orforglipron
Orforglipron is a once-daily GLP-1 tablet sold as Foundayo for long-term weight management in adults with obesity, or overweight plus a weight-related condition. It can be taken with or without food.
Oral small-molecule GLP-1 receptor agonist
- FDA-approved in 2026 as Foundayo
- Once-daily non-peptide small molecule
- Taken with or without food
What exactly did FDA approve?
FDA approved Foundayo, orforglipron tablets, on April 1, 2026 as an adjunct to a reduced-calorie diet and increased physical activity for long-term weight reduction in adults with obesity, or adults with overweight plus at least one weight-related comorbidity.
Orforglipron is the first FDA-approved oral non-peptide small-molecule GLP-1 receptor agonist for this indication. Oral semaglutide is a peptide tablet.
FDA approval · Foundayo
FDA approval announcement
U.S. Food and Drug Administration, April 1, 2026
FDA announced approval of Foundayo tablets for chronic weight management in the labeled adult population and identified orforglipron as a non-peptide small molecule.
- Participants / model
- Adults with obesity or overweight plus a comorbidity
- Treatment
- Foundayo with diet and physical activity
- Follow-up
- Long-term treatment indication
- Study design
- Regulatory action
The announcement is summarized by the final label for exact use and safety conditions.
Read the original sourceFoundayo label · indication, use, results, safety
FDA label
Eli Lilly and Company; U.S. FDA, revised July 2026
The label defines the indication, once-daily administration with or without food, titration, interactions, warnings, and 72-week placebo-controlled weight results.
- Participants / model
- Adults in the labeled chronic-weight-management population; pivotal trials included cohorts with and without type 2 diabetes
- Treatment
- Orforglipron tablets up to 17.2 mg daily or placebo
- Follow-up
- 72 weeks in pivotal efficacy trials
- Study design
- Randomized placebo-controlled trials summarized in an FDA-approved label
The thyroid warning concerns tumors observed with other GLP-1 agonists in rodents. Orforglipron did not produce rodent tumors; the relevance of the class finding to humans is unknown.
Read the original sourceDoes Foundayo require food or water timing?
The July 2026 label says to take Foundayo once daily, with or without food. It does not impose the fasting and post-dose waiting instructions used by oral semaglutide.
The label starts at 0.8 mg daily and uses gradual escalation to maintenance doses, with 17.2 mg as the maximum.
Foundayo label · indication, use, results, safety
FDA label
Eli Lilly and Company; U.S. FDA, revised July 2026
The label defines the indication, once-daily administration with or without food, titration, interactions, warnings, and 72-week placebo-controlled weight results.
- Participants / model
- Adults in the labeled chronic-weight-management population; pivotal trials included cohorts with and without type 2 diabetes
- Treatment
- Orforglipron tablets up to 17.2 mg daily or placebo
- Follow-up
- 72 weeks in pivotal efficacy trials
- Study design
- Randomized placebo-controlled trials summarized in an FDA-approved label
The thyroid warning concerns tumors observed with other GLP-1 agonists in rodents. Orforglipron did not produce rodent tumors; the relevance of the class finding to humans is unknown.
Read the original sourceHow much weight change appeared in the FDA label trials?
In the 72-week trial without diabetes, the 17.2 mg arm averaged 11.1% weight loss under the treatment-regimen estimand versus 2.1% with placebo. In the type 2 diabetes trial, the corresponding values were 9.6% and 2.5%.
| Population | 17.2 mg | Placebo |
|---|---|---|
| Without diabetes | -11.1% | -2.1% |
| With type 2 diabetes | -9.6% | -2.5% |
Treatment-regimen estimand from the FDA label; populations were studied in separate trials.
Foundayo label · indication, use, results, safety
FDA label
Eli Lilly and Company; U.S. FDA, revised July 2026
The label defines the indication, once-daily administration with or without food, titration, interactions, warnings, and 72-week placebo-controlled weight results.
- Participants / model
- Adults in the labeled chronic-weight-management population; pivotal trials included cohorts with and without type 2 diabetes
- Treatment
- Orforglipron tablets up to 17.2 mg daily or placebo
- Follow-up
- 72 weeks in pivotal efficacy trials
- Study design
- Randomized placebo-controlled trials summarized in an FDA-approved label
The thyroid warning concerns tumors observed with other GLP-1 agonists in rodents. Orforglipron did not produce rodent tumors; the relevance of the class finding to humans is unknown.
Read the original sourceWhat safety issues are prominent in the label?
