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Labetalol
Normozide, Trandate (labetalol) is a small molecule pharmaceutical. Labetalol was first approved as Trandate on 1984-08-01. It is used to treat angina pectoris, heart failure, malignant hypertension, and myocardial infarction in the USA. The pharmaceutical is active against beta-1 adrenergic receptor, beta-2 adrenergic receptor, and alpha-1D adrenergic receptor.
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
cardiovascular diseasesD002318
signs and symptoms pathological conditionsD013568
Trade Name
FDA
EMA
Trandate (generic drugs available since 1998-08-03, discontinued: Normodyne)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Hydrochlorothiazide
+
Labetalol hydrochloride
Tradename
Company
Number
Date
Products
TRANDATE HCTGSKN-019174 DISCN1987-04-10
4 products
NORMOZIDEMerck Sharp & DohmeN-019046 DISCN1987-04-06
4 products
Hide discontinued
Labetalol hydrochloride
Tradename
Company
Number
Date
Products
TRANDATEAlvogenN-018716 RX1984-08-01
2 products, RLD
LABETALOL HYDROCHLORIDEHikma PharmaceuticalsN-213330 RX2022-03-18
1 products, RLD, RS
LABETALOL HYDROCHLORIDE IN DEXTROSEHikma PharmaceuticalsN-213330 RX2020-11-09
1 products, RLD, RS
LABETALOL HYDROCHLORIDE IN SODIUM CHLORIDEHikma PharmaceuticalsN-213330 RX2020-11-09
3 products, RLD, RS
Show 4 discontinued
Labels
FDA
EMA
Brand Name
Status
Last Update
labetalol hydrochlorideANDA2023-04-28
trandateNew Drug Application2009-12-14
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
angina pectorisEFO_0003913D000787I20
heart failureEFO_0003144D006333I50
malignant hypertensionEFO_1001031D006974—
myocardial infarctionEFO_0000612D009203I21
Agency Specific
FDA
EMA
No data
Patent Expiration
No data
ATC Codes
C: Cardiovascular system drugs
— C07: Beta-adrenergic blocking agents
— C07A: Beta blocking agents
— C07AG: Alpha and beta blocking agents
— C07AG01: Labetalol
— C07B: Beta blocking agents and thiazides
— C07BG: Alpha and beta blocking agents and thiazides
— C07BG01: Labetalol and thiazides
— C07C: Beta blocking agents and other diuretics
— C07CG: Alpha and beta blocking agents and other diuretics
— C07CG01: Labetalol and other diuretics
HCPCS
No data
Clinical
Clinical Trials
35 clinical trials
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Allergic conjunctivitisD003233EFO_0007141H10.4412111—15
AsthmaD001249EFO_0000270J45———1—1
Pleural effusionD010996J90———1—1
DengueD003715A90———1—1
St elevation myocardial infarctionD000072657———1—1
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Allergic rhinitis perennialD012221EFO_1001417J30.89——2——2
Lens subluxationD007906HP_0001132H27.1——1——1
Chronic painD059350HP_0012532——1——1
Atopic dermatitisD003876EFO_0000274L20——1——1
DermatitisD003872HP_0011123L30.9——1——1
FibromyalgiaD005356EFO_0005687M79.1——1——1
Respiratory tract infectionsD012141J06.9——1——1
Peripheral nervous system diseasesD010523G64——1——1
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Visual acuityD014792—1———1
Peanut hypersensitivityD021183EFO_0007425—1———1
Indications Phases 1
No data
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
PruritusD011537HP_0000989L29————11
Breast neoplasmsD001943EFO_0003869C50————11
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameLABETALOL
INNlabetalol
Description
Labetalol is a diastereoisomeric mixture of approximately equal amounts of all four possible stereoisomers ((R,S)-labetolol, (S,R)-labetolol, (S,S)-labetalol and (R,R)-labetalol). It is an adrenergic antagonist used to treat high blood pressure. It has a role as an antihypertensive agent, a sympatholytic agent, an alpha-adrenergic antagonist and a beta-adrenergic antagonist. It contains a (R,R)-labetalol, a (S,S)-labetalol, a (R,S)-labetolol and a (S,R)-labetolol.
Classification
Small molecule
Drug classcombined alpha and beta blockers
Image (chem structure or protein)
Structure (InChI/SMILES or Protein Sequence)
CC(CCc1ccccc1)NCC(O)c1ccc(O)c(C(N)=O)c1
Identifiers
PDB—
CAS-ID36894-69-6
RxCUI6185
ChEMBL IDCHEMBL429
ChEBI ID6343
PubChem CID3869
DrugBankDB00598
UNII IDR5H8897N95 (ChemIDplus, GSRS)
Target
Agency Approved
ADRB1
ADRB1
ADRB2
ADRB2
ADRA1D
ADRA1D
Organism
Homo sapiens
Gene name
ADRB1
Gene synonyms
ADRB1R, B1AR
NCBI Gene ID
153
Protein name
beta-1 adrenergic receptor
Protein synonyms
adrenergic, beta-1-, receptor, Beta-1 adrenoceptor, Beta-1 adrenoreceptor
Uniprot ID
P08588
Mouse ortholog
Adrb1 (11554)
beta-1 adrenergic receptor (P34971)
Alternate
No data
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 4,984 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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5,352 adverse events reported
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