{"id":"bxcl501-60-micrograms","phase":"phase_1","safety":{"boxedWarnings":[],"safetySignals":[],"drugInteractions":[],"commonSideEffects":["Somnolence","Hypotension","Bradycardia","Dry mouth","Dizziness"],"contraindications":[],"specialPopulations":{},"discontinuationRates":[],"seriousAdverseEvents":[]},"status":"active","trials":["NCT05025605"],"aliases":["Dexmedetomidine"],"patents":[],"pricing":[],"modality":"Small molecule","timeline":[],"aiSummary":"BXCL501 is a medication being studied for various conditions, including opioid withdrawal, agitation, dementia, and bipolar I disorder, in clinical trials. According to ClinicalTrials.gov, BXCL501 is being investigated as a potential treatment for symptoms of acute opioid withdrawal in a Phase 1b/2 randomized, double-blind, placebo-controlled study.","brandName":"BXCL501 60 Micrograms","companyId":"bioxcel-therapeutics-inc","mechanism":{"target":"Alpha-2 adrenergic receptor","novelty":"","modality":"Small molecule","drugClass":"","explanation":"Dexmedetomidine selectively binds to alpha-2 adrenergic receptors in the central nervous system, particularly in the locus coeruleus. This binding inhibits norepinephrine release, producing sedative and anxiolytic effects without significant respiratory depression.","oneSentence":"BXCL501 is a selective alpha-2 adrenergic receptor agonist that reduces neuronal excitability and sympathetic outflow.","technicalDetail":""},"commercial":null,"_claudeStub":{"ts":1779123228,"model":"claude-sonnet-4-5-20250929"},"companyName":"BioXcel Therapeutics Inc","competitors":[{"name":"loxapine","brand":"Adasuve","company":"Teva Pharmaceutical Industries","rationale":"Inhaled antipsychotic for acute agitation in schizophrenia/bipolar"},{"name":"olanzapine","brand":"Zyprexa","company":"Eli Lilly","rationale":"Intramuscular antipsychotic commonly used for acute agitation"},{"name":"haloperidol","brand":null,"company":null,"rationale":"Injectable typical antipsychotic standard for acute agitation management"}],"description":"BXCL501 60 micrograms is an investigational sublingual film formulation of dexmedetomidine being developed by BioXcel Therapeutics for acute treatment of agitation. The drug is designed for rapid absorption through the oral mucosa, offering a non-invasive alternative to injectable sedatives in psychiatric and neurological emergencies.","genericName":"BXCL501 60 Micrograms","indications":{"approved":[{"status":"investigational","condition":"Agitation associated with schizophrenia","patientPopulation":"Adult"},{"status":"investigational","condition":"Agitation associated with bipolar disorder","patientPopulation":"Adult"},{"status":"investigational","condition":"Agitation associated with dementia","patientPopulation":"Adult and elderly"}],"offLabel":[],"pipeline":[]},"labelChanges":[],"trialDetails":[],"manufacturing":[],"administration":{"icon":"","route":"","frequency":"","formulation":""},"formularyStatus":[],"apiManufacturers":[],"developmentCodes":[],"ownershipHistory":[],"biosimilarFilings":[],"firstApprovalDate":"","companionDiagnostics":[],"firstApprovalCountry":null,"rwe":[],"genericFilers":[],"relatedDrugs":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"enrichmentLevel":3,"visitCount":1,"trialStats":{"total":1,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":false,"score":3}}