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dronedarone

Trade name: multaq

Small moleculeapproved

Approved

Jul 1, 2009

Dronedarone is an antiarrhythmic that is FDA approved for the treatment of atrial fibrillation in patients in sinus rhythm with a history of paroxysmal or persistent atrial fibrillation (AF). Dronedarone is multichannel blocker. Common adverse reactions include abdominal pain, diarrhea, indigestion, nausea, vomiting, asthenia and raised serum creatinine. Dronedarone has potentially important pharmacodynamics interactions: Digoxin: Consider discontinuation or halve dose of digoxin before treatment and monitor; Calcium channel blockers (CCB): Initiate CCB with low dose and increase after ECG verification of tolerability; Beta-blockers: May provoke excessive bradycardia, Initiate with low dose and increase after ECG verification of tolerability. — NCATS

Clinical trial activity

32 trials · 29 clinical orgs · 10 marketing orgs

Phase 1
1
Phase 2
12
Phase 3
11
Phase 4
11

Earliest trial started Nov 1, 2001 (NCT00259376)

Timeline

2000s

  1. Jan 1, 2001

    Earliest Phase 3 Sponsor(trial)

  2. Jul 1, 2009

    Sanofi-Aventis — Earliest FDA Approval

  3. Jul 1, 2009

    Sanofi-Aventis — NDA Organization

2010s

  1. Jan 1, 2010

    Earliest Phase 2 Sponsor(trial)

  2. Jan 1, 2011

    Earliest Phase 1 Sponsor(trial)

  3. Dec 31, 2015

    Alkem Labs Ltd — Marketing Organization

  4. Dec 31, 2015

    Glenmark Pharmaceuticals — Marketing Organization

  5. Dec 31, 2015

    Watson Pharmaceuticals — Marketing Organization

  6. Dec 31, 2015

    Allergan PLC (2015) — Marketing Organization

  7. May 12, 2017

    Amneal Pharmaceuticals — Marketing Organization

2020s

  1. May 17, 2021

    Sandoz — Marketing Organization

  2. May 17, 2021

    Novartis — Marketing Organization

  3. Apr 27, 2023

    Aurobindo Pharma — Marketing Organization

  4. Jan 31, 2024

    Lupin — Marketing Organization

Indications

Approved for

Studied for

Mechanism of action

Approval history

  • approvedPriority reviewJul 1, 2009

Chemistry & pharmacology

Loading structure…

SMILES

CCCCc1oc2ccc(NS(C)(=O)=O)cc2c1C(=O)c1ccc(OCCCN(CCCC)CCCC)cc1
Mol. weight
556.77 g/mol
Lipinski Ro5
2 violation(s)
Rule of 3
No
Chirality
Achiral Molecule
Inorganic
No
Polymer
No
Delivery
Oral
Availability
Prescription Only

Oral

Yes

Parenteral

No

Topical

No

Black box warning

Sources

Also known as

  • dronedarone
  • dronedarone
  • dronedarone
  • dronedarone
  • dronedarone
  • dronedarone
  • dronedarone
  • dronedarone
  • dronedarone
  • dronedarone
  • dronedarone
  • dronedarone
  • dronedarone hcl
  • dronedarone hcl
  • dronedarone hcl
  • dronedarone hydrochloride
  • dronedarone hydrochloride
  • dronedarone hydrochloride
  • dronedarone hydrochloride
  • multaq
  • multaq
  • multaq
  • multaq
  • multaq
  • n-(2-butyl-3-(4-(3-(dibutylamino)propoxy)benzoyl)-5-benzofuranyl)-methanesulfonamide
  • n-(2-butyl-3-(4-(3-(dibutylamino)propoxy)benzoyl)-5-benzofuranyl)-methanesulfonamide
  • n-(2-butyl-3-(p-(3-(dibutylamino)propoxy)benzoyl)-5-benzofuranyl)methanesulfonamide
  • n-(2-butyl-3-(p-(3-(dibutylamino)propoxy)benzoyl)-5-benzofuranyl)methanesulfonamide
  • sr 33589
  • sr 33589
  • sr 33589
  • sr 33589b
  • sr 33589b
  • sr 33589b
  • sr33598b
  • sr-33598b
  • sr-33598b

