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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: 02 Sep 2026

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

Most Recent Events

  • 28 Aug 2026 Teva Pharmaceuticals acquires Dexmedetomidine from BioXcel Therapeutics
  • 28 May 2026 Efficacy data from a phase III SERENITY At home trial in Agitation released by BioXcel Therapeutics
  • 01 Apr 2026 FDA assigns PDUFA action date of 14/11/2026 for dexmedetomidine for Agitation (Sublingual, Film)

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