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Foundayo (orforglipron) is a once-daily GLP-1 receptor agonist tablet from Eli Lilly. The FDA approved it on April 1, 2026. It is indicated, together with a reduced-calorie diet and increased physical activity, to reduce excess body weight and maintain weight reduction long term in adults with obesity or adults with overweight and at least one weight-related condition.
The FDA approval announcement and current prescribing information support the approval date, indication, dosing, and safety information below.
What the FDA Approved
- Form: once-daily oral tablet
- Approval date: April 1, 2026
- Approved population: adults with obesity, or adults with overweight and at least one weight-related condition
- Required context: use with a reduced-calorie diet and increased physical activity
- Limitation: use with another GLP-1 receptor agonist is not recommended
Foundayo is not FDA-approved for type 2 diabetes as of this article's August 8, 2026 review. Lilly has reported results from a separate diabetes development program, but a study result or planned submission is not an approval.
FDA-Label Dose Schedule
This table summarizes the FDA-approved titration schedule. It is not a personal dosing plan.
| Stage in the FDA label | Once-daily dose | Minimum time before the next increase |
|---|---|---|
| Starting dosage | 0.8 mg | 30 days |
| First escalation | 2.5 mg | 30 days |
| Second escalation | 5.5 mg | 30 days |
| Later dose levels, when appropriate | 9 mg, 14.5 mg, or 17.2 mg | At least 30 days at each level |
The maximum labeled dose is 17.2 mg once daily. Later increases depend on treatment response, tolerability, other medicines, and the prescriber's assessment.
This reflects the standard FDA-approved titration schedule. Your prescriber determines your actual dose. Do not adjust your dose without consulting them.
The label says the tablet may be taken with or without food and should be swallowed whole.
Weight-Loss Results in Clinical Trials
Lilly reported two ATTAIN-1 estimates at 72 weeks for participants assigned to the highest dose:
- Average weight loss was 11.1% with Foundayo and 2.1% with placebo in the treatment-regimen analysis.
- Average weight loss was 12.4% with Foundayo and 0.9% with placebo in the efficacy analysis, which estimated results if participants stayed on treatment.
These were clinical-trial averages, not guaranteed outcomes. Individual results vary. Results from Foundayo, Wegovy, and Zepbound studies should not be treated as head-to-head comparisons because trial populations, protocols, and follow-up periods differ.
Side Effects and Warnings
Common adverse reactions in the label include nausea, constipation, diarrhea, vomiting, indigestion, abdominal pain, headache, abdominal distension, fatigue, burping, reflux, gas, and hair loss.
The label also includes warnings involving pancreatitis, severe gastrointestinal reactions, acute kidney injury due to volume depletion, hypoglycemia, hypersensitivity, diabetic retinopathy complications, gallbladder disease, and pulmonary aspiration during anesthesia or deep sedation.
Foundayo has a boxed warning about the potential risk of thyroid C-cell tumors. It is contraindicated in people with a personal or family history of medullary thyroid carcinoma or Multiple Endocrine Neoplasia syndrome type 2. The label also states that Foundayo may cause fetal harm.
Price, Coverage, and Availability
Lilly announced that Foundayo became available through LillyDirect and telehealth providers and began shipping to U.S. retail pharmacies on April 9, 2026. Its launch announcement listed:
- a $149 monthly self-pay price for the lowest dose, subject to program terms;
- a savings-card price as low as $25 per month for eligible commercially insured people whose plans cover Foundayo; and
- a $50 monthly option for some eligible Medicare Part D enrollees beginning July 1, 2026.
These are program prices, not a universal list price or guaranteed out-of-pocket cost. Eligibility, dose, pharmacy, insurance benefits, taxes, and fees can change the amount paid.
Optional Products
Some people use ginger tea, a water bottle, or electrolyte packets. These products do not treat serious medication reactions. Ask a clinician about persistent vomiting, diarrhea, dehydration, or abdominal pain.
Bottom Line
Foundayo (orforglipron) has been FDA-approved since April 1, 2026, and was launched in the United States that month. Its label supports once-daily use without a food requirement and staged titration up to 17.2 mg. Clinical-trial averages and access-program prices require context, and individual results and costs vary.
This article is for informational purposes only and does not constitute medical advice. A licensed prescriber determines whether a medication and dose are appropriate. Do not start, stop, or change a prescription medicine without consulting the prescriber.
