maralixibat
maralixibat: sourced relationships with 1 company · 6 clinical trials tracked.
maralixibat evidence translation
What we can confirm
6 tracked trials
What it means
What to watch
Prepared research question
How could maralixibat → MIRM affect its developer, and what evidence supports the link?
Traceable citations · Unknowns marked
See linked entities and source evidence2 indications · 0 study sponsors
Related indications
Study sponsors
No additional listed-company sponsor is linked.
Dated Pipeline Records (2)
| Company | Dated record stage |
|---|---|
| Mirum Pharmaceuticals, Inc. (MIRM) Cholestatic Liver Disease (Except ALGS, PFIC, PBC and PSC); … | Phase 4 |
| Mirum Pharmaceuticals, Inc. (MIRM) | Approved |
Clinical Trial Registry Records (6)
MRX-901: An Open-label Study to Assess Safety and Tolerability of Maralixibat in Participants With Intrahepatic Cholestasis of Pregnancy (ICP) (OASIS)
Primary endpoint: Incidence of treatment-emergent adverse events (TEAEs)
A Cohort Study to Investigate the Risk of Liver Disorder of Livmarli Oral Solution in Patients With Japan Alagille Syndrome (ALGS) and Progressive Familial Intrahepatic Cholestasis (PFIC) Registered in the Comprehensive and Informative Registry System for Childhood Liver Disease (CIRCLe)
Primary endpoint: Percentage of Participants with ALGS who Experience Liver Disorder Evaluated with Outcome Definition 1 (Side Effects)
Randomized Double-Blind Placebo-Controlled Phase 3 Study to Evaluate the Efficacy and Safety of Maralixibat in the Treatment of Participants With Cholestatic Pruritus
Primary endpoint: Mean change in the ItchRO(Obs) severity score
Long-Term SafEty and Clinical Outcomes of LivmArli in Patients in the United States (LEAP-US)
Primary endpoint: Incidence of Long-Term Clinical Outcomes
Open-Label, Phase 2 Study to Evaluate the Safety and Tolerability of Maralixibat in the Treatment of Infants With Cholestatic Liver Diseases Including Progressive Familial Intrahepatic Cholestasis and Alagille Syndrome
Primary endpoint: Frequency of Treatment-emergent Adverse Events [TEAEs]
An Open-label Extension Study to Evaluate the Long-term Safety and Efficacy of Maralixibat in the Treatment of Subjects With Progressive Familial Intrahepatic Cholestasis (PFIC)
Primary endpoint: Mean Change From Baseline Over Time in the Average Morning ItchRO(Obs) Severity Score
Frequently asked questions
Which companies have sourced relationships with maralixibat?
maralixibat has dated SEC/FDA relationship records for Mirum Pharmaceuticals, Inc..
How many clinical trials involve maralixibat?
BioSniper tracks 6 clinical trials involving maralixibat.