Orforglipron
FOUNDAYO
FOUNDAYO is the FDA-approved US product containing orforglipron, an oral small-molecule GLP-1 receptor agonist. It acts at a receptor named for a peptide hormone, but orforglipron itself is not a peptide.
Orforglipron is a small-molecule agonist of the GLP-1 receptor.
FDA approved the exact FOUNDAYO tablet product on April 1, 2026.
The approved route is oral rather than an injection.
The current prescribing information contains a boxed thyroid C-cell tumor warning.
Resolve the application before the claim.
- Brand
- FOUNDAYO
- Active ingredient
- Orforglipron
- US application
- NDA 220934
- Company named in current label
- Lilly USA, LLC
- Dosage form
- Film-coated tablets
- Route
- Oral
- Approval record
- FOUNDAYO NDA approved April 1, 2026
- Label record updated
- April 2026
What this approval covers - and what it does not.
This summary stays intentionally high level. Use the current full prescribing information for complete warnings, contraindications, adverse reactions, and instructions.
The exact approved record
The current US label covers long-term reduction and maintenance of excess body weight, alongside a reduced-calorie diet and increased physical activity, in adults with obesity or adults with overweight and at least one weight-related comorbid condition.
Open current label ↗An ingredient match is not product equivalence
FOUNDAYO is a specific FDA-approved oral product under NDA 220934. Orforglipron is a non-peptide small molecule, so it should not be described as an oral peptide. An online capsule, powder, research product, or imported item using the ingredient name does not inherit FOUNDAYO's approval, manufacturing review, label, or supply record.
Read the category guide →Orforglipron / Foundayo across 42 countries.
This record starts with the exact US FDA medicine identity. The global and state maps keep authorization, presentation, prescription route, market status, pharmacy, and seller records separate.
Compare Orforglipron / Foundayo by country →Compare Orforglipron / Foundayo by US state →The questions behind the medicine search.
Answers are based on the dated FDA and DailyMed records below. They are educational reporting, not a diagnosis, prescription, or treatment recommendation.
Is orforglipron a peptide?
No. Orforglipron is a synthetic small molecule that activates the GLP-1 receptor. GLP-1 itself is a peptide hormone, and semaglutide and tirzepatide are peptide-based medicines, but a shared receptor target does not make every agonist a peptide. FOUNDAYO is therefore an oral non-peptide GLP-1 medicine, not an oral peptide.
Is Foundayo FDA approved?
Yes. FDA approved FOUNDAYO under NDA 220934 on April 1, 2026 for a defined adult weight-management population. The approval applies to the exact tablets, label, company, manufacturing record, and US indication reviewed in that application. It does not authenticate a same-name research product or establish approval in another country.
How much weight loss did orforglipron show?
In the published 72-week ATTAIN-1 trial, the treatment-regimen estimate for the highest studied group was an 11.2% mean reduction versus 2.1% with placebo. The FDA label translates evidence from the investigational formulation to the approved tablet strengths. This is a group average from one trial, not an individual forecast or a head-to-head comparison with Wegovy, Zepbound, or retatrutide.
How much does Foundayo cost?
There is no single amount that every patient pays. Insurance, pharmacy, tablet strength, eligibility, savings programs, and current self-pay offers can change the result. FDA labeling does not establish price. Peptide Local links the official Lilly coverage and savings page so the commercial claim remains separate from the approval and clinical-evidence records.
Is Foundayo approved worldwide?
No worldwide approval follows from the US decision. Lilly said it submitted orforglipron for weight management and/or type 2 diabetes in more than 40 countries, but a submission is not an authorization. Every country needs its own regulator, approved indication, presentation, label, launch, prescription route, and current supply check.
Use the current full prescribing information and a licensed clinician or pharmacist for medicine-specific decisions. Do not substitute a research product, investigational program, or unapproved seller listing for an FDA-approved product.
Open safety and verification resources →