22 completed, 6 active not recruiting, 6 recruiting, 2 not yet recruiting. 21 Phase 2, 12 Phase 3, 4 Phase 1, 1 Phase 4.
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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 |
|---|---|---|---|---|---|---|
| MRX-901: An Open-label Study to Assess Safety and Tolerability of Maralixibat in Participants With Intrahepatic Cholestasis of Pregnancy (ICP) Maralixibat - Intrahepatic Cholestasis of Pregnancy | Phase 2 | Not yet recruiting | Mirum Pharmaceuticals, Inc. | 15 | 2027-01-15 | 2026-09-16 |
| A Study to Evaluate the Absorption, Distribution, Metabolism, and Excretion of [14C]-MRM-3379 [14C]-MRM-3379 - Healthy Volunteers | Phase 1 | Completed | Mirum Pharmaceuticals, Inc. | 7 | 2026-05-29 | 2026-10-07 |
| Pediatric Evaluation and Registry for Liver Cholestasis in Canada PFIC - Progressive Familial Intrahepatic Cholestasis, Alagille Syndrome (ALGS) | Recruiting | Children's Hospital of Eastern Ontario | 220 | 2026-04-21 | 2026-10-08 | |
| Maralixibat for Intrahepatic Cholestasis of Pregnancy Maralixibat - Intrahepatic Cholestasis of Pregnancy | Phase 2 | Not yet recruiting | Imperial College London | 28 | 2026-04-01 | 2026-02-05 |
| Study to Evaluate Switching to Brelovitug for the Treatment of CHD in Participants Receiving Bulevirtide Brelovitug (BJT-778), Bulevirtide - Chronic Hepatitis D | Phase 2 / Phase 3 | Recruiting | Mirum Pharmaceuticals, Inc. | 120 | 2026-02-26 | 2026-09-10 |
| A Trial Evaluating Brelovitug vs Delayed Treatment for the Treatment of Chronic Hepatitis Delta Infection (AZURE-4) Brelovitug 300 mg, Brelovitug 900 mg, Delayed Treatment with Brelovitug 300mg - Chronic Hepatitis D Infection | Phase 3 | Active not recruiting | Mirum Pharmaceuticals, Inc. | 80 | 2026-01-14 | 2026-06-29 |
| Study of MRM-3379 in Male Participants With Fragile X Syndrome (BLOOM) Low dose of MRM-3379, Middle Dose of MRM-3379, High dose of MRM-3379 - Fragile X Syndrome | Phase 2 | Recruiting | Mirum Pharmaceuticals, Inc. | 60 | 2025-11-22 | 2026-09-29 |
| Long-Term Low-Intervention SafEty and Clinical Outcomes Clinical Study of LivmArli® in Patients With Alagille Syndrome or Progressive Familial Intrahepatic Cholestasis in the European Union (LEAP-EU) Livmarli Oral Product - Alagille Syndrome, Progressive Familial Intrahepatic Cholestasis | Phase 4 | Recruiting | Mirum Pharmaceuticals, Inc. | 230 | 2025-09-25 | 2026-06-23 |
| A Trial Evaluating Brelovitug (BJT-778) vs Bulevirtide for the Treatment of Chronic Hepatitis Delta Infection (AZURE-2) Brelovitug 300 mg, Bulevirtide 2 mg and Brelovitug - 300 mg - Chronic Hepatitis D Infection | Phase 3 | Recruiting | Mirum Pharmaceuticals, Inc. | 172 | 2025-08-27 | 2026-10-08 |
| A Trial Evaluating BJT-778 vs Delayed Treatment for the Treatment of Chronic Hepatitis Delta Infection Brelovitug 300 mg, Brelovitug 900 mg, Delayed Treatment with Brelovitug 300mg - Chronic Hepatitis D Infection | Phase 2 / Phase 3 | Active not recruiting | Mirum Pharmaceuticals, Inc. | 150 | 2025-03-25 | 2026-03-02 |
| Evaluation of Maralixibat in Pruritus Associated With General Cholestatic Liver Disease (EXPAND) Maralixibat, Placebo - Cholestatic Liver Disease (Except ALGS, PFIC, PBC and PSC) | Phase 3 | Active not recruiting | Mirum Pharmaceuticals, Inc. | 90 | 2024-10-14 | 2026-10-06 |
| Long-Term SafEty and Clinical Outcomes of LivmArli in Patients in the United States (LEAP-US) Livmarli - Alagille Syndrome, Progressive Familial Intrahepatic Cholestasis | Recruiting | Mirum Pharmaceuticals, Inc. | 70 | 2023-09-21 | 2026-10-08 | |
