Orforglipron
Orforglipron is an oral small-molecule GLP-1 receptor agonist that, unlike peptide GLP-1 drugs, can be taken as a daily tablet without strict food and water restrictions. Published Phase 2 trials in obesity and type 2 diabetes showed reductions in body weight and HbA1c, and the Phase 3 program (ATTAIN in obesity and ACHIEVE in type 2 diabetes) reported positive results. On the basis of the ATTAIN obesity program, the US FDA approved orforglipron (Foundayo) in April 2026 for chronic weight management. It is not yet approved for type 2 diabetes and is not yet authorized by the EMA or Australia's TGA.
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Mechanism
In plain terms, orforglipron is a pill that mimics the gut hormone GLP-1, which lowers blood sugar and reduces appetite. Technically, it is a non-peptide small molecule that agonizes the GLP-1 receptor; because it is not a peptide it is orally bioavailable and does not require the injection or the fasting administration constraints of oral peptide GLP-1 drugs. Receptor activation stimulates glucose-dependent insulin secretion, suppresses glucagon, slows gastric emptying, and reduces food intake.
Regulatory Status by Region
- United States (FDA)Approved. The FDA approved orforglipron (Foundayo) on April 1, 2026 for chronic weight management in adults with obesity, or overweight with weight-related conditions, based on the ATTAIN Phase 3 program. A type 2 diabetes indication (ACHIEVE program) is not yet approved.
- Australia (TGA)Not entered on the Australian Register of Therapeutic Goods (ARTG); not yet approved for supply.
- European Union (EMA)Not authorized; no marketing authorization at this time.
- WADANot listed on the WADA Prohibited List. As a GLP-1 receptor agonist it is not a banned substance.
Key Studies
Related Clinical Trials
- A Study of Orforglipron (LY3502970) in Chinese Participants With Obesity or Overweight and Weight-Related Health ProblemsPhase 3 · Not Yet Recruiting
- Switching to Oral Weight Management Pharmacotherapy to Prevent Weight Regain After GLP-1 Therapy DiscontinuationPhase 4 · Not Yet Recruiting
- PATHS-T2D: A Recall-by-Genotype Study of Physiologic and Pharmacologic ResponsesPhase 4 · Not Yet Recruiting
- IBI3042 Study in Healthy Participants and Overweight or Obese ParticipantsPhase 1 · Not Yet Recruiting
- A Study of Orforglipron (LY3502970) Compared With Dulaglutide in Pediatric Participants With Type 2 DiabetesPhase 3 · Not Yet Recruiting
- A Study of Orforglipron (LY3502970) in Participants With Type 2 Diabetes Who Observe Ramadan FastingPhase 3 · Recruiting
- A Study to Estimate Early Clinical Efficacy Signals of GLP-1 Agonist Administration in Conjunction With Levonorgestrel Intrauterine Device in Obese Patients With Endometrioid Intraepithelial NeoplasiaPhase 2 · Recruiting
- A Study of Orforglipron (LY3502970) on Cardiovascular Outcomes in Adults With Atherosclerotic Cardiovascular Disease and/or Chronic Kidney Disease (ATTAIN-Outcomes)Phase 3 · Recruiting
Related News & Research
- ACHIEVE-J: 52-Week Safety Data for Oral Orforglipron in Japanese Adults With Type 2 Diabetes Published in The Lancet Diabetes & Endocrinology
- JAMA Publishes Companion Phase 3 Trials of Mazdutide in Obesity and Orforglipron Added to Insulin in Type 2 Diabetes
- This Week in Peptide Research: Bone-Building Peptide Mechanisms, Real-World GLP-1 Data, and a Reproductive-Axis Cluster
- This Week in Peptide Research: GIP Receptor Debate, Bone-Building Peptides, and New Safety Signals
- Lilly Posts Phase 3 Results for Oral Orforglipron in Japan-Only ATTAIN-J Obesity Trial
Latest research
- Safety and tolerability of orforglipron in Japanese people with type 2 diabetes. (opens in a new tab)
The lancet. Diabetes & endocrinology · Aug 17, 2026
- Long-term safety of oral orforglipron in Japanese participants with type 2 diabetes (ACHIEVE-J): a multicentre, randomised, open-label, parallel-group phase 3 trial. (opens in a new tab)
The lancet. Diabetes & endocrinology · Aug 17, 2026
- GLP-1s: New daily weight loss pill Foundayo approved by UK regulator. (opens in a new tab)
BMJ (Clinical research ed.) · Aug 11, 2026
Common Questions
- What is Orforglipron?
- Orforglipron is a once-daily oral, non-peptide (small-molecule) GLP-1 receptor agonist from Eli Lilly. The US FDA approved it (brand name Foundayo) in April 2026 for chronic weight management in adults with obesity, or overweight with weight-related conditions. It is not yet approved for type 2 diabetes and is not yet authorized by the EMA or Australia's TGA. It is a prescription medicine used under medical supervision.
- Is Orforglipron approved for medical use?
- Orforglipron is approved for one or more medical uses in at least one major jurisdiction. United States (FDA): Approved. The FDA approved orforglipron (Foundayo) on April 1, 2026 for chronic weight management in adults with obesity, or overweight with weight-related conditions, based on the ATTAIN Phase 3 program. A type 2 diabetes indication (ACHIEVE program) is not yet approved. European Union (EMA): Not authorized; no marketing authorization at this time. Australia (TGA): Not entered on the Australian Register of Therapeutic Goods (ARTG); not yet approved for supply.
- How does Orforglipron work?
- In plain terms, orforglipron is a pill that mimics the gut hormone GLP-1, which lowers blood sugar and reduces appetite. Technically, it is a non-peptide small molecule that agonizes the GLP-1 receptor; because it is not a peptide it is orally bioavailable and does not require the injection or the fasting administration constraints of oral peptide GLP-1 drugs.
- Is Orforglipron legal in Australia?
- Orforglipron in Australia (TGA): Not entered on the Australian Register of Therapeutic Goods (ARTG); not yet approved for supply.
- Is Orforglipron banned in sport?
- Orforglipron under the World Anti-Doping Agency (WADA) code: Not listed on the WADA Prohibited List. As a GLP-1 receptor agonist it is not a banned substance.