Mirum Pharmaceuticals Clinical Trials: 38 Led Studies

Archive historyOct 2022 to Apr 2026

47 recorded changes across Mirum Pharmaceuticals trials

Every status move, completion date shift and enrollment change ComplyRx has recorded across 11 of these trials. One is shown below.

Status changeStatus moved to active not recruiting from recruitingNCT06553768 · recorded 1 Apr 2026

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+43 more recorded changes · Track a drug to see every change the night it lands

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Most active programmes

The drugs appearing most often across Mirum Pharmaceuticals's recently active trials. Comparator arms are excluded.

Maralixibat8 trials
LUM0015 trials
Volixibat4 trials
LUM001 (Maralixibat)4 trials
Brelovitug 300 mg3 trials
SHP6263 trials

Upcoming readouts

Next primary completion dates among Mirum Pharmaceuticals's active phase 2 and phase 3 trials. Dates are registry estimates and move often, which is exactly what the tracker watches.

Apr 2027VANTAGE: A Study to Evaluate Efficacy and Safety of an Investigational Drug Named Volixibat in Patients W…Phase 2
Jun 2027A Trial Evaluating Brelovitug (BJT-778) vs Bulevirtide for the Treatment of Chronic Hepatitis De…Phase 3
Aug 2027Study to Evaluate Switching to Brelovitug for the Treatment of CHD in Participants Receiving Bul…Phase 2
Oct 2027Study of MRM-3379 in Male Participants With Fragile X Syndrome (BLOOM)Phase 2

Top therapeutic areas

Conditions studied most often across Mirum Pharmaceuticals's recently active trials.

Alagille Syndrome10 trials
Progressive Familial Intrahepatic Cholestasis (PFIC)4 trials
Progressive Familial Intrahepatic Cholestasis4 trials
Chronic Hepatitis D Infection3 trials
Non-Alcoholic Steatohepatitis3 trials
Cholestatic Liver Disease2 trials

Mirum Pharmaceuticals trials

The 38 most significant of Mirum Pharmaceuticals's recently active trials, soonest estimated readout first.
Select any row for the full record; the change timeline unlocks with tracking.

