PharmaKB logo
Company Reports
Company Reports
Drug Reports
Drug Reports
Disease Reports
Disease Reports
Sets
Sets
Favorites
Favorites
Log in
Log in
AboutPricing
Drug ReportsDexmedetomidine
Precedex, Dexdor(dexmedetomidine)
Dexdor, Dexmedetomidine, Igalmi, Precedex (dexmedetomidine) is a small molecule pharmaceutical. Dexmedetomidine was first approved as Precedex on 1999-12-17. It is used to treat pain and psychomotor agitation in the USA. It has been approved in Europe to treat conscious sedation and premedication.
Download report
Favorite
Events Timeline
Commercial
Clinical
Drug
Target
Variants
Financial
Trends
Safety
Events Timeline
5D
1M
3M
6M
YTD
1Y
2Y
5Y
Max
Events
FDA approval date
EMA approval date
Patent expiration date
Study first post date
Last update post date
Start date
Primary completion date
Completion date
Results first post date
Plot placeholder
Mock data
Subscribe for the real data
Commercial
Therapeutic Areas
Therapeutic Area
MeSH
nervous system diseasesD009422
signs and symptoms pathological conditionsD013568
therapeuticsD013812
anesthesia and analgesiaD000760
behavior and behavior mechanismsD001520
psychological phenomenaD011579
musculoskeletal and neural physiological phenomenaD055687
Trade Name
FDA
EMA
Dexmedetomidine, Igalmi, Precedex (discontinued: Dexmedetomidine)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Dexmedetomidine hydrochloride
Tradename
Company
Number
Date
Products
IGALMIBioxcel TherapeuticsN-215390 RX2022-04-05
2 products, RLD, RS
PRECEDEXHospiraN-021038 RX1999-12-17
5 products, RLD, RS
DEXMEDETOMIDINE HYDROCHLORIDEHQ Specialty PharmaN-206628 RX2015-10-21
4 products, RLD, RS
Labels
FDA
EMA
Brand Name
Status
Last Update
dexmedetomidineANDA2025-09-25
dexmedetomidine dexmedetomidine hydrochlorideANDA2023-06-01
dexmedetomidine dexmedetomidine in dextroseNew Drug Application2025-03-11
dexmedetomidine hclANDA2023-05-04
dexmedetomidine hydrochlorideANDA2025-09-25
dexmedetomidine hydrochloride dexmedetomidine hydrochloride in dextroseNew Drug Application2021-12-31
dexmedetomidine hydrochloride in 0.9% sodium chlorideANDA2024-11-06
dexmedetomidine hydrochloride in sodium chlorideANDA2023-12-21
igalmiNew Drug Application2022-12-14
precedexNew Drug Application2025-06-18
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
painEFO_0003843D010146R52
psychomotor agitation—D011595—
Agency Specific
FDA
EMA
Expiration
Code
DEXMEDETOMIDINE HYDROCHLORIDE, PRECEDEX, HOSPIRA
2025-12-16NPP
DEXMEDETOMIDINE HYDROCHLORIDE, IGALMI, BIOXCEL
2025-04-05NP
Patent Expiration
Patent
Expires
Flag
FDA Information
Dexmedetomidine Hydrochloride, Igalmi, Bioxcel
107922462039-06-26DPU-3350
114784222039-06-26DP
114977112039-06-26DPU-3645
115175242039-06-26DPU-3645
Dexmedetomidine Hydrochloride, Dexmedetomidine Hydrochloride, Hq Spclt Pharma
96492962036-04-20DP
97177962036-04-20DP
Dexmedetomidine Hydrochloride, Precedex, Hospira
82421582032-01-04DP
83384702032-01-04DP
84555272032-01-04U-421
86481062032-01-04DP
93207122032-01-04DP
96160492032-01-04DP
100163962032-01-04DP
ATC Codes
N: Nervous system drugs
— N05: Psycholeptics
— N05C: Hypnotics and sedatives
— N05CM: Other hypnotics and sedatives in atc
— N05CM18: Dexmedetomidine
HCPCS
No data
Clinical
Clinical Trials
1918 clinical trials
View more details
Plot placeholder
Mock data
Subscribe for the real data
Indications Phases 4
No data
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Conscious sedationD016292————1——1
Respiratory insufficiencyD012131—J96.9——1——1
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
HemorrhageD006470MP_0001914R5811———1
Subarachnoid hemorrhageD013345EFO_0000713I6011———1
AneurysmD000783—I72.911———1
Brain injuriesD001930—S06.9—1———1
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
PharmacokineticsD010599——1————1
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Critical illnessD016638——————11
Epidemiology
Epidemiological information for investigational and approved indications
View more details
Drug
General
Drug common nameDexmedetomidine
INNdexmedetomidine
Description
Dexmedetomidine is a medetomidine. It has a role as an alpha-adrenergic agonist, a non-narcotic analgesic, an analgesic and a sedative. It is an enantiomer of a levomedetomidine.
Classification
Small molecule
Drug class—
Image (chem structure or protein)Loading
Structure (InChI/SMILES or Protein Sequence)
Cc1cccc([C@H](C)c2c[nH]cn2)c1C
Identifiers
PDB—
CAS-ID113775-47-6
RxCUI—
ChEMBL IDCHEMBL778
ChEBI ID4466
PubChem CID5311068
DrugBankDB00633
UNII ID67VB76HONO (ChemIDplus, GSRS)
Target
No data
Variants
No data
Financial
Revenue by drug
$
€
£
₣
Precedex – Pfizer
Plot placeholder
Mock data
Subscribe for the real data
Plot placeholder
Mock data
Subscribe for the real data
Tabular view
Estimated US medical usage
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
Plot placeholder
Mock data
Subscribe for the real data
Additional graphs summarizing 28,403 documents
View more details
Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
Plot placeholder
Mock data
Subscribe for the real data
3,774 adverse events reported
View more details
© 2020-2025 Collaborative Drug Discovery Inc. (CDD) | Terms of Use