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Dexmedetomidine - BioXcel Therapeutics

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Drug Profile

Dexmedetomidine - BioXcel Therapeutics

Alternative Names: BXCL-501; Dex-BioXcel Therapeutics; IGALMI; KalmPen™; Sublingual film containing Igalmi

Latest Information Update: 27 Aug 2025

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At a glance

  • Originator Inveni
  • Developer BioXcel Therapeutics
  • Class Antidepressants; Antipsychotics; Anxiolytics; Behavioural disorder therapies; Drug withdrawal therapies; Hypnosedatives; Imidazoles; Non-opioid analgesics; Sleep disorder therapies; Small molecules
  • Mechanism of Action Alpha 2 adrenergic receptor agonists
  • Orphan Drug Status

    Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

    No
  • New Molecular Entity No

Highest Development Phases

  • Marketed Agitation
  • Phase I/II Opioid-related disorders
  • Phase I Post-traumatic stress disorders
  • Preclinical Psychiatric disorders
  • Suspended Alcoholism; Major depressive disorder

Most Recent Events

  • 19 Aug 2025 The US FDA gave positive Pre-sNDA Meeting Comments for sNDA Submission for BXCL 501 in Agitation associated with bipolar disorders or Schizophrenia
  • 18 Aug 2025 BioXcel Therapeutics announces intention to submit sNDA submission on Q1 2026
  • 06 Aug 2025 Preclinical trials in Psychiatric disorders in USA (Sublingual) before August 2025

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