Trial	Phase	Stability	Status	Enrollment	Est. readout
A Trial Evaluating Brelovitug vs Delayed Treatment for the Treatment of Chronic Hepatitis Delta Infection (AZURE-4)NCT07298330Brelovitug 300 mg	Phase 3	Locked · track to reveal	OngoingActive, not recruiting	80 est.	Aug 2026
Evaluation of Maralixibat in Pruritus Associated With General Cholestatic Liver Disease (EXPAND)NCT06553768Maralixibat	Phase 3	Locked · track to reveal	OngoingActive, not recruiting	90 est.	Oct 2026
VANTAGEA Study to Evaluate Efficacy and Safety of an Investigational Drug Named Volixibat in Patients With Itching Caused by Primary Biliary CholangitisNCT05050136Volixibat	Phase 2	Locked · track to reveal	OngoingRecruiting	260 est.	Apr 2027
A Trial Evaluating Brelovitug (BJT-778) vs Bulevirtide for the Treatment of Chronic Hepatitis Delta Infection (AZURE-2)NCT07200908Brelovitug 300 mg	Phase 3	Locked · track to reveal	OngoingRecruiting	172 est.	30 Jun 2027
Study to Evaluate Switching to Brelovitug for the Treatment of CHD in Participants Receiving BulevirtideNCT07454837Brelovitug (BJT-778)	Phase 2	Locked · track to reveal	OngoingRecruiting	120 est.	31 Aug 2027
Study of MRM-3379 in Male Participants With Fragile X Syndrome (BLOOM)NCT07209462Low dose of MRM-3379	Phase 2	Locked · track to reveal	OngoingRecruiting	60 est.	Oct 2027
LEAPLong-Term SafEty and Clinical Outcomes of LivmArli in Patients in the United States (LEAP-US)NCT06193928Livmarli	—	Not yet scored	OngoingRecruiting	70 est.	20 Sept 2028
A Trial Evaluating BJT-778 vs Delayed Treatment for the Treatment of Chronic Hepatitis Delta InfectionNCT06907290Brelovitug 300 mg	Phase 2	Locked · track to reveal	OngoingActive, not recruiting	150 est.	May 2029
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)NCT07290257Livmarli Oral Product	Phase 4	Locked · track to reveal	OngoingRecruiting	230 est.	22 Sept 2030
The REPLACE Registry for Cholbam® (Cholic Acid)NCT03115086Cholbam	—	Not yet scored	OngoingActive, not recruiting	55 est.	Jul 2038
A Study to Evaluate the Absorption, Distribution, Metabolism, and Excretion of [14C]-MRM-3379NCT07712718[14C]-MRM-3379	Phase 1	Not yet scored	OngoingRecruiting	8 est.	Jul 2026
VISTASA Study to Evaluate Efficacy and Safety of an Investigational Drug Named Volixibat in Patients With Itching Caused by Primary Sclerosing Cholangitis (PSC)NCT04663308Volixibat	Phase 2	Locked · track to reveal	OngoingActive, not recruiting	182 est.	Jun 2026
An Extension Study of Maralixibat in Patients With Progressive Familial Intrahepatic Cholestasis (PFIC)NCT04185363Maralixibat	Phase 3	Locked · track to reveal	Completed	84 est.	23 Apr 2025
RISEA 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).NCT04729751Maralixibat	Phase 2	Locked · track to reveal	Completed	27 est.	17 Dec 2024
MERGEMRX-800: A Long-Term Safety Study of Maralixibat in the Treatment of Cholestatic Liver Disease in Subjects Who Previously Participated in a Maralixibat StudyNCT04168385Maralixibat	Phase 2	Locked · track to reveal	Completed	52 est.	4 Sept 2024
EMBARKEvaluation of Maralixibat in Biliary Atresia Response Post-KasaiNCT04524390Maralixibat	Phase 2	Locked · track to reveal	Completed	75 est.	7 Nov 2023
Study to Evaluate Patients With Cerebrotendinous Xanthomatosis (RESTORE)NCT04270682Blinded CDCA 250 mg TID	Phase 3	Locked · track to reveal	Completed	19 est.	13 Jul 2023
OHANAA Placebo-controlled Study of Volixibat in Subjects With Elevated Serum Bile Acids Associated With Intrahepatic Cholestasis of Pregnancy (OHANA)NCT04718961Volixibat	Phase 2	Locked · track to reveal	StoppedTerminated	4 est.	7 Dec 2022
MARCH-PFICA Study to Evaluate the Efficacy and Safety of Maralixibat in Subjects With Progressive Familial Intrahepatic Cholestasis (MARCH-PFIC)NCT03905330Maralixibat	Phase 3	Locked · track to reveal	Completed	93 est.	1 Sept 2022
IMAGINEAn 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)NCT02047318LUM001 (Maralixibat)	Phase 2	Locked · track to reveal	Completed	19 est.	17 Jun 2020
A Placebo-controlled Study of Maralixibat (SHP625) in Pediatric Subjects With Progressive Familial Intrahepatic Cholestasis (PFIC)NCT03353454Maralixibat	Phase 3	Locked · track to reveal	StoppedWithdrawn	0 est.	15 Jun 2020
IMAGINE-IIAn 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 SyndromeNCT02117713LUM001 (Maralixibat)	Phase 2	Locked · track to reveal	Completed	34 est.	1 Jun 2020
ICONICSafety and Efficacy Study of LUM001 (Maralixibat) With a Drug Withdrawal Period in Participants With Alagille Syndrome (ALGS)NCT02160782LUM001 (Maralixibat)	Phase 2	Locked · track to reveal	Completed	31 est.	28 May 2020
INDIGOOpen 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 CholestasisNCT02057718LUM001 (Maralixibat)	Phase 2	Locked · track to reveal	Completed	33 est.	8 May 2020
Volixibat (SHP626) in the Treatment of Adults With Nonalcoholic Steatohepatitis (NASH)NCT02787304SHP626	Phase 2	Locked · track to reveal	StoppedTerminated	197 est.	27 Jul 2018
CASCADEAn Open-label Study to Evaluate the Long-term Safety and Tolerability of LUM001 in Patients With Primary Biliary CirrhosisNCT02321306LUM001	Phase 2	Locked · track to reveal	StoppedWithdrawn	0 est.	Dec 2017
ITCHEvaluation of LUM001 in the Reduction of Pruritus in Alagille SyndromeNCT02057692LUM001	Phase 2	Locked · track to reveal	Completed	37 est.	16 Nov 2016
Open Label, Continuation Study of Cholic Acid in Subjects With Inborn Errors of Bile Acid SynthesisNCT01438411Cholic Acid	Phase 3	Locked · track to reveal	Completed	53 est.	Jul 2016
CAMEOOpen Label Study to Evaluate Safety and Efficacy of LUM001 in Patients With Primary Sclerosing CholangitisNCT02061540LUM001	Phase 2	Locked · track to reveal	Completed	27 est.	Feb 2016
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 ExcretionNCT02475317Maralixibat	Phase 1	Locked · track to reveal	Completed	84 est.	1 Dec 2015
A Study to Investigate How the Study Drug SHP626 is Eliminated From the Body After One DoseNCT02571192SHP626	Phase 1	Locked · track to reveal	Completed	8 est.	1 Oct 2015
Safety and Tolerability Study of SHP626 in Overweight and Obese AdultsNCT02287779SHP626	Phase 1	Locked · track to reveal	Completed	84 est.	19 Jun 2015
CLARITYPhase 2 Study to Evaluate LUM001 in Combination With Ursodeoxycholic Acid in Patients With Primary Biliary CirrhosisNCT01904058LUM001	Phase 2	Locked · track to reveal	Completed	66 est.	Apr 2015
Validation of the Itch Reported Outcome (ItchRO) Diaries in Pediatric Cholestatic Liver DiseaseNCT02131623	—	Not yet scored	Completed	23 est.	Mar 2015
IMAGOSafety and Efficacy Study of LUM001 in the Treatment of Cholestatic Liver Disease in Patients With Alagille SyndromeNCT01903460LUM001	Phase 2	Locked · track to reveal	Completed	20 est.	Feb 2015
Efficacy of To Be Marketed (TBM) Cholic Acid Capsules Used to Treat Children With Inborn Errors of Bile Acid SynthesisNCT01115582Cholic acid	Phase 3	Locked · track to reveal	Completed	16 est.	Aug 2010
Compassionate Treatment of Patients With Inborn Errors of Bile Acid Metabolism With Cholic AcidNCT00007020Cholic Acids	Phase 3	Locked · track to reveal	Completed	85 est.	Dec 2009
A Maralixibat Expanded Access Program for Patients With Cholestatic Pruritus Associated With Alagille Syndrome (ALGS)NCT04530994maralixibat	—	Not yet scored	Unknown	—	—

