Mirum Pharmaceuticals, Inc. (MIRM)
Mirum Pharmaceuticals, Inc. is a biopharmaceutical firm dedicated to discovering and commercializing groundbreaking therapies for serious rare and orphan conditions. Its lead experimental drug, LIVMARLI, an oral treatment, is currently undergoing trials for progressive familial intrahepatic cholestasis (PFIC), Alagille syndrome, and biliary atresia. Furthermore, the company is advancing Volixibat to address intrahepatic cholestasis of pregnancy and primary sclerosing cholangitis. Founded in 2018, Mirum Pharmaceuticals, Inc. operates from its headquarters in Foster City, California.
Sector: Pharmaceutical Preparations
Industry: Biotechnology
Mirum Pharmaceuticals, Inc.
- Cash runway at this date: -4mo
- ATEBRIOZ (zilurgisertib)READOUTCash runway at this date: 4mo
Trials need funding. See this company's dilution risk and cash position.
- Phase 4Recruiting
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
NCT07290257Enrollment230StartSep 2025Primary CompletionSep 2030est.CompletionDec 2030est. - Phase 3Completed
Compassionate Treatment of Patients With Inborn Errors of Bile Acid Metabolism With Cholic Acid
Cholic Acids
Infantile Refsum's Disease, Zellweger Syndrome +3
NCT00007020Enrollment85StartJan 1992Primary CompletionDec 2009CompletionDec 2009 - Phase 3Completed
Efficacy of To Be Marketed (TBM) Cholic Acid Capsules Used to Treat Children With Inborn Errors of Bile Acid Synthesis
Cholic acid
Inborn Errors of Bile Acid Synthesis
NCT01115582Enrollment16StartApr 2010Primary CompletionAug 2010CompletionAug 2010 - Phase 3Completed
Open Label, Continuation Study of Cholic Acid in Subjects With Inborn Errors of Bile Acid Synthesis
Cholic Acid
Bile Acid Synthesis Defect
NCT01438411Enrollment53StartJan 2010Primary CompletionJul 2016CompletionJul 2016 - Phase 3Withdrawn
A Placebo-controlled Study of Maralixibat (SHP625) in Pediatric Subjects With Progressive Familial Intrahepatic Cholestasis (PFIC)
Maralixibat, Placebo
Progressive Familial Intrahepatic Cholestasis (PFIC)
NCT03353454Enrollment0StartOct 2018est.Primary CompletionJun 2020est.CompletionJun 2020est. - Phase 3Completed
A Study to Evaluate the Efficacy and Safety of Maralixibat in Subjects With Progressive Familial Intrahepatic Cholestasis (MARCH-PFIC)
Maralixibat
Progressive Familial Intrahepatic Cholestasis (PFIC)
NCT03905330Enrollment93StartJul 2019Primary CompletionSep 2022CompletionSep 2022 - Phase 3Completed
An Extension Study of Maralixibat in Patients With Progressive Familial Intrahepatic Cholestasis (PFIC)
Maralixibat
Progressive Familial Intrahepatic Cholestasis (PFIC)
NCT04185363Enrollment84StartJan 2020Primary CompletionApr 2025CompletionApr 2025 - Phase 3Completed
Study to Evaluate Patients With Cerebrotendinous Xanthomatosis (RESTORE)
Blinded CDCA 250 mg TID, Placebo
CTX
NCT04270682Enrollment19StartJan 2020Primary CompletionJul 2023CompletionOct 2023 - Phase 3Active, not recruiting
Evaluation of Maralixibat in Pruritus Associated With General Cholestatic Liver Disease (EXPAND)
Maralixibat
Cholestatic Liver Disease (Except ALGS, PFIC, PBC and PSC)
NCT06553768Enrollment90StartOct 2024Primary CompletionOct 2026est.CompletionFeb 2027est. - Phase 3Recruiting
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
NCT07200908Enrollment172StartAug 2025Primary CompletionJun 2027est.CompletionSep 2029est. - Phase 3Active, not recruiting
A Trial Evaluating Brelovitug vs Delayed Treatment for the Treatment of Chronic Hepatitis Delta Infection (AZURE-4)
Brelovitug 300 mg, Brelovitug 900 mg
Chronic Hepatitis D Infection
NCT07298330Enrollment80StartJan 2026Primary CompletionAug 2026est.CompletionJan 2029est. - Phase 2/3Active, not recruiting
A Trial Evaluating BJT-778 vs Delayed Treatment for the Treatment of Chronic Hepatitis Delta Infection
Brelovitug 300 mg, Brelovitug 900 mg
Chronic Hepatitis D Infection
NCT06907290Enrollment150StartMar 2025Primary CompletionMay 2029est.CompletionSep 2029est. - Phase 2/3Recruiting
Study to Evaluate Switching to Brelovitug for the Treatment of CHD in Participants Receiving Bulevirtide
Brelovitug (BJT-778), Bulevirtide
Chronic Hepatitis D
NCT07454837Enrollment120StartFeb 2026Primary CompletionAug 2027est.CompletionMar 2029est. - Phase 2Completed
Safety and Efficacy Study of LUM001 in the Treatment of Cholestatic Liver Disease in Patients With Alagille Syndrome
LUM001, Placebo
Alagille Syndrome
NCT01903460Enrollment20StartAug 2013Primary CompletionFeb 2015CompletionMar 2015 - Phase 2Completed