The label carries a boxed warning about thyroid C-cell tumors observed in rodents and says the human relevance is unknown. It also warns about pancreatitis, severe gastrointestinal reactions, kidney injury from volume depletion, hypoglycemia with insulin or secretagogues, diabetic retinopathy complications, gallbladder disease, aspiration during anesthesia or deep sedation, pregnancy, and clinically relevant oral-drug interactions.
Across the two weight-management trials, gastrointestinal events occurred in 69% at 17.2 mg versus 37% with placebo, and permanent discontinuation because of adverse events occurred in 10% versus 3%. The label also requires temporary backup or nonoral contraception after starting and after each dose escalation because exposure to oral hormonal contraceptives can fall.
Foundayo label · indication, use, results, safety
FDA label
Eli Lilly and Company; U.S. FDA, revised July 2026
The label defines the indication, once-daily administration with or without food, titration, interactions, warnings, and 72-week placebo-controlled weight results.
- Participants / model
- Adults in the labeled chronic-weight-management population; pivotal trials included cohorts with and without type 2 diabetes
- Treatment
- Orforglipron tablets up to 17.2 mg daily or placebo
- Follow-up
- 72 weeks in pivotal efficacy trials
- Study design
- Randomized placebo-controlled trials summarized in an FDA-approved label
The thyroid warning concerns tumors observed with other GLP-1 agonists in rodents. Orforglipron did not produce rodent tumors; the relevance of the class finding to humans is unknown.
Read the original sourceWhat are Foundayo's contraindications?
Foundayo is contraindicated with a personal or family history of medullary thyroid carcinoma, Multiple Endocrine Neoplasia syndrome type 2, or a known serious hypersensitivity to orforglipron or any Foundayo excipient. The label also says not to combine it with another GLP-1 receptor agonist.
The thyroid warning concerns other GLP-1 medicines that caused tumors in rodents: orforglipron is not pharmacologically active in rats or mice and did not produce rodent tumors, but FDA retains the class warning because it activates the human GLP-1 receptor and the human relevance of GLP-1-related rodent C-cell tumors is unknown.
Foundayo label · indication, use, results, safety
FDA label
Eli Lilly and Company; U.S. FDA, revised July 2026
The label defines the indication, once-daily administration with or without food, titration, interactions, warnings, and 72-week placebo-controlled weight results.
- Participants / model
- Adults in the labeled chronic-weight-management population; pivotal trials included cohorts with and without type 2 diabetes
- Treatment
- Orforglipron tablets up to 17.2 mg daily or placebo
- Follow-up
- 72 weeks in pivotal efficacy trials
- Study design
- Randomized placebo-controlled trials summarized in an FDA-approved label
The thyroid warning concerns tumors observed with other GLP-1 agonists in rodents. Orforglipron did not produce rodent tumors; the relevance of the class finding to humans is unknown.
Read the original sourceHow common were the main adverse effects at 17.2 mg?
In the pooled label trials, 17.2 mg was associated with nausea in 35%, constipation in 24%, diarrhea in 25%, vomiting in 24%, dyspepsia in 13%, abdominal pain in 14%, headache in 9%, and fatigue in 9%. The placebo rates were 10%, 9%, 11%, 4%, 4%, 7%, 7%, and 4%.
Across doses, nausea, vomiting, and diarrhea were most frequent during escalation and decreased over time. Severe gastrointestinal reactions occurred in about 3% with orforglipron versus 1% with placebo, and the label does not recommend Foundayo in severe gastroparesis.
Foundayo label · indication, use, results, safety
FDA label
Eli Lilly and Company; U.S. FDA, revised July 2026
The label defines the indication, once-daily administration with or without food, titration, interactions, warnings, and 72-week placebo-controlled weight results.
- Participants / model
- Adults in the labeled chronic-weight-management population; pivotal trials included cohorts with and without type 2 diabetes
- Treatment
- Orforglipron tablets up to 17.2 mg daily or placebo
- Follow-up
- 72 weeks in pivotal efficacy trials
- Study design
- Randomized placebo-controlled trials summarized in an FDA-approved label
The thyroid warning concerns tumors observed with other GLP-1 agonists in rodents. Orforglipron did not produce rodent tumors; the relevance of the class finding to humans is unknown.
Read the original sourceWhat does the label say about missed doses?
Take a missed dose as soon as possible and do not double the next dose. If seven or more consecutive doses are missed, the label says to restart escalation at a lower dose to reduce gastrointestinal reactions.
Foundayo label · indication, use, results, safety
FDA label
Eli Lilly and Company; U.S. FDA, revised July 2026
The label defines the indication, once-daily administration with or without food, titration, interactions, warnings, and 72-week placebo-controlled weight results.
