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Drug ReportsSotalol
Sotalol
Betapace, Sorine, Sotalol, Sotylize (sotalol) is a small molecule pharmaceutical. Sotalol was first approved as Betapace on 1992-10-30. It is used to treat atrial fibrillation, atrial flutter, cardiac arrhythmias, supraventricular tachycardia, and ventricular fibrillation amongst others in the USA. The pharmaceutical is active against beta-2 adrenergic receptor and beta-1 adrenergic receptor.
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Commercial
Clinical
Drug
Target
Variants
Financial
Trends
Safety
Events Timeline
5D
1M
3M
6M
YTD
1Y
2Y
5Y
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FDA approval date
EMA approval date
Patent expiration date
Study first post date
Last update post date
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
cardiovascular diseasesD002318
signs and symptoms pathological conditionsD013568
Trade Name
FDA
EMA
Sorine, Sotalol, Sotylize (discontinued: Sotalol)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Sotalol hydrochloride
Tradename
Company
Number
Date
Products
SOTALOL HYDROCHLORIDEAltaThera PharmaceuticalsN-022306 RX2009-07-02
1 products, RLD, RS
SOTYLIZEAzurityN-205108 RX2014-10-22
1 products, RLD, RS
Labels
FDA
EMA
Brand Name
Status
Last Update
betapace betapace afNew Drug Application2023-06-15
sorineANDA2024-01-16
sorine sorineANDA2011-12-06
sotalolANDA2024-05-17
sotalol hydrochlorideANDA2024-10-03
sotylizeNew Drug Application2024-01-24
Agency Specific
FDA
EMA
No data
Patent Expiration
Patent
Expires
Flag
FDA Information
Sotalol Hydrochloride, Sotalol Hydrochloride, Altathera Pharms Llc
115832162039-08-21U-3549
107991382039-04-05U-3125, U-3549
105126202038-08-14U-2769, U-3547
116969022038-08-14U-2769
Sotalol Hydrochloride, Sotylize, Azurity
97242972035-08-31DPU-2096
118502222034-11-19U-2096, U-2494
102068952034-04-01DPU-2096, U-2494
110137032034-04-01DP
ATC Codes
C: Cardiovascular system drugs
C07: Beta-adrenergic blocking agents
C07A: Beta blocking agents
C07AA: Beta blocking agents, non-selective
C07AA07: Sotalol
C07B: Beta blocking agents and thiazides
C07BA: Beta blocking agents, non-selective, and thiazides
C07BA07: Sotalol and thiazides
C07F: Beta blocking agents, other combinations
C07FX: Beta blocking agents, other combinations
C07FX02: Sotalol and acetylsalicylic acid
HCPCS
Code
Description
C9482
Injection, sotalol hydrochloride, 1 mg
Clinical
Clinical Trials
69 clinical trials
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Atrial fibrillationD001281EFO_0000275I48.011891837
Cardiac arrhythmiasD001145EFO_0004269I49.945615
TachycardiaD013610HP_0001649R00.055414
Ventricular tachycardiaD017180I47.245413
Heart diseasesD006331EFO_0003777I51.94419
Heart failureD006333HP_0001635I501326
Ventricular fibrillationD014693HP_0001663I49.01314
Diastolic heart failureD054144EFO_1000899I50.3033
CardiomyopathiesD009202EFO_0000318I42213
Ventricular premature complexesD018879I49.3213
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Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Cardiovascular diseasesD002318HP_0001626415
Sudden deathD003645HP_000169933
Sudden death cardiacD016757EFO_000427822
Atrial flutterD001282EFO_0003911112
Catheter ablationD01711511
Coronary diseaseD00332711
Coronary artery diseaseD003324I25.111
Myocardial ischemiaD017202EFO_1001375I20-I2511
StrokeD020521EFO_0000712I63.911
Heart arrestD006323EFO_0009492I4611
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Indications Phases 2
No data
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Therapeutic equivalencyD01381011
Healthy volunteers/patients11
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameSotalol
INNsotalol
Description
Sotalol is a sulfonamide that is N-phenylmethanesulfonamide in which the phenyl group is substituted at position 4 by a 1-hydroxy-2-(isopropylamino)ethyl group. It has both beta-adrenoreceptor blocking (Vaughan Williams Class II) and cardiac action potential duration prolongation (Vaughan Williams Class III) antiarrhythmic properties. It is used (usually as the hydrochloride salt) for the management of ventricular and supraventricular arrhythmias. It has a role as a beta-adrenergic antagonist, an anti-arrhythmia drug, an environmental contaminant and a xenobiotic. It is a member of ethanolamines, a secondary amino compound, a secondary alcohol and a sulfonamide. It is a conjugate base of a sotalol(1+).
Classification
Small molecule
Drug classcombined alpha and beta blockers
Image (chem structure or protein)Loading
Structure (InChI/SMILES or Protein Sequence)
CC(C)NCC(O)c1ccc(NS(C)(=O)=O)cc1
Identifiers
PDB
CAS-ID3930-20-9
RxCUI
ChEMBL IDCHEMBL471
ChEBI ID63622
PubChem CID5253
DrugBankDB00489
UNII IDA6D97U294I (ChemIDplus, GSRS)
Target
Agency Approved
ADRB2
ADRB2
ADRB1
ADRB1
Organism
Homo sapiens
Gene name
ADRB2
Gene synonyms
ADRB2R, B2AR
NCBI Gene ID
Protein name
beta-2 adrenergic receptor
Protein synonyms
adrenergic, beta-2-, receptor, surface, adrenoceptor beta 2 surface, Beta-2 adrenoceptor, Beta-2 adrenoreceptor, catecholamine receptor
Uniprot ID
Mouse ortholog
Adrb2 (11555)
beta-2 adrenergic receptor (Q8BH38)
Alternate
No data
Variants
No data
Financial
Revenue by drug
$
£
No data
Estimated US medical usage
Sotalol
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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Safety
Black-box Warning
Black-box warning for: Betapace betapace af, Sorine, Sorine sorine, Sotalol, Sotalol hydrochloride, Sotylize
Adverse Events
Top Adverse Reactions
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4,989 adverse events reported
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