Either you have JavaScript disabled or your browser does not support Javascript . To work properly, this page requires JavaScript to be enabled.
How to enable JavaScript in your browser?

Dexmedetomidine - BioXcel Therapeutics

Next Previous
Drug Profile

Dexmedetomidine - BioXcel Therapeutics

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

Latest Information Update: 15 Apr 2026

Price :
$50 *
Note:
  • Adis is an information provider. We do not sell or distribute actual drugs.
  • Final gross price and currency may vary according to local VAT and billing address.
  • Your purchase entitles you to full access to the information contained in our drug profile at the time of purchase.
  • A link to download a PDF version of the drug profile will be included in your email receipt.

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

  • 01 Apr 2026 US FDA accepts sNDA for IGALMI® for Agitation for review
  • 01 Apr 2026 FDA assigns PDUFA action date of 14/11/2026 for dexmedetomidine for Agitation (Sublingual, Film)
  • 27 Mar 2026 BioXcel Therapeutics expects to receive approval from US FDA for sNDA for Agitation by end of 2026

You need to be a logged in or subscribed to view this content

Request demo (opens in a new window)
If your organization or you do not have a subscription, try one of the following: If your organization has a subscription, there are several access options, even while working remotely:
  • Working within your organization’s network
  • with username/password or try to via your institution
  • Persisted access using your organization’s identifier stored in your user browser for 90 days
Back to top