BioXcel Therapeutics
BioXcel Therapeutics is a clinical-stage biopharmaceutical company using its proprietary NovareAI platform to re-innovate existing drugs, commercializing IGALMI for acute agitation in schizophrenia/bipolar disorder and developing pipeline candidates BXCL501 (multiple neuroscience indications) and BXCL701 (immuno-oncology).
- Company typePublic
- Founded2017
- HeadquartersNew Haven, United States
- Headcount51–100
- GTM typeB2B
- OfferingHardware or Manufacturing
What BioXcel Therapeutics does
BioXcel Therapeutics is a clinical-stage biopharmaceutical company that applies its proprietary NovareAI platform — a composite of machine learning and big data analytics — to identify new therapeutic indications for existing approved drugs and clinically evaluated candidates, focusing on neuroscience and immuno-oncology. The company's lead commercial asset is IGALMI (BXCL501), a proprietary sublingual film formulation of dexmedetomidine that received FDA approval in April 2022 for the acute treatment of agitation associated with schizophrenia and bipolar I or II disorder in adults, distributed as a prescription pharmaceutical through healthcare providers under direct supervision.
The pipeline is built around BXCL501 extensions into adjacent indications (at-home use of IGALMI under FDA review with a November 14, 2026 decision target, agitation in Alzheimer's dementia with Breakthrough Therapy designation, opioid withdrawal with positive Phase 2 data, and Department of War-funded acute stress trials) plus BXCL701, an oral innate immune activator housed in the OnkosXcel Therapeutics subsidiary for aggressive cancers including metastatic castration-resistant prostate cancer and pancreatic cancer. The company also lists early-stage candidates BXCL502 (chronic dementia agitation) and BXCL503 (dementia apathy).
BioXcel generates revenue solely from IGALMI product sales, which declined sharply from $2.266 million in FY2024 to $0.642 million in FY2025 as the company pivoted resources toward an at-home launch and FDA submission. The business model combines product commercialization with repeated dilutive registered direct equity offerings; capital has also been raised through a $260 million strategic financing agreement with Oaktree Capital Management and Qatar Investment Authority. The company has engaged MTS Health Partners to explore strategic options including a potential sale, merger, collaboration, or licensing for the IGALMI franchise. BioXcel is headquartered in New Haven, Connecticut, trades on NASDAQ under ticker BTAI, and operates as a Delaware-incorporated C-corporation.
BioXcel Therapeutics firmographics
Firmographics- Name
- BioXcel Therapeutics
- Legal name
- BioXcel Therapeutics, Inc.
- Website
- https://bioxceltherapeutics.com
- Company type
- Public
- Founded year
- 2017
- Operating status
- Operating
- Headcount range
- 51–100 employees
- Short description
- BioXcel Therapeutics is a clinical-stage biopharmaceutical company using its proprietary NovareAI platform to re-innovate existing drugs, commercializing IGALMI for acute agitation in schizophrenia/bipolar disorder and developing pipeline candidates BXCL501 (multiple neuroscience indications) and BXCL701 (immuno-oncology).
- Ownership category
- akta.pro rank
BioXcel Therapeutics industry classification
Industry- Product category
- Clinical-stage biopharmaceutical (neuroscience and immuno-oncology)
- NAICS
- Pharmaceutical and Medicine Manufacturing (3254), Biological Product (except Diagnostic) Manufacturing (325414), Research and Development in Biotechnology (except Nanobiotechnology) (541714)
- SIC
- Pharmaceutical Preparations (2834), Biological Products, (No Disgnostic Substances) (2836)
- akta.pro primary industry
- Neurology & CNS Specialty Pharmaceuticals (HLAIACAC)
- akta.pro secondary industries
- Neurology & Psychiatry (CNS) Pharmaceuticals (HLAIAAAF), Immunology & Autoimmune Specialty Pharmaceuticals (HLAIACAB), Cytokines, Interferons & Immunomodulatory Proteins (HLAAAAAC), Protein Interaction & Structural Biology Platforms (cryo-EM, X-ray, NMR, biophysics) (HLAAAIAH)
Keywords
Where BioXcel Therapeutics is headquartered
LocationHeadquarters
- HQ city
- New Haven
- HQ country
- United States
- HQ region
- North America
Offices1 record
Markets served
BioXcel Therapeutics business model
Business model- GTM type
- B2B
- Offering type
- Hardware or Manufacturing
- Cost components
- Technology or R&D, Personnel, Marketing or Sales
Revenue model
- IGALMI Product Sales: BioXcel Therapeutics generates revenue from commercial sales of IGALMI (dexmedetomidine sublingual film), FDA-approved for acute treatment of agitation associated with schizophrenia or bipolar I or II disorder in adults. The company reports declining revenue as focus shifts to at-home launch preparations.
