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dronedarone

Generic: DRONEDARONE HYDROCHLORIDE·Brand: DRONEDARONE HYDROCHLORIDE, MULTAQ

dronedarone: developed by 1 company · 1 clinical trial tracked · 1 FDA decision.

dronedarone evidence translation

What we can confirm

1 FDA record · 1 tracked trial

What it means

Source-backed records connect dronedarone to SNY; that link alone does not prove the drug works.

What to watch

Watch active trials and any change in FDA or trial status.
BioSniper AIPage evidence connected

Prepared research question

How could dronedarone → SNY affect its developer, and what evidence supports the link?

Run cited research

Traceable citations · Unknowns marked

See linked entities and source evidence1 indications · 0 study sponsors

Related indications

Atrial Fibrillation

Study sponsors

No additional listed-company sponsor is linked.

Development Pipeline (2)
CompanyPhase
Sanofi (SNY)Approved
Sanofi (SNY)Approved
Clinical Trials (1)

Effect of Dronedarone on Atrial Fibrosis Progression and Atrial Fibrillation Recurrence Post Ablation: The EDORA Trial

NCT04704050·Phase 4
Terminated

Primary endpoint: Post-ablation Atrial Fibrillation Recurrence

InterventionalRandomizedsingle22 targetStarted 2021-05Completion 2022-124 sites · United StatesTulane University School of Medicine
FDA Decisions1 records
Approval1 INDICATIONS AND USAGE MULTAQ ® is indicated to reduce the risk of hospitalization for atrial fibrillation in patients in sinus rhythm with a history of paroxysmal or persistent atrial fibrillation (AF) [see Clinical Studies (14) ] . MULTAQ is an antiarrhythmic drug indicated to reduce the risk of hospitalization for atrial fibrillation (AF) in patients in sinus rhythm with a history of paroxysmal or persistent AF ( 1 , 14 ).(SNY)FDA ↗
NDA022425Type 1 - New Molecular EntityPriorityOralTablet

Frequently asked questions

Who is developing dronedarone?

dronedarone is being developed by Sanofi.

How many clinical trials involve dronedarone?

BioSniper tracks 1 clinical trial involving dronedarone.

What is dronedarone's latest FDA decision?

The most recent tracked FDA decision for dronedarone is Approval for 1 INDICATIONS AND USAGE MULTAQ ® is indicated to reduce the risk of hospitalization for atrial fibrillation in patients in sinus rhythm with a history of paroxysmal or persistent atrial fibrillation (AF) [see Clinical Studies (14) ] . MULTAQ is an antiarrhythmic drug indicated to reduce the risk of hospitalization for atrial fibrillation (AF) in patients in sinus rhythm with a history of paroxysmal or persistent AF ( 1 , 14 )., dated July 1, 2009.