sotalol
Trade name: betapace
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
Earliest trial started Jul 1, 1985 (NCT00000518)
Timeline
1980s
- Jan 1, 1985
Earliest Phase 3 Sponsor(trial)
- Sep 23, 1988
Orphan Drug Designation
1990s
- Oct 30, 1992
Schering — Earliest FDA Approval
- Oct 30, 1992
Covis — NDA Secondary Org
- Oct 30, 1992
Covis — Marketing Organization
- Oct 30, 1992
Schering — NDA Organization
- Oct 30, 1992
LEGACY PHARMA — Marketing Organization
- Oct 30, 1992
LEGACY PHARMA — NDA Secondary Org
2000s
- May 1, 2000
Mylan — Marketing Organization
- May 1, 2000
Teva — Marketing Organization
- May 1, 2000
Upsher-Smith Laboratories — Marketing Organization
- Jul 13, 2000
Watson Pharmaceuticals — Marketing Organization
- Nov 7, 2000
Impax Laboratories — Marketing Organization
- Oct 15, 2001
Sun Pharmaceuticals — Marketing Organization
- Aug 27, 2003
Apotex — Marketing Organization
- Nov 7, 2003
Oxford Pharmaceuticals — Marketing Organization
- Nov 4, 2005
Epic Pharma Llc — Marketing Organization
- Jan 1, 2007
Earliest Phase 2 Sponsor(trial)
- Feb 7, 2007
Aurobindo Pharma — Marketing Organization
- Jan 1, 2008
Earliest Phase 1 Sponsor(trial)
- Jul 2, 2009
Altathera Pharms Llc — NDA Secondary Org
2010s
- Oct 22, 2014
Arbor Pharmaceuticals — NDA Secondary Org
- Oct 22, 2014
Azurity — Marketing Organization
- Oct 22, 2014
Azurity — NDA Secondary Org
- Oct 21, 2016
Beximco — Marketing Organization
Indications
Approved for
Studied for
- Ablation Techniques · Phase 2
- Arrhythmias, Cardiac · Phase 4
- Atrial Fibrillation · Phase 4
- Cardiovascular Diseases · Phase 3
- Catheter Ablation · Phase 3
- Coronary Artery Disease · Phase 3
- Death, Sudden · Phase 3
- Death, Sudden, Cardiac · Phase 3
- Drug-Related Side Effects and Adverse Reactions · Phase 4
- Fetal Development · Phase 3
- Healthy Volunteers · Phase 1
- Heart Arrest · Phase 3
- Heart Diseases · Phase 3
- Myocardial Infarction · Phase 3
- Stroke · Phase 3
- Tachycardia · Phase 4
- Tachycardia, Ventricular · Phase 4
- Therapeutic Equivalency · Phase 1
- Ventricular Fibrillation · Phase 3
- Ventricular Premature Complexes · Phase 4
Mechanism of action
- Beta-1 adrenergic receptorANTAGONIST
ADRB1 antagonist
- Beta-2 adrenergic receptorANTAGONIST
ADRB2 antagonist
- HERGBLOCKER
KCNH2 blocker
Approval history
- approvedPriority reviewOct 30, 1992
Chemistry & pharmacology
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
Sources
- ChEMBLCHEMBL471 ↗
- WikipediaSotalol ↗
- NCATSA6D97U294I ↗
- ChEMBLCHEMBL1700 ↗
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 ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT06669299 | N/A | Dec 31, 2024 | — |
| NCT06322017 | N/A | Apr 9, 2024 | University of Nantes |
| NCT06096337 | N/A | Dec 15, 2023 | Boston Scientific Corporation, The Cleveland Clinic |
| NCT05939076 | Phase 3 | Aug 21, 2023 | Orebro University, Swedish Heart Lung Foundation, The Swedish Research Council, Uppsala University |
| NCT04942834 | N/A | Aug 31, 2021 | Jiao Tong University |
| NCT05418036 | Phase 4 | Oct 26, 2020 | University of Sao Paulo |
| NCT04473807 | Phase 4 | Aug 31, 2020 | Kansas City Heart Rhythm Research Foundation |
| NCT04208997 | Phase 3 | Dec 21, 2019 | Vanderbilt University |
| NCT03895411 | Phase 4 | Aug 31, 2019 | Shengjing Hospital |
| NCT04037397 | Phase 3 | Jul 22, 2019 | Biosense Webster, Inc., Texas Cardiac Arrhythmia Institute, University of Pennsylvania |
| NCT03845010 | N/A | Feb 12, 2019 | Isala Clinics, Zwolle, The Netherlands, Maatschap Cardiologie Zwolle |
