Drugs / sotalol
sotalol
also known as
Sotacor · Beta-cardone · Betapace · Betapace af · C07AA07 · Darob · Darob mite · DL-MJ-1999 · +11 more
Small molecule targets ADRB1, ADRB2, KCNH2 via inhibition
Regulatory milestones approvals, filings & regulatory actions · 4 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansions (2) | US (FDA) | SOTALOL HYDROCHLORIDE | — | 2020-03-06 – 2025-07-23 | fda.gov ↗ |
| Label expansion | US (FDA) | BETAPACE | — | 2001-10-01 | fda.gov ↗ |
| Approved | US (FDA) | BETAPACE | — | 1992-10-30 | fda.gov ↗ |
Trials 20
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT00773201 | Feb 2008 → Mar 2012 | — | Assistance Publique - Hôpitaux de Paris | Completed | No outcome recorded |
| Phase 35 trials | ||||||
| Phase 3 | NCT04208997 | Dec 2019 → Jun 2021 | ventricular tachycardia | Vanderbilt University Medical Center | Terminated | No outcome recorded Stop: Enrollment |
| Phase 3 | NCT00000556 | Mar 1995 → Sep 2002 | atrial fibrillation | National Heart, Lung, and Blood Institute (NHLBI) | Completed | No outcome recorded |
| Phase 3 | NCT00000531 | Sep 1992 → Aug 2002 | sudden cardiac arrest, ventricular fibrillation, ventricular tachycardia | National Heart, Lung, and Blood Institute (NHLBI) | Completed | No outcome recorded |
| Phase 3 | NCT00000464 | Apr 1987 → Dec 1992 | cardiac arrest, myocardial infarction, ventricular fibrillation | University of Washington | Completed | No outcome recorded |
| Phase 3 | NCT00000518 | Jul 1985 → Dec 1992 | sudden cardiac arrest, ventricular fibrillation, ventricular tachycardia | University of Utah | Completed | No outcome recorded |
| Phase 48 trials · 2 met primary | ||||||
| Phase 4 | NCT04473807 | Jan 2021 → Apr 2022 | atrial fibrillation | Kansas City Heart Rhythm Research Foundation | Unknown | No outcome recorded |
| Phase 4 | NCT02347111 | Dec 2020 → Jun 2026 overdue | atrial fibrillation | University of Illinois at Chicago | Recruiting | No outcome recorded |
| Phase 4 | NCT05418036 | Oct 2020 → Feb 2023 | cardiac rhythm disease | University of Sao Paulo General Hospital | Unknown | No outcome recorded |
| Phase 4 | NCT03895411 | Aug 2019 → Dec 2020 | cardiac rhythm disease | Shengjing Hospital | Unknown | No outcome recorded |
| Phase 4 | NCT02145546 | May 2014 → May 2017 | atrial fibrillation | Xinhua Hospital, Shanghai Jiao Tong University School of Medicine | Unknown | No outcome recorded |
| Phase 4 | NCT01505296 | Dec 2011 → Jan 2014 | atrial fibrillation | Valley Health System | Withdrawn | No outcome recorded |
| Phase 4 | NCT00340314 | Jan 2005 → May 2006 | atrial fibrillation | IRCCS San Raffaele | Completed | Met primary |
| Phase 4 | NCT00257959 | Jan 2001 → Oct 2004 | ventricular tachycardia | Connolly, Stuart, M.D. | Completed | Met primary |
| Phase not applicable6 trials · 2 met primary | ||||||
| — | NCT06669299 | Jun 2025 → Dec 2027 expected | ventricular tachycardia | IRCCS Ospedale San Raffaele | Recruiting | No outcome recorded |
| — | NCT07447297 | Jan 2024 → Dec 2027 expected | atrial fibrillation, atrial flutter | Samsung Medical Center | Recruiting | No outcome recorded |
| — | NCT02825979 | Jan 2017 → Sep 2022 | atrial fibrillation | Jason Andrade | Unknown | Met primary |
| — | NCT01576042 | May 2012 → May 2014 | ventricular tachycardia | Duke University | Terminated | No outcome recorded |
