Metabolic · FDA Approved
Orforglipron
FDA-approved
01 · Overview
Orforglipron is a non-peptide, oral small-molecule glucagon-like peptide-1 receptor (GLP-1R) agonist developed as an alternative to injectable GLP-1 drugs (PMID 37369232). It activates the GLP-1 receptor to enhance glucose-dependent insulin secretion, suppress glucagon release, and slow gastric emptying.
The FDA approved it in April 2026 as Foundayo, a once-daily tablet used with diet and physical activity for weight reduction in adults with obesity, or overweight with at least one weight-related condition.
02 · Research summary & key findings
In a 26-week phase 2 trial in type 2 diabetes, orforglipron lowered HbA1c by up to 2.1 percentage points and body weight by up to 10.1 kg, with mostly mild to moderate gastrointestinal adverse events (PMID 37369232). In the phase 3 ACHIEVE-1 trial in early type 2 diabetes, all three doses lowered HbA1c more than placebo over 40 weeks (PMID 40544435). In the phase 3 ATTAIN-1 trial in adults with obesity without diabetes, mean weight change at 72 weeks was up to -11.2 percent versus -2.1 percent with placebo, and gastrointestinal effects were the most common adverse events (PMID 40960239).
03 · Regulatory status
Orforglipron has received FDA approval and is available for clinical use under appropriate medical supervision. Consult a qualified healthcare provider for prescribing information.
Orforglipron is an FDA-approved medicine prescribed for the conditions on its label. It is not part of our intake, so we do not propose protocols for it. If you think it may be relevant to you, talk to your own doctor. How to ask your doctor.
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Orforglipron is prescribed for the conditions on its label, and it is not part of our intake. If you are working on metabolic health and weight, a licensed clinician can tell you at a free consultation whether an FDA-approved or lawfully compounded treatment fits you, or whether nothing does.
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04 · Administration routes
- Oral
References
- [1]Efficacy and safety of oral orforglipron in patients with type 2 diabetes: a multicentre, randomised, dose-response, phase 2 study Lancet, 2023. PMID 37369232
- [2]Orforglipron, an Oral Small-Molecule GLP-1 Receptor Agonist, in Early Type 2 Diabetes N Engl J Med, 2025. PMID 40544435
- [3]Orforglipron, an Oral Small-Molecule GLP-1 Receptor Agonist for Obesity Treatment N Engl J Med, 2025. PMID 40960239
Primary literature
- PubMed: "Orforglipron"
Peer-reviewed literature indexed by the National Library of Medicine.
- ClinicalTrials.gov: "Orforglipron"
Registered interventional and observational studies, including status and phase.
- PubChem: "Orforglipron"
Chemical structure, molecular properties, and bioactivity data.
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