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Esperion (ESPR)
NASDAQ:ESPR
Bempedoic Acid 180 Mg Oral Tablet, Bempedoic Acid/Ezetimibe 180 Mg-10 Mg Oral Tablet
Healthy Lactating Women
Phase IV
Completed
Milk-Only Lactation Study to Evaluate the Concentration of Bempedoic Acid and Bempedoic Acid/Ezetimibe Fixed Combination Drug Product (FCDP) in the Breast Milk of Healthy Lactating Women
Aug 27, 2023
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Bempedoic Acid
Hypercholesterolemia
Phase II
Completed
A Clinical Study in Children With Heterozygous Familial Hypercholesterolemia (HeFH) Aged 6 to 17 Treated Once Daily With Bempedoic Acid Oral Dosing (CLEAR Path 1)
Jan 12, 2023
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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 Esperion (ESPR) have in its pipeline
ESPR is currently developing the following drugs: Bempedoic Acid 180 Mg Oral Tablet, Bempedoic Acid/Ezetimibe 180 Mg-10 Mg Oral Tablet, Bempedoic Acid. These drug candidates are in various stages of clinical development as the company works toward FDA approval.