| A Study to Evaluate Efficacy and Safety of an Investigational Drug Named Volixibat in Patients With Itching Caused by Primary Biliary Cholangitis Volixibat, Placebo - Primary Biliary Cholangitis, PBC | Phase 2 | Active not recruiting | Mirum Pharmaceuticals, Inc. | 333 | 2021-09-22 | 2026-08-25 |
| 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). Maralixibat - Progressive Familial Intrahepatic Cholestasis, Alagille Syndrome | Phase 2 | Completed | Mirum Pharmaceuticals, Inc. | 27 | 2021-09-09 | 2026-06-02 |
| Evaluation of Maralixibat in Biliary Atresia Response Post-Kasai Maralixibat, Placebo - Biliary Atresia | Phase 2 | Completed | Mirum Pharmaceuticals, Inc. | 75 | 2021-07-08 | 2025-03-19 |
| ScreenPlus: A Comprehensive, Flexible, Multi-disorder Newborn Screening Program Confirmatory Testing - Acid Sphingomyelinase Deficiency, Ceroid Lipofuscinosis, Neuronal, 2 | Enrolling by invitation | Albert Einstein College of Medicine | 100000 | 2021-05-10 | 2026-07-28 | |
| A Placebo-controlled Study of Volixibat in Subjects With Elevated Serum Bile Acids Associated With Intrahepatic Cholestasis of Pregnancy (OHANA) Volixibat, Placebo - Intrahepatic Cholestasis of Pregnancy | Phase 2 | Terminated | Mirum Pharmaceuticals, Inc. | 4 | 2021-01-04 | 2024-08-06 |
| A Study to Evaluate Efficacy and Safety of an Investigational Drug Named Volixibat in Patients With Itching Caused by Primary Sclerosing Cholangitis (PSC) Volixibat, Placebo - Primary Sclerosing Cholangitis | Phase 2 | Active not recruiting | Mirum Pharmaceuticals, Inc. | 182 | 2020-12-18 | 2026-10-19 |
| Study to Evaluate Patients With Cerebrotendinous Xanthomatosis (RESTORE) Blinded CDCA 250 mg TID, Placebo, Open-Label CDCA 250 mg TID - CTX | Phase 3 | Completed | Mirum Pharmaceuticals, Inc. | 19 | 2020-01-31 | 2024-10-28 |
| 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 Maralixibat - Cholestatic Liver Disease | Phase 2 | Completed | Mirum Pharmaceuticals, Inc. | 52 | 2020-01-16 | 2025-12-08 |
Showing 20 of 42. Sign in to see all of them.
Alagille Syndrome (11) · Cholestasis (11) · Cholestasis, progressive familial intrahepatic 1 (9) · Liver Diseases (9) · Pruritus (8) · Bile Duct Diseases (7) · Biliary Tract Diseases (6) · Digestive System Diseases (5) · Cholangitis, Sclerosing (3) · Hepatitis D (3) · Intrahepatic Cholestasis of Pregnancy (3) · Liver Cirrhosis, Biliary (3) · Non-alcoholic Fatty Liver Disease (3) · Biliary Atresia (2) · Cholestasis, Intrahepatic (2)
maralixibat (17) · volixibat (7) · Cholic Acid (4) · Treatment Delay (2) · bulevirtide (2) · Cholic Acids (1) · Ursodeoxycholic Acid (1)
United States (32) · United Kingdom (20) · Canada (14) · France (12) · Belgium (9) · Germany (9) · Spain (9) · Italy (8) · Poland (8) · Brazil (7) · Argentina (4) · Australia (4) · Austria (4) · Israel (4) · Lebanon (3)
James E Heubi, MD (2) · Kenneth Setchell, PhD (2) · Catherine Williamson, MD (1) · James Heubi, MD (1) · Kimberly Cruz, MD (1) · Melissa Wasserstein, MD (1) · Nicholas Siebers, MD (1) · Sagar A Vaidya, MD, PhD (1)
PMID 42002216, PMID 28644367, PMID 28702877, PMID 29548345, PMID 31899729, PMID 32234329, PMID 34755627, PMID 35507739, PMID 36096175, PMID 37184523, PMID 38723644, PMID 40439725, PMID 41603551
2014 (2), 2019 (2), 2016 (1), 2017 (1), 2023 (1), 2025 (1), R01HD073292 (1)