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JCR Pharmaceuticals Co., Ltd. (JP:4552)
:4552
Jr-446
Mucopolysaccharidosis Iii-B
Phase I/II
Recruiting
An Open-label Phase I/II Study of JR-446 in Mucopolysaccharidosis Type IIIB
Jun 28, 2024
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Jr-441
Mucopolysaccharidosis Iii-A
Phase I/II
Active Not Recruiting
Phase I/II Study of JR-441 in Patients With Mucopolysaccharidosis Type IIIA
Sep 13, 2023
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Jr-141
Mucopolysaccharidosis Ii
Phase III
Enrolling By Invitation
An Extension Study of JR-141 to Evaluate the Long-term Safety and Efficacy in MPS II (Hunter Syndrome) Subjects
Oct 06, 2022
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Jr-141, Idursulfase, Jr-141 Or Idursulfase
Mucopolysaccharidosis Ii
Phase III
Active Not Recruiting
A Phase III Study of JR-141 in Patients With Mucopolysaccharidosis II (STARLIGHT)
Sep 17, 2020
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Jr-171
Mucopolysaccharidosis I
Phase I/II
Completed
An Extension Study of JR-171-101 Study in Patients With Mucopolysaccharidosis Type I (MPS I)
Jun 04, 2020
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Jr-171 (Lepunafusp Alfa)
Mucopolysaccharidosis I
Phase I/II
Completed
A Study of JR-171 in Patients With Mucopolysaccharidosis I
Dec 27, 2019
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Jr-141
Mucopolysaccharidosis Ii
Phase II/III
Active Not Recruiting
An Extension Study of JR-141 in Patients With Mucopolysaccharidosis Type II
Dec 18, 2019
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Jr-141
Mucopolysaccharidosis Ii
Phase II
Active Not Recruiting
An Extension Study of JR-141-BR21 in Patients With Mucopolysaccharidosis II
Sep 27, 2018
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Jr-141
Mucopolysaccharidosis Ii
Phase II
Completed
A Study of JR-141 in Patients With Mucopolysaccharidosis II (BR21)
Nov 17, 2017
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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 JCR Pharmaceuticals Co., Ltd. (4552) have in its pipeline
4552 is currently developing the following drugs: Jr-446, Jr-441, Jr-141. These drug candidates are in various stages of clinical development as the company works toward FDA approval.