Key Highlights

Risk & Performance

Pipeline Risk Assessment

Pipeline Risk Assessment

Based on historical performance

Moderate Risk

Score: 40/100

Failure Rate

10.5%

2 terminated/withdrawn out of 19 trials

Success Rate

83.3%

-3.2% vs industry average

Late-Stage Pipeline

16%

3 trials in Phase 3/4

Results Transparency

60%

6 of 10 completed trials have results

Key Signals

3 recruiting6 with results

Enrollment Performance

Analytics

Phase 2
10(52.6%)
Phase 1
6(31.6%)
Phase 3
3(15.8%)
19Total
Phase 2(10)
Phase 1(6)
Phase 3(3)

Activity Timeline

Global Presence

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Clinical Trials (19)

Showing 19 of 19 trials
NCT05133336Phase 2Completed

Saroglitazar Magnesium for Treatment of Primary Biliary Cholangitis

Role: lead

NCT07424677Phase 3Not Yet Recruiting

Study of Saroglitazar Magnesium for PBC Patients With Incomplete Response or Intolerant to UDCA Therapy

Role: lead

NCT07216235Phase 3Not Yet Recruiting

Long-Term Study to Evaluate the Safety and Efficacy in Participants With Primary Biliary Cholangitis of Saroglitazar Magnesium-V on Clinical Outcomes

Role: lead

NCT05045482Phase 1Recruiting

Hepatic Impairment With Cirrhosis Due to Cholestatic Liver Disease

Role: lead

NCT06427395Phase 3Recruiting

Open-Label Extension Study of Saroglitazar Magnesium in Participants With Primary Biliary Cholangitis

Role: lead

NCT07023835Phase 2Active Not Recruiting

Usnoflast Neuromuscular Investigation for Treatment Efficacy in Amyotrophic Lateral Sclerosis

Role: lead

NCT03617263Phase 2Terminated

Saroglitazar Magnesium 4 mg in the Treatment of Nonalcoholic Fatty Liver Disease (NAFLD) in Women With PCOS (EVIDENCES VII)

Role: lead

NCT06825559Phase 1Recruiting

Evaluate PK & Safety of Saroglitazar in Subjects With Moderate Hepatic Impairment Due to Cholestatic Liver Disease

Role: lead

NCT05011305Phase 2Completed

Saroglitazar Magnesium for the Treatment of Nonalcoholic Steatohepatitis With Fibrosis

Role: lead

NCT05211284Phase 2Terminated

Saroglitazar Magnesium 4 mg for Nonalcoholic Fatty Liver Disease (NAFLD) in People Living With HIV in the US

Role: lead

NCT03639623Phase 2Completed

Safety, Tolerability, and Efficacy of Saroglitazar Mg 4 mg in Liver Transplant Recipients With Nonalcoholic Fatty Liver Disease (NAFLD)

Role: lead

NCT03061721Phase 2Completed

Saroglitazar Magnesium in Patients With Nonalcoholic Fatty Liver Disease and/or Nonalcoholic Steatohepatitis

Role: lead

NCT03863574Phase 2Completed

Saroglitazar Magnesium in the Treatment of Non-Alcoholic Steatohepatitis

Role: lead

NCT04469920Phase 1Completed

Hepatic Impairment, Cholestatic Liver Disease, & NASH with Advanced Fibrosis & Normal Hepatic Function

Role: lead

NCT04446507Phase 1Completed

A Pharmacokinetic Study of Saroglitazar Magnesium in Subjects with Severe Renal Impairment and Normal Renal Function

Role: lead

NCT03112681Phase 2Completed

Study to Evaluate Safety, Tolerability and Efficacy of Saroglitazar Mg in Patients With Primary Biliary Cholangitis

Role: lead

NCT03097107Phase 2Suspended

Evaluate the Safety and Efficacy of Saroglitazar Mg in Patients With Fasting Triglyceride ≥500 mg/dL and ≤1500 mg/dL

Role: lead

NCT04045769Phase 1Completed

A Study to Evaluate the Effect of Saroglitazar Magnesium on the QTc Interval in Healthy Volunteers

Role: lead

NCT04112446Phase 1Completed

Study to Evaluate Absorption, Metabolism and Excretion of Single-dose [14C]-Saroglitazar in Healthy Male Subjects

Role: lead

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