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Mirum Pharmaceuticals (MIRM) Drug Pipeline

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Drug pipeline
Drug NameConditionStageStatusStudy NameTrial Start DateArticle
[14C]-Mrm-3379Healthy VolunteersPhase ICompletedA Study to Evaluate the Absorption, Distribution, Metabolism, and Excretion of [14C]-MRM-3379Jun 26, 2026
Bulevirtide, BrelovitugChronic Hepatitis Dphase2AndPhase3RecruitingStudy to Evaluate Switching to Brelovitug for the Treatment of CHD in Participants Receiving BulevirtideMar 02, 2026
Low Dose Of Mrm-3379, Middle Dose Of Mrm-3379, High Dose Of Mrm-3379, Low Dose Of Mrm-3379 Open-LabelFragile X SyndromePhase IIRecruitingStudy of MRM-3379 in Male Participants With Fragile X Syndrome (BLOOM)Oct 02, 2025
Livmarli Oral Product, MaralixibatAlagille Syndrome, Progressive Familial Intrahepatic CholestasisPhase IVRecruitingLong-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)Sep 17, 2025
Brelovitug 300 Mg, Bulevirtide 2 Mg And Brelovitug - 300 MgChronic Hepatitis D InfectionPhase IIIRecruitingA Trial Evaluating Brelovitug (BJT-778) vs Bulevirtide for the Treatment of Chronic Hepatitis Delta Infection (AZURE-2)Sep 16, 2025―
MaralixibatCholestatic Liver Disease (Except Algs, Pfic, Pbc And Psc)Phase IIIRecruitingEvaluation of Maralixibat in Pruritus Associated With General Cholestatic Liver Disease (EXPAND)Aug 08, 2024
VolixibatPrimary Biliary Cholangitis, PbcPhase IIActive Not RecruitingA Study to Evaluate Efficacy and Safety of an Investigational Drug Named Volixibat in Patients With Itching Caused by Primary Biliary CholangitisSep 09, 2021
MaralixibatAlagille Syndrome, Progressive Familial Intrahepatic Cholestasis, Cholestatic Liver DiseasePhase IICompletedA 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).Jan 25, 2021―
VolixibatPrimary Sclerosing CholangitisPhase IIActive Not RecruitingA Study to Evaluate Efficacy and Safety of an Investigational Drug Named Volixibat in Patients With Itching Caused by Primary Sclerosing Cholangitis (PSC)Nov 17, 2020―
MaralixibatBiliary AtresiaPhase IICompletedEvaluation of Maralixibat in Biliary Atresia Response Post-KasaiAug 20, 2020―

FAQ

What are the FDA phases for drug approval?
The FDA approval process for new drugs is divided into several phases: a. Preclinical testing b. Phase 1 – Safety and dosage c. Phase 2 – Effectiveness and side effects d. Phase 3 – Confirmation of effectiveness, monitoring of adverse reactions, and comparison with existing treatments e. Phase 4 – Post-marketing studies to track long-term safety and effectiveness
What is a clinical trial?
A clinical trial is a carefully designed study in which researchers test a drug, treatment, or medical device in people to evaluate its safety, effectiveness, and potential side effects. These trials are essential for determining whether a new treatment should be approved for widespread use.
What drugs does Mirum Pharmaceuticals (MIRM) have in its pipeline
Mirum Pharmaceuticals MIRM is currently developing the following drugs: [14C]-Mrm-3379, Bulevirtide, Brelovitug, Low Dose Of Mrm-3379, Middle Dose Of Mrm-3379, High Dose Of Mrm-3379, Low Dose Of Mrm-3379 Open-Label, Livmarli Oral Product, Maralixibat, Brelovitug 300 Mg, Bulevirtide 2 Mg And Brelovitug - 300 Mg, Maralixibat, Volixibat. These drug candidates are in various stages of clinical development as the company works toward FDA approval.