Biotech RadarJobs updated

COMPANY

BioXcel Therapeutics

HQ: New Haven, CT source · bioxceltherapeutics.com ↗

FDA-approved therapeutic company Clinical Phase 3

Keywords: neurology oncology immuno-oncology dementia Schizophrenia Schizoaffective Disorder Schizophreniform Disorders Agitation Schizo-Affective Disorder Agitation,Psychomotor Bipolar I Disorder Bipolar II Disorder Bipolar Disorder Psychomotor Agitation Bipolar Disorder I Bipolar Disorder II Cancer of Pancreas Cancer of the Pancreas Pancreatic Neoplasms Pancreas Cancer Pancreatic Cancer Agitation Associated With Bipolar Disorder Opioid Withdrawal Delirium Prostate Cancer Neuroendocrine Tumors Small Cell Carcinoma BXCL501 Talabostat Dexmedetomidine

Location: New Haven, CT · source · Oct 14, 2026

Profile checked Oct 10, 2026

$14.0MRaised (2 yrs)15Trials (company is sponsor)1FDA records (2 yrs)

Timeline

  1. FDA FDA New indication / efficacy supplement: IGALMI (dexmedetomidine hydrochloride) — NDA215390/2, Nov 19, 2025. Applicant at approval: BioXcel Therapeutics, Inc. source ↗
  2. Trial start Phase 2: Assessment of Acute Psychomotor Agitation Measures Associated With Schizophrenia and Bipolar Disorder source ↗
  3. Raise Follow-on offering — Registered direct: $14M (total, as published), announced Mar 3, 2025. Source: company release on GlobeNewswire. source ↗
  4. Grant Government grant: $2.8M (total, as published), announced Oct 15, 2024. Source: company release on GlobeNewswire. source ↗
  5. Trial start Phase 4: Tachyphylaxis, Tolerance, & Withdrawal Post Treatment With Igalmi for Agitation in Schizophrenia or Bipolar Disorder source ↗
  6. Trial start Phase 3: Dexmedetomidine in the Treatment of Agitation Associated With Dementia (TRANQUILITY III) source ↗
  7. Trial start Phase 3: Dexmedetomidine in the Treatment of Agitation Associated With Schizophrenia and Bipolar Disorder (SERENITY III) source ↗
  8. Trial start Phase 3: Dexmedetomidine in the Treatment of Agitation Associated With Dementia (TRANQUILITY II) source ↗
  9. Trial start Phase 2: An Efficacy, and Safety Study Of BXCL501 For The Treatment Of Agitation Associated With Dementia source ↗
  10. Trial start Phase 1: Determining Efficacy and Safety of BXCL501 in Agitation Associated With Pediatric Schizophrenia and Bipolar Disorder source ↗
  11. Trial start Phase 2: Study of BXCL501 In Agitation Associated With Delirium in ICU Patients source ↗
  12. Trial start Phase 1/Phase 2: Dexmedetomidine in the Treatment of Symptoms Of Acute Opioid Withdrawal source ↗
  13. Trial start Phase 3: Dexmedetomidine in the Treatment of Agitation Associated With Bipolar Disorder source ↗
  14. Trial start Phase 3: Dexmedetomidine in the Treatment of Agitation Associated With Schizophrenia source ↗
  15. Trial start Phase 1/Phase 2: Sub-Lingual Dexmedetomidine in Agitation Associated With Dementia source ↗
  16. Trial start Early phase 1: A Pilot Study of BXCL701 in Patients With Pancreatic Cancer source ↗
  17. Trial start Phase 1: Sub-Lingual Dexmedetomidine in Agitation Associated With Schizophrenia source ↗
  18. Trial start Phase 1/Phase 2: A Trial of BXCL701 and Pembrolizumab in Patients With mCRPC Either Small Cell Neuroendocrine Prostate Cancer or Adenocarcinoma Phenotype. source ↗

Upcoming milestones

Estimated primary completion per ClinicalTrials.gov. Dates move.

Funding

Raised: $14.0M. Last 2 years.

Clinical trials (lead sponsor) 15

RecordTitlePhaseStatusStartPrimary completion
NCT07116694Assessment of Acute Psychomotor Agitation Measures Associated With Schizophrenia and Bipolar DisorderPhase 2CompletedJun 19, 2025Oct 7, 2025 (actual)
NCT05665088Dexmedetomidine in the Treatment of Agitation Associated With Dementia (TRANQUILITY III)Phase 3TerminatedDec 5, 2022Sep 11, 2023 (actual)
NCT05271552Dexmedetomidine in the Treatment of Agitation Associated With Dementia (TRANQUILITY II)Phase 3CompletedApr 27, 2022Apr 21, 2023 (actual)
NCT05025605Determining Efficacy and Safety of BXCL501 in Agitation Associated With Pediatric Schizophrenia and Bipolar DisorderPhase 1RecruitingAug 27, 2021Jul 31, 2027 (estimated)
NCT05276830An Efficacy, and Safety Study Of BXCL501 For The Treatment Of Agitation Associated With DementiaPhase 2TerminatedFeb 8, 2022Apr 1, 2022 (actual)
NCT04123574A Pilot Study of BXCL701 in Patients With Pancreatic CancerEarly phase 1WithdrawnOct 15, 2019Dec 6, 2021 (estimated)
NCT06041646Tachyphylaxis, Tolerance, & Withdrawal Post Treatment With Igalmi for Agitation in Schizophrenia or Bipolar DisorderPhase 4CompletedOct 2, 2023Apr 29, 2024 (actual)
NCT04276883Dexmedetomidine in the Treatment of Agitation Associated With Bipolar DisorderPhase 3CompletedFeb 24, 2020May 21, 2020 (actual)
NCT04251910Sub-Lingual Dexmedetomidine in Agitation Associated With DementiaPhase 1/Phase 2CompletedDec 27, 2019Jan 24, 2022 (actual)
NCT04268303Dexmedetomidine in the Treatment of Agitation Associated With SchizophreniaPhase 3CompletedJan 24, 2020May 6, 2020 (actual)
NCT04470050Dexmedetomidine in the Treatment of Symptoms Of Acute Opioid WithdrawalPhase 1/Phase 2CompletedJun 9, 2020Feb 18, 2021 (actual)
NCT04010305Sub-Lingual Dexmedetomidine in Agitation Associated With SchizophreniaPhase 1CompletedMay 22, 2019Jul 31, 2019 (actual)
NCT05313386Study of BXCL501 In Agitation Associated With Delirium in ICU PatientsPhase 2WithdrawnFeb 23, 2021Feb 21, 2022 (estimated)
NCT05658510Dexmedetomidine in the Treatment of Agitation Associated With Schizophrenia and Bipolar Disorder (SERENITY III)Phase 3CompletedNov 21, 2022Aug 15, 2025 (actual)
NCT03910660A Trial of BXCL701 and Pembrolizumab in Patients With mCRPC Either Small Cell Neuroendocrine Prostate Cancer or Adenocarcinoma Phenotype.Phase 1/Phase 2CompletedFeb 12, 2019Oct 31, 2023 (actual)

FDA records (last 2 years)

Connect

See your connections at BioXcel Therapeutics on LinkedIn (search by name, results not checked)

LinkedIn shows your 1st and 2nd-degree connections here from your own login, including who could introduce you. Radar doesn't see your connections.

LinkedIn page linked from the company's own site: source · seen 2026-10-12

Feedback