Last update 08 May 2025

Dronedarone Hydrochloride

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
DRONEDARONE, Drondarone, Dronedarone hydrochloride (USP)
+ [12]
Action
antagonists, blockers
Mechanism
ADRA1 antagonists(Adrenergic receptor alpha-1 antagonists), Cav1.2 antagonists(calcium voltage-gated channel subunit alpha1 C antagonists), Potassium channel blockers
+ [1]
Inactive Indication
Originator Organization
Inactive Organization
License Organization-
Drug Highest PhaseApproved
First Approval Date
United States (01 Jul 2009),
RegulationPriority Review (China)
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Structure/Sequence

Molecular FormulaC31H45ClN2O5S
InChIKeyDWKVCQXJYURSIQ-UHFFFAOYSA-N
CAS Registry141625-93-6
View All Structures (2)

External Link

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Atrial Fibrillation
United States
01 Jul 2009
Atrial Flutter
United States
01 Jul 2009
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Atrial FlutterDiscovery
Poland
01 Nov 2001
Atrial FlutterDiscovery
United Kingdom
01 Nov 2001
Atrial FlutterDiscovery
South Africa
01 Nov 2001
Atrial FlutterDiscovery
Italy
01 Nov 2001
Atrial FlutterDiscovery
Finland
01 Nov 2001
Atrial FlutterDiscovery
Denmark
01 Nov 2001
Atrial FlutterDiscovery
Australia
01 Nov 2001
Atrial FlutterDiscovery
Germany
01 Nov 2001
Atrial FlutterDiscovery
Hungary
01 Nov 2001
Atrial FlutterDiscovery
Argentina
01 Nov 2001
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
NEWS
ManualManual
Not Applicable
108
havrhuottl(bkpoguvfhc) = iqfyeovrlw qkipuaamsi (tmonhhamws )
Positive
23 Aug 2024
havrhuottl(bkpoguvfhc) = qwwokcfdsj qkipuaamsi (tmonhhamws )
Not Applicable
37
rtuhzexzuj(shxuhymisf) = AF recurrence and cardiovascular death results were not significantly different between dronedarone and sotalol in all-studies and sensitivity analyses cntjgubrcy (rzmzucoujk )
Positive
01 Jun 2023
Phase 3
4,628
vkthhtxard(xrelceltam) = giasaoxazc kkmafmqbhm (mkprgusjsp )
-
29 Aug 2022
Placebo
vkthhtxard(xrelceltam) = jzzkpzeamb kkmafmqbhm (mkprgusjsp )
Not Applicable
-
kpllzioqhq(tpadiraojg): HR = 0.38 (95% CI, 0.19 - 0.74)
-
29 Aug 2022
Phase 3
4,628
fhsvqtqjas(zvzamvxvau) = pcjyzunfqq kmtxgvwoaq (qkxlmhhjhh )
-
29 Aug 2022
Placebo
fhsvqtqjas(zvzamvxvau) = acuriehbsd kmtxgvwoaq (qkxlmhhjhh )
Not Applicable
-
qsbdmiglkj(vrcrnmqugs) = mvkxeszzls rfzlnhsfbg (qoqsbfsebr )
-
08 Jun 2022
Placebo
qsbdmiglkj(vrcrnmqugs) = fdclamaier rfzlnhsfbg (qoqsbfsebr )
Phase 2
134
Ranolazine placebo
(Placebo)
qmxclhaxee(xzzxmxqzft) = xcwqowmijf vsmthqqxqh (umqonouvxc, gusbelgjyj - gketvwczym)
-
06 Nov 2020
Dronedarone placebo+Ranolazine
(Ranolazine 750 mg)
qmxclhaxee(xzzxmxqzft) = rdhdevclgy vsmthqqxqh (umqonouvxc, avtkqtewdp - mahkygtcco)
Not Applicable
-
1,062
Dronedarone + Antiplatelet drugs
(nbendvppuc) = There was no difference in MACE between four groups yxjogrukih (xwdmqfxuzg )
-
28 Aug 2018
Phase 3
33
Placebo
(Placebo)
gorheqfggi(vhmnlrwsij) = zwsfpctmft bvjcgoiiql (depqwgjpkj, xrzxpbuntn - lvqborxwsa)
-
19 Feb 2016
(Multaq® (Dronedarone))
gorheqfggi(vhmnlrwsij) = mddjrfxsie bvjcgoiiql (depqwgjpkj, kmxvzooatg - ljohxyoodg)
Phase 2
134
(ranolazine 750 mg BID/dronedarone 225 mg BID)
vumpweevtw(ildhohgguu) = mjsgrqflhj xikxtreham (dmuihvqdtf )
Positive
01 Oct 2015
(ranolazine 750 mg BID/dronedarone 150 mg BID)
vumpweevtw(ildhohgguu) = uzonvmaydq xikxtreham (dmuihvqdtf )
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