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Actinogen Medical Limited (AU:ACW)
:ACW
Xanamem
Alzheimer Disease, Dementia, Mild, Dementia Moderate
Phase II
Recruiting
Effect of 10 mg Xanamem on Dementia Due to Alzheimer's Disease
Oct 23, 2023
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Xanamem™
Major Depressive Disorder, Cognitive Impairment, Mdd
Phase II
Completed
Xanamem® in Adults With Major Depressive Disorder and Impaired Cognition (XanaCIDD)
Oct 17, 2022
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Xanamem® 5 Mg, Xanamem® 10 Mg
Mild Cognitive Impairment, Alzheimer'S Disease
Phase I/II
Completed
A Double-Blind, Placebo-Controlled, Dose Ranging Study of Xanamem® in Healthy Elderly Volunteers
Jul 17, 2021
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Xanamem™
Dementia, Alzheimer Type
Phase II
Completed
A Phase II Study to Assess the Safety, Tolerability and Efficacy of Xanamem™ in Subjects With Mild Dementia Due to AD (XanADu)
Mar 21, 2016
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Ue2343
Healthy Volunteers
Phase I
Completed
Phase I MAD, Fed-Fasted, CSF Study of UE2343 in Healthy Subjects
Nov 05, 2015
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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 Actinogen Medical Limited (ACW) have in its pipeline
ACW is currently developing the following drugs: Xanamem, Xanamem™, Xanamem® 5 Mg, Xanamem® 10 Mg. These drug candidates are in various stages of clinical development as the company works toward FDA approval.