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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.
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EMA approval date
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Study first post date
Last update post date
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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
1917 clinical trials
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Psychomotor agitationD011595——2552—13
SchizophreniaD012559EFO_0000692F202122—7
Bipolar disorderD001714EFO_0000289F30.91122—6
Psychotic disordersD011618—F20.811122—6
Psychotic affective disordersD000341—F391—12—4
Mood disordersD019964EFO_0004247F30-F391—12—4
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
DementiaD003704EFO_0003862F03122——4
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
DeliriumD003693—R41.0—2———2
Substance withdrawal syndromeD013375EFO_0005800—11———1
Opioid-related disordersD009293EFO_0005611F1111———1
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
AlcoholismD000437EFO_0003829F10.12————2
Post-traumatic stress disordersD013313EFO_0001358F43.12————2
Alcohol drinkingD000428EFO_0004329—2————2
Traumatic stress disordersD040921——1————1
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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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—
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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
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Estimated US medical usage
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 28,061 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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3,774 adverse events reported
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