Madrigal (MDGL)
NASDAQ:MDGL
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100 Mg Resmetirom Tablet
Renal Impairment
Phase I
Completed
A Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Multiple Oral Doses (6 Days) of 100 mg Resmetirom in Subjects With Severe Renal Impairment and in Matched Healthy Control Subjects With Normal Renal Function
Apr 30, 2024
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Resmetirom
Nash, Cirrhosis, Liver
Phase III
Active Not Recruiting
A Phase 3 Study to Evaluate the Effect of Resmetirom on Clinical Outcomes in Patients With Well-compensated NASH Cirrhosis (MAESTRO-NASH-OUTCOMES)
Aug 11, 2022
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Resmetirom
Non-Alcoholic Fatty Liver Disease
Phase III
Active Not Recruiting
A Phase 3 Study to Evaluate Safety and Biomarkers of Resmetirom (MGL-3196) in Patients With Non-alcoholic Fatty Liver Disease (NAFLD), MAESTRO-NAFLD-Open-Label-Extension (MAESTRO-NAFLD-OLE)
Jun 18, 2021
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Mgl-3196, Liver Biopsy, Resmetirom
Nash - Nonalcoholic Steatohepatitis
Phase III
Active Not Recruiting
A Phase 3 Study to Evaluate the Efficacy and Safety of MGL-3196 (Resmetirom) in Patients With NASH and Fibrosis
Mar 26, 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 Madrigal (MDGL) have in its pipeline
MDGL is currently developing the following drugs: Resmetirom, 100 Mg Resmetirom Tablet, Resmetirom. These drug candidates are in various stages of clinical development as the company works toward FDA approval.