- Strategic Financing: The company has raised capital through registered direct offerings of common stock and warrants, and strategic financing agreements with institutional investors including credit facilities and revenue interest financing.
Go-to-market motion1 record
Distribution channels1 record
Marketing channels4 records
BioXcel Therapeutics product offering
Product offeringCore offering
BioXcel Therapeutics develops and commercializes AI-enabled pharmaceutical products in neuroscience and immuno-oncology. Its commercial product is IGALMI, a sublingual dexmedetomidine film FDA-approved for acute agitation in schizophrenia and bipolar I/II disorder. The company also develops pipeline candidates including BXCL501 (additional agitation, opioid withdrawal, and acute stress indications), BXCL701 (immuno-oncology), BXCL502, and BXCL503, leveraging its proprietary NovareAI platform for drug re-innovation.
Product overview
BioXcel Therapeutics is a clinical-stage biopharmaceutical company utilizing artificial intelligence to develop medicines in neuroscience and immuno-oncology. The company's commercial product is IGALMI™ (dexmedetomidine sublingual film), FDA-approved for acute treatment of agitation associated with schizophrenia or bipolar disorder. Its pipeline includes BXCL501, the same formulation in development for at-home use, Alzheimer's agitation, acute stress reactions, and opioid withdrawal. Through its OnkosXcel Therapeutics subsidiary, the company is developing BXCL701, an innate immune activator for aggressive cancers. The company's proprietary NovareAI platform enables AI-driven drug re-innovation by identifying new indications for existing drugs and clinically evaluated compounds.
Differentiator
Problem solved
Functional benefit
Brands
- IGALMI: FDA-approved dexmedetomidine sublingual film for acute treatment of agitation associated with schizophrenia or bipolar I or II disorder in adults.
- NovareAI
Products and services
- IGALMI (dexmedetomidine) sublingual film FDA-approved sublingual film formulation of dexmedetomidine for the acute treatment of agitation associated with schizophrenia or bipolar I/II disorder in adults. Self-administered under healthcare provider supervision. Commercial product generating net revenue of $0.642 million in FY2025.
- BXCL501 (investigational dexmedetomidine sublingual film) Proprietary orally dissolving film formulation of dexmedetomidine being evaluated for agitation associated with dementia due to probable Alzheimer's disease, bipolar disorder/schizophrenia in the at-home setting, acute stress reactions, and opioid withdrawal symptoms. Has demonstrated over 30% reduction in opioid withdrawal scores versus placebo and significantly lower orthostatic hypotension rates (18%) versus lofexidine (50%).
- BXCL701 Investigational oral innate immune activator developed to render 'cold' tumors 'hot,' making them more detectable by the adaptive immune system and potentially synergistic with checkpoint inhibitors. Being developed for metastatic castration-resistant prostate cancer (mCRPC) including small cell neuroendocrine carcinoma (SCNC) and adenocarcinoma phenotypes, pancreatic cancer, and other solid tumors.
- BXCL502 Early-stage pipeline candidate being developed for the treatment of chronic agitation in dementia.
- BXCL503 Early-stage pipeline candidate being developed for the treatment of apathy in dementia.
