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KOWA CO. LTD. (JP:7807)
:7807
K-877 0.1 Mg Tablet, Fenofibrate 200 Mg Capsule
Hyperlipidemia
Phase III
Completed
A Phase 3 Study to Evaluate the Efficacy and Safety of K-877 in Chinese Patients With High TG and Low HDL-C
Jul 14, 2021
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K-877 Er 0.2 Mg/Day Morning Administration (Once Daily), K-877 Er 0.2 Mg/Day Evening Administration (Once Daily)
Dyslipidemias
Phase III
Completed
A Phase III Long Term Study of K-877 Extended Release Tablet
Jan 15, 2021
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K-877 Ir 0.2 Mg/Day, K-877 Cr 0.4 Mg/Day, K-877 Cr 0.8 Mg/Day
Dyslipidemias
Phase II
Completed
A Clinical Pharmacology Study of K-877 Controlled Release Tablet
Sep 03, 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 KOWA CO. LTD. (7807) have in its pipeline
7807 is currently developing the following drugs: K-877 0.1 Mg Tablet, Fenofibrate 200 Mg Capsule, K-877 Er 0.2 Mg/Day Morning Administration (Once Daily), K-877 Er 0.2 Mg/Day Evening Administration (Once Daily), K-877 Ir 0.2 Mg/Day, K-877 Cr 0.4 Mg/Day, K-877 Cr 0.8 Mg/Day. These drug candidates are in various stages of clinical development as the company works toward FDA approval.