Dexmedetomidine is under clinical development by BioXcel Therapeutics and currently in Phase III for Bipolar Disorder (Manic Depression). According to GlobalData, Phase III drugs for Bipolar Disorder (Manic Depression) have a 68% phase transition success rate (PTSR) indication benchmark for progressing into Pre-Registration. GlobalData’s report assesses how Dexmedetomidine’s drug-specific PTSR and Likelihood of Approval (LoA) scores compare to the indication benchmarks. Buy the report here.
GlobalData tracks drug-specific phase transition and likelihood of approval scores, in addition to indication benchmarks based off 18 years of historical drug development data. Attributes of the drug, company and its clinical trials play a fundamental role in drug-specific PTSR and likelihood of approval.
Dexmedetomidine (Igalmi) is an imidazole derivate and active d-isomer of medetomidine with analgesic, anxiolytic and sedative properties. It is formulated as film for Sublingual route of administration. Igalmi indicated for acute treatment of agitation associated with schizophrenia or bipolar I or II disorder in adults.
Dexmedetomidine is under development for the treatment of agitation in schizophrenia patients, bipolar patients, Alzheimer’s patients, haloperidol-refractory delirium patients, geriatric dementia, major depressive disorder (MDD) and opioid withdrawal symptoms. The drug candidate is administered by sublingual route as thin film and through intravenous route. It acts by targeting selective alpha 2 adrenergic receptors.
BioXcel Therapeutics overview
BioXcel Therapeutics is a commercial-stage biopharmaceutical company focused on novel artificial intelligence-based drug development in the fields of neuroscience and immuno-oncology. Its pipeline product portfolio comprises BXCL501, an adrenergic agent with a sublingual route of administration is used for treating neuropsychiatric and neurodegenerative diseases; BXCL701, an immuno-oncology agent designed for the treatment of prostate and pancreatic cancers; and BXCL502, a novel approach to the treatment of symptoms resulting from neurological disorders. The company’s drug re-innovation approach leverages existing approved drugs and clinically validated product candidates with big data and proprietary machine learning algorithms to develop new therapeutic candidates. BioXcel Therapeutics is headquartered in New Haven, Connecticut, the US.
For a complete picture of Dexmedetomidine’s drug-specific PTSR and LoA scores, buy the report here.