- Participants / model
- Adults in the labeled chronic-weight-management population; pivotal trials included cohorts with and without type 2 diabetes
- Treatment
- Orforglipron tablets up to 17.2 mg daily or placebo
- Follow-up
- 72 weeks in pivotal efficacy trials
- Study design
- Randomized placebo-controlled trials summarized in an FDA-approved label
The thyroid warning concerns tumors observed with other GLP-1 agonists in rodents. Orforglipron did not produce rodent tumors; the relevance of the class finding to humans is unknown.
Read the original sourceWhich interactions and reproductive instructions are specific to Foundayo?
The label caps Foundayo at 9 mg with a strong CYP3A4 inhibitor, says to avoid strong CYP3A4 inhibitors that also inhibit OATP1B and to avoid strong CYP3A4 inducers, and caps simvastatin at 20 mg daily. Delayed gastric emptying can also affect other oral medicines.
Insulin or a sulfonylurea can increase hypoglycemia risk. The label says to stop Foundayo when pregnancy is recognized. People using oral hormonal contraception should switch to a nonoral method or add a barrier method for 30 days after starting and for 30 days after every dose increase.
Foundayo label · indication, use, results, safety
FDA label
Eli Lilly and Company; U.S. FDA, revised July 2026
The label defines the indication, once-daily administration with or without food, titration, interactions, warnings, and 72-week placebo-controlled weight results.
- Participants / model
- Adults in the labeled chronic-weight-management population; pivotal trials included cohorts with and without type 2 diabetes
- Treatment
- Orforglipron tablets up to 17.2 mg daily or placebo
- Follow-up
- 72 weeks in pivotal efficacy trials
- Study design
- Randomized placebo-controlled trials summarized in an FDA-approved label
The thyroid warning concerns tumors observed with other GLP-1 agonists in rodents. Orforglipron did not produce rodent tumors; the relevance of the class finding to humans is unknown.
Read the original sourceWas Foundayo directly shown to beat injectable GLP-1 medicines?
The pivotal weight-management trials summarized in the FDA label used placebo controls. They do not establish superiority to semaglutide, tirzepatide, or another injectable medicine.
The tablet avoids injections. A direct comparison is needed to determine how its weight loss and side effects compare with a specific injectable medicine.
Foundayo label · indication, use, results, safety
FDA label
Eli Lilly and Company; U.S. FDA, revised July 2026
The label defines the indication, once-daily administration with or without food, titration, interactions, warnings, and 72-week placebo-controlled weight results.
- Participants / model
- Adults in the labeled chronic-weight-management population; pivotal trials included cohorts with and without type 2 diabetes
- Treatment
- Orforglipron tablets up to 17.2 mg daily or placebo
- Follow-up
- 72 weeks in pivotal efficacy trials
- Study design
- Randomized placebo-controlled trials summarized in an FDA-approved label
The thyroid warning concerns tumors observed with other GLP-1 agonists in rodents. Orforglipron did not produce rodent tumors; the relevance of the class finding to humans is unknown.
Read the original sourceStudies and sources
FDA approval · Foundayo
FDA approval announcement
U.S. Food and Drug Administration, April 1, 2026
FDA announced approval of Foundayo tablets for chronic weight management in the labeled adult population and identified orforglipron as a non-peptide small molecule.
- Participants / model
- Adults with obesity or overweight plus a comorbidity
- Treatment
- Foundayo with diet and physical activity
- Follow-up
- Long-term treatment indication
- Study design
- Regulatory action
The announcement is summarized by the final label for exact use and safety conditions.
Read the original sourceFoundayo label · indication, use, results, safety
FDA label
Eli Lilly and Company; U.S. FDA, revised July 2026
The label defines the indication, once-daily administration with or without food, titration, interactions, warnings, and 72-week placebo-controlled weight results.
- Participants / model
- Adults in the labeled chronic-weight-management population; pivotal trials included cohorts with and without type 2 diabetes
- Treatment
- Orforglipron tablets up to 17.2 mg daily or placebo
- Follow-up
- 72 weeks in pivotal efficacy trials
- Study design
- Randomized placebo-controlled trials summarized in an FDA-approved label
The thyroid warning concerns tumors observed with other GLP-1 agonists in rodents. Orforglipron did not produce rodent tumors; the relevance of the class finding to humans is unknown.
Read the original sourceWhy is orforglipron in S tier?
S tier reflects weight loss in phase 3 trials and FDA approval of Foundayo. The pivotal weight-management trials compared it with placebo, so they do not rank it against injectable medicines.