Bupropion, Axs-05
Smoking Cessation
Phase III
Recruiting
A Study to Evaluate the Efficacy and Safety of AXS-05 for Smoking Cessation in Adults
Aug 11, 2026
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Axs-05
Alzheimer Disease, Agitation In Patients With Dementia Of The Alzheimer's Type, Agitation, Psychomotor
Phase III
Terminated
An Open-Label Study to Assess the Long-term Safety of AXS-05 in Subjects With Dementia of the Alzheimer's Type, ADVANCE-2 and ACCORD-2 Extension Study
Dec 12, 2024
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Solriamfetol 300 Mg
Major Depressive Disorder
Phase III
Completed
Progressing TAAR-1, Dopamine, and Norepinephrine in Depression Using Solriamfetol
Apr 08, 2024
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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 Axsome Therapeutics Inc (19X) have in its pipeline
19X is currently developing the following drugs: Bupropion, Axs-05, Axs-14, Solriamfetol 150 Mg. These drug candidates are in various stages of clinical development as the company works toward FDA approval.