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Linical Co., Ltd. (JP:2183)
:2183
Neural Precursor Cells Derived From Human Embryonic Stem Cell Line
Spinal Cord Injury, Acute, Spinal Cord Injury At C4 Level With Complete Lesion, Spinal Cord Injury At C5-C7 Level With Complete Lesion
Phase I/II
Recruiting
Safety and Exploratory Efficacy of Transplantation Therapy Using PSA-NCAM(+) NPC in AIS-A Level of Sub-acute SCI
Feb 24, 2021
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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 Linical Co., Ltd. (2183) have in its pipeline
2183 is currently developing the following drugs: Neural Precursor Cells Derived From Human Embryonic Stem Cell Line. These drug candidates are in various stages of clinical development as the company works toward FDA approval.