At a glance
- Orforglipron is an FDA-approved drug, marketed as Foundayo (first approval: April 1, 2026).
- PubMed lists 156 publications mentioning it, including 19 randomized controlled trials and 0 animal-only studies.
- ClinicalTrials.gov lists 54 registered studies testing it (21 active).
- FDA's adverse event system (FAERS) holds 728 reports mentioning it; 20 classified as serious. Reports do not prove causation.
Research topics
Most frequent MeSH subject headings in the latest PubMed records (English, as indexed).
Regulatory status
Drugs@FDA applications
| Application | Product | Status | First approval | Sponsor |
|---|---|---|---|---|
| NDA220934 | FOUNDAYO | Approved, marketed | April 1, 2026 | ELI LILLY AND CO |
Source: Drugs@FDA (openFDA) · verified October 30, 2026 · API query
FDA compounding safety list
Not on FDA's list of bulk drug substances that may present significant safety risks in compounding.
Source: FDA.gov — Category 2 bulk drug substances · verified October 30, 2026
Removal of a substance from a regulatory list does not mean it has been approved. A "research use only" label does not make a product safe or legal for human use.
Scientific publications
Counts are PubMed records that mention the peptide in the title or abstract. Categories overlap, and a mention is not the same as testing the peptide as a treatment. Each number opens the exact PubMed search. Effects seen in laboratory or animal studies may not occur in humans. A registered clinical trial does not show that a substance is effective or safe.
Latest publications
- Incretin and nutrient-sensing GPCR therapeutics in type 2 diabetes: what target-modality-formulation matching explains.
- Progress in Anti-Obesity Drug Development: A Pharmacodynamics Perspective.
- Efficacy and safety of orforglipron in adults with body mass index of 27 to less than 30 kg/m2 and adiposity-related complications: A post hoc analysis of the ATTAIN-1 trial.
- Orforglipron for Type 2 Diabetes and Pancreatic Risk Assessment-Reply.
- Orforglipron for Type 2 Diabetes and Pancreatic Risk Assessment.
- Oral Small-Molecule GLP-1 Receptor Agonists: Lessons from Clinical Candidates and a Blueprint for Next-Generation Design.
- Oral Versus Injectable Incretin-Based Anti-Obesity Therapies: An Integrated Computational and Evidence-Based Comparison of Orforglipron, Semaglutide, and Tirzepatide.
- Qualitative Exit Interviews to Characterize the Positive Treatment Experiences of Patients in the Phase III Trial of Orforglipron Versus Oral Semaglutide for the Treatment of Type 2 Diabetes.
- Establishing cardiovascular safety of the small-molecule GLP-1 receptor agonist orforglipron in type 2 diabetes.
- Oral Obesity Medicines in the Era of Cardiovascular-Kidney-Metabolic Syndrome (CKM): Beyond Weight Loss Toward Disease Modification.
Source: PubMed (NCBI) · verified October 30, 2026
Clinical trials
- Registered
- 54
- Active
- 21
- With posted results
- 29
Conditions studied
Show 40 more studies
All 54 studies on ClinicalTrials.gov ↗
Source: ClinicalTrials.gov · verified October 30, 2026
Adverse event reports
- Reports
- 728
- Serious
- 20
- With death outcome
- 0
Most reported reactions
Adverse event reports do not prove that the substance caused these effects. Side effects not listed here may still occur. Reaction terms are MedDRA terms as reported to FAERS.
Source: FDA FAERS (FAERS data as of July 30, 2026) · verified October 30, 2026 · API query
FDA prescribing information
Official US prescribing information. Dosing sections are intentionally not shown.
Original FDA text (English) WARNING: RISK OF THYROID C-CELL TUMORS In products with glucagon-like peptide-1 (GLP-1) receptor agonist activity that are pharmacologically active in rats and mice, rodent thyroid C-cell tumors (adenomas and carcinomas) have been observed at clinically relevant exposures and are considered GLP-1 receptor-dependent effects in rodents. Orforglipron is not pharmacologically active in rats or mice and did not produce tumors in rodents [see Nonclinical Toxicology ( 13.1 )] . While orforglipron is pharmacologically active at the human GLP-1 receptor, the human relevance of GLP-1 receptor-dependent thyroid C-cell tumors observed in rodents has not been determined [see Warnings and Precautions ( 5.1 ), Nonclinical Toxicology ( 13.1 )] . FOUNDAYO is contraindicated in patients with a personal or family history of medullary thyroid carcinoma (MTC) or in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2) [see Contraindications ( 4 )] . Counsel patients regarding the potential risk for MTC with the use of FOUNDAYO and inform them of symptoms of thyroid tumors (e.g., a mass in the neck, dysphagia, dyspnea, persistent hoarseness). Routine monitoring of serum calcitonin or using thyroid ultrasound is of uncertain value for early detection of MTC in patients treated with FOUNDAYO [see Contraindications ( 4 ), Warnings and Precautions ( 5.1 )] . WARNING: RISK OF THYROID C-CELL TUMORS See full prescribing information for complete boxed warning. In products with glucagon-like peptide-1 (GLP-1) receptor agonist activity that are pharmacologically active in rats and mice, rodent thyroid C-cell tumors (adenomas and carcinomas) have been observed at clinically relevant exposures and are considered GLP-1 receptor-dependent effects in rodents. Orforglipron is not pharmacologically active in rats or mice and did not produce tumors in rodents ( 13.1 ) . While orforglipron is pharmacologically active at the human GLP-1 receptor, the human relevance of GLP-1 receptor-dependent thyroid C-cell tumors observed in rodents has not been determined ( 5.1 , 13.1 ). FOUNDAYO is contraindicated in patients with a personal or family history of medullary thyroid carcinoma (MTC) or in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2). Counsel patients regarding the potential risk of MTC and symptoms of thyroid tumors ( 4 , 5.1 ). Source: DailyMed / openFDA
In the news
Latest headlines and official notices that mention this substance, in their original language. Third-party content, not medical advice.
- Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 12-15 October 2026
Agency summary (EMA): Six new medicines recommended for approvalEMA’s human medicines committee (CHMP) recommended six medicines for approval at its October 2026 meeting. Rasonque (daraxonrasib)…
Change history
No changes since monitoring began on October 30, 2026.