NDABUCCAL, SUBLINGUALFILM
Approved
Apr 2022
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
20
Data completeness
6/8 — Strong
IGALMI (dexmedetomidine) by BioXcel Therapeutics is adrenergic alpha2-agonists [moa]. First approved in 2022.
Drug data last refreshed 9h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
IGALMI is a buccal/sublingual film formulation of dexmedetomidine, a central alpha-2 adrenergic agonist approved in April 2022. The drug is indicated for acute agitation in adults, leveraging its sedative and anxiolytic properties via selective alpha-2 receptor binding in the central nervous system. This novel delivery format targets rapid onset in acute care settings without IV administration.
$0.065BPart D
Peak16.6 years to LOEProduct is in peak commercial phase with modest Part D penetration; brand team likely stabilized at full operational scale with opportunity for market expansion strategies.
Mechanism of Action
Adrenergic alpha2-Agonists
Pharmacologic Class:
Central alpha-2 Adrenergic Agonist
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (20)
Dexmedetomidine-esketamine and tDCS for Prevention of Neurocognitive Complications After Surgery
Started Jun 2026
1,160 enrolled
Older PatientsSurgeryDexmedetomidine+3 more
Long-term Follow-up of Dexmedetomidine-esketamine and tDCS for Neurocognitive Complications After Surgery
Started Jun 2026
1,160 enrolled
Older PatientsSurgeryDexmedetomidine+4 more
Effect of Sublingual Formulation of Dexmedetomidine Hydrochloride (HCl) (BXCL501) - Outpatient Study
Started Jul 2025
10 enrolled
Alcohol Use Disorder (AUD)Post Traumatic Stress Disorder (PTSD)
Effect of Perioperative Dexmedetomidine on Chronic Post-Surgical Pain
Started Jul 2025
364 enrolled
Chronic Post-Surgical Pain
Liposomal Bupivacaine Vs Bupivacaine with Dexmedetomidine in Erector Spinae Plane Blocks for Mastectomies
Started Oct 2024
200 enrolled
Breast Cancer
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.