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Axsome Therapeutics Inc (AXSM)
NASDAQ:AXSM
Solriamfetol 75Mg, 150 Mg, Or 300 Mg
Binge-Eating Disorder
Phase III
Enrolling By Invitation
Open-Label Safety Study of Solriamfetol in Subjects with Binge Eating Disorder
Mar 14, 2025
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Axs-05 (Dextromethorphan-Bupropion)
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 150 Mg, Solriamfetol 300 Mg
Excessive Sleepiness, Shift-Work Disorder
Phase III
Recruiting
Studying Solriamfetol Modulation of TAAR-1, Dopamine, and Norepinephrine in Shift Work Disorder (SUSTAIN)
Aug 21, 2024
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Solriamfetol 150 Mg, Solriamfetol 300 Mg
Binge-Eating Disorder
Phase III
Recruiting
Elucidating TAAR-1, Dopamine, and Norepinephrine in Binge Eating Disorder Using Solriamfetol
May 09, 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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Axs-05, Bupropion
Major Depressive Disorder
Phase IV
Recruiting
A Study to Evaluate the Efficacy of AXS-05 Compared to Bupropion in Preventing the Relapse of Depressive Symptoms
Jan 16, 2024
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Solriamfetol 150 Mg, Solriamfetol 300 Mg
Adhd
Phase III
Completed
A Study to Assess the Efficacy and Safety of Solriamfetol in Subjects With ADHD (FOCUS)
Jul 25, 2023
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Axs-05
Alzheimer Disease, Agitation, Agitation In Patients With Dementia Of The Alzheimer's Type
Phase III
Completed
A Study to Assess the Efficacy and Safety of AXS-05 in Subjects with Alzheimer's Disease Agitation
Sep 23, 2022
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Axs-07 (Meloxicam-Rizatriptan)
Migraine
Phase III
Completed
Open-Label Study of AXS-07 for the Acute Treatment of Migraine in Adults With a Prior Inadequate Response to an Oral CGRP Inhibitor (EMERGE)
Sep 19, 2022
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Axs-12 (Reboxetine)
Narcolepsy, Cataplexy, Excessive Daytime Sleepiness
Phase III
Completed
A Study to Assess the Long-term Efficacy and Safety of AXS-12 (Reboxetine) in Subjects with Narcolepsy (ENCORE)
Oct 29, 2021
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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 (AXSM) have in its pipeline
AXSM is currently developing the following drugs: Solriamfetol 75Mg, 150 Mg, Or 300 Mg, Axs-05 (Dextromethorphan-Bupropion), Solriamfetol 150 Mg, Solriamfetol 300 Mg. These drug candidates are in various stages of clinical development as the company works toward FDA approval.