{"id":"bxcl501-sublingual-film","safety":{"commonSideEffects":[{"rate":null,"effect":"somnolence"},{"rate":null,"effect":"dizziness"},{"rate":null,"effect":"headache"}]},"_chembl":{"chemblId":"CHEMBL2109194","moleculeType":"Unknown"},"_dailymed":null,"mechanism":{"_ai_source":"featherless-qwen","explanation":"BXCL501 works by selectively inhibiting the reuptake of serotonin into presynaptic neurons, thereby increasing the levels of serotonin in the synaptic cleft, which can help reduce symptoms of acute agitation associated with certain psychiatric disorders.","oneSentence":"BXCL501 is a selective serotonin reuptake inhibitor (SSRI) that modulates serotonin levels in the brain to treat acute agitation.","_ai_confidence":"medium"},"_scrapedAt":"2026-03-28T03:58:59.545Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Acute agitation associated with schizophrenia or bipolar I disorder"}]},"trialDetails":[{"nctId":"NCT06943404","phase":"PHASE2","title":"BXCL501 After Stress to Increase Recovery Success","status":"NOT_YET_RECRUITING","sponsor":"University of North Carolina, Chapel Hill","startDate":"2026-02-11","conditions":"Acute Stress Reaction, Acute Stress Disorder, Post-traumatic Stress Disorder","enrollment":100},{"nctId":"NCT05974527","phase":"PHASE4","title":"Pilot Study 1: Efficacy and Safety of Sublingual Dexmedetomidine (BXCL501) for the Treatment of Agitation in the Emergency Department","status":"WITHDRAWN","sponsor":"Brigham and Women's Hospital","startDate":"2023-09-01","conditions":"Agitation, Schizophrenia, Schizoaffective Disorder","enrollment":""},{"nctId":"NCT06041646","phase":"PHASE4","title":"Tachyphylaxis, Tolerance, & Withdrawal Post Treatment With Igalmi for Agitation in Schizophrenia or Bipolar Disorder","status":"COMPLETED","sponsor":"BioXcel Therapeutics Inc","startDate":"2023-10-02","conditions":"Bipolar Disorder, Schizophrenia, Agitation,Psychomotor","enrollment":29},{"nctId":"NCT05271552","phase":"PHASE3","title":"Dexmedetomidine in the Treatment of Agitation Associated With Dementia (TRANQUILITY II)","status":"COMPLETED","sponsor":"BioXcel Therapeutics Inc","startDate":"2022-04-27","conditions":"Agitation, Dementia","enrollment":151},{"nctId":"NCT06335407","phase":"PHASE1","title":"Effect of Sublingual Formulation of Dexmedetomidine Hydrochloride (HCl) (BXCL501) - Outpatient Study","status":"RECRUITING","sponsor":"Pharmacotherapies for Alcohol and Substance Use Disorders Alliance","startDate":"2025-07-28","conditions":"Alcohol Use Disorder (AUD), Post Traumatic Stress Disorder (PTSD)","enrollment":10},{"nctId":"NCT05658510","phase":"PHASE3","title":"Dexmedetomidine in the Treatment of Agitation Associated With Schizophrenia and Bipolar Disorder (SERENITY III)","status":"COMPLETED","sponsor":"BioXcel Therapeutics Inc","startDate":"2022-11-21","conditions":"Agitation,Psychomotor, Bipolar I Disorder, Bipolar II Disorder","enrollment":452},{"nctId":"NCT07116694","phase":"PHASE2","title":"Assessment of Acute Psychomotor Agitation Measures Associated With Schizophrenia and Bipolar Disorder","status":"ACTIVE_NOT_RECRUITING","sponsor":"BioXcel Therapeutics Inc","startDate":"2025-06-19","conditions":"Bipolar I Disorder, Bipolar II Disorder, Schizophrenia","enrollment":30},{"nctId":"NCT03708315","phase":"PHASE1","title":"BXCL501 for Agitation in Schizophrenia","status":"COMPLETED","sponsor":"Yale University","startDate":"2020-03-09","conditions":"Schizophrenia, Schizoaffective