IGALMI
Treatment for agitation associated with bipolar disorders or schizophrenia
Other · OtherCompany source
Company profile
About BioXcel Therapeutics
BioXcel Therapeutics Inc. is a biopharmaceutical company leveraging artificial intelligence for drug re-innovation and development. The company focuses on identifying and developing breakthrough therapies primarily in neuroscience and immuno-oncology. BioXcel's proprietary AI-based drug re-innovation platform analyzes vast amounts of data to identify new therapeutic applications for existing drug candidates, accelerating the drug development process. The company's lead commercial product is IGALMI® (dexmedetomidine), an FDA-approved sublingual film for the acute treatment of agitation associated with schizophrenia or bipolar I or II disorder in adults. BioXcel is expanding IGALMI's indications through clinical trials, including the SERENITY At-Home Phase 3 trial for at-home use in agitation associated with bipolar disorders or schizophrenia. BioXcel Therapeutics serves healthcare providers, patients, and healthcare systems treating psychiatric and neurological conditions. The company operates through its subsidiary OnkosXcel Therapeutics for oncology programs. As a publicly traded company on NASDAQ, BioXcel combines cutting-edge AI technology with pharmaceutical expertise to address significant unmet medical needs in mental health and cancer treatment.
Company description BioXcel Therapeutics official website
Primary marketDrug Discovery & Development
Commercial modelCommercial information available on request
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01 · Operating footprint
Where the Company operates
Company-profile context for clinical focus, customers, deployment, integration, milestones, and partnerships.
Clinical focus
- Acute agitation associated with bipolar I disorder
- Acute agitation associated with bipolar II disorder
- Acute agitation associated with schizophrenia
- Immuno-oncology conditions
Who it serves
- Health Systems
- Healthcare providers
- Patients
Deployment & integration
Other deployment with recorded integration context.
Geographic context
MarketsUnited States
Company sourceOfficial website
Company milestones
Platform expansion
SERENITY At-Home Phase 3 trial data presentation at 2026 ASCP Annual Meeting; Virtual event announced for commercial launch plan for IGALMI in at-home setting (April 2026); Q1 2026 financial results reported (May 2026)
Partnerships
Recorded partners
No partners are currently listed.
02 · Flagship portfolio
Products, workflows, and platform capabilities
Selected source-backed Company products and the available commercial context.
03 · Research intelligence
Research Intelligence evidence
Publications, preprints, clinical validation, and regulatory records in Evidence Position order.
Evidence position
Publications, clinical validation, and regulatory records connected to this Company appear here.
Research
Publications & preprints
Phase 2 study of talabostat, a small molecule inhibitor of dipeptidyl peptidases (DPP), administered in combination with pembrolizumab in patients with small cell neuroendocrine prostate cancer.Journal for immunotherapy of cancer · May 11, 2026
Ascending single-dose study of the safety, pharmacokinetics, and pharmacodynamics of CSTI-500, a novel monoamine triple reuptake inhibitor, first-in-human.Psychopharmacology · Mar 1, 2026
Latrepirdine (Dimebon), a potent 5-HT7 receptor antagonist, modulates stress-mediated behaviors in rodents.Frontiers in pharmacology · Jan 1, 2026
Dexmedetomidine HCL (BXCL501) as a potential treatment for alcohol use disorder and comorbid PTSD: A phase 1b, placebo-controlled crossover laboratory study.The American journal on addictions · Jan 1, 2025
Dexmedetomidine potently and reversibly regulates stress-mediated behaviors.Frontiers in pharmacology · Jan 1, 2025
Developing a pragmatic consensus procedure supporting the ICH S1B(R1) weight of evidence carcinogenicity assessment.Frontiers in toxicology · Jan 1, 2024
Clinical validation
Clinical-trial records
An Efficacy, and Safety Study Of BXCL501 For The Treatment Of Agitation Associated With DementiaNCT05276830 · Sponsor · TERMINATED
Dexmedetomidine in the Treatment of Symptoms Of Acute Opioid WithdrawalNCT04470050 · Sponsor · COMPLETED
Determining Efficacy and Safety of BXCL501 in Agitation Associated With Pediatric Schizophrenia and Bipolar DisorderNCT05025605 · Sponsor · RECRUITING
Dexmedetomidine in the Treatment of Agitation Associated With Dementia (TRANQUILITY II)NCT05271552 · Sponsor · COMPLETED
Sub-Lingual Dexmedetomidine in Agitation Associated With SchizophreniaNCT04010305 · Sponsor · COMPLETED
Study of BXCL501 In Agitation Associated With Delirium in ICU PatientsNCT05313386 · Sponsor · WITHDRAWN
Regulatory
Regulatory records
No linked records are currently available.
04 · Company-reported outcomes
Outcomes and case studies
Company-reported outcomes and customer stories are distinct from linked Research Intelligence evidence.
No Company-reported outcomes are currently listed.
05 · Leadership
Leadership team
Leadership profiles and professional links from the current Company record.
No active leadership profiles are currently listed.
06 · Company updates
Updates from BioXcel Therapeutics
Recent articles published on BioXcel Therapeutics's official website.
No Company updates are currently listed.
07 · HAIC coverage
Coverage and analysis
Health AI Central reporting that mentions this Company.
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08 · Official presence
Company sources and channels
Curated official destinations from the active Company record.
09 · Market pathway
Additional Companies in this Market
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Market context
Drug Discovery & Development
Companies using AI, machine learning, or computational biology to discover new drug candidates, identify drug targets, predict drug efficacy, or accelerate pharmaceutical development. Includes both small molecule and biologics development, precision oncology drug discovery, and AI-driven target identification and molecule design.
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