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Igalmi FDA Approval History

Last updated by Judith Stewart, BPharm on Aug 10, 2022.

FDA Approved: Yes (First approved April 5, 2022)
Brand name: Igalmi
Generic name: dexmedetomidine
Dosage form: Sublingual Film
Company: BioXcel Therapeutics, Inc.
Treatment for: Agitation

Igalmi (dexmedetomidine) is a sublingual film formulation of the approved alpha2-adrenergic receptor agonist dexmedetomidine indicated for the acute treatment of agitation associated with schizophrenia or bipolar I or II disorder in adults.

  • Dexmedetomidine was first approved in injection form under the brand name Precedex in 1999 for the sedation of ventilated patients in intensive care.
  • Igalmi should be administered under the supervision of a healthcare provider, who will monitor vital signs and alertness to prevent falls and syncope.
  • Igalmi sublingual film is for sublingual or buccal administration, and should not be chewed or swallowed. Patients should not not eat or drink for at least 15 minutes after sublingual administration, or at least one hour after buccal administration.
  • Warnings and precautions associated with Igalmi include hypotension, orthostatic hypotension, and bradycardia; QT interval prolongation; and somnolence.
  • Common adverse reactions include somnolence, paresthesia or oral hypoesthesia, dizziness, dry mouth, hypotension, and orthostatic hypotension.

Development timeline for Igalmi

Apr  6, 2022Approval FDA Approves Igalmi (dexmedetomidine) Sublingual Film for Acute Treatment of Agitation Associated with Schizophrenia or Bipolar I or II Disorder in Adults
May 19, 2021BioXcel Therapeutics Announces FDA Acceptance for Filing of NDA for BXCL501 for the Acute Treatment of Agitation Associated with Schizophrenia and Bipolar Disorders I and II
Mar 11, 2021BioXcel Therapeutics Submits New Drug Application to U.S. Food and Drug Administration for BXCL501 for the Acute Treatment of Agitation Associated with Schizophrenia and Bipolar Disorders
Dec 27, 2018BioXcel Therapeutics Receives FDA Fast Track Designation for BXCL501 for Acute Treatment of Agitation

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.