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT07270848Phase 4Dec 1, 2025Inha University
NCT05939076Phase 3Aug 21, 2023Orebro University, Swedish Heart Lung Foundation, The Swedish Research Council, Uppsala University
NCT05655468Phase 4Jan 31, 2023Huazhong University of Science and Technology
NCT05130268Phase 4Dec 31, 2021American Heart Association, Duke University, Sanofi
NCT04942834N/AAug 31, 2021Jiao Tong University
NCT04704050Phase 4May 15, 2021Cardiac Designs Inc., Marrek, INC, Preventice, Sanofi, Tulane University, University of Washington
NCT04037397Phase 3Jul 22, 2019Biosense Webster, Inc., Texas Cardiac Arrhythmia Institute, University of Pennsylvania
NCT03905759Phase 2/Phase 3 (Phase 3)Apr 3, 2019Beni Suef University
NCT02825979N/AJan 1, 2017University of British Columbia, University of Ottawa
NCT02459574N/AMay 1, 2015University of London
NCT01522651Phase 2Jan 1, 2012Gilead Sciences
NCT01430806N/AOct 1, 2011Tel Aviv University
NCT01991119N/AMay 1, 2011Sungkyunkwan University
NCT01266681N/AMar 1, 2011Eastbourne General Hospital
NCT01306162Phase 1Feb 1, 2011Boehringer Ingelheim
NCT01182376Phase 3Nov 1, 2010Sanofi, University of Utah
NCT01199081Phase 4Oct 1, 2010Sanofi
NCT01213368Phase 2Sep 1, 2010Sanofi
NCT01140581Phase 4Sep 1, 2010Sanofi
NCT01198873Phase 4Sep 1, 2010Sanofi
Showing 20 of 32 trials
Page 1 / 2

Organizations

Research & Development (29)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
SanofiFor profit171432001
Eastbourne General HospitalAcademic/Hospital2222010
Swedish Heart Lung FoundationAcademic/Hospital2022008
Uppsala UniversityAcademic/Hospital2122008
American Heart AssociationAcademic/Hospital1112021
Beni Suef UniversityAcademic/Hospital1112019
Biosense Webster, Inc.For profit1012019
Boehringer IngelheimFor profit1112011
Cardiac Designs Inc.For profit1012021
Duke UniversityAcademic/Hospital1012021
Gilead SciencesFor profit1112012
Huazhong University of Science and TechnologyAcademic/Hospital1112023
Inha UniversityAcademic/Hospital1112025
Jiao Tong UniversityAcademic/Hospital1112021
Marrek, INCAcademic/Hospital1012021
Orebro UniversityAcademic/Hospital1112023
PreventiceFor profit1012021
Sungkyunkwan UniversityAcademic/Hospital1112011
Tel Aviv UniversityAcademic/Hospital1112011
Texas Cardiac Arrhythmia InstituteAcademic/Hospital1012019
29 organizations
Page 1 / 2

Marketing (10)

OrganizationOrg typeRelationshipDate
Alkem Labs LtdFor profitMKTGDec 31, 2015
Allergan PLC (2015)For profitMKTGDec 31, 2015
Amneal PharmaceuticalsFor profitMKTGMay 12, 2017
Aurobindo PharmaFor profitMKTGApr 27, 2023
Glenmark PharmaceuticalsFor profitMKTGDec 31, 2015
LupinFor profitMKTGJan 31, 2024
NovartisFor profitMKTGMay 17, 2021
SandozFor profitMKTGMay 17, 2021
Sanofi-AventisFor profitNDAJul 1, 2009
Watson PharmaceuticalsFor profitMKTGDec 31, 2015