View all trials38

A Trial Evaluating Brelovitug vs Delayed Treatment for the Treatment of Chronic Hepatitis Delta Infection (AZURE-4)

Phase 3Active, not recruitingNCT07298330 ↗

Primary completion: Aug 2026; estimated
Enrollment: 80; estimated
Start: Jan 2026; Mirum Pharmaceuticals, Inc.

Conditions

Chronic Hepatitis D Infection

Interventions

Brelovitug 300 mg
Brelovitug 900 mg
Delayed Treatment with Brelovitug 300mg

Brief summary

This is a Phase 3, global, randomized, open-label, multicenter trial designed to evaluate the safety and efficacy of chronic treatment with brelovitug (BJT-778) for chronic hepatitis delta virus (HDV) infection. The objective of this study is to test the safety and effectiveness of brelovitug compared to delayed…

Full record on ClinicalTrials.gov ↗

Change timeline

No changes recorded on this trial in the observed window.

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

Phase 3Active, not recruitingNCT06553768 ↗

Primary completion: Oct 2026; estimated
Enrollment: 90; estimated
Start: Oct 2024; Mirum Pharmaceuticals, Inc.

Conditions

Cholestatic Liver Disease (Except ALGS, PFIC, PBC and PSC)

Interventions

Maralixibat
Placebo

Brief summary

The purpose of this study is to determine whether the investigational treatment (maralixibat) is safe and effective in pediatric and adult participants who have cholestatic liver disease with pruritus that has been refractory to other therapies, and who have no other treatment options.

Full record on ClinicalTrials.gov ↗

Change timeline

3 recorded · latest 1 Apr 2026

Status change · 2

Completion date move · 1

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VANTAGE: A Study to Evaluate Efficacy and Safety of an Investigational Drug Named Volixibat in Patients With Itching Caused by Primary Biliary Cholangitis

Phase 2RecruitingNCT05050136 ↗

Primary completion: Apr 2027; estimated
Enrollment: 260; estimated
Start: Sept 2021; Mirum Pharmaceuticals, Inc.

Conditions

Primary Biliary Cholangitis
PBC

Interventions

Volixibat
Placebo

Brief summary

The purpose of this clinical research study is to learn more about the use of the study medicine, volixibat, for the treatment of pruritus (itching) associated with Primary Biliary Cholangitis (PBC), and to assess the possible impact on the disease progression of PBC.