Quantifiable outcome
- Phase 3 SERENITY At-Home trial met primary safety objective; BXCL501 reduced agitation compared to placebo across all baseline severity levels
- +2 more outcomes
Companies that use BioXcel Therapeutics
Customer profileNamed customers1 record
Segments4 records
Ideal customer profiles2 records
BioXcel Therapeutics technology and API
TechnologyTechnology focussed Yes
API detail
- Has API
- No
- API docs
- API detail
Core technology
AI maturity
App detail
AI capability4 records
Feature3 records
BioXcel Therapeutics partnerships and signals
Strategic signalPartnerships
Four partnerships are on record, tiered flagship, core and minor.
- MTS Health PartnersflagshipEngaged as financial advisor to explore strategic options for IGALMI franchise, including potential outright sale, merger, collaboration, or licensing agreements. The FDA decision on November 14, 2026 represents a critical binary event for potential transactions.
- University of North Carolina at Chapel HillcorePhase 2a trial of BXCL501 for acute stress reactions funded by U.S. Department of War, led by UNC Institute for Trauma Recovery. Trial evaluates drug's potential to reduce symptom severity and prevent progression to chronic neuropsychiatric symptoms following trauma.
- Columbia UniversitycoreClinical trial collaboration for BXCL501, including Phase 2 trial for opioid withdrawal symptoms in adults with opioid use disorder undergoing methadone taper.
- Yale University Medical SchoolminorClinical trial collaboration for BXCL501 neuroscience programs.
Scale indicators12 records
Recent moves8 records
Expansion highlights7 records
BioXcel Therapeutics competitors and assessment
Company assessmentMarket position
Competitive moat4 records
Key risks6 records
Key highlights7 records
Customer concentration
BioXcel Therapeutics social profiles
Digital presenceBioXcel Therapeutics financial estimates
Financial estimateRevenue estimate
Valuation estimate
BioXcel Therapeutics leadership team
Management profileNumber of profiles
Profiles11 records
BioXcel Therapeutics subsidiaries and ownership
Company hierarchySubsidiaries1 record
BioXcel Therapeutics funding detail
Funding detailFunding overview
Funding rounds8 records
Investors2 records
Funding detail is available on the Subscription and Enterprise plan.Contact sales →
BioXcel Therapeutics M&A and investment
M&A and investmentM&A
Investments
M&A and investment is available on the Subscription and Enterprise plan.Contact sales →
Frequently asked questions about BioXcel Therapeutics
What does BioXcel Therapeutics do?
BioXcel Therapeutics develops and commercializes AI-enabled pharmaceutical products in neuroscience and immuno-oncology. Its commercial product is IGALMI, a sublingual dexmedetomidine film FDA-approved for acute agitation in schizophrenia and bipolar I/II disorder. The company also develops pipeline candidates including BXCL501 (additional agitation, opioid withdrawal, and acute stress indications), BXCL701 (immuno-oncology), BXCL502, and BXCL503, leveraging its proprietary NovareAI platform for drug re-innovation.
Is BioXcel Therapeutics a public or private company?
BioXcel Therapeutics is a public company. It is classified as public and is currently operating.
When was BioXcel Therapeutics founded?
BioXcel Therapeutics was founded in 2017. It employs 51 to 100 people.
Where is BioXcel Therapeutics based?
BioXcel Therapeutics is headquartered in New Haven, United States, in the North America region.
How does BioXcel Therapeutics make money?
Two revenue lines are on record. IGALMI Product Sales are the primary driver. The others are strategic Financing.
Does BioXcel Therapeutics have an API?
No public API is recorded for BioXcel Therapeutics.
What industry is BioXcel Therapeutics in?
BioXcel Therapeutics's product category is Clinical-stage biopharmaceutical (neuroscience and immuno-oncology). Its primary akta.pro industry code is HLAIACAC, Neurology & CNS Specialty Pharmaceuticals, with a secondary code of HLAIAAAF, Neurology & Psychiatry (CNS) Pharmaceuticals. Its NAICS code is 3254 and its SIC code is 2834.