DeepMed Research

Axsome Therapeutics

🇺🇸United States

Country: 🇺🇸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.

Clinical Trials

Open-Label Safety Study of Solriamfetol in Subjects with Binge Eating Disorder

Phase 3

Conditions: Binge-Eating Disorder

Interventions: Drug: Solriamfetol 75mg, 150 mg, or 300 mg

First Posted Date: 2025-03-17

Last Posted Date: 2025-03-17

Lead Sponsor: Axsome Therapeutics, Inc.

Target Recruit Count: 300

Registration Number: NCT06878976

Locations: 🇺🇸
Clinical Research Site, Dallas, Texas, United States

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

Phase 3

Terminated

Conditions: Agitation in Patients With Dementia of the Alzheimer's Type
Alzheimer Disease
Agitation, Psychomotor

Interventions: Drug: AXS-05 (dextromethorphan-bupropion)

First Posted Date: 2024-12-16

Last Posted Date: 2025-05-22

Lead Sponsor: Axsome Therapeutics, Inc.

Target Recruit Count: 139

Registration Number: NCT06736509

Locations: 🇵🇷
Clinical Research Site, San Juan, Puerto Rico

Studying Solriamfetol Modulation of TAAR-1, Dopamine, and Norepinephrine in Shift Work Disorder (SUSTAIN)

Phase 3

Recruiting

Conditions: Shift-work Disorder
Excessive Sleepiness

Interventions: Drug: Solriamfetol 300 mg
Drug: Solriamfetol 150 mg
Drug: Placebo

First Posted Date: 2024-08-23

Last Posted Date: 2025-01-23

Lead Sponsor: Axsome Therapeutics, Inc.

Target Recruit Count: 520

Registration Number: NCT06568367

Locations: 🇺🇸
Clinical Research Site, San Antonio, Texas, United States

Elucidating TAAR-1, Dopamine, and Norepinephrine in Binge Eating Disorder Using Solriamfetol

Phase 3

Recruiting

Conditions: Binge-Eating Disorder

Interventions: Drug: Solriamfetol 150 mg
Drug: Placebo
Drug: Solriamfetol 300 mg

First Posted Date: 2024-05-14

Last Posted Date: 2025-01-23

Lead Sponsor: Axsome Therapeutics, Inc.

Target Recruit Count: 450

Registration Number: NCT06413433

Locations: 🇺🇸
Clinical Research Site, Draper, Utah, United States

SUNOSI® (Solriamfetol) Pregnancy Registry

Recruiting

Conditions: Narcolepsy
Obstructive Sleep Apnea
Pregnant Women and Their Offspring

Interventions: Drug: Sunosi (solriamfetol)
Other: No treatment
Drug: Other prescription wake-promoting medications or stimulants

First Posted Date: 2024-05-14

Last Posted Date: 2024-05-14

Lead Sponsor: Axsome Therapeutics, Inc.

Target Recruit Count: 1731

Registration Number: NCT06413420

Locations: 🇺🇸
Evidera, a PPD business unit, Morrisville, North Carolina, United States
🇺🇸
PPD, Inc., Wilmington, North Carolina, United States

Progressing TAAR-1, Dopamine, and Norepinephrine in Depression Using Solriamfetol

Phase 3

Completed

Conditions: Major Depressive Disorder

Interventions: Drug: Solriamfetol 300 mg
Drug: Placebo

First Posted Date: 2024-04-11

Last Posted Date: 2025-04-17

Lead Sponsor: Axsome Therapeutics, Inc.

Target Recruit Count: 346

Registration Number: NCT06360419

Locations: 🇺🇸
Clinical Research Site, Everett, Washington, United States

A Study to Evaluate the Efficacy of AXS-05 Compared to Bupropion in Preventing the Relapse of Depressive Symptoms

Phase 4

Recruiting

Conditions: Major Depressive Disorder

Interventions: Drug: AXS-05
Drug: Bupropion

First Posted Date: 2024-01-25

Last Posted Date: 2025-01-23

Lead Sponsor: Axsome Therapeutics, Inc.

Target Recruit Count: 350

Registration Number: NCT06223880

Locations: 🇺🇸
Clinical Research Site, Everett, Washington, United States

A Study to Assess the Efficacy and Safety of Solriamfetol in Subjects With ADHD (FOCUS)

Phase 3

Completed

Conditions: ADHD

Interventions: Drug: Solriamfetol 150 mg
Drug: Solriamfetol 300 mg
Drug: Placebo

First Posted Date: 2023-08-02

Last Posted Date: 2025-04-03

Lead Sponsor: Axsome Therapeutics, Inc.

Target Recruit Count: 516

Registration Number: NCT05972044

Locations: 🇺🇸
Clinical Research Site, Everett, Washington, United States

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

Phase 3

Completed

Conditions: Agitation in Patients with Dementia of the Alzheimer's Type
Alzheimer Disease
Agitation

Interventions: Drug: AXS-05
Drug: Placebo

First Posted Date: 2022-09-28

Last Posted Date: 2025-01-17

Lead Sponsor: Axsome Therapeutics, Inc.

Target Recruit Count: 408

Registration Number: NCT05557409

Locations: 🇵🇷
Clinical Research Site, San Juan, Puerto Rico

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)

Phase 3

Completed

Conditions: Migraine

Interventions: Drug: AXS-07 (meloxicam-rizatriptan)

First Posted Date: 2022-09-22

Last Posted Date: 2025-01-20

Lead Sponsor: Axsome Therapeutics, Inc.

Target Recruit Count: 100

Registration Number: NCT05550207

Locations: 🇺🇸
Clinical Research Site, McLean, Virginia, United States

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