{"id":"ly03005-extended-release-tablet","safety":{"commonSideEffects":[{"rate":null,"effect":"Extrapyramidal symptoms"},{"rate":null,"effect":"Akathisia"},{"rate":null,"effect":"Sedation"},{"rate":null,"effect":"Weight gain"},{"rate":null,"effect":"Hyperprolactinemia"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"LY03005 acts as a dopamine D2 receptor antagonist, reducing dopaminergic neurotransmission. The extended-release formulation provides sustained drug delivery over an extended period, allowing for once-daily or less frequent dosing. This mechanism is typical of antipsychotic medications used to manage psychotic symptoms and behavioral disturbances.","oneSentence":"LY03005 is a dopamine D2 receptor antagonist that blocks dopamine signaling in the central nervous system.","_ai_confidence":"medium"},"_scrapedAt":"2026-03-28T01:19:51.168Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Schizophrenia"},{"name":"Bipolar disorder"}]},"trialDetails":[{"nctId":"NCT04853407","phase":"PHASE3","title":"A Study to Evaluate the Efficacy and Safety of Ansofaxine Hydrochloride Extended-release Tablets in the Treatment of Major Depressive Disorder (MDD)","status":"COMPLETED","sponsor":"Luye Pharma Group Ltd.","startDate":"2018-12-05","conditions":"Major Depressive Disorder (MDD)","enrollment":558},{"nctId":"NCT03785652","phase":"PHASE1","title":"Dose-Finding Clinical Trial to Evaluate the Efficacy and Safety of LY03005 Extended-release Tablets in the Treatment of Major Depressive Disorder (MDD)","status":"COMPLETED","sponsor":"Luye Pharma Group Ltd.","startDate":"2015-10-09","conditions":"Major Depressive Disorder","enrollment":260},{"nctId":"NCT02271412","phase":"PHASE1","title":"Multiple Ascending Dose Study in Healthy Subjects to Evaluate the Safety, Tolerability, and Pharmacokinetics of LY03005","status":"COMPLETED","sponsor":"Luye Pharma Group Ltd.","startDate":"2014-10","conditions":"Major Depressive Disorder, Recurrent, Unspecified","enrollment":58}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":1,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":["Desvenlafaxine","4-Methylbenzoate of desvenlafaxine hydrochloride"],"phase":"phase_3","status":"active","brandName":"LY03005 extended-release tablet","genericName":"LY03005 extended-release tablet","companyName":"Luye Pharma Group Ltd.","companyId":"luye-pharma-group-ltd","modality":"Small molecule","firstApprovalDate":"","aiSummary":"LY03005 extended-release tablet is being studied for the treatment of Major Depressive Disorder. The safety, tolerability, and pharmacokinetics of LY03005 extended-release tablet have been evaluated in a multiple ascending dose study in healthy subjects.","enrichmentLevel":3,"visitCount":0,"regulatoryByCountry":[{"country_code":"EU","regulator":"EMA","status":"withdrawn","approval_date":"2009-12-31T00:00:00.000Z","mah":"Wyeth Europe Ltd.","brand_name_local":"Pristiqs","application_number":"EMEA/H/C/000794"}],"trialStats":{"total":1,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}