Rythmol Sr

(propafenone)

ApprovedSmall molecule

GGlaxo Dba Glaxosmithkline

Rythmol Sr is one of 100 small molecule programs targeting Arrhythmia. It is currently in Approved.

Indications

Total Trials

Active Trials

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[3][1]

Indication

ArrhythmiaActive, not recruiting

Cardiac ArrestActive, not recruiting

Atrial FibrillationActive, not recruiting

ArrhythmiaApproved

Active, not recruiting

Cardiac ArrestPhase 3

Active, not recruiting

Atrial FibrillationApproved

Active, not recruiting

Competition

Competitive Landscape

376 competitors in Atrial Fibrillation

#DrugCompanyPhaseTrials

Rythmol Sr

GGlaxo Dba Glaxosmithkline

Approved

9 2

Calquence

AstraZeneca

Preclinical

1 3

Rituxan

Calan

4 5

Ondexxya

UUnion Hospital, Tongji Medical College, Huazhong University of Science and Technology

Preclinical

1 6

Romazicon

CConrado Roberto Hoffmann Filho

Preclinical

1 7

Brukinsa

BBeOne Medicines

Preclinical

1 8

Imbruvica

PPharmacyclics LLC.

Preclinical

1 9

Xylocaine

MMEDRx USA, Inc.

Preclinical

1 10

Versed

CConrado Roberto Hoffmann Filho

Preclinical

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

Timeline

Expected Milestones

Q4 2028

Post-ApprovalNot yet recruiting

Atrial Fibrillation

NCT07270848

Clinical

Trials by Indication[1]

Atrial Fibrillation9 trials

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

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

Antiarrhythmic Drugs Assessment in Preventing Atrial Fibrillation

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

Efficacy and Safety of Electrical Versus Pharmacological Cardioversion in Early Atrial Fibrillation

Completed·VValduce Hospital·N/A·NCT00933634·247 enrolled

Show 6 more trials

Antazoline in Comparison to Propafenone in Pharmacological Cardioversion of Atrial Fibrillation.

Unknown status·CCentre of Postgraduate Medical Education·Phase 4·NCT05720572·105 enrolled

Comparison of Brain Perfusion in Rhythm Control and Rate Control of Persistent Atrial Fibrillation

Unknown status·YYonsei University·N/A·NCT02633774·200 enrolled

Propafenone in the Treatment of Atrial Fibrillation

Completed·TTSH Biopharm Corporation Limited·N/A·NCT03674658·71 enrolled

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

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

Dronedarone Rhythm Intervention for Early Atrial Fibrillation

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

Efficacy of Propafenone Versus Dronedarone for the Maintenance of Sinus Rhythm in Patients With Atrial Fibrillation

Completed·SSamsung Medical Center·N/A·NCT01991119·98 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 Two Formulations of Propafenone 300 mg Film-coated Tablets in Healthy Adult Volunteers After a Single Oral Dose Administration Under Fasting Conditions

Completed·PPharmtechnology LLC·Phase 1·NCT03915340·32 enrolled

Drug1 trial

Beta-blocker vs. Ic Antiarrhythmic Drug for PVC

Withdrawn·YYong Seog Oh·N/A·NCT03561935

Arrhythmia1 trial

Efficacy and Safety of Sotalol in Children With Arrhythmia

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

2 more indications

Ultrasound1 trial

High Intensity Focused Ultrasound (HIFU) Ablation System Study

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

Unspecified1 trial

Bioequivalence of RYTHMOL SR® Manufactured at Two Different Sites

Completed· GSK logo

GSK·Phase 1·NCT01956487·38 enrolled

Regulatory

FDA Approval Timeline[4]

Nov 27, 1989

RYTHMOL

NDA NDA019151

Sep 4, 2003

RYTHMOL SR

NDA NDA021416

Sources

References

[1]
ClinicalTrials.gov — 15 trial records for propafenone. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — propafenone compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for propafenone. EMBL-EBI & Wellcome Sanger Institute.
[4]
OpenFDA — FDA approval records (NDA NDA021416). U.S. Food & Drug Administration.
[5]
SEC EDGAR — Glaxo Dba Glaxosmithkline company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Highest Phase: Approved[1]
Company: GGlaxo Dba Glaxosmithkline

Rythmol Sr

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q4 2028

Trials by Indication[1]

Atrial Fibrillation9 trials

Cardiac Arrest1 trial

Fasting Conditions1 trial

Drug1 trial

Arrhythmia1 trial

Ultrasound1 trial

Unspecified1 trial

FDA Approval Timeline[4]

References

Drug Info

Quick Facts

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