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Cogstate Ltd (AU:CGS)
:CGS
Nyx-458
Parkinson Disease, Mild Cognitive Impairment, Mild Dementia, Lewy Body Disease
Phase II
Active Not Recruiting
NYX-458 in Subjects With Mild Cognitive Impairment or Mild Dementia Due to Parkinson's Disease or Lewy Body Dementia (Cognition, Memory, Attention, Thinking)
Oct 30, 2019
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Abx-1431
Tourette Syndrome, Motor Tic Disorder
Phase II
Completed
Study of ABX-1431 in Adult Patients With Tourette Syndrome or Chronic Motor Tic Disorder
Aug 08, 2018
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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 Cogstate Ltd (CGS) have in its pipeline
CGS is currently developing the following drugs: Nyx-458, Abx-1431. These drug candidates are in various stages of clinical development as the company works toward FDA approval.