Pipeline › olatorepatide
olatorepatide
Not FDA-approved, and in phase 2 development, not authorised in the European Union. 3 active trials, the next due to complete 2026-11-13.
incretin (auto-detected) agonist, unknown, from Regeneron Pharmaceuticals. 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
- phase2
- Target
- incretin (auto-detected)
- Route
- unknown
- Sponsor
- Regeneron Pharmaceuticals
- First FDA approval
- Not approved
- EU authorisation
- Not authorised
- Active trials
- 3 (0 in phase 3)
- Participants enrolled
- 780
- Trials with a reporting date
- 3
- Approved FDA submissions
- 0
Recent changes
| Detected | Change | Trial | Detail | Phase |
|---|---|---|---|---|
| 2026-09-21 | New trial registered | Efficacy and Safety of Olatorepatide Versus Placebo in Adults With Moderate to Severe Hidradenitis Suppurativa Living With Overweight or Obesity NCT07830329 · Regeneron Pharmaceuticals | Not yet recruiting, n=300 | P2 |
| 2026-08-21 | New trial registered | Study of Olatorepatide in Adult Participants Living With Overweight or Obesity Without Diabetes NCT07685808 · Regeneron Pharmaceuticals | Recruiting, n=360 | P2 |
| 2026-08-21 | New trial registered | Study of Olatorepatide in Adult Participants Living With Overweight or Obesity in the US NCT07431086 · Regeneron Pharmaceuticals | Active, not recruiting, n=120 | P2 |
When these trials report
Next 3 of 3 active trials by estimated primary completion.
| Est. completion | Trial | Sponsor | Phase | Participants |
|---|---|---|---|---|
| 2026-11-13 | Study of Olatorepatide in Adult Participants Living With Overweight or Obesity in the US NCT07431086 · Occurrence of Treatment-Emergent Adverse Events (TEAEs) | Regeneron Pharmaceuticals | P2 | 120 |
| 2028-01-21 | Study of Olatorepatide in Adult Participants Living With Overweight or Obesity Without Diabetes NCT07685808 · Occurrence of Treatment-Emergent Adverse Events (TEAEs) | Regeneron Pharmaceuticals | P2 | 360 |
| 2028-11-24 | Efficacy and Safety of Olatorepatide Versus Placebo in Adults With Moderate to Severe Hidradenitis Suppurativa Living With Overweight or Obesity NCT07830329 · Percent change in total Abscess and inflammatory Nodule (AN) count | Regeneron Pharmaceuticals | P2 | 300 |
Indications under study
Hidradenitis Suppurativa; Overweight or Obesity.
Every olatorepatide trial on file
All 3 registered trials of olatorepatide, largest first. Each links to its own page and to the registry record.
| Trial | Status | Phase | Participants |
|---|---|---|---|
| Study of Olatorepatide in Adult Participants Living With Overweight or Obesity Without Diabetes NCT07685808 · Regeneron Pharmaceuticals | Recruiting | P2 | 360 |
| Efficacy and Safety of Olatorepatide Versus Placebo in Adults With Moderate to Severe Hidradenitis Suppurativa Living With Overweight or Obesity NCT07830329 · Regeneron Pharmaceuticals | Not yet recruiting | P2 | 300 |
| Study of Olatorepatide in Adult Participants Living With Overweight or Obesity in the US NCT07431086 · Regeneron Pharmaceuticals | Active, not recruiting | P2 | 120 |