Investigational Drug Details
| Drug ID: | D321 |
| Drug Name: | Saroglitazar |
| Synonyms: | -- |
| Type: | Chemical drug |
| DrugBank ID: | DB13115 |
| DrugBank Description: | Saroglitazar has been investigated for the treatment of Fatty Liver. |
| PubChem ID: | 60151560 |
| CasNo: | 495399-09-2 |
| Repositioning for NAFLD: | No |
| SMILES: | CCO[C@@H](CC1=CC=C(OCCN2C(C)=CC=C2C2=CC=C(SC)C=C2)C=C1)C(O)=O |
| Structure: |
|
| InChiKey: | MRWFZSLZNUJVQW-DEOSSOPVSA-N |
| Molecular Weight: | 439.577 |
| DrugBank Targets: | -- |
| DrugBank MoA: | -- |
| DrugBank Pharmacology: | -- |
| DrugBank Indication: | -- |
| Targets: | PPARA agonist; PPARG agonist |
| Therapeutic Category: | Antidiabetic drug |
| Clinical Trial Progress: | Phase 2 completed (NCT03061721: Saroglitazar 4 mg significantly improved ALT, LFC, insulin resistance, and atherogenic dyslipidemia in participants with NAFLD/NASH.) Phase 3 on-going (NCT03639623) |
| Latest Progress: | Approved in India |
| Trial ID | Source ID | Phases | Status | Study Results | Start Date | Last Update Posted | |
|---|---|---|---|---|---|---|---|
| L0043 | NCT03061721 | Phase 2 | Completed | No Results Available | April 6, 2017 | April 23, 2021 | Details |
| L0104 | NCT02265276 | Phase 3 | Unknown status | No Results Available | October 2014 | October 16, 2014 | Details |
| L0106 | NCT03617263 | Phase 2 | Recruiting | No Results Available | December 4, 2018 | November 30, 2021 | Details |
| L0139 | NCT03639623 | Phase 2 | Recruiting | No Results Available | February 25, 2019 | January 5, 2022 | Details |
| L0201 | NCT03863574 | Phase 2 | Completed | No Results Available | June 12, 2019 | December 14, 2020 | Details |
| L0254 | NCT05211284 | Phase 2 | Not yet recruiting | No Results Available | April 1, 2022 | January 28, 2022 | Details |
| L0325 | NCT05011305 | Phase 2 | Recruiting | No Results Available | August 18, 2021 | August 19, 2021 | Details |
| L0716 | CTRI/2019/12/022339 | Phase 3/Phase 4 | Not Recruiting | No Results Available | 12/12/2019 | 24 November 2021 | Details |
| L0735 | NCT04193982 | Phase 3 | Recruiting | No Results Available | 14/08/2019 | 1 February 2021 | Details |
| L0742 | CTRI/2019/06/019592 | Phase 4 | Recruiting | No Results Available | 10/06/2019 | 24 November 2021 | Details |
| Target ID | Target Name | GENE | Action | Class | UniProtKB ID | Entry Name | |
|---|---|---|---|---|---|---|---|
| T03 | Peroxisome proliferator-activated receptor alpha | PPARA | agonist | Nuclear hormone receptor | Q07869 | PPARA_HUMAN | Details |
| T05 | Peroxisome proliferator-activated receptor gamma | PPARG | agonist | Nuclear hormone receptor | P37231 | PPARG_HUMAN | Details |
| Strategy ID | Strategy | Synonyms | Related Targets | Related Drugs | |
|---|---|---|---|---|---|
| S01 | Improve insulin resistance | insulin sensitizer; insulin resistance; glucose tolerance | Biguanide: increases 5-AMP activated protein kinase signaling; SGLT-2 inhibitor; Thiazalidinedione: selective PPAR-γ agonists; GLP-1 agonist | Metformin; Empagliflozin; Canagliflozin; Rosiglitazone; Pioglitazone; Liraglutide | Details |
| Article ID | PMID | Source | Title | |
|---|---|---|---|---|
| A00475 | 35068786 | J Clin Exp Hepatol | Safety and Efficacy of Saroglitazar in Nonalcoholic Fatty Liver Patients With Diabetic Dyslipidemia-A Prospective, Interventional, Pilot Study. | Details |
