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Kaken Pharmaceutical Co (JP:4521)
:4521
Kp-001, Fluvoxamine, Rosuvastatin Calcium10mg, Caffeine Citrate
Healty Volunteers
Phase I
Completed
To Determine the Effect of KP-001 on Rosuvastatin, Caffeine PK and the Effect of Fluvoxamine on KP-001 PK in Volunteers
Feb 06, 2025
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Kp-001, Moxifloxacin 400 Mg
Healthy Volunteers - Male And Female
Phase I
Completed
A Study to Evaluate the Effects of KP-001 on the QT/QTc Intervals in Healthy Adults
Sep 26, 2024
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Midazolam, Metformin, Clarithromycin, Kp-001
Healthy Adults
Phase I
Completed
A Study to Determine the Effect of KP-001 on Metformin and Midazolam Pharmacokinetics and the Effect of Clarithromycin on KP-001 Pharmacokinetics in Healthy Adult Participants
Jan 17, 2024
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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 Kaken Pharmaceutical Co (4521) have in its pipeline
4521 is currently developing the following drugs: Kp-001, Fluvoxamine, Rosuvastatin Calcium10mg, Caffeine Citrate, Kp-001, Moxifloxacin 400 Mg, Midazolam, Metformin, Clarithromycin, Kp-001. These drug candidates are in various stages of clinical development as the company works toward FDA approval.