sotalol

Trade name: betapace

Small moleculeapprovedOrphan Drug FDA

Approved

Oct 30, 1992

Sotalol has both beta-adrenoreceptor blocking and cardiac action potential duration prolongation antiarrhythmic properties. Sotalol inhibits response to adrenergic stimuli by competitively blocking β1-adrenergic receptors within the myocardium and β2-adrenergic receptors within bronchial and vascular smooth muscle. It is FDA approved for the treatment of ventricular arrhythmias, symptomatic atrial fibtillation, symptomatic atriall flutter. Common adverse reactions include bradyarrhythmia, chest pain, lightheadedness, palpitations, rash, nausea, dizziness, headache, dyspnea, fatigue. Proarrhythmic events were more common in sotalol treated patients also receiving digoxin. Sotalol should be administered with caution in conjunction with calcium blocking drugs because of possible additive effects on atrioventricular conduction or ventricular function. Patients treated with sotalol plus a catecholamine depletor should therefore be closely monitored for evidence of hypotension and/or marked bradycardia which may produce syncope. — NCATS

Clinical trial activity

39 trials · 54 clinical orgs · 17 marketing orgs

Phase 1
3
Phase 2
14
Phase 3
13
Phase 4
11

Earliest trial started Jul 1, 1985 (NCT00000518)

Timeline

1980s

  1. Jan 1, 1985

    Earliest Phase 3 Sponsor(trial)

  2. Sep 23, 1988

    Orphan Drug Designation

1990s

  1. Oct 30, 1992

    Schering — Earliest FDA Approval

  2. Oct 30, 1992

    Covis — NDA Secondary Org

  3. Oct 30, 1992

    Covis — Marketing Organization

  4. Oct 30, 1992

    Schering — NDA Organization

  5. Oct 30, 1992

    LEGACY PHARMA — Marketing Organization

  6. Oct 30, 1992

    LEGACY PHARMA — NDA Secondary Org

2000s

  1. May 1, 2000

    Mylan — Marketing Organization

  2. May 1, 2000

    Teva — Marketing Organization

  3. May 1, 2000

    Upsher-Smith Laboratories — Marketing Organization

  4. Jul 13, 2000

    Watson Pharmaceuticals — Marketing Organization

  5. Nov 7, 2000

    Impax Laboratories — Marketing Organization

  6. Oct 15, 2001

    Sun Pharmaceuticals — Marketing Organization

  7. Aug 27, 2003

    Apotex — Marketing Organization

  8. Nov 7, 2003

    Oxford Pharmaceuticals — Marketing Organization

  9. Nov 4, 2005

    Epic Pharma Llc — Marketing Organization

  10. Jan 1, 2007

    Earliest Phase 2 Sponsor(trial)

  11. Feb 7, 2007

    Aurobindo Pharma — Marketing Organization

  12. Jan 1, 2008

    Earliest Phase 1 Sponsor(trial)

  13. Jul 2, 2009

    Altathera Pharms Llc — NDA Secondary Org

2010s

  1. Oct 22, 2014

    Arbor Pharmaceuticals — NDA Secondary Org

  2. Oct 22, 2014

    Azurity — Marketing Organization

  3. Oct 22, 2014

    Azurity — NDA Secondary Org

  4. Oct 21, 2016

    Beximco — Marketing Organization

Indications

Mechanism of action

Approval history

  • approvedPriority reviewOct 30, 1992

Chemistry & pharmacology

Loading structure…

SMILES

CC(C)NCC(O)c1ccc(NS(C)(=O)=O)cc1
Mol. weight
272.37 g/mol
Lipinski Ro5
Pass
Rule of 3
No
Chirality
Racemic Mixture
Inorganic
No
Polymer
No
Delivery
Oral, Parenteral
Availability
Prescription Only

Oral

Yes

Parenteral

Yes

Topical

No

Black box warning

Sources

Also known as

  • 4'-(1-hydroxy-2-(isopropylamino)ethyl)methane sulfonanilide
  • 4'-(1-hydroxy-2-(isopropylamino)ethyl)methane sulfonanilide
  • beta-cardone
  • beta-cardone
  • betapace
  • betapace
  • betapace
  • betapace af
  • betapace af
  • dl-sotalol
  • mj-1999
  • mj-1999
  • sorine
  • sorine
  • sotacor
  • sotacor
  • sotalex
  • sotalex
  • sotalol
  • sotalol
  • sotalol
  • sotalol
  • sotalol
  • sotalol
  • sotalol
  • sotalol
  • sotalol
  • sotalol hcl
  • sotalol hcl
  • sotalol hcl
  • sotalol hydrochloride
  • sotalol hydrochloride
  • sotalol hydrochloride
  • sotalol hydrochloride
  • sotalolo
  • sotalolo
  • sotalolum
  • sotalolum
  • sotylize

