Saroglitazar
As of the edition of 20 October 2026, Saroglitazar is a small molecule: marketed, first approved in 2013 (IN); acts on PPARA and PPARG.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2013
- Kind
- Small molecule
- First approved
- 26 June 2013 (IN)
- Approvals on record
- 1 in 1 region
- Holder of the most recent approval
- CADILA HEALTHCARE
- Registered trials
- 20, 2 stopped early
- Disease areas
- Digestive system; Nutrition and metabolism; Hormones; Pregnancy and women's health; Urinary and reproductive
US protection
No US approval on record.
With no US approval on record there are no listed US patents or exclusivities.
This is the US only.
Targets
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase 1 | 6 | 4 | 2 | 0 |
| Phase 2 | 8 | 5 | 0 | 2 |
| Phase 3 | 5 | 1 | 3 | 0 |
| Phase 4 | 1 | 0 | 0 | 0 |
| All trials | 20 |