drugset
Drugs / BXCL501
last change Aug 2026 re-read 3 minutes ago

BXCL501

also known as dexmedetomidine · IgalmiTM
Developed for
schizophrenia · bipolar I disorder · bipolar II disorder · dementia · schizoaffective disorder · schizophreniform disorder · delirium · substance withdrawal syndrome
Investigated by
BioXcel Therapeutics Inc · Cognitive Research Corporation · CenExel HRI · Clinilabs, Inc. · National Institute on Drug Abuse (NIDA) · New York State Psychiatric Institute
+4 more · Premier Research · ProPharma Group · Worldwide Clinical Trials · Yale University

Trials 9

today NCT07116694 · Ph 2 NCT05712707 · Ph 1/2 NCT05665088 · Ph 3 NCT05658510 · Ph 3 NCT05271552 · Ph 3 NCT05276830 · Ph 2 NCT05025605 · Ph 1 NCT05313386 · Ph 2 NCT04010305 · Ph 1
20202021202220232024202520262027
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 12 trials
Phase 1 NCT05025605 Aug 2021 → Jul 2027 expected bipolar I disorder, bipolar II disorder, schizoaffective disorder, schizophrenia +1 BioXcel Therapeutics Inc Recruiting No outcome recorded
Phase 1 NCT04010305 May → Jul 2019 schizophrenia BioXcel Therapeutics Inc Completed No outcome recorded
Phase 1/21 trial
Phase 1/2 NCT05712707 Feb 2023 → Jun 2025 overdue substance withdrawal syndrome New York State Psychiatric Institute Active not recruiting No outcome recorded
Phase 23 trials
Phase 2 NCT07116694 Jun → Oct 2025 bipolar I disorder, bipolar II disorder, schizoaffective disorder, schizophrenia +1 BioXcel Therapeutics Inc Completed No outcome recorded
Phase 2 NCT05276830 Feb → Apr 2022 dementia BioXcel Therapeutics Inc Terminated No outcome recorded Stop: Business
Phase 2 NCT05313386 Feb 2021 → Feb 2022 delirium BioXcel Therapeutics Inc Withdrawn No outcome recorded Stop: Enrollment
Phase 33 trials
Phase 3 NCT05665088 Dec 2022 → Sep 2023 dementia BioXcel Therapeutics Inc Terminated No outcome recorded Stop: Business
Phase 3 NCT05658510 Nov 2022 → Aug 2025 bipolar I disorder, bipolar II disorder, schizoaffective disorder, schizophrenia +1 BioXcel Therapeutics Inc Completed No outcome recorded
Phase 3 NCT05271552 Apr 2022 → Apr 2023 dementia BioXcel Therapeutics Inc Completed No outcome recorded

Press releases naming this drug 60 releases

DateIssuerRelease
2026-04-08 BioXcel Therapeutics Inc BioXcel Therapeutics Announces Enrollment of First Patients in U.S. Department of War-Funded Study of BXCL501 (Sublingual Dexmedetomidine) for Treatment of Acute Stress Reactions bioxceltherapeutics.com ↗
2026-03-05 BioXcel Therapeutics Inc BioXcel Therapeutics Announces Positive Phase 2 Topline Results from Columbia University-Led Study of BXCL501 for Treatment of Opioid Withdrawal bioxceltherapeutics.com ↗
2025-08-18 BioXcel Therapeutics Inc BioXcel Therapeutics Announces Positive FDA Pre-sNDA Meeting Comments for sNDA Submission for BXCL501 in Agitation Associated with Bipolar Disorders or Schizophrenia bioxceltherapeutics.com ↗
2025-08-06 BioXcel Therapeutics Inc BioXcel Therapeutics Announces Publication in Frontiers in Pharmacology on the Effects of Dexmedetomidine (the active ingredient in BXCL-501) on Stress-Mediated Behaviors in Non-clinical Studies bioxceltherapeutics.com ↗
2024-11-12 BioXcel Therapeutics Inc BioXcel Therapeutics Advances Pivotal Phase 3 Trials of BXCL501 for Acute Treatment of Agitation Associated with Bipolar Disorders, Schizophrenia, and Alzheimer’s Dementia bioxceltherapeutics.com ↗
2024-10-15 BioXcel Therapeutics Inc BioXcel Therapeutics Announces U.S. Department of Defense Grant to University of North Carolina to Fund Study of BXCL501 (Sublingual Dexmedetomidine) for Treating Acute Stress Disorder bioxceltherapeutics.com ↗
2024-09-19 BioXcel Therapeutics Inc BioXcel Therapeutics Announces Clinical Prioritization and Update on BXCL501 Late-Stage Programs for Agitation bioxceltherapeutics.com ↗
2024-09-05 BioXcel Therapeutics Inc BioXcel Therapeutics Announces Initiation of SERENITY At-Home Pivotal Phase 3 Safety Trial of BXCL501 for Acute Treatment of Agitation Associated with Bipolar Disorders or Schizophrenia bioxceltherapeutics.com ↗
2024-07-16 BioXcel Therapeutics Inc BioXcel Therapeutics Announces Preliminary Estimated Unaudited Second Quarter Net Revenues from Sales of IGALMI™ (dexmedetomidine) Sublingual Film bioxceltherapeutics.com ↗
2024-06-25 BioXcel Therapeutics Inc BioXcel Therapeutics Announces Positive Topline Results from Post-Marketing Requirement Study Evaluating PRN Treatment of IGALMI™ (dexmedetomidine) Sublingual Film for Agitation Associated with Bipolar Disorders or Schizophrenia bioxceltherapeutics.com ↗
2024-04-22 BioXcel Therapeutics Inc BioXcel Therapeutics Announces Plan for Evaluating BXCL501 in the At-Home Setting to Expand Its Market Potential bioxceltherapeutics.com ↗
2024-04-10 BioXcel Therapeutics Inc BioXcel Therapeutics Announces TRANQUILITY In-Care Pivotal Phase 3 Trial Plan With BXCL501 for Agitation Associated With Alzheimer’s Dementia bioxceltherapeutics.com ↗

Evidence & citations 4 cited values

Every value below carries the sentence it was read from. 9 sources stand behind the page.

FieldValueCited text
Known as BXCL501 ClinicalTrials.gov intervention name — accepted as the source's own label NCT05271552 ↗
8

NCT05712707 ↗

NCT05276830 ↗

NCT05665088 ↗

NCT07116694 ↗

NCT04010305 ↗

NCT05025605 ↗

NCT05658510 ↗

NCT05313386 ↗
Known as dexmedetomidine “BioXcel Therapeutics has developed BXCL501 (dexmedetomidine: sublingual film) to reduce symptoms associated with opioid withdrawal.” NCT05712707 ↗
Known as IgalmiTM “BXCL501 (120 and 180 mcg: IgalmiTM) was recently FDA approved for the acute treatment of agitation associated with schizophrenia or bipolar I or II disorder in adults.” NCT05712707 ↗
Route Other “Sublingual film” NCT05025605 ↗