Pipeline › orforglipron
orforglipron
FDA-approved since 2026 and marketed in the US as Foundayo, not authorised in the European Union, with no open FDA shortage or discontinuation records. 19 active trials, the next due to complete 2026-11.
GLP-1 (oral small molecule) agonist, oral, from Eli Lilly. Every figure below is taken directly from ClinicalTrials.gov, Drugs@FDA, the FDA Drug Shortage Database, the EMA register or Europe PMC, and re-checked every four hours.
- Status
- phase3
- Target
- GLP-1 (oral small molecule)
- Route
- oral
- Sponsor
- Eli Lilly
- Brand names
- Foundayo
- First FDA approval
- 2026-04-01
- EU authorisation
- Not authorised
- Active trials
- 19 (17 in phase 3)
- Participants enrolled
- 21,378
- Trials with a reporting date
- 14
- Approved FDA submissions
- 2
Approved indications
Quoted from the current FDA label for each application. This is what the drug is approved to treat in the US — separate from the conditions it is being studied in.
FOUNDAYO TM is indicated in combination 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 in the presence of at least one weight-related comorbid condition. FOUNDAYO™ is a GLP-1 receptor agonist indicated in combination 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 in the presence of at least one weight-related comorbid condition. ( 1 ) Limitations of Use Concomitant use with another GLP-1 receptor agonist is not recommended. ( 1 ) Limitations of Use Concomitant use with another GLP-1 receptor agonist is not recommended.
Structure
Recent changes
| Detected | Change | Trial | Detail | Phase |
|---|---|---|---|---|
| 2026-08-31 | New trial registered | A Study of Orforglipron in Participants With Overweight at Risk of Development of Obesity-Related Complications or Progression to Class 1 Obesity NCT07794579 · Eli Lilly and Company | Not yet recruiting, n=2,001 | P3 |
| 2026-08-27 | New trial registered | A Study of Orforglipron (LY3502970) in Chinese Participants With Obesity or Overweight and Weight-Related Health Problems NCT07790861 · Eli Lilly and Company | Not yet recruiting, n=192 | P3 |
When these trials report
Next 14 of 14 active trials by estimated primary completion.
Regulatory history
| Date | Action | Brands | Application |
|---|---|---|---|
| 2026-08-04 | Labeling | FOUNDAYO | NDA220934 · label |
| 2026-04-01 | Type 1 - New Molecular Entity original | FOUNDAYO | NDA220934 · label |
Indications under study
Atherosclerosis Cardiovascular Disease; Behavior; Chronic Kidney Disease; Diabete Type 2; Diabetes Melletus; Diabetes Mellitus, Type 2; Endocrine System Diseases; Fasting; Feeding Behavior; Glucagon-Like Peptide Receptors; Glucagon-Like Peptide-1 Receptor; Glucose Metabolism Disorders; Hypertension; Membrane Proteins; Metabolic Disorders; Nutritional and Metabolic Diseases; OSA; Obesity; Obesity, Abdominal; Osteoarthritis; Overweight; Overweight or Obesity; Peripheral Arterial Disease; Pharmacogenomic Drug Interaction; Prediabetic State; Prehypertension; Proteins; Receptors, Cell Surface; Receptors, G-Protein-Coupled; Receptors, Peptide; Type 2 Diabetes; Urinary Incontinence,Stress.