{"id":"axs-02","safety":{"commonSideEffects":[{"rate":null,"effect":"Dizziness"},{"rate":null,"effect":"Nausea"},{"rate":null,"effect":"Fatigue"},{"rate":null,"effect":"Headache"},{"rate":null,"effect":"Dissociation or cognitive effects"}]},"_chembl":{"chemblId":"CHEMBL4297744","moleculeType":"Unknown"},"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"AXS-02 combines dextromethorphan (a dissociative NMDA receptor antagonist) with quinidine (which inhibits dextromethorphan metabolism, increasing its bioavailability and CNS penetration). This combination targets both NMDA receptors and sigma-1 receptors, which are implicated in neuropathic pain signaling. The formulation is designed to provide sustained pain relief in conditions characterized by central sensitization and neuropathic mechanisms.","oneSentence":"AXS-02 is a combination of dextromethorphan and quinidine that enhances NMDA receptor antagonism and sigma-1 receptor modulation to reduce neuropathic pain.","_ai_confidence":"medium"},"_scrapedAt":"2026-03-28T01:03:11.007Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Neuropathic pain associated with chemotherapy-induced peripheral neuropathy (CIPN)"},{"name":"Fibromyalgia"}]},"trialDetails":[{"nctId":"NCT02746068","phase":"PHASE3","title":"A Study to Assess the Efficacy and Safety of AXS-02 in Subjects With Knee OA Associated With Bone Marrow Lesions","status":"UNKNOWN","sponsor":"Axsome Therapeutics, Inc.","startDate":"2016-03","conditions":"Osteoarthritis, Knee","enrollment":346},{"nctId":"NCT02504008","phase":"PHASE3","title":"CREATE-1: A Study to Assess the Efficacy and Safety of AXS-02 in Patients With CRPS-1","status":"UNKNOWN","sponsor":"Axsome Therapeutics, Inc.","startDate":"2015-07","conditions":"Complex Regional Pain Syndrome, Reflex Sympathetic Dystrophy","enrollment":190}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":0,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":[],"phase":"phase_3","status":"active","brandName":"AXS-02","genericName":"AXS-02","companyName":"Axsome Therapeutics, Inc.","companyId":"axsome-therapeutics-inc","modality":"Small molecule","firstApprovalDate":"","aiSummary":"AXS-02 is a combination of dextromethorphan and quinidine that enhances NMDA receptor antagonism and sigma-1 receptor modulation to reduce neuropathic pain. Used for Neuropathic pain associated with chemotherapy-induced peripheral neuropathy (CIPN), Fibromyalgia.","enrichmentLevel":3,"visitCount":1,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}