drug · small molecule
dexmedetomidine
Marketedupdated 3mo agoby $BTAI BioXcel Therapeutics, Inc.🔗 ChEMBL
Approvedcommunity read0 votes
🐶 often sniffed alongside
top 8- tagApproval34 co-mentions · 14 sources
- drugIGALMI28 co-mentions · 19 sources
- drugDEXMEDETOMIDINE HYDROCHLORIDE22 co-mentions · 19 sources
- tagPain5 co-mentions · 5 sources
- tagDrug Shortage5 co-mentions · 5 sources
- companyAffiliated Hospital of Xuzhou Medical University3 co-mentions · 3 sources
- companyJawaharlal Nehru Medical College2 co-mentions · 2 sources
- tagPulmonology2 co-mentions · 1 sources
Small molecule drug with a maximum clinical stage of Approval (across all indications), with an approval for irritability and 84 investigational indications.
indications
investigational
Schizophrenia
targets
Adrenergic receptor alpha-2
all catalysts(18)
approval · 3
Apr 5, 2022
approval
$BTAI0.9215-10.53%
IGALMI (DEXMEDETOMIDINE HYDROCHLORIDE) — FDA approval
dexmedetomidine
→
Oct 24, 2022
approval
$BTAI0.9215-10.53%
IGALMI (DEXMEDETOMIDINE HYDROCHLORIDE) — FDA approval
dexmedetomidine
→
Nov 19, 2025
approval
$BTAI0.9215-10.53%
IGALMI (DEXMEDETOMIDINE HYDROCHLORIDE) — FDA approval
dexmedetomidine
→
phase 0 trial completion · 7
Apr 30, 2026
phase 0 trial completion
Civil Aviation General Hospital — dexmedetomidine (Phase 0 Trial Completion)
dexmedetomidine
→
Apr 30, 2026
phase 0 trial completion
Affiliated Hospital of Xuzhou Medical University — dexmedetomidine (Phase 0 Trial Completion)
dexmedetomidine
→
Apr 30, 2026
phase 0 trial completion
Affiliated Hospital of Xuzhou Medical University — dexmedetomidine (Phase 0 Trial Completion)
dexmedetomidine
→
Apr 30, 2026
phase 0 trial completion
Funing County People's Hospital — dexmedetomidine (Phase 0 Trial Completion)
dexmedetomidine
→
Apr 30, 2026
phase 0 trial completion
Kunming Yan'an Hospital — dexmedetomidine (Phase 0 Trial Completion)
dexmedetomidine
→
Apr 30, 2026
phase 0 trial completion
Ruijin Hospital — dexmedetomidine (Phase 0 Trial Completion)
dexmedetomidine
→
Apr 30, 2026
phase 0 trial completion
Affiliated Hospital of Xuzhou Medical University — dexmedetomidine (Phase 0 Trial Completion)
dexmedetomidine
→
phase 2 3 completion · 1
phase 2 completion · 6
Apr 25, 2026
phase 2 completion
Jawaharlal Nehru Medical College — dexmedetomidine (Phase II Trial Completion)
dexmedetomidine
→
Apr 25, 2026
phase 2 completion
Jawaharlal Nehru Medical College Ajmer — dexmedetomidine (Phase II Trial Completion)
dexmedetomidine
→
Apr 26, 2026
phase 2 completion
All India Institute of Medical Sciences Bibinagar — dexmedetomidine (Phase II Trial Completion)
dexmedetomidine
→
Apr 30, 2026
phase 2 completion
Gandhi Medical College & Hospital — dexmedetomidine (Phase II Trial Completion)
dexmedetomidine
→
Apr 30, 2026
phase 2 completion
Wannan Medical College First Affiliated Hospital — dexmedetomidine (Phase II Trial Completion)
dexmedetomidine
→
Apr 30, 2026
phase 2 completion
Smt.B.K.Shah Medical Institute & Research Centre & Dhiraj Hospital — dexmedetomidine (Phase II Trial Completion)
dexmedetomidine
→
Trials studying dexmedetomidine
- phase1Sub-Lingual Dexmedetomidine in Agitation Associated With Schizophrenia
- phase2Pharmacological Enhancement of Glymphatic Function in Humans
- phase3Observation of the Effect of Preoperative Use of Dexmedetomidine Hydrochloride Nasal Spray on Optimizing Awake Sedation During Breast-Conserving Surgery for Breast Cancer and Postoperative Awake Status
- phase4Tachyphylaxis, Tolerance, & Withdrawal Post Treatment With Igalmi for Agitation in Schizophrenia or Bipolar Disorder
- phase1Effect of Sublingual Formulation of Dexmedetomidine Hydrochloride (HCl) (BXCL501) - Outpatient Study
- phase3Goal-Directed Sedation in Mechanically Ventilated Infants and Children
- phase2The Study is Being Conducted to Evaluate the Efficacy and Safety of Dexmedetomidine Hydrochloride Microneedles for Preoperative Sedation in Children
- —A Study to Learn About the Study Medicine - Precedex in Children From Japan.
Patent cliff
source: FDA Orange Bookfirst barrier falls
Nov 19, 2028
~2.3 years out
Earliest of all listed patents + FDA exclusivities. Generic / biosimilar entry typically only becomes possible AFTER both patent and exclusivity barriers expire.
patents (28)
- Jan 12, 2043method-of-use (U-3725)US 11806334
- Jan 12, 2043method-of-use (U-3725)US 11806334
- Jan 12, 2043method-of-use (U-3935)US 11998528
- Jan 12, 2043method-of-use (U-3935)US 11998528
- Jan 12, 2043method-of-use (U-3986)US 12090140
- Jan 12, 2043method-of-use (U-3986)US 12090140
- Jan 12, 2043method-of-use (U-4029)US 12138247
- Jan 12, 2043method-of-use (U-4029)US 12138247
- Jan 12, 2043method-of-use (U-4029)US 12364683
- Jan 12, 2043method-of-use (U-4029)US 12364683
- Jul 17, 2040method-of-use (U-3756)US 11890272
- Jul 17, 2040method-of-use (U-3756)US 11890272
- Jul 17, 2040method-of-use (U-3935)US 11998529
- Jul 17, 2040method-of-use (U-3935)US 11998529
- Jul 17, 2040method-of-use (U-3935)US 12109196
- Jul 17, 2040method-of-use (U-3935)US 12109196
- Jun 26, 2039formulationUS 10792246
- Jun 26, 2039formulationUS 10792246
- Jun 26, 2039formulationUS 11478422
- Jun 26, 2039formulationUS 11478422
- Jun 26, 2039formulationUS 11497711
- Jun 26, 2039formulationUS 11497711
- Jun 26, 2039formulationUS 11517524
- Jun 26, 2039formulationUS 11517524
- Dec 29, 2037method-of-use (U-3698)US 11786508
- Dec 29, 2037method-of-use (U-3698)US 11786508
- Dec 29, 2037method-of-use (U-3756)US 11839604
- Dec 29, 2037method-of-use (U-3756)US 11839604
FDA exclusivities (2)
- Nov 19, 2028M-82Method (3y)2.3y
- Nov 19, 2028M-82Method (3y)2.3y
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