Axsome Therapeutics
- 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
31
Trial Phases
4 Phases
Drug Approvals
2
Clinical Trials
Distribution across different clinical trial phases (30 trials with phase data)• Click on a phase to view related trials
Open-Label Safety Study of Solriamfetol in Subjects with Binge Eating Disorder
- 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
- Conditions
- Agitation in Patients With Dementia of the Alzheimer's TypeAlzheimer DiseaseAgitation, 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)
- Conditions
- Shift-work DisorderExcessive Sleepiness
- Interventions
- 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
- Conditions
- Binge-Eating Disorder
- Interventions
- 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
- Conditions
- NarcolepsyObstructive Sleep ApneaPregnant Women and Their Offspring
- Interventions
- Other: No treatmentDrug: 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
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News
FDA Rejects Axsome's Fibromyalgia Drug Application Due to Trial Design Issues
The FDA issued a Refusal to File letter for Axsome Therapeutics' AXS-14 (esreboxetine) fibromyalgia application, citing inadequate trial design in one of two submitted studies.
Axsome Therapeutics Secures $570 Million Credit Facility from Blackstone to Strengthen CNS Portfolio
Axsome Therapeutics has entered into a $570 million credit facility with Blackstone, expanding their available credit by over $200 million while significantly reducing capital costs.
Major Depressive Disorder Pipeline Advances with 75+ Companies Developing Novel Therapies
A comprehensive pipeline report reveals over 75 companies are developing innovative treatments for major depressive disorder, with several promising candidates advancing through Phase III trials.
Migraine Treatment Pipeline Shows Robust Activity with 30+ Companies Advancing Novel Therapies Through Clinical Trials
DelveInsight's 2025 pipeline report reveals over 30 companies are actively developing more than 30 pipeline therapies for migraine treatment, indicating a robust therapeutic landscape.
Axsome's Sunosi Shows Positive Phase 3 Results in Adult ADHD Trial
Axsome Therapeutics' Sunosi (solriamfetol) demonstrated statistically significant improvement in ADHD symptoms in adults during a Phase 3 clinical trial, meeting its primary endpoint.
Hypersomnia Pipeline Shows Promise with 10+ Emerging Therapies in Development
DelveInsight's latest report reveals 8+ companies developing 10+ therapies for hypersomnia, with Avadel's Lumryz, Zevra's KP1077, and Alkermes' ALKS 2680 among the key candidates advancing through clinical trials.
Axsome Therapeutics Reports Strong Growth with 88% Revenue Increase in 2024, Advances CNS Pipeline
Axsome Therapeutics achieved remarkable financial performance in 2024, with total net product revenue reaching $385.7 million, representing an 88% year-over-year growth driven by strong Auvelity and Sunosi sales.
Alzheon to Present Phase 3 Data for ALZ-801, Aiming to Slow Alzheimer's Progression
Alzheon is set to present Phase 3 trial data for ALZ-801 in April 2025, a drug designed to prevent the formation of toxic beta-amyloid plaques in early Alzheimer's patients with the ApoE4 gene.
FDA Approves Axsome's Symbravo (Meloxicam and Rizatriptan) for Acute Migraine Treatment
The FDA has approved Symbravo (meloxicam and rizatriptan) for the acute treatment of migraine with or without aura in adults, offering a novel multi-mechanistic approach.
FDA Roundup: Approvals, Breakthrough Designations, and Clinical Holds in Neurology and Rare Diseases
• The FDA granted breakthrough therapy designation to STK-001 for Dravet syndrome, highlighting its potential to improve upon current treatments by restoring NaV1.1 protein levels. • Tolebrutinib received breakthrough therapy designation for non-relapsing secondary progressive multiple sclerosis based on phase 3 trial results showing delayed disability progression. • The FDA placed a clinical hold on PepGen’s PGN-EDO51 phase 2 study for Duchenne muscular dystrophy, pending further clarification from the agency.