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
Therapeutic Areas
Therapeutic Area | MeSH |
|---|---|
| cardiovascular diseases | D002318 |
| signs and symptoms pathological conditions | D013568 |
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 HYDROCHLORIDE | AltaThera Pharmaceuticals | N-022306 RX | 2009-07-02 | 1 products, RLD, RS |
| SOTYLIZE | Azurity | N-205108 RX | 2014-10-22 | 1 products, RLD, RS |
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| betapace betapace af | New Drug Application | 2024-12-16 |
| sotalol | ANDA | 2026-06-11 |
| sotalol hydrochloride | ANDA | 2026-09-17 |
| sotalol sotalol hydrochloride | ANDA | 2026-04-22 |
| sotylize | New Drug Application | 2024-01-24 |
Agency Specific
FDA
EMA
No data
Patent Expiration
Patent | Expires | Flag | FDA Information |
|---|---|---|---|
| Sotalol Hydrochloride, Sotalol Hydrochloride, Altathera Pharms Llc | |||
| 11583216 | 2039-08-21 | U-3549 | |
| 10799138 | 2039-04-05 | U-3125, U-3549 | |
| 10512620 | 2038-08-14 | U-2769, U-3547 | |
| 11696902 | 2038-08-14 | U-2769 | |
| Sotalol Hydrochloride, Sotylize, Azurity | |||
| 9724297 | 2035-08-31 | DP | U-2096 |
| 11850222 | 2034-11-19 | U-2096, U-2494 | |
| 10206895 | 2034-04-01 | DP | U-2096, U-2494 |
| 11013703 | 2034-04-01 | DP | |
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
74 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 fibrillation | D001281 | EFO_0000275 | I48.0 | 1 | 1 | 8 | 10 | 20 | 40 |
| Cardiac arrhythmias | D001145 | EFO_0004269 | I49.9 | — | — | 4 | 4 | 6 | 14 |
| Ventricular tachycardia | D017180 | — | I47.2 | — | — | 4 | 5 | 5 | 14 |
| Tachycardia | D013610 | — | R00.0 | — | — | 4 | 4 | 3 | 11 |
| Heart diseases | D006331 | EFO_0003777 | I51.9 | — | — | 4 | 3 | 2 | 9 |
| Heart failure | D006333 | EFO_0003144 | I50 | — | — | 1 | 3 | 2 | 6 |
| Ventricular premature complexes | D018879 | — | I49.3 | — | — | — | 2 | 2 | 4 |
| Ventricular fibrillation | D014693 | EFO_0004287 | I49.01 | — | — | 3 | 1 | — | 4 |
| Diastolic heart failure | D054144 | EFO_1000899 | I50.30 | — | — | — | 3 | — | 3 |
| Cardiomyopathies | D009202 | EFO_0000318 | I42 | — | — | — | 2 | 1 | 3 |
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Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Cardiovascular diseases | D002318 | EFO_0000319 | I98 | — | — | 4 | — | 2 | 6 |
| Sudden death | D003645 | — | — | — | — | 3 | — | — | 3 |
| Stroke | D020521 | EFO_0000712 | I63.9 | — | — | 1 | — | 1 | 2 |
| Sudden death cardiac | D016757 | EFO_0004278 | — | — | — | 2 | — | — | 2 |
| Atrial flutter | D001282 | EFO_0003911 | — | — | — | 1 | — | 1 | 2 |
| Catheter ablation | D017115 | — | — | — | — | 1 | — | — | 1 |
| Coronary disease | D003327 | — | — | — | — | 1 | — | — | 1 |
| Myocardial ischemia | D017202 | EFO_1001375 | I20-I25 | — | — | 1 | — | — | 1 |
| Heart arrest | D006323 | EFO_0009492 | I46 | — | — | 1 | — | — | 1 |
Indications Phases 2
No data
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Therapeutic equivalency | D013810 | — | — | 1 | — | — | — | — | 1 |
| Healthy volunteers/patients | — | — | — | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Recurrence | D012008 | — | — | — | — | — | — | 1 | 1 |
| Hypersensitivity | D006967 | EFO_0003785 | T78.40 | — | — | — | — | 1 | 1 |
| Long qt syndrome | D008133 | HP_0001657 | I45.81 | — | — | — | — | 1 | 1 |
| Hypertension | D006973 | EFO_0000537 | I10 | — | — | — | — | 1 | 1 |
| Takotsubo cardiomyopathy | D054549 | EFO_1002000 | I51.81 | — | — | — | — | 1 | 1 |
| Sarcoidosis | D012507 | EFO_0000690 | D80-D89 | — | — | — | — | 1 | 1 |
| Hypertrophic cardiomyopathy | D002312 | EFO_0000538 | I42.1 | — | — | — | — | 1 | 1 |
| Arrhythmogenic right ventricular dysplasia | D019571 | Orphanet_247 | I42.8 | — | — | — | — | 1 | 1 |
| Dilated cardiomyopathy | D002311 | EFO_0000407 | I42.0 | — | — | — | — | 1 | 1 |
| Cognitive dysfunction | D060825 | — | G31.84 | — | — | — | — | 1 | 1 |
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Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Sotalol |
| INN | sotalol |
| 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 class | combined alpha and beta blockers |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | CC(C)NCC(O)c1ccc(NS(C)(=O)=O)cc1 |
Identifiers
| PDB | — |
| CAS-ID | 3930-20-9 |
| RxCUI | — |
| ChEMBL ID | CHEMBL471 |
| ChEBI ID | 63622 |
| PubChem CID | 5253 |
| DrugBank | DB00489 |
| UNII ID | A6D97U294I (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
$
€
£
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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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Price per prescription (USD)
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Tabular view
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 9,107 documents
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Safety
Black-box Warning
Black-box warning for: Betapace betapace af, Sotalol, Sotalol hydrochloride, Sotalol sotalol hydrochloride, Sotylize
Adverse Events
Top Adverse Reactions
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5,950 adverse events reported
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