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Island Pharmaceuticals Ltd (AU:ILA)
ASX:ILA
Isla101, Dengue 1 Live Virus Human Challenge (Denv-1-Lvhc)
Dengue
Phase II
Completed
Study to Examine the Effects of Oral Fenretinide
Jul 15, 2024
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Fenretinide
Safety And Tolerability
Phase I
Completed
A Study to Evaluate the Safety of Fenretinide in Healthy Volunteers
Oct 25, 2023
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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 Island Pharmaceuticals Ltd (ILA) have in its pipeline
ILA is currently developing the following drugs: Isla101, Dengue 1 Live Virus Human Challenge (Denv-1-Lvhc), Fenretinide. These drug candidates are in various stages of clinical development as the company works toward FDA approval.