{"id":"tnx-601-er","_chembl":null,"_dailymed":null,"_scrapedAt":"2026-03-28T02:09:51.312Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"_claudeStub":{"ts":1779122991,"model":"claude-sonnet-4-5-20250929"},"description":"TNX-601 ER is an investigational extended-release formulation being developed by Tonix Pharmaceuticals for potential therapeutic applications. The drug is currently in Phase 2 clinical development, though specific details regarding its molecular target, mechanism of action, and therapeutic indications have not been publicly disclosed.","indications":{"approved":[{"status":"investigational","condition":null,"patientPopulation":null}]},"trialDetails":[{"nctId":"NCT05686408","phase":"PHASE2","title":"Study to Evaluate TNX-601 ER Monotherapy Versus Placebo in Patients With Major Depressive Disorder (MDD)","status":"COMPLETED","sponsor":"Tonix Pharmaceuticals, Inc.","startDate":"2023-03-02","conditions":"Depression, Depressive Disorder, Depressive Symptoms","enrollment":132}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":132262,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":["Tianeptine"],"phase":"phase_2","status":"active","brandName":"TNX-601 ER","genericName":"TNX-601 ER","companyName":"Tonix Pharmaceuticals, Inc.","companyId":"tonix-pharmaceuticals-inc","modality":"Small molecule","firstApprovalDate":"","aiSummary":"TNX-601 ER is a small molecule being studied as a potential treatment for major depressive disorder (MDD). It is being evaluated in a Phase 2 clinical trial as a monotherapy compared to a placebo.","enrichmentLevel":2,"visitCount":3,"trialStats":{"total":1,"withResults":1},"verificationStatus":"partial","dataCompleteness":{"mechanism":false,"indications":true,"safety":false,"trials":true,"score":2}}