10 completed, 5 recruiting, 2 terminated, 1 active not recruiting. 10 Phase 2, 6 Phase 1, 4 Phase 3.
| Phase | Trials | Status |
|---|---|---|
| Phase 2 | 10 | Completed 6, Terminated 2, Recruiting 1, Suspended 1 |
| Phase 1 | 6 | Completed 4, Recruiting 2 |
| Phase 3 | 4 | Recruiting 2, Active not recruiting 1, Completed 1 |
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Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| Study of Saroglitazar Magnesium for PBC Patients With Incomplete Response or Intolerant to UDCA Therapy Saroglitazar Magnesium 1 mg, Placebo - Primary Biliary Cholangitis | Phase 3 | Recruiting | Zydus Therapeutics Inc. | 90 | 2026-08-11 | 2026-09-15 |
| Long-Term Study to Evaluate the Safety and Efficacy in Participants With Primary Biliary Cholangitis of Saroglitazar Magnesium-V on Clinical Outcomes Saroglitazar magnesium 1 mg, Placebo - Primary Biliary Cholangitis | Phase 3 | Recruiting | Zydus Therapeutics Inc. | 386 | 2026-03-24 | 2026-08-04 |
| Usnoflast Neuromuscular Investigation for Treatment Efficacy in Amyotrophic Lateral Sclerosis 50 mg Usnoflast, 75 mg Usnoflast, Placebo - Amyotrophic Lateral Sclerosis (ALS) | Phase 2 | Recruiting | Zydus Therapeutics Inc. | 240 | 2025-09-17 | 2026-09-01 |
| Evaluate PK & Safety of Saroglitazar in Subjects With Moderate Hepatic Impairment Due to Cholestatic Liver Disease Saroglitazar Magnesium 1 mg - Cholestatic Liver Disease | Phase 1 | Recruiting | Zydus Therapeutics Inc. | 6 | 2025-08-05 | 2026-09-14 |
| Open-Label Extension Study of Saroglitazar Magnesium in Participants With Primary Biliary Cholangitis Saroglitazar Magnesium 1 mg - Primary Biliary Cholangitis | Phase 3 | Active not recruiting | Zydus Therapeutics Inc. | 102 | 2024-07-16 | 2026-05-12 |
| Saroglitazar Magnesium 4 mg for Nonalcoholic Fatty Liver Disease (NAFLD) in People Living With HIV in the US Saroglitazar Magnesium 4 mg, Placebo - Nonalcoholic Fatty Liver Disease | Phase 2 | Terminated | Zydus Therapeutics Inc. | 4 | 2022-12-08 | 2025-09-02 |
| Saroglitazar Magnesium for Treatment of Primary Biliary Cholangitis Saroglitazar Magnesium 1 mg, Saroglitazar Magnesium 2 mg, Placebo - Primary Biliary Cholangitis | Phase 2 / Phase 3 | Completed | Zydus Therapeutics Inc. | 196 | 2022-04-01 | 2026-09-17 |
| Hepatic Impairment With Cirrhosis Due to Cholestatic Liver Disease Saroglitazar Magnesium 1 mg, Saroglitazar Magnesium 2 mg - Hepatic Impairment, Cirrhosis | Phase 1 | Recruiting | Zydus Therapeutics Inc. | 30 | 2021-10-21 | 2026-09-14 |
| Saroglitazar Magnesium for the Treatment of Nonalcoholic Steatohepatitis With Fibrosis Saroglitazar Magnesium 2 mg, Saroglitazar Magnesium 4 mg, Placebo - Nonalcoholic Steatohepatitis, Fibrosis | Phase 2 | Completed | Zydus Therapeutics Inc. | 189 | 2021-08-18 | 2026-09-21 |
| A Pharmacokinetic Study of Saroglitazar Magnesium in Subjects with Severe Renal Impairment and Normal Renal Function Saroglitazar magnesium - Renal Impairment | Phase 1 | Completed | Zydus Therapeutics Inc. | 32 | 2020-07-27 | 2024-09-20 |
| Hepatic Impairment, Cholestatic Liver Disease, & NASH with Advanced Fibrosis & Normal Hepatic Function Saroglitazar Magnesium 2 mg, Saroglitazar Magnesium 4 mg - Hepatic Impairment | Phase 1 | Completed | Zydus Therapeutics Inc. | 98 | 2020-07-16 | 2024-09-20 |
