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Flumazenil
Romazicon (flumazenil) is a small molecule pharmaceutical. Flumazenil was first approved as Romazicon on 1991-12-20. It is used to treat drug overdose in the USA. The pharmaceutical is active against gamma-aminobutyric acid receptor subunit alpha-5, gamma-aminobutyric acid receptor subunit alpha-3, gamma-aminobutyric acid receptor subunit alpha-1, and gamma-aminobutyric acid receptor subunit alpha-2. In addition, it is known to target gamma-aminobutyric acid receptor subunit alpha-6 and gamma-aminobutyric acid receptor subunit alpha-4.
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
chemically-induced disordersD064419
therapeuticsD013812
Trade Name
FDA
EMA
No data
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Flumazenil
Tradename
Company
Number
Date
Products
ROMAZICONRocheN-020073 DISCN1991-12-20
2 products, RLD
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Labels
FDA
EMA
Brand Name
Status
Last Update
flumazenilANDA2023-05-31
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
drug overdose—D062787—
Agency Specific
FDA
EMA
No data
Patent Expiration
No data
ATC Codes
V: Various drug classes in atc
— V03: All other therapeutic products
— V03A: All other therapeutic products
— V03AB: Antidotes
— V03AB25: Flumazenil
HCPCS
No data
Clinical
Clinical Trials
19 clinical trials
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Mock data
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Psychological sexual dysfunctionsD020018F52.01—111114
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
DepressionD003863F33.9——1——1
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
AdenocarcinomaD000230—1———1
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Healthy volunteers/patients—2————2
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Breast neoplasmsD001943EFO_0003869C50————11
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameFLUMAZENIL
INNflumazenil
Description
Flumazenil is an organic heterotricyclic compound that is 5,6-dihydro-4H-imidazo[1,5-a][1,4]benzodiazepine which is substituted at positions 3, 5, 6, and 8 by ethoxycarbonyl, methyl, oxo, and fluoro groups, respectively. It is used as an antidote to benzodiazepine overdose. It has a role as a GABA antagonist and an antidote to benzodiazepine poisoning. It is an ethyl ester, an organofluorine compound and an imidazobenzodiazepine.
Classification
Small molecule
Drug classbenzodiazepine receptor agonists/antagonists
Image (chem structure or protein)
Structure (InChI/SMILES or Protein Sequence)
CCOC(=O)c1ncn2c1CN(C)C(=O)c1cc(F)ccc1-2
Identifiers
PDB—
CAS-ID78755-81-4
RxCUI4457
ChEMBL IDCHEMBL407
ChEBI ID5103
PubChem CID3373
DrugBankDB01205
UNII ID40P7XK9392 (ChemIDplus, GSRS)
Target
Agency Approved
GABRA5
GABRA5
GABRA3
GABRA3
GABRA1
GABRA1
GABRA2
GABRA2
Organism
Homo sapiens
Gene name
GABRA5
Gene synonyms
NCBI Gene ID
2558
Protein name
gamma-aminobutyric acid receptor subunit alpha-5
Protein synonyms
GABA(A) receptor subunit alpha-5, gamma-aminobutyric acid (GABA) A receptor, alpha 5, gamma-aminobutyric acid type A receptor alpha5 subunit
Uniprot ID
Q9NYT5
Mouse ortholog
Gabra5 (110886)
gamma-aminobutyric acid receptor subunit alpha-5 (Q8BHJ7)
Alternate
GABRA6
GABRA6
GABRA4
GABRA4
Organism
Homo sapiens
Gene name
GABRA6
Gene synonyms
NCBI Gene ID
2559
Protein name
gamma-aminobutyric acid receptor subunit alpha-6
Protein synonyms
GABA subunit A receptor alpha 6, GABA(A) receptor subunit alpha-6, GABA(A) receptor, alpha 6, gamma-aminobutyric acid (GABA) A receptor, alpha 6, gamma-aminobutyric acid type A receptor alpha6 subunit
Uniprot ID
Q4VAV2
Mouse ortholog
Gabra6 (14399)
gamma-aminobutyric acid receptor subunit alpha-6 (Q9R0V5)
Variants
Clinical Variant
No data
Financial
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
Mock data
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Additional graphs summarizing 5,017 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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323 adverse events reported
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