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Skye Bioscience (SKYE)
NASDAQ:SKYE
Nimacimab Injection, Semaglutide Injection
Obesity
Phase II
Active Not Recruiting
Study to Evaluate the Effect on Obesity of QW Nimacimab and QW Nimacimab Co-administered With Semaglutide vs Placebo
Aug 19, 2024
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Sbi-100 Ophthalmic Emulsion, 0.5%, Sbi-100 Ophthalmic Emulsion, 1.0%
Primary Open Angle Glaucoma, Ocular Hypertension
Phase II
Completed
Ph2 Placebo-Controlled Study for Safety & Ocular Efficacy of SBI-100 Ophthalmic Emulsion in Pts w/ Elevated Eye Pressure
Nov 14, 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 Skye Bioscience (SKYE) have in its pipeline
SKYE is currently developing the following drugs: Nimacimab Injection, Semaglutide Injection, Sbi-100 Ophthalmic Emulsion, 0.5%, Sbi-100 Ophthalmic Emulsion, 1.0%. These drug candidates are in various stages of clinical development as the company works toward FDA approval.