| Study to Evaluate Absorption, Metabolism and Excretion of Single-dose [14C]-Saroglitazar in Healthy Male Subjects Saroglitazar magnesium - Healthy | Phase 1 | Completed | Zydus Therapeutics Inc. | 8 | 2019-09-20 | 2019-11-13 |
| A Study to Evaluate the Effect of Saroglitazar Magnesium on the QTc Interval in Healthy Volunteers Saroglitazar magnesium 4mg, Placebos, Moxifloxacin 400mg - Healthy | Phase 1 | Completed | Zydus Therapeutics Inc. | 52 | 2019-08-19 | 2020-04-21 |
| Saroglitazar Magnesium in the Treatment of Non-Alcoholic Steatohepatitis Saroglitazar Magnesium 2mg, Saroglitazar Magnesium 4mg, Placebos - Non Alcoholic Steatohepatitis | Phase 2 | Completed | Zydus Therapeutics Inc. | 16 | 2019-06-12 | 2024-10-15 |
| Safety, Tolerability, and Efficacy of Saroglitazar Mg 4 mg in Liver Transplant Recipients With Nonalcoholic Fatty Liver Disease (NAFLD) Saroglitazar - Liver Transplant; Complications, NAFLD | Phase 2 | Completed | Zydus Therapeutics Inc. | 20 | 2019-02-25 | 2024-10-24 |
| Saroglitazar Magnesium 4 mg in the Treatment of Nonalcoholic Fatty Liver Disease (NAFLD) in Women With PCOS (EVIDENCES VII) Saroglitazar Magnesium 4 mg Tablet, Placebo - Non-alcoholic Fatty Liver Disease in Women With PCOS | Phase 2 | Terminated | Zydus Therapeutics Inc. | 60 | 2019-02-12 | 2025-12-18 |
| Study to Evaluate Safety, Tolerability and Efficacy of Saroglitazar Mg in Patients With Primary Biliary Cholangitis Saroglitazar magnesium 2 mg, Saroglitazar magnesium 4 mg, Placebo Oral Tablet - Primary Biliary Cirrhosis | Phase 2 | Completed | Zydus Therapeutics Inc. | 37 | 2017-08-18 | 2024-09-19 |
| Saroglitazar Magnesium in Patients With Nonalcoholic Fatty Liver Disease and/or Nonalcoholic Steatohepatitis Saroglitazar magnesium 1 mg, Saroglitazar magnesium 2 mg, Saroglitazar magnesium 4 mg - Non-Alcoholic Fatty Liver Disease, Nonalcoholic Steatohepatitis | Phase 2 | Completed | Zydus Therapeutics Inc. | 106 | 2017-04-06 | 2024-10-24 |
| Evaluate the Safety and Efficacy of Saroglitazar Mg in Patients With Fasting Triglyceride ≥500 mg/dL and ≤1500 mg/dL Saroglitazar Magnesium 1 mg, Saroglitazar Magnesium 2 mg, Saroglitazar Magnesium 4 mg - Dyslipidemias | Phase 2 | Suspended | Zydus Therapeutics Inc. | 124 | 2017-04-06 | 2023-02-08 |
Liver Cirrhosis, Biliary (6) · Non-alcoholic Fatty Liver Disease (6) · Fibrosis (2) · Amyotrophic Lateral Sclerosis (1) · Dyslipidemias (1) · Hypertriglyceridemia (1) · Lipid Metabolism Disorders (1) · Renal Insufficiency (1)
saroglitazar (18) · Moxifloxacin (1) · Tablets (1)
United States (18) · Argentina (3) · Turkey (Türkiye) (3) · Australia (1) · Belgium (1) · Canada (1) · France (1) · Germany (1) · Iceland (1) · India (1) · Ireland (1) · Italy (1) · Mexico (1) · Netherlands (1) · Poland (1)
Deven Parmar, MD (3) · Deven Parmar (2) · Deven V Parmar (2) · Deven V Parmar, MD (2) · Deven V Parmar, MD,FACP,FCP (2) · Deven Parmar, MD FACP FCP (1) · Deven Parmar, MD FCP (1) · Deven V Parmar, MD, FCP (1) · Deven V. Parmar, MD, FCP (1) · Dr. Deven V Parmar, MD,FCP (1) · John E. Blanchard, MD (1)
PMID 33152542, PMID 33769355, PMID 33811367, PMID 34487750, PMID 36731585, PMID 36847136