Dexmedetomidine - BioXcel Therapeutics
Alternative Names: BXCL-501; Dex-BioXcel Therapeutics; IGALMI; KalmPen™; Sublingual film containing IgalmiLatest Information Update: 22 May 2025
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
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Orphan Drug Status
Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.
- New Molecular Entity No
Highest Development Phases
- Marketed Agitation
- Phase I/II Opioid-related disorders
- Phase I Post-traumatic stress disorders
- Suspended Alcoholism; Major depressive disorder
Most Recent Events
- 12 May 2025 BioXcel Therapeutics completes enrolment in the phase-III SERENITY At-Home trial for Agitation in USA
- 07 Mar 2025 BioXcel Therapeutics announces intention to submit sNDA for Agitation (At-Home setting) (Sublingual, Film)
- 03 Mar 2025 US FDA closes the inspection of a single site in the phase III TRANQUILITY II trial, under 21 C.F.R.20.64(d), for Agitation in USA (Sublingual) (947226)