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Kaken Pharmaceutical Co (4521) Drug Pipeline
| Drug Name | Condition | Stage | Status | Study Name | Trial Start Date | Article |
|---|---|---|---|---|---|---|
| Kp-001 | Lymphatic Malformations, Cloves Syndrome, Venous Malformations, Klippel-Trenaunay Syndrome | Phase III | Not Yet Recruiting | A Study to Investigate Efficacy and Safety of KP-001 Compared With Placebo in Patients Aged ≥2 Years With Common VM, Common LM, or KTS/CLOVES Syndrome | Nov 19, 2025 | ― |
| 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 | ― |
| 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 | ― |
| 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 | ― |
| Drug Name | Stage | Condition | Status | Study Name | Trial Start Date | Article |
|---|---|---|---|---|---|---|
| Kp-001 | Phase III | Lymphatic Malformations, Cloves Syndrome, Venous Malformations, Klippel-Trenaunay Syndrome | Not Yet Recruiting | A Study to Investigate Efficacy and Safety of KP-001 Compared With Placebo in Patients Aged ≥2 Years With Common VM, Common LM, or KTS/CLOVES Syndrome | Nov 19, 2025 | ― |
| Kp-001, Fluvoxamine, Rosuvastatin Calcium10mg, Caffeine Citrate | Phase I | Healty Volunteers | 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 | ― |
| Kp-001, Moxifloxacin 400 Mg | Phase I | Healthy Volunteers - Male And Female | Completed | A Study to Evaluate the Effects of KP-001 on the QT/QTc Intervals in Healthy Adults | Sep 26, 2024 | ― |
| Midazolam, Metformin, Clarithromycin, Kp-001 | Phase I | Healthy Adults | 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 | ― |
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 Kaken Pharmaceutical Co (JP:4521) have in its pipeline
Kaken Pharmaceutical Co JP:4521 is currently developing the following drugs: Kp-001, 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.