saroglitazar
Saroglitazar is a drug for the treatment of type 2 diabetes mellitus, dyslipidemia, NASH and NAFLD It is approved for use in India by the Drug Controller General of India. Saroglitazar is indicated for the treatment of diabetic dyslipidemia and hypertriglyceridemia with type 2 diabetes mellitus not controlled by statin therapy. In clinical studies, saroglitazar has demonstrated reduction of triglycerides (TG), LDL cholesterol, VLDL cholesterol, non-HDL cholesterol and an increase in HDL cholesterol a characteristic hallmark of atherogenic diabetic dyslipidemia (ADD). It has also shown anti-diabetic medication properties by reducing the fasting plasma glucose and HBA1c in diabetes patients. — Wikipedia
Clinical trial activity
23 trials · 9 clinical orgs · 0 marketing orgs
Earliest trial started Jun 1, 2009 (NCT00924430)
Timeline
Indications
Approved for
Studied for
- Diabetes Mellitus, Type 2 · Phase 4
- Dyslipidemias · Phase 4
- Fatty Liver · Phase 3
- Fibrosis · Phase 2
- Healthy Volunteers · Phase 1
- Kidney Failure, Chronic · Phase 1
- Liver Cirrhosis, Biliary · Phase 3
- Liver Diseases · Phase 1
- Liver Transplantation · Phase 2
- Metabolic Syndrome · Phase 4
- Non-alcoholic Fatty Liver Disease · Phase 4
- Obesity · Phase 4
- Polycystic Ovary Syndrome · Phase 2
Mechanism of action
Peroxisome proliferator-activated receptor alpha agonist
Peroxisome proliferator-activated receptor gamma agonist
PPARA inhibitor
PPARG inhibitor
Chemistry & pharmacology
SMILES
CCO[C@@H](Cc1ccc(OCCn2c(C)ccc2-c2ccc(SC)cc2)cc1)C(=O)O- Mol. weight
- 439.58 g/mol
- Lipinski Ro5
- 1 violation(s)
- Rule of 3
- No
- Chirality
- Single Stereoisomer
- Inorganic
- No
- Polymer
- No
Oral
No
Parenteral
No
Topical
No
Sources
- WikipediaSaroglitazar ↗
- ChEMBLCHEMBL4297530 ↗
Also known as
- alpha-ethoxy-4-(2-(2-methyl-5-(4-methylthio)phenyl))-1h-pyrrol-1-yl)ethoxy))benzenepropanoic acid
- alpha-ethoxy-4-(2-(2-methyl-5-(4-methylthio)phenyl))-1h-pyrrol-1-yl)ethoxy))benzenepropanoic acid magnesium salt
- lipaglyn
- saroglitazar
- saroglitazar
- saroglitazar
- saroglitazar
- saroglitazar
- saroglitazar
- saroglitazar magnesium
- saroglitazar magnesium
- saroglitazar magnesium
- slv337
- zyh1
- zyh1 compound
Clinical trials
| NCT ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT07216235 | Phase 3 | Dec 31, 2025 | Zydus Discovery DMCC |
| NCT06825559 | Phase 1 | Mar 31, 2025 | Zydus Discovery DMCC |
| NCT06427395 | Phase 3 | Jul 16, 2024 | Zydus Discovery DMCC |
| NCT05872269 | Phase 4 | Jul 20, 2023 | Zydus Discovery DMCC |
| NCT05211284 | Phase 2 | Jul 1, 2022 | Zydus Discovery DMCC |
| NCT05133336 | Phase 2/Phase 3 (Phase 3) | Feb 1, 2022 | Zydus Discovery DMCC |
| NCT05045482 | Phase 1 | Oct 21, 2021 | Zydus Discovery DMCC |
| NCT05011305 | Phase 2 | Aug 18, 2021 | Zydus Discovery DMCC |
| NCT04446507 | Phase 1 | Jul 27, 2020 | American Research Corporation (ARC), Zydus Discovery DMCC |
| NCT04469920 | Phase 1 | Jul 16, 2020 | Zydus Discovery DMCC |
| NCT04193982 | Phase 3 | Jan 1, 2020 | Asian Institute of Gastroenterology |
| NCT04112446 | Phase 1 | Sep 20, 2019 | Covance, Zydus Discovery DMCC |
| NCT04045769 | Phase 1 | Aug 31, 2019 | Zydus Discovery DMCC |
| NCT03863574 | Phase 2 | Jun 1, 2019 | Zydus Discovery DMCC |
| NCT03617263 | Phase 2 | Sep 30, 2018 | Cadila Healthcare, Zydus Discovery DMCC |
| NCT03639623 | Phase 2 | Aug 23, 2018 | Zydus Discovery DMCC |
| NCT03061721 | Phase 2 | Apr 6, 2017 | Zydus Discovery DMCC |
| NCT03097107 | Phase 2 | Apr 6, 2017 | Zydus Discovery DMCC |
| NCT03112681 | Phase 2 | Apr 1, 2017 | Zydus Discovery DMCC |
| NCT02265276 | Phase 3 | Oct 1, 2014 | Command Hospital, India |
Organizations
Research & Development (9)
| Organization | Org type | Trials | As lead sponsor | Phases | Earliest year |
|---|---|---|---|---|---|
| Zydus Discovery DMCC | For profit | 18 | 18 | 4 | 2017 |
| Abbott | For profit | 2 | 2 | 2 | 2009 |
| American Research Corporation (ARC) | For profit | 1 | 0 | 1 | 2020 |
| Asian Institute of Gastroenterology | Academic/Hospital | 1 | 1 | 1 | 2020 |
| Cadila Healthcare | For profit | 1 | 0 | 1 | 2018 |
| Command Hospital, India | Academic/Hospital | 1 | 1 | 1 | 2014 |
| Covance | For profit | 1 | 0 | 1 | 2019 |
| IQVIA | For profit | 1 | 0 | 1 | 2009 |
| Solvay | For profit | 1 | 1 | 1 | 2009 |