Disorder","enrollment":11},{"nctId":"NCT05025605","phase":"PHASE1","title":"Determining Efficacy and Safety of BXCL501 in Agitation Associated With Pediatric Schizophrenia and Bipolar Disorder","status":"RECRUITING","sponsor":"BioXcel Therapeutics Inc","startDate":"2021-08-27","conditions":"Schizophrenia, Schizo-Affective Disorder, Schizophreniform; Schizophrenic","enrollment":140},{"nctId":"NCT05665088","phase":"PHASE3","title":"Dexmedetomidine in the Treatment of Agitation Associated With Dementia (TRANQUILITY III)","status":"TERMINATED","sponsor":"BioXcel Therapeutics Inc","startDate":"2022-12-14","conditions":"Agitation, Dementia","enrollment":13},{"nctId":"NCT04470050","phase":"PHASE1, PHASE2","title":"Dexmedetomidine in the Treatment of Symptoms Of Acute Opioid Withdrawal","status":"COMPLETED","sponsor":"BioXcel Therapeutics Inc","startDate":"2020-06-09","conditions":"Opioid Withdrawal","enrollment":225},{"nctId":"NCT04827056","phase":"PHASE1","title":"Effect of Sublingual Formulation of Dexmedetomidine HCl (BXCL501) - Alcohol Interaction Study","status":"COMPLETED","sponsor":"Pharmacotherapies for Alcohol and Substance Use Disorders Alliance","startDate":"2021-11-09","conditions":"Alcohol Use Disorder (AUD), Post Traumatic Stress Disorder (PTSD)","enrollment":10},{"nctId":"NCT04251910","phase":"PHASE1, PHASE2","title":"Sub-Lingual Dexmedetomidine in Agitation Associated With Dementia","status":"COMPLETED","sponsor":"BioXcel Therapeutics Inc","startDate":"2019-12-27","conditions":"Agitation,Psychomotor, Dementia","enrollment":100},{"nctId":"NCT04276883","phase":"PHASE3","title":"Dexmedetomidine in the Treatment of Agitation Associated With Bipolar Disorder","status":"COMPLETED","sponsor":"BioXcel Therapeutics Inc","startDate":"2020-02-24","conditions":"Agitation Associated With Bipolar Disorder, Agitation,Psychomotor, Bipolar Disorder","enrollment":380},{"nctId":"NCT05276830","phase":"PHASE2","title":"An Efficacy, and Safety Study Of BXCL501 For The Treatment Of Agitation Associated With Dementia","status":"TERMINATED","sponsor":"BioXcel Therapeutics Inc","startDate":"2022-02-08","conditions":"Agitation, Dementia","enrollment":5},{"nctId":"NCT04268303","phase":"PHASE3","title":"Dexmedetomidine in the Treatment of Agitation Associated With Schizophrenia","status":"COMPLETED","sponsor":"BioXcel Therapeutics Inc","startDate":"2020-01-24","conditions":"Agitation, Schizophrenia, Schizo Affective Disorder","enrollment":380},{"nctId":"NCT04010305","phase":"PHASE1","title":"Sub-Lingual Dexmedetomidine in Agitation Associated With Schizophrenia","status":"COMPLETED","sponsor":"BioXcel Therapeutics Inc","startDate":"2019-05-22","conditions":"Agitation, Schizophrenia","enrollment":135}],"_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":["Dexmedetomidine"],"phase":"phase_2","status":"active","brandName":"BXCL501 Sublingual Film","genericName":"BXCL501 Sublingual Film","companyName":"BioXcel Therapeutics Inc","companyId":"bioxcel-therapeutics-inc","modality":"Small molecule","firstApprovalDate":"","aiSummary":"BXCL501 is a selective serotonin reuptake inhibitor (SSRI) that modulates serotonin levels in the brain to treat acute agitation. Used for Acute agitation associated with schizophrenia or bipolar I disorder.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":1,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}