| — | NCT00408200 | Nov 2006 → Apr 2008 | paroxysmal atrial fibrillation | University of Pennsylvania | Completed | Met primary |
| — | NCT00578617 | Sep 2006 → Feb 2009 | atrial fibrillation | Mayo Clinic | Completed | No outcome recorded |
| Comparator or background therapy34 trials | ||||||
| Phase 1 | NCT02153437 Comparator | Oct 2014 → Oct 2016 | atrial fibrillation | Bristol-Myers Squibb | Terminated | No outcome recorded |
| Phase 2 | NCT01709682 Comparator | Nov 2007 → Jan 2012 | paroxysmal atrial fibrillation | Meshalkin Research Institute of Pathology of Circulation | Completed | No outcome recorded |
| Phase 3 | NCT05939076 Comparator | Aug 2023 → Dec 2027 expected | persistent atrial fibrillation | Region Örebro County | Not yet recruiting | No outcome recorded |
| Phase 3 | NCT04037397 Comparator | Sep 2019 → Oct 2024 | atrial fibrillation | University of Pennsylvania | Completed | No outcome recorded |
| Phase 3 | NCT02624765 Comparator | Feb 2016 → Mar 2024 | atrial flutter, hydrops fetalis | Edgar Jaeggi | Completed | No outcome recorded |
| Phase 3 | NCT01798277 Comparator | Apr 2013 → Jun 2015 | coronary artery disorder, ventricular tachycardia | Newmarket Electrophysiology Research Group Inc | Withdrawn | No outcome recorded |
| Phase 3 | NCT00589303 Comparator | Dec 2007 → Jul 2011 | atrial fibrillation, heart failure | Mayo Clinic | Terminated | No outcome recorded Stop: Business |
| Phase 3 | NCT00523978 Comparator | Oct 2006 → Aug 2010 | paroxysmal atrial fibrillation | Medtronic Cardiac Rhythm and Heart Failure | Completed | No outcome recorded |
| Phase 3 | NCT00035451 Comparator | Feb 2001 → Jun 2003 | atrial fibrillation | Forest Laboratories | Completed | No outcome recorded |
| Phase 3 | NCT00007605 Comparator | Apr 1998 → Oct 2002 | atrial fibrillation, stroke disorder, sudden cardiac arrest | US Department of Veterans Affairs | Completed | No outcome recorded |
| Phase 4 | NCT07405671 Comparator | Sep 2026 → Dec 2029 expected | atrial fibrillation, coronary artery disorder | Universitaire Ziekenhuizen KU Leuven | Recruiting | No outcome recorded |
| Phase 4 | NCT04767061 Comparator | Apr 2021 → Apr 2022 | diastolic heart failure | Weill Medical College of Cornell University | Completed | No outcome recorded |
| Phase 4 | NCT04757584 Comparator | Apr 2021 → Apr 2023 | diastolic heart failure | Weill Medical College of Cornell University | Completed | No outcome recorded |
| Phase 4 | NCT02830360 Comparator | Oct 2016 → Jun 2024 | ventricular tachycardia | John Sapp | Completed | No outcome recorded |
| Phase 4 | NCT02303639 Comparator | Apr 2015 → Jun 2017 | myocardial infarction, ventricular tachycardia | Central Finland Hospital District | Unknown | No outcome recorded |
| Phase 4 | NCT02389218 Comparator | Mar 2015 → May 2020 | atrial fibrillation | University Hospital, Ghent | Completed | No outcome recorded |
| Phase 4 | NCT02114528 Comparator | Oct 2014 → Nov 2015 | ventricular tachycardia | Ottawa Heart Institute Research Corporation | Terminated | No outcome recorded Stop: Enrollment |
| Phase 4 | NCT01780311 Comparator | Jan 2013 → Jan 2014 | ventricular tachycardia | Ospedale San Donato | Unknown | No outcome recorded |
| Phase 4 | NCT01477983 Comparator | Nov 2011 → Jul 2017 | atrial fibrillation | Kyoto University, Graduate School of Medicine | Completed | No outcome recorded |
