Betapace

(sotalol)

ApprovedSmall molecule

Sotalol is used to treat irregular heartbeats (arrhythmias) and to help maintain a normal heart rhythm in patients with certain heart conditions.[2] Betapace is currently approved and in use across 7 indications[4].[1]

Betapace is one of 186 small molecule programs targeting Arrhythmia. It is currently in Approved.

Indications

Total Trials

Active Trials

185

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[4][1]

Indication

ArrhythmiaActive, not recruiting

Cardiovascular DiseaseActive, not recruiting

Endothelial DysfunctionActive, not recruiting

Cardiac ArrestActive, not recruiting

Ventricular TachycardiaActive, not recruiting

Supraventricular TachycardiaActive, not recruiting

Atrial FibrillationApproved

ArrhythmiaApproved

Active, not recruiting

Cardiovascular DiseaseApproved

Active, not recruiting

Endothelial DysfunctionPreclinical

Active, not recruiting

Cardiac ArrestPhase 3

Active, not recruiting

Ventricular TachycardiaPreclinical

Active, not recruiting

Supraventricular TachycardiaPhase 3

Active, not recruiting

Atrial FibrillationApproved

Approved

Competition

Competitive Landscape

376 competitors in Atrial Fibrillation

#DrugCompanyPhaseTrials

Betapace

LLegacy Health System

Approved

7 2

Calquence

AstraZeneca

Preclinical

1 3

Romazicon

CConrado Roberto Hoffmann Filho

Preclinical

1 4

Imbruvica

PPharmacyclics LLC.

Preclinical

1 5

Versed

CConrado Roberto Hoffmann Filho

Preclinical

1 6

Anticoagulants

Sanofi

Preclinical

2 7

Direct Anticoagulant

Bayer

Preclinical

1 8

Liquamar

OOrganon and Co

Preclinical

4 9

Magnesium SO4

HHospital de Base

Preclinical

2 10

Anticoagulation

HHospital Álvaro Cunqueiro

Preclinical

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Clinical

Trials by Indication[1]

Atrial Fibrillation7 trials

Atrial Fibrillation Follow-up Investigation of Rhythm Management (AFFIRM)

Completed·NNational Heart, Lung, and Blood Institute (NHLBI)·Phase 3·NCT00000556

Catheter Ablation Compared With Pharmacological Therapy for Atrial Fibrillation (CAPTAF Trial)

Unknown status·UUppsala University Hospital·N/A·NCT02294955·152 enrolled

Pharmacogenetic Study of Antiarrhythmic Drugs for Atrial Fibrillation

Recruiting·UUniversity of Illinois at Chicago·Phase 4·NCT02347111·162 enrolled

Show 4 more trials

Systematic Review and Meta-Analysis of Multaq® for Safety in Atrial Fibrillation

Completed· Sanofi logo

Sanofi··NCT05279833·87,810 enrolled

Comparing the Effects of Amiodarone, Sotalol, and Placebo in Maintaining Sinus Rhythm in Patients With Atrial Fibrillation Converted to Sinus Rhythm

Completed·UUS Department of Veterans Affairs·Phase 3·NCT00007605·706 enrolled

Efficacy and Safety Evaluation of Azimilide or Sotalol vs Placebo for Treatment of Patients With Atrial Fibrillation.

Completed·FForest Laboratories·Phase 3·NCT00035451·658 enrolled

Antiarrhythmic Drugs Assessment in Preventing Atrial Fibrillation

Unknown status·XXinhua Hospital, Shanghai Jiao Tong University School of Medicine·Phase 4·NCT02145546·600 enrolled

Cardiac Arrest1 trial

Cardiac Arrest in Seattle: Conventional Versus Amiodarone Drug Evaluation (CASCADE)

Completed·UUniversity of Washington·Phase 3·NCT00000464

Fasting Conditions1 trial

Bioequivalence Study of Sotalol, Tablets, 160 mg (Pharmtechnology LLC, Belarus), and Sotalex ®, Tablets, 160 mg (Bristol-Myers Squibb GmbH & Co. KGaA, Germany), in Healthy Volunteers Under Fasting Conditions

Completed·PPharmtechnology LLC·Phase 1·NCT03799536·36 enrolled

Ventricular Tachycardia1 trial

Pilot Study of Catheter Ablation for Ventricular Tachycardia in Patients With an Implantable Cardioverter Defibrillator