Phase 2 Study to Evaluate LUM001 in Combination With Ursodeoxycholic Acid in Patients With Primary Biliary Cirrhosis
LUM001, Placebo
PBC, Primary Biliary Cirrhosis
NCT01904058Enrollment66StartAug 2013Primary CompletionApr 2015CompletionApr 2015 - Phase 2Completed
An Extension Study to Evaluate the Long-Term Safety and Durability of Effect of LUM001 in the Treatment of Cholestatic Liver Disease in Subjects With Alagille Syndrome (ALGS)
LUM001 (Maralixibat)
Alagille Syndrome
NCT02047318Enrollment19StartDec 2013Primary CompletionJun 2020CompletionJun 2020 - Phase 2Completed
Evaluation of LUM001 in the Reduction of Pruritus in Alagille Syndrome
LUM001, Placebo
Alagille Syndrome
NCT02057692Enrollment37StartNov 2014Primary CompletionNov 2016CompletionNov 2016 - Phase 2Completed
Open Label Study to Evaluate Efficacy and Long Term Safety of LUM001 (Maralixibat) in the Treatment of Cholestatic Liver Disease in Patients With Progressive Familial Intrahepatic Cholestasis
LUM001 (Maralixibat)
Progressive Familial Intrahepatic Cholestasis (PFIC)
NCT02057718Enrollment33StartMar 2014Primary CompletionMay 2020CompletionMay 2020 - Phase 2Completed
Open Label Study to Evaluate Safety and Efficacy of LUM001 in Patients With Primary Sclerosing Cholangitis
LUM001
Primary Sclerosing Cholangitis (PSC)
NCT02061540Enrollment27StartMar 2014Primary CompletionFeb 2016CompletionFeb 2016 - Phase 2Completed
An Extension Study to Evaluate the Long-Term Safety and Durability of Effect of LUM001 in the Treatment of Cholestatic Liver Disease in Pediatric Subjects With Alagille Syndrome
LUM001 (Maralixibat)
Alagille Syndrome
NCT02117713Enrollment34StartMar 2015Primary CompletionJun 2020CompletionJun 2020 - Phase 2Completed
Safety and Efficacy Study of LUM001 (Maralixibat) With a Drug Withdrawal Period in Participants With Alagille Syndrome (ALGS)
LUM001 (Maralixibat), Placebo
Alagille Syndrome
NCT02160782Enrollment31StartOct 2014Primary CompletionMay 2020CompletionMay 2020 - Phase 2Withdrawn
An Open-label Study to Evaluate the Long-term Safety and Tolerability of LUM001 in Patients With Primary Biliary Cirrhosis
LUM001
Primary Biliary Cirrhosis
NCT02321306Enrollment0StartMay 2015Primary CompletionDec 2017est.CompletionMar 2018est. - Phase 2Terminated
Volixibat (SHP626) in the Treatment of Adults With Nonalcoholic Steatohepatitis (NASH)
SHP626, Placebo
Non-Alcoholic Steatohepatitis
NCT02787304Enrollment197StartOct 2016Primary CompletionJul 2018CompletionJul 2018 - Phase 2Completed
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
NCT04168385Enrollment52StartJan 2020Primary CompletionSep 2024CompletionSep 2024 - Phase 2Completed
Evaluation of Maralixibat in Biliary Atresia Response Post-Kasai
Maralixibat
Biliary Atresia
NCT04524390Enrollment75StartJul 2021Primary CompletionNov 2023CompletionFeb 2024
| Drug / Therapy | Link | ||
|---|---|---|---|
| Phase 4 | Recruiting | Livmarli Oral Product | NCT07290257 |
| Phase 3 | Completed | Cholic Acids | NCT00007020 |
| Phase 3 | Completed | Cholic acid | NCT01115582 |
| Phase 3 | Completed | Cholic Acid | NCT01438411 |
| Phase 3 | Withdrawn | Maralixibat, Placebo | NCT03353454 |
| Phase 3 | Completed | Maralixibat | NCT03905330 |
| Phase 3 | Completed | Maralixibat | NCT04185363 |
| Phase 3 | Completed | Blinded CDCA 250 mg TID, Placebo | NCT04270682 |
| Phase 3 | Active, not recruiting | Maralixibat | NCT06553768 |
| Phase 3 | Recruiting | Brelovitug 300 mg, Bulevirtide 2 mg and Brelovitug - 300 mg | NCT07200908 |
| Phase 3 | Active, not recruiting | Brelovitug 300 mg, Brelovitug 900 mg | NCT07298330 |
| Phase 2/3 | Active, not recruiting | Brelovitug 300 mg, Brelovitug 900 mg | NCT06907290 |
| Phase 2/3 | Recruiting | Brelovitug (BJT-778), Bulevirtide | NCT07454837 |
| Phase 2 | Completed | LUM001, Placebo | NCT01903460 |
| Phase 2 | Completed | LUM001, Placebo | NCT01904058 |
| Phase 2 | Completed | LUM001 (Maralixibat) | NCT02047318 |
| Phase 2 | Completed | LUM001, Placebo | NCT02057692 |
| Phase 2 | Completed | LUM001 (Maralixibat) | NCT02057718 |
| Phase 2 | Completed | LUM001 | NCT02061540 |
| Phase 2 | Completed | LUM001 (Maralixibat) | NCT02117713 |
| Phase 2 | Completed | LUM001 (Maralixibat), Placebo | NCT02160782 |
| Phase 2 | Withdrawn | LUM001 | NCT02321306 |
| Phase 2 | Terminated | SHP626, Placebo | NCT02787304 |
| Phase 2 | Completed | Maralixibat | NCT04168385 |
| Phase 2 | Completed | Maralixibat | NCT04524390 |
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