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KOWA CO. LTD. (7807) Drug Pipeline
| Drug Name | Condition | Stage | Status | Study Name | Trial Start Date | Article |
|---|---|---|---|---|---|---|
| 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 | ― |
| 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 | ― |
| 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 | ― |
| Drug Name | Stage | Condition | Status | Study Name | Trial Start Date | Article |
|---|---|---|---|---|---|---|
| K-877 0.1 Mg Tablet, Fenofibrate 200 Mg Capsule | Phase III | Hyperlipidemia | 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 | ― |
| K-877 Er 0.2 Mg/Day Morning Administration (Once Daily), K-877 Er 0.2 Mg/Day Evening Administration (Once Daily) | Phase III | Dyslipidemias | Completed | A Phase III Long Term Study of K-877 Extended Release Tablet | Jan 15, 2021 | ― |
| K-877 Ir 0.2 Mg/Day, K-877 Cr 0.4 Mg/Day, K-877 Cr 0.8 Mg/Day | Phase II | Dyslipidemias | Completed | A Clinical Pharmacology Study of K-877 Controlled Release Tablet | Sep 03, 2019 | ― |
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 KOWA CO. LTD. (JP:7807) have in its pipeline
KOWA CO. LTD. JP: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.