Terminated·—·N/A·NCT01576042·27 enrolled

Endothelial Dysfunction1 trial

Improvement in Endothelial Dysfunction After Initiation of Anti-arrhythmic Therapy in Atrial Fibrillation Patients

Completed·SSamir Saba··NCT04128878·12 enrolled

9 more indications

TIA1 trial

Antiarrhythmics Versus Implantable Defibrillators (AVID)

Completed·NNational Heart, Lung, and Blood Institute (NHLBI)·Phase 3·NCT00000531

CAR1 trial

Electrophysiologic Study Versus Electrocardiographic Monitoring (ESVEM)

Completed·UUniversity of Utah·Phase 3·NCT00000518

Treatment1 trial

Elimination of VPB With Ablation Versus Anti-arrhythmic Drug Treatment

Completed·MMaatschap Cardiologie Zwolle·N/A·NCT03845010·22 enrolled

Arrhythmia1 trial

Efficacy and Safety of Sotalol in Children With Arrhythmia

Unknown status·SShengjing Hospital·Phase 4·NCT03895411·500 enrolled

Pacemaker1 trial

Study of the Effects of BMS-919373 on the Electrical Activity of the Heart Using Pacemakers

Terminated· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 1·NCT02153437·7 enrolled

ESS1 trial

Safety Assessment for Sotalol Protocol in Outpatient Unit

Unknown status·UUniversity of Sao Paulo General Hospital·Phase 4·NCT05418036·110 enrolled

Prospective1 trial

Prospective Evaluation Analysis and Kinetics Registry

Completed·UUniversity of Utah··NCT05247320·167 enrolled

Supraventricular tachycardia1 trial

Prospective Randomized Clinical Trial of Fetal Atrial Flutter & Supraventricular Tachycardia Therapy (FAST RCT)

Completed·EEdgar Jaeggi·Phase 3·NCT02624765·105 enrolled

Unspecified1 trial

Genetic Sources of Variability of the Adaptation of the Ventricular Repolarisation

Completed·AAssistance Publique - Hôpitaux de Paris·Phase 1·NCT00773201·997 enrolled

Regulatory

FDA Approval Timeline[5]

Oct 30, 1992

BETAPACE

NDA NDA019865

Apr 2, 2003

BETAPACE AF

NDA NDA021151

Jul 2, 2009

SOTALOL HYDROCHLORIDE

NDA NDA022306

Oct 22, 2014

SOTYLIZE

NDA NDA205108

Sources

References

[1]
ClinicalTrials.gov — 20 trial records for sotalol. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Betapace drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — sotalol compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for sotalol. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA NDA205108). U.S. Food & Drug Administration.
[6]
FDA Orange Book — Patent and exclusivity data for Betapace. U.S. Food & Drug Administration.
[7]
SEC EDGAR — Legacy Health System company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Beta-1 Adrenergic Receptor Antagonist; Beta-2 Adrenergic Receptor Antagonist; HERG Blocker[3]
Modality: Small molecule[3]
Highest Phase: Approved[1]
Company: LLegacy Health System

Patent Landscape[6]

Patent Cliff

Aug 14, 2028

Earliest patent expiration — generic entry possible after this date

Patent #Expires

12403109Aug 14, 2028

11013703Apr 1, 2034

12290495Apr 1, 2034

10206895Apr 1, 2034

11850222Nov 19, 2034

7 more patents

9724297Aug 31, 2035

12390431Aug 14, 2038

10512620Aug 14, 2038

11696902Aug 14, 2038

12569183Apr 5, 2039

10799138Apr 5, 2039

11583216Aug 21, 2039

Betapace

Status by Indication[4][1]

Competitive Landscape

Trials by Indication[1]

Atrial Fibrillation7 trials

Cardiac Arrest1 trial

Fasting Conditions1 trial

Ventricular Tachycardia1 trial

Endothelial Dysfunction1 trial

TIA1 trial

CAR1 trial

Treatment1 trial

Arrhythmia1 trial

Pacemaker1 trial

ESS1 trial

Prospective1 trial

Supraventricular tachycardia1 trial

Unspecified1 trial

FDA Approval Timeline[5]

References

Drug Info

Quick Facts

Patent Landscape[6]

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