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Tambocor

(flecainide)

ApprovedSmall molecule

Flecainide is used to treat abnormal heart rhythms (arrhythmias) by helping the heart beat in a more regular pattern. It slows down electrical signals in the heart to prevent dangerous irregular heartbeats.[2] Tambocor is currently approved and in use across 10 indications[4].[1]

Tambocor is one of 161 small molecule programs targeting Coronary Artery Disease. It is currently in Approved.

10

Indications

25

Total Trials

8

Active Trials

160

Competitors

1

FDA Application

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[4][1]

Indication

Coronary Artery DiseaseActive, not recruiting

Cardiac ArrhythmiaActive, not recruiting

CardiomyopathyActive, not recruiting

Ventricular TachycardiaActive, not recruiting

Paroxysmal Atrial FibrillationApproved

Arrhythmogenic Right Ventricular DysplasiaApproved

Supraventricular TachycardiaActive, not recruiting

Ventricular ArrhythmiaActive, not recruiting

Patent Foramen OvaleActive, not recruiting

Atrial FibrillationApproved

Coronary Artery DiseaseApproved

Active, not recruiting

Cardiac ArrhythmiaApproved

Active, not recruiting

CardiomyopathyPreclinical

Active, not recruiting

Ventricular TachycardiaApproved

Active, not recruiting

Paroxysmal Atrial FibrillationApproved

Approved

Arrhythmogenic Right Ventricular DysplasiaApproved

Approved

Supraventricular TachycardiaPreclinical

Active, not recruiting

Ventricular ArrhythmiaPhase 3

Active, not recruiting

Patent Foramen OvalePhase 3

Active, not recruiting

Atrial FibrillationApproved

Approved

Competition

Competitive Landscape

376 competitors in Atrial Fibrillation

#DrugCompanyPhaseTrials

Tambocor

Anticoagulants

SGLT2 Inhibitor

Direct Anticoagulant

Magnesium SO4

HHospital de Base

Anticoagulation

HHospital Álvaro Cunqueiro

Medication

NNYU Langone Health

Blood Taken

HHospices Civils de Lyon

Standard BP Control

NNational Heart, Lung, and Blood Institute (NHLBI)

Propacetamol

YYonsei University

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

Timeline

Expected Milestones

Q4 2027

Cardiomyopathy

NCT06949748

Q4 2028

Post-ApprovalNot yet recruiting

Atrial Fibrillation

NCT07270848

Q4 2029

Post-ApprovalNot yet recruiting

Coronary Artery Disease

NCT07405671

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

Dronedarone Rhythm Intervention for Early Atrial Fibrillation

Not yet recruiting·IInha University Hospital·Phase 4·NCT07270848·1,898 enrolled

Acupuncture in Persistent Atrial Fibrillation

Unknown status·KKyunghee University Medical Center·N/A·NCT02110537·80 enrolled

Show 4 more trials

Comparative Study of Flecainide CR and Placebo in the Early Treatment of Atrial Fibrillation.

Terminated·MMEDA Pharma GmbH & Co. KG·Phase 4·NCT00408473·256 enrolled

Single Dose Flecainide for Early Sinus Rhythm Conversion of Perioperative Atrial Fibrillation After Noncardiac Surgery

Withdrawn·PPopulation Health Research Institute·Phase 4·NCT06142604

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

Paroxysmal atrial fibrillation4 trials

Predictive Factors to Effectively Terminate Paroxysmal Atrial Fibrillation by Blocking Atrial Selective Ionic Currents

Completed·DDavid Filgueiras-Rama·Phase 4·NCT03005366·50 enrolled

To Evaluate the Impact of Oral Flecainide on Quality of Life in Patients With Paroxysmal Atrial Fibrillation

Completed·MMEDA Pharma GmbH & Co. KG·Phase 4·NCT00189319·200 enrolled

Flecainide Versus Amiodarone in the Cardioversion of Paroxysmal Atrial Fibrillation at the Emergency Department, in Patients With Coronary Artery Disease Without Residual Ischemia

Recruiting·HHippocration General Hospital·Phase 3·NCT05549752·80 enrolled

Show 1 more trial

Beta Blockers Plus Intravenous Flecainide for Paroxysmal Atrial Fibrillation: a Real-world Chios Registry (BETAFLEC-CHIOS)

Completed·—··NCT04991896·81 enrolled

Cardiac Arrhythmia3 trials

Ajmaline Utilization in the Diagnosis and Treatment of Cardiac Arrhythmias

Completed·HHospital Clinic of Barcelona·Phase 4·NCT00702117·123 enrolled

Cardiac Arrhythmia Suppression Trial (CAST)

Completed·NNational Heart, Lung, and Blood Institute (NHLBI)·Phase 3·NCT00000526

Cardiac Arrhythmia Pilot Study (CAPS)

Completed·NNational Heart, Lung, and Blood Institute (NHLBI)·Phase 2·NCT00000504

Coronary Artery Disease1 trial

Flecainide Safety in Patients With Coronary Artery Disease and Atrial Fibrillation

Not yet recruiting·UUniversitaire Ziekenhuizen KU Leuven·Phase 4·NCT07405671·988 enrolled

Trial1 trial

Vernakalant Versus Flecainide: Atrial Contractility

Unknown status·MMaastricht University Medical Center·Phase 4·NCT01646281·70 enrolled

9 more indications

Cardiomyopathy1 trial

Flecainide in Idiopathic Premature Ventricular Contractions and Related Cardiomyopathy

Recruiting·UUniversity of Athens··NCT06949748·300 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

Medication1 trial

Shortening Duration of Antiarrhythmic Medication for SVT in Infants

Completed·TTampere University Hospital··NCT04837261·107 enrolled

Patent foramen ovale1 trial

Assessment of Flecainide to Lower the Patent Foramen Ovale Closure Risk of Atrial Arrhythmia or Tachycardia

Active, not recruiting·AAssistance Publique - Hôpitaux de Paris·Phase 3·NCT05213104·186 enrolled

AIN1 trial

Flecainide-Short Long Study (Flec-SL)

Completed·AAtrial Fibrillation Network·N/A·NCT00215774·760 enrolled

Ventricular Tachycardia1 trial

Effects of Carvedilol on Suppressing the Premature Ventricular Complex/Ventricular Tachycardia From Outflow Tract

Unknown status·KKeimyung University Dongsan Medical Center·Phase 4·NCT03587558·104 enrolled

Ultrasound1 trial

High Intensity Focused Ultrasound (HIFU) Ablation System Study

Suspended·PProRhythm, Inc.·Phase 3·NCT00392106·240 enrolled

Ventricular arrhythmia1 trial

Effect and Safety of Flecainide and Metoprolol Versus Metoprolol Alone to Suppress Ventricular Arrhythmias in Arrhythmic Mitral Valve Prolapse

Recruiting·OOslo University Hospital·Phase 3·NCT05631730·50 enrolled

Unspecified1 trial

N-of-1 in ATS and MEPPC

Not yet recruiting·—·Phase 2·NCT06205550·10 enrolled

Regulatory

FDA Approval Timeline[5]

Aug 23, 1988

TAMBOCOR

NDA NDA018830

Sources

References

[1]
ClinicalTrials.gov — 25 trial records for flecainide. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Tambocor drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — flecainide compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for flecainide. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA NDA018830). U.S. Food & Drug Administration.
[6]
SEC EDGAR — Alvogen Korea company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Sodium Channel Protein Type V Alpha Subunit Blocker[3]
Modality: Small molecule[3]
Highest Phase: Approved[1]
Company: AAlvogen Korea

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