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT06669299N/ADec 31, 2024
NCT06322017N/AApr 9, 2024University of Nantes
NCT06096337N/ADec 15, 2023Boston Scientific Corporation, The Cleveland Clinic
NCT05939076Phase 3Aug 21, 2023Orebro University, Swedish Heart Lung Foundation, The Swedish Research Council, Uppsala University
NCT04942834N/AAug 31, 2021Jiao Tong University
NCT05418036Phase 4Oct 26, 2020University of Sao Paulo
NCT04473807Phase 4Aug 31, 2020Kansas City Heart Rhythm Research Foundation
NCT04208997Phase 3Dec 21, 2019Vanderbilt University
NCT03895411Phase 4Aug 31, 2019Shengjing Hospital
NCT04037397Phase 3Jul 22, 2019Biosense Webster, Inc., Texas Cardiac Arrhythmia Institute, University of Pennsylvania
NCT03845010N/AFeb 12, 2019Isala Clinics, Zwolle, The Netherlands, Maatschap Cardiologie Zwolle
NCT03799536Phase 1Jan 9, 2019Pharmtechnology LLC
NCT02825979N/AJan 1, 2017University of British Columbia, University of Ottawa
NCT02830360Phase 4Oct 1, 2016Biosense Webster, Inc., Government of Canada, Harvard University, Heart and Stroke Foundation of Canada, McMaster University, Nova Scotia Health Authority, St. Jude Medical, University of Ottawa, University of Western Ontario
NCT02624765Phase 3Dec 1, 2015Canadian Institutes of Health Research (CIHR), The Hospital for Sick Children, University of London, University of Toronto
NCT02459574N/AMay 1, 2015University of London
NCT02389218Phase 4Mar 3, 2015Ghent University
NCT02347111Phase 4Feb 1, 2015Medtronic, Vanderbilt University
NCT02153437Phase 1Oct 1, 2014Bristol-Myers Squibb
NCT02145546Phase 4May 1, 2014Beijing CTSmed Co. Ltd, Jiao Tong University, Medtronic
Showing 20 of 39 trials
Page 1 / 2

Organizations

Research & Development (54)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
Biosense Webster, Inc.For profit4122003
National Heart, Lung, and Blood Institute (NHLBI)Government4211985
MedtronicFor profit3122006
Harvard UniversityAcademic/Hospital2022012
Jiao Tong UniversityAcademic/Hospital2222014
McMaster UniversityAcademic/Hospital2012001
St. Jude MedicalAcademic/Hospital2012001
Swedish Heart Lung FoundationAcademic/Hospital2022008
University of LondonAcademic/Hospital2122015
University of OttawaAcademic/Hospital2022016
University of PennsylvaniaAcademic/Hospital2222006
University of WashingtonAcademic/Hospital2111987
Uppsala UniversityAcademic/Hospital2122008
Vanderbilt UniversityAcademic/Hospital2222015
Beijing CTSmed Co. LtdFor profit1012014
Boston Scientific CorporationFor profit1112023
Bristol-Myers SquibbFor profit1112014
Canadian Institutes of Health Research (CIHR)Academic/Hospital1012015
Connolly, Stuart, M.D.Academic/Hospital1112001
Department of Veteran AffairsGovernment1111998
54 organizations
Page 1 / 3

Marketing (22)

OrganizationOrg typeRelationshipDate
Altathera Pharms LlcFor profitNDA2Jul 2, 2009
ApotexFor profitMKTGAug 27, 2003
ApotexFor profitSYNSep 26, 2002
Arbor PharmaceuticalsFor profitNDA2Oct 22, 2014
Aurobindo PharmaFor profitMKTGFeb 7, 2007
AzurityFor profitMKTGOct 22, 2014
AzurityFor profitNDA2Oct 22, 2014
BeximcoFor profitMKTGOct 21, 2016
CovisFor profitNDA2Oct 30, 1992
CovisFor profitMKTGOct 30, 1992
Epic Pharma LlcFor profitMKTGNov 4, 2005
Epic Pharma LlcFor profitSYNNov 4, 2005
Impax LaboratoriesFor profitMKTGNov 7, 2000
LEGACY PHARMAFor profitMKTGOct 30, 1992
LEGACY PHARMAFor profitNDA2Oct 30, 1992
MylanFor profitMKTGMay 1, 2000
Oxford PharmaceuticalsFor profitMKTGNov 7, 2003
ScheringFor profitNDAOct 30, 1992
Sun PharmaceuticalsFor profitMKTGOct 15, 2001
TevaFor profitMKTGMay 1, 2000
Upsher-Smith LaboratoriesFor profitMKTGMay 1, 2000
Watson PharmaceuticalsFor profitMKTGJul 13, 2000