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Vivani Medical, Inc. (DE:U5P)
:U5P
Exenatide Implant, Bydureon Bcise (Exenatide Extended Release), Semaglutide, 1.0 Mg/Ml
Type2diabetes, Overweight And Obesity
Phase I
Completed
Assessment of Safety, Tolerability and Drug Levels of Exenatide Implant
Dec 13, 2022
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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 Vivani Medical, Inc. (U5P) have in its pipeline
U5P is currently developing the following drugs: Exenatide Implant, Bydureon Bcise (Exenatide Extended Release), Semaglutide, 1.0 Mg/Ml. These drug candidates are in various stages of clinical development as the company works toward FDA approval.