Kps-0373
Spinocerebellar Degeneration
Phase III
Recruiting
Confirmatory Study 3 of KPS-0373 in Patients With Spinocerebellar Degeneration
Jun 25, 2025
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Klh-2109, Leuprorelin Acetate
Endometriosis
Phase III
Recruiting
A Clinical Study of KLH-2109 in Patients With Endometriosis
Jun 03, 2025
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Kdt-3594
Parkinson Disease
Phase II
Recruiting
A Late Phase II Clinical Trial of KDT-3594 in Patients With Parkinson's Disease
Nov 26, 2024
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Ksp-0243
Colitis, Ulcerative
Phase II
Completed
An Early Phase 2 Clinical Study of KSP-0243
Mar 02, 2023
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Klh-2109
Uterine Fibroids (Mesh Heading: Leiomyoma)
Phase III
Completed
A Clinical Study of KLH-2109 in Uterine Fibroids Patient With Menorrhagia and Pain
Jun 27, 2022
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Leuprorelin, Klh-2109
Uterine Fibroids (Mesh Heading: Leiomyoma)
Phase III
Completed
A Clinical Study of KLH-2109 in Uterine Fibroids Patient With Menorrhagia
Jun 27, 2022
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Mr13a9
Uremic Pruritus
Phase III
Completed
A Phase III Clinical Study of MR13A9 in Hemodialysis Patients With Pruritus.
Jan 13, 2021
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75 Mg Linzagolix Tablet, 200 Mg Linzagolix Tablet, Add-Back Capsule (E2 1 Mg / Neta 0.5 Mg)
Endometriosis
Phase III
Terminated
Extension to Study on Efficacy and Safety of Linzagolix for the Treatment of Endometriosis-associated Pain
Apr 29, 2020
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75 Mg Linzagolix Tablet, 200 Mg Linzagolix Tablet, Add-Back Capsule (E2 1 Mg / Neta 0.5 Mg)
Endometriosis
Phase III
Completed
Extension to Study on Efficacy and Safety of Linzagolix for the Treatment of Endometriosis-associated Pain (EDELWEISS 6)
Apr 03, 2020
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R788
Idiopathic Thrombocytopenic Purpura
Phase III
Completed
A Clinical Study in Patients With Chronic Idiopathic Thrombocytopenic Purpura in R788
Oct 15, 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 Kissei Pharmaceutical Co Ltd (KSPHF) have in its pipeline
KSPHF is currently developing the following drugs: Kps-0373, Klh-2109, Leuprorelin Acetate, Kdt-3594. These drug candidates are in various stages of clinical development as the company works toward FDA approval.