Axsome Therapeutics Inc. is focused on developing innovative treatments for various central nervous system (CNS) conditions, including depression, Alzheimer's disease agitation, migraine, narcolepsy, and fibromyalgia. The company is advancing a pipeline of investigational products, notably AXS-05, AXS-07, AXS-12, and AXS-14. AXS-05 is a novel oral NMDA receptor antagonist that combines dextromethorphan and bupropion, aiming to modulate glutamatergic neurotransmission and enhance the bioavailability of dextromethorphan. This product is currently under development for indications such as Alzheimer's disease agitation and smoking cessation, having received Breakthrough Therapy designation from the FDA for the former.

In addition to AXS-05, Axsome is developing AXS-07, which utilizes a proprietary formulation known as MoSEIC™ (Meloxicam/Rizatriptan) for the acute treatment of migraine. AXS-12 is also in development for narcolepsy, showcasing the company's commitment to addressing unmet medical needs in CNS disorders. The efficacy and safety of these products are being evaluated through various clinical trials, with a focus on improving patient outcomes and quality of life. Axsome's research is supported by a robust pipeline and ongoing clinical studies, reflecting its dedication to transforming patient needs into effective therapeutic solutions.

United States

Our Mission: For the many people facing unsatisfactory treatments for CNS disorders, Axsome accelerates the invention and adoption of life-changing medicines

Central Nervous System (CNS)

Musculoskeletal Diseases

Nervous System Diseases

Psychological Diseases

Axsome Therapeutics Inc.

Major depressive disorder

Mental health

AXS-05 (dextromethorphan-bupropion modulated delivery tablet) is a novel, oral, patent-protected, investigational NMDA receptor antagonist with multimodal activity under development for the treatment of major depressive disorder and other central nervous system (CNS) disorders. AXS-05 utilizes a proprietary formulation and dose of dextromethorphan and bupropion, and Axsome’s metabolic inhibition technology, to modulate the delivery of the components. The dextromethorphan component of AXS-05 is an uncompetitive N-methyl-D-aspartate (NMDA) receptor antagonist, also known as a glutamate receptor modulator, which is a novel mechanism of action, meaning it works differently than currently approved therapies for major depressive disorder. The dextromethorphan component of AXS-05 is also a sigma-1 receptor agonist, nicotinic acetylcholine receptor antagonist, and inhibitor of the serotonin and norepinephrine transporters. The bupropion component of AXS-05 serves to increase the bioavailability of dextromethorphan, and is a norepinephrine and dopamine reuptake inhibitor, and a nicotinic acetylcholine receptor antagonist. AXS-05 is covered by more than 93 issued U.S. and international patents which provide protection out to 2040. AXS-05 has been granted U.S. Food and Drug Administration (FDA) Breakthrough Therapy designation for the treatment of MDD. AXS-05 is not approved by the FDA.

AUVELITY [AXS-05]  (NMDA receptor antagonist & sigma-1 agonist)

Migraines

AXS-07 is a novel, oral, rapidly absorbed, multi-mechanistic investigational medicine for the acute treatment of migraine, consisting of MoSEIC™ meloxicam and rizatriptan. Meloxicam is a new molecular entity for migraine enabled by Axsome’s MoSEIC (Molecular Solubility Enhanced Inclusion Complex) technology, which results in rapid absorption of meloxicam while maintaining a long plasma half-life. Meloxicam is a COX-2 preferential non-steroidal anti-inflammatory drug and rizatriptan is a 5-HT1B/1D agonist. AXS-07 is designed to provide rapid, enhanced and consistent relief of migraine, with reduced symptom recurrence. AXS-07 is covered by more than 80 issued U.S. and international patents which provide protection out to 2036. AXS-07 is not approved by the FDA.

SYMBRAVO® (meloxicam & rizatriptan) (AXS-07)

Excessive daytime sleepiness

Sunosi® (solriamfetol)

Narcolepsy

AXS-12 (reboxetine) is a highly selective and potent norepinephrine &nbsp;reuptake inhibitor. Reboxetine has an extensive safety record in Europe &nbsp;and in over 40 countries where it is approved for the treatment of &nbsp;Depression. AXS-12 in narcolepsy is supported by positive pre-clinical &nbsp;and preliminary clinical results where it significantly reduced &nbsp;narcoleptic episodes in hypocretin (orexin)-deficient mice as well as &nbsp;improving daytime sleepiness with reduced cataplexy in patients with &nbsp;narcolepsy in an open-label pilot trial.
<a href="https://axsome.com/axs-pipeline/about-axs-12/">Source</a>

AXS-12 (reboxetine) (NE reuptake inhibitor) 

Alzheimer's disease

AXS-05 (dextromethorphan-bupropion modulated delivery tablet) is a novel, oral, patent-protected, investigational NMDA receptor antagonist with multimodal activity under development for the treatment of major depressive disorder and other central nervous system (CNS) disorders. AXS-05 utilizes a proprietary formulation and dose of dextromethorphan and bupropion, and Axsome’s metabolic inhibition technology, to modulate the delivery of the components. The dextromethorphan component of AXS-05 is an uncompetitive N-methyl-D-aspartate (NMDA) receptor antagonist, also known as a glutamate receptor modulator, which is a novel mechanism of action, meaning it works differently than currently approved therapies for major depressive disorder. The dextromethorphan component of AXS-05 is also a sigma-1 receptor agonist, nicotinic acetylcholine receptor antagonist, and inhibitor of the serotonin and norepinephrine transporters. The bupropion component of AXS-05 serves to increase the bioavailability of dextromethorphan, and is a norepinephrine and dopamine reuptake inhibitor, and a nicotinic acetylcholine receptor antagonist. AXS-05 is covered by more than 93 issued U.S. and international patents which provide protection out to 2040. AXS-05 has been granted U.S. Food and Drug Administration Breakthrough Therapy and Fast Track designations for Alzheimer’s disease agitation. AXS-05 is not approved by the FDA.

AXS-05 

Fibromyalgia

Muscle pain

Pain

AXS-14 (esreboxetine) is Axsome’s novel, oral, potent, and highly &nbsp;selective norepinephrine reuptake inhibitor for the treatment of &nbsp;fibromyalgia. Esreboxetine, the SS-enantiomer of reboxetine, is more &nbsp;potent and selective than racemic reboxetine.

AXS-14 (esreboxetine) (NE reuptake inhibitor) 

Attention deficit hyperactivity disorder

Dual-acting dopamine and norepinephrine reuptake inhibitor

Solriamfetol

Binge eating disorder

Shift work disorder

Solriamfetol is a dopamine and norepinephrine reuptake inhibitor and trace amine-associated receptor 1 (TAAR1) agonist. Solriamfetol is not approved by the FDA for the treatment of major depressive disorder.

Axsome Therapeutics Inc.

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