| A01308 | 34794234 | Biomed Pharmacother | Saroglitazar and Hepano treatment offers protection against high fat high fructose diet induced obesity, insulin resistance and steatosis by modulating various class of hepatic and circulating lipids. | Details |
| A01843 | 34593018 | BMC Pharmacol Toxicol | Saroglitazar improved hepatic steatosis and fibrosis by modulating inflammatory cytokines and adiponectin in an animal model of non-alcoholic steatohepatitis. | Details |
| A01853 | 34588764 | Drug Des Devel Ther | Non-Alcoholic Steatohepatitis (NASH) - A Review of a Crowded Clinical Landscape, Driven by a Complex Disease. | Details |
| A02181 | 34471049 | Biol Pharm Bull | Structural Basis for Anti-non-alcoholic Fatty Liver Disease and Diabetic Dyslipidemia Drug Saroglitazar as a PPAR α/γ Dual Agonist. | Details |
| A03942 | 33811367 | Hepatology | Saroglitazar, a PPAR-α/γ Agonist, for Treatment of NAFLD: A Randomized Controlled Double-Blind Phase 2 Trial. | Details |
| A04466 | 33604254 | J Clin Transl Hepatol | Drugs for Non-alcoholic Steatohepatitis (NASH): Quest for the Holy Grail. | Details |
| A05390 | 33273703 | Sci Rep | Saroglitazar in patients with non-alcoholic fatty liver disease and diabetic dyslipidemia: a prospective, observational, real world study. | Details |
| A05696 | 33152542 | Clin Gastroenterol Hepatol | A Phase 2 Double Blinded, Randomized Controlled Trial of Saroglitazar in Patients With Nonalcoholic Steatohepatitis. | Details |
| A06680 | 32782883 | Cureus | An Observational Study of Reduction in Glycemic Parameters and Liver Stiffness by Saroglitazar 4 mg in Patients With Type 2 Diabetes Mellitus and Nonalcoholic Fatty Liver Disease. | Details |
| A07125 | 32613381 | Cell Biol Toxicol | Human hepatic in vitro models reveal distinct anti-NASH potencies of PPAR agonists. | Details |
| A07385 | 32518275 | Sci Rep | The PPAR α/γ Agonist Saroglitazar Improves Insulin Resistance and Steatohepatitis in a Diet Induced Animal Model of Nonalcoholic Fatty Liver Disease. | Details |
| A08014 | 32280349 | Case Rep Med | Clinical Case Series of Decrease in Shear Wave Elastography Values in Ten Diabetic Dyslipidemia Patients Having NAFLD with Saroglitazar 4 mg: An Indian Experience. | Details |
| A09046 | 31889755 | J Clin Exp Hepatol | Peroxisome Proliferator-Activated Receptors and Their Agonists in Nonalcoholic Fatty Liver Disease. | Details |
| A09096 | 31877771 | Cells | Anti-NASH Drug Development Hitches a Lift on PPAR Agonism. | Details |
| A09774 | 31614690 | Int J Mol Sci | Exploration and Development of PPAR Modulators in Health and Disease: An Update of Clinical Evidence. | Details |
| A10755 | 31208414 | Cardiovasc Diabetol | New dual peroxisome proliferator activated receptor agonist-Saroglitazar in diabetic dyslipidemia and non-alcoholic fatty liver disease: integrated analysis of the real world evidence. | Details |
| A11796 | 30737662 | Inflammation | Saroglitazar Deactivates the Hepatic LPS/TLR4 Signaling Pathway and Ameliorates Adipocyte Dysfunction in Rats with High-Fat Emulsion/LPS Model-Induced Non-alcoholic Steatohepatitis. | Details |
| A12835 | 30261763 | Expert Rev Gastroenterol Hepatol | An update on the recent advances in antifibrotic therapy. | Details |
| A14940 | 29164820 | Liver Int | Dual PPARα/γ agonist saroglitazar improves liver histopathology and biochemistry in experimental NASH models. | Details |