| NCT03799536 | Phase 1 | Jan 9, 2019 | Pharmtechnology LLC |
| NCT02825979 | N/A | Jan 1, 2017 | University of British Columbia, University of Ottawa |
| NCT02830360 | Phase 4 | Oct 1, 2016 | Biosense 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 |
| NCT02624765 | Phase 3 | Dec 1, 2015 | Canadian Institutes of Health Research (CIHR), The Hospital for Sick Children, University of London, University of Toronto |
| NCT02459574 | N/A | May 1, 2015 | University of London |
| NCT02389218 | Phase 4 | Mar 3, 2015 | Ghent University |
| NCT02347111 | Phase 4 | Feb 1, 2015 | Medtronic, Vanderbilt University |
| NCT02153437 | Phase 1 | Oct 1, 2014 | Bristol-Myers Squibb |
| NCT02145546 | Phase 4 | May 1, 2014 | Beijing CTSmed Co. Ltd, Jiao Tong University, Medtronic |
Organizations
Research & Development (54)
| Organization | Org type | Trials | As lead sponsor | Phases | Earliest year |
|---|---|---|---|---|---|
| Biosense Webster, Inc. | For profit | 4 | 1 | 2 | 2003 |
| National Heart, Lung, and Blood Institute (NHLBI) | Government | 4 | 2 | 1 | 1985 |
| Medtronic | For profit | 3 | 1 | 2 | 2006 |
| Harvard University | Academic/Hospital | 2 | 0 | 2 | 2012 |
| Jiao Tong University | Academic/Hospital | 2 | 2 | 2 | 2014 |
| McMaster University | Academic/Hospital | 2 | 0 | 1 | 2001 |
| St. Jude Medical | Academic/Hospital | 2 | 0 | 1 | 2001 |
| Swedish Heart Lung Foundation | Academic/Hospital | 2 | 0 | 2 | 2008 |
| University of London | Academic/Hospital | 2 | 1 | 2 | 2015 |
| University of Ottawa | Academic/Hospital | 2 | 0 | 2 | 2016 |
| University of Pennsylvania | Academic/Hospital | 2 | 2 | 2 | 2006 |
| University of Washington | Academic/Hospital | 2 | 1 | 1 | 1987 |
| Uppsala University | Academic/Hospital | 2 | 1 | 2 | 2008 |
| Vanderbilt University | Academic/Hospital | 2 | 2 | 2 | 2015 |
| Beijing CTSmed Co. Ltd | For profit | 1 | 0 | 1 | 2014 |
| Boston Scientific Corporation | For profit | 1 | 1 | 1 | 2023 |
| Bristol-Myers Squibb | For profit | 1 | 1 | 1 | 2014 |
| Canadian Institutes of Health Research (CIHR) | Academic/Hospital | 1 | 0 | 1 | 2015 |
| Connolly, Stuart, M.D. | Academic/Hospital | 1 | 1 | 1 | 2001 |
| Department of Veteran Affairs | Government | 1 | 1 | 1 | 1998 |
Marketing (22)
| Organization | Org type | Relationship | Date |
|---|---|---|---|
| Altathera Pharms Llc | For profit | NDA2 | Jul 2, 2009 |
| Apotex | For profit | MKTG | Aug 27, 2003 |
| Apotex | For profit | SYN | Sep 26, 2002 |
| Arbor Pharmaceuticals | For profit | NDA2 | Oct 22, 2014 |
| Aurobindo Pharma | For profit | MKTG | Feb 7, 2007 |
| Azurity | For profit | MKTG | Oct 22, 2014 |
| Azurity | For profit | NDA2 | Oct 22, 2014 |
| Beximco | For profit | MKTG | Oct 21, 2016 |
| Covis | For profit | NDA2 | Oct 30, 1992 |
| Covis | For profit | MKTG | Oct 30, 1992 |
| Epic Pharma Llc | For profit | MKTG | Nov 4, 2005 |
| Epic Pharma Llc | For profit | SYN | Nov 4, 2005 |
| Impax Laboratories | For profit | MKTG | Nov 7, 2000 |
| LEGACY PHARMA | For profit | MKTG | Oct 30, 1992 |
| LEGACY PHARMA | For profit | NDA2 | Oct 30, 1992 |
| Mylan | For profit | MKTG | May 1, 2000 |
| Oxford Pharmaceuticals | For profit | MKTG | Nov 7, 2003 |
| Schering | For profit | NDA | Oct 30, 1992 |
| Sun Pharmaceuticals | For profit | MKTG | Oct 15, 2001 |
| Teva | For profit | MKTG | May 1, 2000 |
| Upsher-Smith Laboratories | For profit | MKTG | May 1, 2000 |
| Watson Pharmaceuticals | For profit | MKTG | Jul 13, 2000 |