Success Metrics

Clinical Success Rate
100.0%

Based on 6 completed trials

Completion Rate
100%(6/6)
Active Trials
2(18%)
Results Posted
50%(3 trials)

Phase Distribution

Ph phase_3
4
36%
Ph phase_2
4
36%
Ph phase_1
1
9%

Phase Distribution

1

Early Stage

4

Mid Stage

4

Late Stage

Phase Distribution9 total trials
Phase 1Safety & dosage
1(11.1%)
Phase 2Efficacy & side effects
4(44.4%)
Phase 3Large-scale testing
4(44.4%)

Highest Phase Reached

Phase 3

Trial Status & Enrollment

Completion Rate

85.7%

6 of 7 finished

Non-Completion Rate

14.3%

1 ended early

Currently Active

2

trials recruiting

Total Trials

11

all time

Status Distribution
Active(3)
Completed(6)
Terminated(1)
Other(1)

Detailed Status

Completed6
unknown1
Withdrawn1
Recruiting1
Not yet recruiting1
Active, not recruiting1

Development Timeline

Analytics

Development Status

Total Trials
11
Active
2
Success Rate
100.0%
Most Advanced
Phase 3

Trials by Phase

Phase 11 (11.1%)
Phase 24 (44.4%)
Phase 34 (44.4%)

Trials by Status

unknown19%
completed655%
withdrawn19%
recruiting19%
not_yet_recruiting19%
active_not_recruiting19%

Recent Activity

Clinical Trials (11)

Showing 11 of 11 trials
NCT06553768Phase 3

Evaluation of Maralixibat in Pruritus Associated With General Cholestatic Liver Disease (EXPAND)

Active Not Recruiting
NCT07293897

A Database Study of Maralixibat (TAK-625) in Participants With Alagille Syndrome (ALGS) and Progressive Familial Intrahepatic Cholestasis (PFIC)

Recruiting
NCT07389031Phase 2

Maralixibat for Intrahepatic Cholestasis of Pregnancy

Not Yet Recruiting
NCT04168385Phase 2

MRX-800: A Long-Term Safety Study of Maralixibat in the Treatment of Cholestatic Liver Disease in Subjects Who Previously Participated in a Maralixibat Study

Completed
NCT04185363Phase 3

An Extension Study of Maralixibat in Patients With Progressive Familial Intrahepatic Cholestasis (PFIC)

Completed
NCT04524390Phase 2

Evaluation of Maralixibat in Biliary Atresia Response Post-Kasai

Completed
NCT04729751Phase 2

A Study to Evaluate the Safety and Tolerability of Maralixibat in Infant Participants With Cholestatic Liver Diseases Including Progressive Familial Intrahepatic Cholestasis (PFIC) and Alagille Syndrome (ALGS).

Completed
NCT03905330Phase 3

A Study to Evaluate the Efficacy and Safety of Maralixibat in Subjects With Progressive Familial Intrahepatic Cholestasis (MARCH-PFIC)

Completed
NCT04530994

A Maralixibat Expanded Access Program for Patients With Cholestatic Pruritus Associated With Alagille Syndrome (ALGS)

Unknown
NCT02475317Phase 1

Study to Assess the Relative Potency of Multiple Oral Doses of LUM001 and SHP626 in Overweight and Obese Adults as Assessed by Fecal Bile Acid Excretion

Completed
NCT03353454Phase 3

A Placebo-controlled Study of Maralixibat (SHP625) in Pediatric Subjects With Progressive Familial Intrahepatic Cholestasis (PFIC)

Withdrawn

All 11 trials loaded

Drug Details

Intervention Type
DRUG
Total Trials
11