GLP-1 pill FoundayoReference · established-news
- [21]Associated Press via ABC30: FDA grants speedy approval to the weight-loss pill FoundayoReference · established-news
Last verified · 6 facts · 8 sources
- abc30.com
- clinicaltrials.gov
- dailymed.nlm.nih.gov
- peptideindex.ai
- peptideindex.ai
- pubmed.ncbi.nlm.nih.gov
- accessdata.fda.gov
- accessdata.fda.gov
Primary source: https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=220934
Machine readers: JSON · Markdown · Status history: Change log
Information, not medical advice.
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