| Phase 4 | NCT00540787 Comparator | Aug 2003 → Jun 2006 | paroxysmal atrial fibrillation | Biosense Webster, Inc. | Completed | No outcome recorded |
| — | NCT07445334 Comparator | Mar 2026 → Sep 2027 expected | ventricular tachycardia | Western Sydney Local Health District | Recruiting | No outcome recorded |
| — | NCT06322017 Comparator | Apr 2024 → Apr 2030 expected | atrial fibrillation | Nantes University Hospital | Recruiting | No outcome recorded |
| — | NCT06096337 Comparator | Dec 2023 → Feb 2026 overdue | persistent atrial fibrillation | Boston Scientific Corporation | Active not recruiting | No outcome recorded |
| — | NCT05790707 Comparator | Apr 2023 → Jan 2027 expected | cognitive impairment with or without cerebellar ataxia, persistent atrial fibrillation | Poitiers University Hospital | Recruiting | No outcome recorded |
| — | NCT04942834 Comparator | Oct 2021 → Jul 2025 | persistent atrial fibrillation | Ruijin Hospital | Unknown | No outcome recorded |
| — | NCT05524077 Comparator | Jul 2020 → Jun 2026 overdue | arrhythmogenic right ventricular cardiomyopathy, dilated cardiomyopathy, familial cardiomyopathy, sarcoidosis +1 | Western Sydney Local Health District | Active not recruiting | No outcome recorded |
| — | NCT03845010 Comparator | Feb 2019 → Jan 2023 | cardiac rhythm disease | Maatschap Cardiologie Zwolle | Completed | No outcome recorded |
| — | NCT03437356 Comparator | Feb 2018 → May 2022 | atrial fibrillation | AZ Sint-Jan AV | Completed | No outcome recorded |
| — | NCT05514860 Comparator | Jan 2017 → Sep 2022 | atrial fibrillation | University of British Columbia | Unknown | No outcome recorded |
| — | NCT02459574 Comparator | May 2015 → Sep 2018 | atrial fibrillation, heart failure | Imperial College London | Completed | No outcome recorded |
| — | NCT03734562 Comparator | Jul 2010 → Sep 2017 | ventricular tachycardia | Hospital General Universitario Gregorio Marañon | Completed | No outcome recorded |
| — | NCT00911508 Comparator | Nov 2009 → Dec 2017 | atrial fibrillation | Mayo Clinic | Completed | No outcome recorded |
| — | NCT02294955 Comparator | May 2008 → Sep 2018 | atrial fibrillation | Uppsala University Hospital | Unknown | No outcome recorded |
| — | NCT01411371 Comparator | Mar 2005 → Feb 2013 | heart failure, persistent atrial fibrillation | Barts & The London NHS Trust | Completed | No outcome recorded |
Evidence & citations 26 cited values
Every value below carries the sentence it was read from. 56 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Sotalol | “Treatment will be as per current guidelines for persistent atrial fibrillation, with rate control as first line (using beta-blockers, calcium channel blockers and digoxin as...” NCT01411371 ↗53“Antiarrhythmic drug therapy (Class I - flecainide, propafenone; Class III - sotalol, dronedarone) will prescribed and monitored based on local clinical practice, and according...” NCT05514860 ↗ “Antiarrhythmic drug therapy (Class I - flecainide, propafenone; Class III - sotalol, dronedarone) will prescribed and monitored based on local clinical practice, and according...” NCT02825979 ↗ “Patients will be prescribed antiarrhythmic drugs (either amiodarone or sotalol based on specific clinical presentation, including medical history, functional class, ejection...” NCT02830360 ↗ “The recommended drugs are flecainide, propafenone, sotalol and amiodarone, but the final choice of drug and dosage is left to the discretion of the attending physician.” NCT01477983 ↗ “If deferred to the trial team, clinical protocol suggests sotalol (which has both AAD and BB properties) 80mg twice daily, or a lower dose if indicated.” NCT07445334 ↗ “Either one or more of the following antiarrhythmic drugs: sotalol, mexiletine, procainamide, or amiodarone.” NCT02114528 ↗ “* procainamide * quinidine * disopyramide * propafenone * flecainide * sotalol * dofetilide * amiodarone” NCT00589303 ↗ “Amiodarone; Dronaderone; Sotalol Beta blockers; Calcium channel blockers; Flecainide; or Propafenone.” NCT02459574 ↗ “maximum tolerable doses of another ADT, which included flecainide, sotalol, and amiodarone.” PMID 17161267 ↗ Oct 2006 “Amiodarone, flecainide, sotalol, propafenone are the anti arrhythmic drugs allowed.” NCT05790707 ↗ |
| Known as | Beta-cardone | ChEMBL registry synonym — accepted as the source's own label CHEMBL471 ↗ |
| Known as | Betapace | ChEMBL registry synonym — accepted as the source's own label CHEMBL471 ↗ |
| Known as | Betapace af | ChEMBL registry synonym — accepted as the source's own label CHEMBL471 ↗ |
| Known as | C07AA07 | ChEMBL registry synonym — accepted as the source's own label CHEMBL471 ↗ |
| Known as | Darob | ChEMBL registry synonym — accepted as the source's own label CHEMBL471 ↗ |
| Known as | Darob mite | ChEMBL registry synonym — accepted as the source's own label CHEMBL471 ↗ |
| Known as | DL-MJ-1999 | ChEMBL registry synonym — accepted as the source's own label CHEMBL471 ↗ |
| Known as | Dl-sotalol | ChEMBL registry synonym — accepted as the source's own label CHEMBL471 ↗ |
| Known as | MJ 1999 | ChEMBL registry synonym — accepted as the source's own label CHEMBL471 ↗ |
| Known as | NSC-337251 | ChEMBL registry synonym — accepted as the source's own label CHEMBL471 ↗ |
| Known as | NSC-760358 | ChEMBL registry synonym — accepted as the source's own label CHEMBL471 ↗ |
| Known as | Sorine | ChEMBL registry synonym — accepted as the source's own label CHEMBL471 ↗ |
| Known as | Sotacor | “dronedarone - Multaq™ OR flecainide - Tambocor™ OR propafenone - Rytmonorm™ OR sotalol - Sotacor™” NCT05939076 ↗1“Amiodarone (Cordarone) or Sotalol (Sotacor)” NCT02830360 ↗ |
| Known as | Sotalex | “Sotalol: Sotalex or Sotalol EG 80mg b.i.d.” NCT03437356 ↗ |
| Known as | Sotalol EG | “Sotalol: Sotalex or Sotalol EG 80mg b.i.d.” NCT03437356 ↗ |
| Known as | Sotalol hcl | ChEMBL registry synonym — accepted as the source's own label CHEMBL471 ↗ |
| Known as | SOTALOL HYDROCHLORIDE | ChEMBL registry synonym — accepted as the source's own label CHEMBL471 ↗ |
| Known as | Sotalol hydrochloride component of sotylize | ChEMBL registry synonym — accepted as the source's own label CHEMBL471 ↗ |
| Known as | Sotylize | ChEMBL registry synonym — accepted as the source's own label CHEMBL471 ↗ |
| Action | Inhibit | “Beta-2 adrenergic receptor antagonist” CHEMBL471 ↗ |
| Modality | Small molecule | — CHEMBL471 ↗ |
| Route | Oral | “an oral 80mg sotalol dose” PMID 28800628 ↗ Aug 2017 |
| Target | ADRB1 | “Beta-1 adrenergic receptor antagonist” CHEMBL471 ↗ |
| Target | ADRB2 | “Beta-2 adrenergic receptor antagonist” CHEMBL471 ↗ |
| Target | KCNH2 | “HERG blocker” CHEMBL471 ↗ |