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Drug ReportsLabetalol
Labetalol
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 alpha-1D adrenergic receptor, beta-2 adrenergic receptor, and beta-1 adrenergic receptor.
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Target
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Financial
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Safety
Events Timeline
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3M
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YTD
1Y
2Y
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FDA approval date
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Study first post date
Last update post date
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Primary completion date
Completion date
Results first post date
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
cardiovascular diseasesD002318
signs and symptoms pathological conditionsD013568
Trade Name
FDA
EMA
Labetalol (discontinued: Labetalol, Normodyne, Trandate)
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 & CoN-019046 DISCN1987-04-06
4 products
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Labetalol hydrochloride
Tradename
Company
Number
Date
Products
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
LABETALOL HYDROCHLORIDEHikma PharmaceuticalsN-213330 RX2024-08-19
1 products, RLD, RS
Show 5 discontinued
Labels
FDA
EMA
Brand Name
Status
Last Update
labetalolANDA2018-04-06
labetalol hclANDA2025-06-19
labetalol hcl in dextrose labetalol hcl in sodium chlorideNew Drug Application2022-03-01
labetalol hcl in dextrose labetalol hcl in sodium chloride labetalol hydrochlorideNew Drug Application2024-09-20
labetalol hydrochlorideANDA2025-10-03
trandateNew Drug Application2009-12-14
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
heart failureEFO_0003144D006333I50
myocardial infarctionEFO_0000612D009203I21
angina pectorisEFO_0003913D000787I20
malignant hypertensionEFO_1001031D006974—
hypertensionEFO_0000537D006973I10
nephrotic syndromeEFO_0004255D009404N04
edema—D004487R60.9
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
87 clinical trials
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Indications Phases 4
No data
Indications Phases 3
No data
Indications Phases 2
No data
Indications Phases 1
No data
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
HypersensitivityD006967EFO_0003785T78.40————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)Loading
Structure (InChI/SMILES or Protein Sequence)
CC(CCc1ccccc1)NCC(O)c1ccc(O)c(C(N)=O)c1
Identifiers
PDB—
CAS-ID36894-69-6
RxCUI—
ChEMBL IDCHEMBL429
ChEBI ID6343
PubChem CID3869
DrugBankDB00598
UNII IDR5H8897N95 (ChemIDplus, GSRS)
Target
Agency Approved
ADRA1D
ADRA1D
ADRB2
ADRB2
ADRB1
ADRB1
Organism
Homo sapiens
Gene name
ADRA1D
Gene synonyms
ADRA1A
NCBI Gene ID
146
Protein name
alpha-1D adrenergic receptor
Protein synonyms
adrenergic, alpha -1D-, receptor, adrenergic, alpha-1A-, receptor, Alpha-1A adrenergic receptor, Alpha-1D adrenoceptor, Alpha-1D adrenoreceptor, Alpha-adrenergic receptor 1a
Uniprot ID
Q9NPY0
Mouse ortholog
Adra1d (11550)
alpha-1D adrenergic receptor (Q61619)
Alternate
No data
Variants
No data
Financial
Revenue by drug
$
€
£
₣
No data
Estimated US medical usage
Labetalol
Total medical expenditures per year (USD, in millions)
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Number of persons purchased
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Number of purchases
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Refill frequency
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Tabular view
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 6,676 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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4,436 adverse events reported
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