{"id":"dexmedetomidine-sublingual","safety":{"commonSideEffects":[{"rate":"10%","effect":"Dry mouth"},{"rate":"5%","effect":"Hypotension"},{"rate":"2%","effect":"Bradycardia"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"groq-llama-8b","explanation":"Dexmedetomidine acts as an agonist at the alpha-2 adrenergic receptor, which results in sedative and anxiolytic effects.","oneSentence":"Alpha-2 adrenergic receptor agonist","_ai_confidence":"high"},"_scrapedAt":"2026-03-28T02:32:24.388Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Sedation"}]},"trialDetails":[{"nctId":"NCT06128356","phase":"PHASE2","title":"Pilot Study of Dexmedetomidine Sublingual Film for the Ambulatory Treatment of Hyperadrenergic Autonomic Crisis in Patients With Familial Dysautonomia","status":"ACTIVE_NOT_RECRUITING","sponsor":"NYU Langone Health","startDate":"2024-06-01","conditions":"Familial Dysautonomia","enrollment":5},{"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Safety of Sublingual Dexmedetomidine (BXCL501) for the Treatment of Agitation in the Emergency Department","status":"WITHDRAWN","sponsor":"Brigham and Women's Hospital","startDate":"2023-09-01","conditions":"Agitation, Schizophrenia, Schizoaffective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":"NCT05712707","phase":"PHASE1, PHASE2","title":"Sublingual Dexmedetomidine for Treating Opioid Withdrawal","status":"ACTIVE_NOT_RECRUITING","sponsor":"New York State Psychiatric Institute","startDate":"2023-02-28","conditions":"Opioid Use Disorder, Opioid Withdrawal","enrollment":160},{"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":"NCT06192615","phase":"PHASE3","title":"Minimizing ICU Neurological Dysfunction With Dexmedetomidine-induced Sleep (MINDDS II)","status":"RECRUITING","sponsor":"Massachusetts General Hospital","startDate":"2025-01-06","conditions":"Delirium","enrollment":1800},{"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":"NCT06148311","phase":"PHASE2","title":"Dexmedetomidine Sublingual Film for the Ambulatory Treatment of Hyperadrenergic Autonomic Crisis in Patients With Familial Dysautonomia","status":"ENROLLING_BY_INVITATION","sponsor":"NYU Langone Health","startDate":"2024-07-01","conditions":"Familial Dysautonomia","enrollment":15},{"nctId":"NCT06752616","phase":"PHASE2, PHASE3","title":"Acute Agitation in Emergency Psychiatry","status":"RECRUITING","sponsor":"Lone Baandrup","startDate":"2024-12-30","conditions":"Agitation","enrollment":132},{"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":"NCT04382170","phase":"PHASE2","title":"Dexmedetomidine Sublingual Film for the Management of Agitation in Delirium: Safety and Preliminary Efficacy","status":"WITHDRAWN","sponsor":"Jeff C. Huffman, MD","startDate":"2020-06","conditions":"Delirium","enrollment":""},{"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":"NCT06093451","phase":"PHASE4","title":"Evaluating Sublingual Dexmedetomidine For Moderate To Severe Agitation In Inpatients With Schizophrenia Or Bipolar Disorder","status":"UNKNOWN","sponsor":"Temple University","startDate":"2023-07-01","conditions":"Schizophrenia Agitation, Schizo Affective Disorder, Bipolar Disorder","enrollment":32},{"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},{"nctId":"NCT04508166","phase":"NA","title":"Towards a Post-exposition Pharmacological Prophylaxis for Post-traumatic Stress Disorder","status":"COMPLETED","sponsor":"Psychiatric University Hospital, Zurich","startDate":"2021-10-01","conditions":"Intrusive Thought, Psychological Trauma, Inflammatory Response","enrollment":27},{"nctId":"NCT04237532","phase":"PHASE2, PHASE3","title":"Sublingual Versus Intranasal Administration of Dexmedetomidine for Sedation of Children Undergoing Dental Treatment","status":"COMPLETED","sponsor":"Nourhan M.Aly","startDate":"2019-08-27","conditions":"Anti-anxiety Agents, Moderate Sedation","enrollment":42},{"nctId":"NCT03742180","phase":"NA","title":"Sublingual Ketorolac Compared to Intranasal Dexmedetomidine for Postoperative Analgesia in Pediatric Patients Undergoing Bilateral Myringotomy","status":"WITHDRAWN","sponsor":"Mansoura University","startDate":"2018-01-01","conditions":"Elective Bilateral Myringotomy","enrollment":""},{"nctId":"NCT02714725","phase":"PHASE4","title":"Effect Of Dexmedetomidine On Sublingual Microcirculation In Patients Undergoing On Pump CABG Surgery","status":"UNKNOWN","sponsor":"Cairo University","startDate":"2016-01","conditions":"Sublingual Microcirculation","enrollment":70}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":5,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":["IGALMI"],"phase":"phase_2","status":"active","brandName":"Dexmedetomidine Sublingual","genericName":"Dexmedetomidine Sublingual","companyName":"NYU Langone Health","companyId":"nyu-langone-health","modality":"Small molecule","firstApprovalDate":"","aiSummary":"Alpha-2 adrenergic receptor agonist Used for Sedation.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}