Full record on ClinicalTrials.gov ↗

Change timeline

4 recorded · latest 1 Sept 2025

Completion date move · 2

Enrollment change · 2

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A Trial Evaluating BJT-778 vs Delayed Treatment for the Treatment of Chronic Hepatitis Delta Infection

Phase 2Active, not recruitingNCT06907290 ↗

Primary completion: May 2029; estimated
Enrollment: 150; estimated
Start: Mar 2025; Mirum Pharmaceuticals, Inc.

Conditions

Chronic Hepatitis D Infection

Interventions

Brelovitug 300 mg
Brelovitug 900 mg
Delayed Treatment with Brelovitug 300mg

Brief summary

This is a Phase 2b/3 study designed to evaluate the safety and efficacy of chronic treatment with brelovitug (a.k.a BJT-778; BTG) for chronic hepatitis delta virus (HDV) infection. The comparator in this study will be 24-weeks of delayed treatment. During the 24-weeks of delayed treatment, participants will complete…

Full record on ClinicalTrials.gov ↗

Change timeline

2 recorded · latest 1 Mar 2026

Status change · 1

Completion date move · 1

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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)

Phase 4RecruitingNCT07290257 ↗

Primary completion: Sept 2030; estimated
Enrollment: 230; estimated
Start: Sept 2025; Mirum Pharmaceuticals, Inc.

Conditions

Alagille Syndrome
Progressive Familial Intrahepatic Cholestasis

Interventions

Livmarli Oral Product

Brief summary

In patients with Alagille syndrome (ALGS), the key objectives are to evaluate the tolerability, long-term safety (including possible liver toxicity) and long-term efficacy of Livmarli treatment. In patients with Progressive Familial Intrahepatic Cholestasis (PFIC), the key objectives are to evaluate tolerability,…

Full record on ClinicalTrials.gov ↗

Change timeline

No changes recorded on this trial in the observed window.

VISTAS: A Study to Evaluate Efficacy and Safety of an Investigational Drug Named Volixibat in Patients With Itching Caused by Primary Sclerosing Cholangitis (PSC)

Phase 2Active, not recruitingNCT04663308 ↗

Primary completion: Jun 2026; estimated
Enrollment: 182; estimated
Start: Dec 2020; Mirum Pharmaceuticals, Inc.

Conditions

Primary Sclerosing Cholangitis

Interventions

Volixibat
Placebo

Brief summary

The purpose of this clinical research study is to learn more about the use of the study medicine, volixibat, for the treatment of pruritus (itching) associated with Primary Sclerosing Cholangitis (PSC), and to assess the possible impact on the disease progression of PSC.

Full record on ClinicalTrials.gov ↗

Change timeline

4 recorded · latest 1 Oct 2025

Completion date move · 2

Status change · 1

Enrollment change · 1

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RISE: 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).

Phase 2CompletedNCT04729751 ↗

Primary completion: Dec 2024; actual
Enrollment: 27; estimated
Start: Sept 2021; Mirum Pharmaceuticals, Inc.

Conditions

Progressive Familial Intrahepatic Cholestasis
Alagille Syndrome
Cholestatic Liver Disease

Interventions

Maralixibat

Brief summary

This study is designed to assess whether the investigational drug maralixibat, is safe and well tolerated in children \<12 months of age with Alagille Syndrome \[ALGS\] or Progressive Familial Intrahepatic Cholestasis \[PFIC\].

Full record on ClinicalTrials.gov ↗

Change timeline

7 recorded · latest 1 Apr 2025

Completion date move · 4

Status change · 2

Enrollment change · 1

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MERGE: 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

Phase 2CompletedNCT04168385 ↗

Primary completion: Sept 2024; actual
Enrollment: 52; estimated
Start: Jan 2020; Mirum Pharmaceuticals, Inc.

Conditions

Cholestatic Liver Disease

Interventions

Maralixibat

Brief summary

Evaluate the long-term safety of maralixibat (MRX) in subjects with cholestatic liver disease including, but not limited to, Alagille Syndrome (ALGS), Progressive Familial Intrahepatic Cholestasis (PFIC) and Biliary Atresia.

Full record on ClinicalTrials.gov ↗

Change timeline

4 recorded · latest 1 Apr 2025

Completion date move · 3

Status change · 1

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Study to Evaluate Patients With Cerebrotendinous Xanthomatosis (RESTORE)

Phase 3CompletedNCT04270682 ↗

Primary completion: Jul 2023; actual
Enrollment: 19; estimated
Start: Jan 2020; Mirum Pharmaceuticals, Inc.

