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Mirum Pharmaceuticals Inc (MIRM)
NASDAQ:MIRM
Low Dose Of Mrm-3379, Middle Dose Of Mrm-3379, High Dose Of Mrm-3379, Low Dose Of Mrm-3379 Open-Label
Fragile X Syndrome
Phase II
Recruiting
Study of MRM-3379 in Male Participants With Fragile X Syndrome
Oct 02, 2025
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Maralixibat
Cholestatic Liver Disease (Except Algs, Pfic, Pbc And Psc)
Phase III
Recruiting
Evaluation of Maralixibat in Pruritus Associated With General Cholestatic Liver Disease (EXPAND)
Aug 08, 2024
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Volixibat
Primary Biliary Cholangitis, Pbc
Phase II
Recruiting
A Study to Evaluate Efficacy and Safety of an Investigational Drug Named Volixibat in Patients With Itching Caused by Primary Biliary Cholangitis
Sep 09, 2021
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Maralixibat
Alagille Syndrome, Progressive Familial Intrahepatic Cholestasis, Cholestatic Liver Disease
Phase II
Completed
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).
Jan 25, 2021
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Volixibat
Primary Sclerosing Cholangitis
Phase II
Active Not Recruiting
A 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
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Maralixibat
Biliary Atresia
Phase II
Completed
Evaluation of Maralixibat in Biliary Atresia Response Post-Kasai
Aug 20, 2020
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Maralixibat
Progressive Familial Intrahepatic Cholestasis (Pfic)
Phase III
Completed
An Extension Study of Maralixibat in Patients With Progressive Familial Intrahepatic Cholestasis (PFIC)
Dec 02, 2019
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Maralixibat
Cholestatic Liver Disease
Phase II
Completed
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
Oct 01, 2019
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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
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 Inc (MIRM) have in its pipeline
MIRM is currently developing the following drugs: Low Dose Of Mrm-3379, Middle Dose Of Mrm-3379, High Dose Of Mrm-3379, Low Dose Of Mrm-3379 Open-Label, Maralixibat, Volixibat. These drug candidates are in various stages of clinical development as the company works toward FDA approval.