Key Highlights

Risk & Performance

Pipeline Risk Assessment

Based on historical performance

High Risk

Score: 70/100

Failure Rate

42.9%

12 terminated/withdrawn out of 28 trials

Success Rate

53.8%

-32.7% vs industry average

Late-Stage Pipeline

21%

6 trials in Phase 3/4

Results Transparency

129%

18 of 14 completed trials have results

Key Signals

18 with results11 terminated

Enrollment Performance

Analytics

Phase 2

12(50.0%)

Phase 3

4(16.7%)

Phase 1

3(12.5%)

N/A

3(12.5%)

Phase 4

2(8.3%)

24Total

Phase 2(12)

Phase 3(4)

Phase 1(3)

N/A(3)

+1 more

Activity Timeline

Global Presence

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Clinical Trials (28)

Showing 20 of 28 trials

NCT04594694Phase 2Terminated

Study of OCA in Combination With BZF Evaluating Efficacy, Safety, and Tolerability in Participants With PBC

Role: lead

NCT05239468Phase 2Completed

Study of OCA in Combination With BZF Evaluating Efficacy, Safety and Tolerability in Participants With PBC

Role: lead

NCT06121375Phase 2Terminated

Study to Assess Efficacy, Safety, Tolerability, Pharmacokinetics (PK), and Pharmacodynamics (PD) of Obeticholic Acid (OCA) Compared to Placebo in Pediatric Participants With Biliary Atresia, Post-hepatoportoenterostomy

Role: lead

NCT06488911Phase 3Terminated

To Evaluate Safety and Tolerability of the Fixed- Dose Combination of Obeticholic Acid and Bezafibrate

Role: lead

NCT05639543Phase 2Terminated

FXR Effect on Severe Alcohol-Associated Hepatitis (FRESH) Study

Role: lead

NCT02846896Completed

The Health Burden of Primary Biliary Cirrhosis (PBC) in Switzerland

Role: collaborator

NCT05479721Active Not Recruiting

LITMUS Imaging Study

Role: collaborator

NCT05292872Completed

Real-World Data Study to Evaluate the Effectiveness of OCA on Hepatic Outcomes in PBC Patients

Role: lead

NCT02548351Phase 3Terminated

Randomized Global Phase 3 Study to Evaluate the Impact on NASH With Fibrosis of Obeticholic Acid Treatment

Role: lead

NCT00550862Phase 2Terminated

Study of INT 747 in Combination With URSO in Patients With Primay Biliary Cirrhosis (PBC)

Role: lead

NCT03439254Phase 3Completed

Study Evaluating the Efficacy and Safety of Obeticholic Acid in Subjects With Compensated Cirrhosis Due to Nonalcoholic Steatohepatitis

Role: lead

NCT05293938Withdrawn

A Real-World Data Study to Evaluate the Effectiveness of OCA on Hepatic Outcomes in PBC Patients

Role: lead

NCT02654236Not ApplicableCompleted

Effect of Heavy Alcohol Consumption on Farnesoid X Receptor (FXR) Signaling

Role: collaborator

NCT05321524Phase 2Terminated

Obeticholic Acid in Pediatric Subjects With Biliary Atresia

Role: lead

NCT02308111Phase 4Terminated

Phase 4 Study of Obeticholic Acid Evaluating Clinical Outcomes in Patients With Primary Biliary Cholangitis

Role: lead

NCT05740631Not ApplicableUnknown

The Effect of Obeticholic Acid in Healthy Volunteers

Role: collaborator

NCT03633227Phase 4Terminated

Study of Obeticholic Acid (OCA) Evaluating Pharmacokinetics and Safety in Participants With Primary Biliary Cholangitis (PBC) and Hepatic Impairment

Role: lead

NCT01865812Phase 2Completed

Phase 2 Study on Effects of Obeticholic Acid (OCA) on Lipoprotein Metabolism in Participants With Primary Biliary Cirrhosis

Role: lead

NCT02177136Phase 2Completed

Obeticholic Acid (OCA) in Primary Sclerosing Cholangitis (PSC)

Role: lead

NCT00570765Phase 2Completed

Study of INT-747 as Monotherapy in Participants With Primary Biliary Cirrhosis (PBC)

Role: lead