Pipeline

Axsome Therapeutics is building a portfolio of differentiated product candidates that address unmet medical needs. Some of our product candidates combine multiple mechanisms of action to produce novel medicines that address deficiencies of current approaches. The company’s current pipeline includes two late-stage product candidates and one preclinical candidate.

AXS-05

AXS-05 is a novel, oral, investigational drug product under development for the treatment of central nervous system (CNS) disorders. AXS-05 utilizes Axsome’s technology of combining bupropion and dextromethorphan. Dextromethorphan is an NMDA receptor antagonist, sigma-1 receptor agonist, and inhibitor of the serotonin and norepinephrine transporters. Bupropion serves to increase the bioavailability of dextromethorphan, and is a norepinephrine and dopamine reuptake inhibitor, and a nicotinic acetylcholine receptor antagonist. We are initially developing AXS-05 for the treatment of the following conditions: treatment resistant depression (TRD), and agitation in patients with Alzheimer’s disease (AD). AXS-05 is an investigational drug product not approved by the FDA.

Learn more about AXS-05 and our target indications.

AXS-02

AXS-02 (disodium zoledronate tetrahydrate), is a potentially first in class, oral, targeted, non opioid therapeutic for chronic pain. We are initially developing AXS-02 for the treatment of pain in the following three conditions: complex regional pain syndrome (CRPS), knee osteoarthritis (OA) associated with bone marrow lesions (BMLs) and chronic low back pain (CLBP) associated with Modic changes (MCs). AXS-02 has been granted Fast Track designation by the FDA for the treatment of pain associated with CRPS as well as for the treatment of knee OA associated with BMLs. AXS-02 has also been granted Orphan Drug Designation by the FDA and Orphan Medicinal Product Designation by the EMA for the treatment of CRPS. AXS-02 is an investigational product candidate not approved by the FDA.

Learn more about AXS-02 and our target indications.

AXS-06

AXS-06 is an oral, non-opioid, fixed-dose combination of MoSEIC™ meloxicam and esomeprazole which is being developed for the treatment of chronic pain. Meloxicam is a long-acting nonsteroidal anti-inflammatory drug (NSAID) with COX-2 preferential inhibition and potent pain-relieving efficacy. AXS-06 utilizes Axsome’s proprietary MoSEIC™ (Molecular Solubility Enhanced Inclusion Complex) technology to substantially increase the solubility and speed the absorption of meloxicam while maintaining durability of action. Esomeprazole is a proton pump inhibitor which lowers stomach acidity and which has been shown to reduce the occurrence of NSAID-induced gastrointestinal ulcers. AXS-06 is designed to provide rapid, effective pain relief, and to reduce the risk of NSAID-induced ulcers, with convenient once-daily dosing.