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Heartseed, Inc. (JP:219A)
:219A
Hs-001 Cs, Hs-001-D Needle, Hs-001-D Adaptor
Heart Failure, Ischemic Heart Disease
Phase I/II
Active Not Recruiting
A Study of iPS Cell-derived Cardiomyocyte Spheroids (HS-001) in Patients With Heart Failure (LAPiS Study)
Jun 22, 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 Heartseed, Inc. (219A) have in its pipeline
219A is currently developing the following drugs: Hs-001 Cs, Hs-001-D Needle, Hs-001-D Adaptor. These drug candidates are in various stages of clinical development as the company works toward FDA approval.