Conditions

Interventions

Blinded CDCA 250 mg TID
Placebo
Open-Label CDCA 250 mg TID
Rescue Medication CDCA 250 mg TID
CDCA Weight-Based Dose TID

Brief summary

The study is made up of two cohorts: a randomized double-blind crossover (placebo withdrawal with rescue) study among patients ≥ 16 years of age (adult cohort) and an open-label dose titration study among pediatric patients ≥1 month and \<16 years of age (pediatric cohort)

Full record on ClinicalTrials.gov ↗

Change timeline

4 recorded · latest 1 Jan 2024

Status change · 2

Enrollment change · 1

Completion date move · 1

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OHANA: A Placebo-controlled Study of Volixibat in Subjects With Elevated Serum Bile Acids Associated With Intrahepatic Cholestasis of Pregnancy (OHANA)

Phase 2TerminatedNCT04718961 ↗

Primary completion: Dec 2022; actual
Enrollment: 4; estimated
Start: Jan 2021; Mirum Pharmaceuticals, Inc.

Conditions

Intrahepatic Cholestasis of Pregnancy

Interventions

Volixibat
Placebo

Brief summary

Part 1 is an open-label randomized study of volixibat in patients with Intrahepatic Cholestasis of Pregnancy (ICP) and elevated serum bile acid concentrations (sBA) to evaluate safety and tolerability of two doses of volixibat. Part 2 is a double-blind, placebo controlled, study designed to evaluate the safety and…

Full record on ClinicalTrials.gov ↗

Change timeline

4 recorded · latest 1 Apr 2023

Status change · 2

Completion date move · 1

Enrollment change · 1

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

Phase 3CompletedNCT03905330 ↗

Primary completion: Sept 2022; actual
Enrollment: 93; estimated
Start: Jul 2019; Mirum Pharmaceuticals, Inc.

Conditions

Progressive Familial Intrahepatic Cholestasis (PFIC)

Interventions

Maralixibat
Placebo

Brief summary

The purpose of this study is to determine whether the investigational treatment (maralixibat) is safe and effective in pediatric participants with Progressive Familial Intrahepatic Cholestasis (PFIC).

Full record on ClinicalTrials.gov ↗

Change timeline

3 recorded · latest 1 Apr 2023

Completion date move · 1

Status change · 1

Enrollment change · 1

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IMAGINE: 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)

Phase 2CompletedNCT02047318 ↗

Primary completion: Jun 2020; actual
Enrollment: 19; estimated
Start: Dec 2013; Mirum Pharmaceuticals, Inc.

Conditions

Alagille Syndrome

Interventions

LUM001 (Maralixibat)

Brief summary

The purpose of this extension study is to determine the long-term safety and tolerability of an investigational treatment (LUM001 also known as Maralixibat) in children with ALGS who have completed participation in a core LUM001 treatment protocol. Efficacy will be assessed by evaluating the effect of LUM001 on…

Full record on ClinicalTrials.gov ↗

Change timeline

No changes recorded on this trial in the observed window.

IMAGINE-II: 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

Phase 2CompletedNCT02117713 ↗

Primary completion: Jun 2020; actual
Enrollment: 34; estimated
Start: Mar 2015; Mirum Pharmaceuticals, Inc.

Conditions

Alagille Syndrome

Interventions

LUM001 (Maralixibat)

Brief summary

This is a multicentre, extension study of LUM001 in children diagnosed with Alagille Syndrome who have completed participation in a core LUM001 treatment protocol. The primary objective is to evaluate long-term safety and tolerability of LUM001. Efficacy will be assessed by evaluating the effect of LUM001 on the…

Full record on ClinicalTrials.gov ↗

Change timeline

No changes recorded on this trial in the observed window.

INDIGO: 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

Phase 2CompletedNCT02057718 ↗

Primary completion: May 2020; actual
Enrollment: 33; estimated
Start: Mar 2014; Mirum Pharmaceuticals, Inc.

Conditions

Progressive Familial Intrahepatic Cholestasis (PFIC)

Interventions

LUM001 (Maralixibat)

Brief summary

This is an open label study in children with Progressive Familial Intrahepatic Cholestasis (PFIC) designed to evaluate the safety and efficacy of LUM001, also known as Maralixibat (MRX). Efficacy will be assessed by evaluating the effect of LUM001 on pruritus and the biochemical markers of pruritus associated with…

Full record on ClinicalTrials.gov ↗

Change timeline

No changes recorded on this trial in the observed window.