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Rohto Pharmaceutical Co (JP:4527)
:4527
Mesenchymal Stem Cell
Ischemic Heart Disease
Phase II
Not Yet Recruiting
Exploratory Study of ADR-002K for Heart Failure Patients With Ischemic Heart Disease Who Undergo CABG
Aug 28, 2025
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Udi-001
Cerebral Palsy, Periventricular Leukomalacia
Phase I/II
Completed
A Study to Investigate the Safety and Efficacy of UC-MSCs in Pediatric Patients With Cerebral Palsy
Apr 30, 2021
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Mesenchymal Stem Cell
Severe Acute Respiratory Syndrome Coronavirus 2
Phase I
Completed
An Exploratory Study of ADR-001 in Patients with Severe Pneumonia Caused by SARS-CoV-2 Infection
Aug 20, 2020
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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 Rohto Pharmaceutical Co (4527) have in its pipeline
4527 is currently developing the following drugs: Mesenchymal Stem Cell, Udi-001, Mesenchymal Stem Cell. These drug candidates are in various stages of clinical development as the company works toward FDA approval.