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Axsome Therapeutics

Axsome Therapeutics logo
🇺🇸United States
Ownership
Public
Established
2012-01-01
Employees
545
Market Cap
$4.2B
Website
http://www.axsome.com
Introduction

Axsome Therapeutics, Inc. is a commercial-stage biopharmaceutical company, which engages in the development of novel therapies for the management of central nervous system disorders. Its portfolio consists of Products Overview and Pipeline Overview. The Products Overview includes Auvelity and Sunosi. The Pipeline Overview contain AXS-05, AXS-07, AXS-12, and AXS-14. The company was founded by Herriot Tabuteau on January 12, 2012 and is headquartered in New York, NY.

A Study to Assess the Efficacy and Safety of AXS-12 (Reboxetine) in Patients With Narcolepsy

Phase 3
Completed
Conditions
Narcolepsy
Cataplexy
Excessive Daytime Sleepiness
Interventions
Drug: AXS-12 (reboxetine)
Drug: Placebo
First Posted Date
2021-09-28
Last Posted Date
2024-04-22
Lead Sponsor
Axsome Therapeutics, Inc.
Target Recruit Count
90
Registration Number
NCT05059223
Locations
🇨🇦

Clinical Research Site, Toronto, Ontario, Canada

Evaluate Sunosi® PK in Breast Milk and Plasma of Healthy Postpartum Women Following Single Dose Oral Administration

Phase 1
Completed
Conditions
Obstructive Sleep Apnea
Narcolepsy
Excessive Daytime Somnolence
Excessive Sleepiness
Postpartum
Interventions
First Posted Date
2021-08-17
Last Posted Date
2023-04-14
Lead Sponsor
Axsome Therapeutics, Inc.
Target Recruit Count
6
Registration Number
NCT05008341
Locations
🇺🇸

M3-Wake Research, Inc., Raleigh, North Carolina, United States

An Evaluation of AXS-05 for the Treatment of TRD in Treatment-Adherent Patients

Phase 2
Conditions
Major Depressive Disorder
Treatment Resistant Depression
Interventions
Drug: AXS-05
Drug: Bupropion SR
First Posted Date
2021-07-21
Last Posted Date
2021-07-26
Lead Sponsor
Axsome Therapeutics, Inc.
Target Recruit Count
312
Registration Number
NCT04971291
Locations
🇺🇸

Axsome Research Site, New York, New York, United States

A Study to Assess the Long-term Safety and Efficacy of AXS-05 in Subjects with Alzheimer's Disease Agitation

Phase 3
Active, not recruiting
Conditions
Agitation in Patients with Dementia of the Alzheimer's Type
Alzheimer Disease
Agitation, Psychomotor
Interventions
Drug: AXS-05 (dextromethorphan-bupropion)
Drug: Placebo
First Posted Date
2021-07-01
Last Posted Date
2024-12-19
Lead Sponsor
Axsome Therapeutics, Inc.
Target Recruit Count
300
Registration Number
NCT04947553
Locations
🇵🇷

Clinical Research Site, San Juan, Puerto Rico

Assessing Clinical Outcomes in Alzheimer's Disease Agitation

Phase 3
Completed
Conditions
Agitation in Patients With Dementia of the Alzheimer's Type
Alzheimer Disease
Agitation,Psychomotor
Interventions
Drug: AXS-05
Drug: Placebo
First Posted Date
2021-03-15
Last Posted Date
2023-11-29
Lead Sponsor
Axsome Therapeutics, Inc.
Target Recruit Count
178
Registration Number
NCT04797715
Locations
🇨🇦

Clinical Research Site, Newmarket, Ontario, Canada

Solriamfetol's Effect on Cognitive Health in Apnea Participants During a Randomized Placebo-controlled Study

Phase 4
Completed
Conditions
Excessive Daytime Sleepiness
Obstructive Sleep Apnea
Impaired Cognitive Function
Interventions
Drug: Placebo
Drug: Solriamfetol
First Posted Date
2021-03-09
Last Posted Date
2022-10-17
Lead Sponsor
Axsome Therapeutics, Inc.
Target Recruit Count
59
Registration Number
NCT04789174
Locations
🇺🇸

FutureSearch Trials of Neuroglogy, Austin, Texas, United States

🇳🇱

Amphia Hospital, Breda, Netherlands

🇪🇸

Instiut de Reccerca Biomedica de Lledia, Lleida, Spain

and more 25 locations

Open-Label Safety Study of AXS-05 in Subjects With TRD (EVOLVE)

Phase 2
Completed
Conditions
Treatment Resistant Depression
Major Depressive Disorder
Interventions
Drug: AXS-05 (dextromethorphan-bupropion)
First Posted Date
2020-11-18
Last Posted Date
2023-03-07
Lead Sponsor
Axsome Therapeutics, Inc.
Target Recruit Count
186
Registration Number
NCT04634669
Locations
🇺🇸

Clinical Research Site, Everett, Washington, United States

Mechanistic Evaluation of Response in TRD (MERIT)

Phase 2
Completed
Conditions
Treatment Resistant Depression
Major Depressive Disorder
Interventions
Drug: AXS-05
Drug: Placebo
First Posted Date
2020-10-29
Last Posted Date
2022-07-12
Lead Sponsor
Axsome Therapeutics, Inc.
Target Recruit Count
44
Registration Number
NCT04608396
Locations
🇺🇸

Clinical Research Site, Everett, Washington, United States

Initiating Early Control of Migraine Pain and Associated Symptoms

Phase 3
Completed
Conditions
Migraine
Interventions
Drug: AXS-07 (MoSEIC meloxicam and rizatriptan)
Drug: Placebo
First Posted Date
2019-11-14
Last Posted Date
2021-04-30
Lead Sponsor
Axsome Therapeutics, Inc.
Target Recruit Count
302
Registration Number
NCT04163185
Locations
🇺🇸

Clinical Research Site, Charlottesville, Virginia, United States

Multimechanistic Treatment Over Time of Migraine Symptoms (MOVEMENT)

Phase 3
Completed
Conditions
Migraine
Interventions
Drug: AXS-07
First Posted Date
2019-08-28
Last Posted Date
2023-10-10
Lead Sponsor
Axsome Therapeutics, Inc.
Target Recruit Count
706
Registration Number
NCT04068051
Locations
🇺🇸

Clinical Research Site, Seattle, Washington, United States

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