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Drugs A–Z › BXCL501
Approved
FDA, Apr 2022
1
Registered trials
What is BXCL501?
BXCL501 (Igalmi) is an alpha-2 adrenergic receptor agonist with sedative properties. It is being studied for opioid withdrawal.
Summary written with AI from the sources listed at the end of this page.
At a glance
Also known as Igalmi, Precedex Drug type Small molecule
Targets
alpha-2 adrenergic receptor (ADRA2A)
Mechanism Agonist of alpha-2 adrenergic receptor (ADRA2A) Pathways sedation Therapy area Psychiatry Developer
Bioxcel (BTAI )
FDA status
Approved as Igalmi, Precedex (April 5, 2022), NDA215390 · FDA label
✅ FDA-approved uses
Sedation of initially intubated and mechanically ventilated adult patients during treatment in an intensive care setting (Precedex)
Sedation of non-intubated adult patients prior to and/or during surgical and other procedures (Precedex)
Sedation of non-intubated pediatric patients aged 1 month to less than 18 years prior to and during non-invasive procedures (Precedex)
From the indications section of the FDA label (version of Jun 9, 2026). Read the full label for the exact wording, limitations and safety information.
🧪 Clinical trials
Trial Phase Condition Status Sponsor
NCT05712707 Phase 1/2
Opioid Use Disorder
Active not recruiting
BTAI
Trials of the companies BioRadar tracks, from ClinicalTrials.gov, most advanced phase first.
Conditions studied
Opioid Use Disorder Opioid Withdrawal
Other drugs acting on ADRA2A
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Data: FDA (Drugs@FDA, Purple Book, DailyMed), NIH (NCI Thesaurus, GSRS, RxNorm), ClinicalTrials.gov • Informational purposes only, not medical or investment advice. • All drugs A–Z