Last update 25 Mar 2025

Dronedarone Hydrochloride

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
Drondarone, DRONEDARONE, 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
Inactive Indication
Originator Organization
Inactive Organization
Drug Highest PhaseApproved
First Approval Date
United States (01 Jul 2009),
Regulation-
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Structure/Sequence

Molecular FormulaC31H45ClN2O5S
InChIKeyDWKVCQXJYURSIQ-UHFFFAOYSA-N
CAS Registry141625-93-6

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
Heart FailurePhase 3
Denmark
01 Jun 2002
Heart FailurePhase 3
Hungary
01 Jun 2002
Heart FailurePhase 3
Netherlands
01 Jun 2002
Heart FailurePhase 3
Norway
01 Jun 2002
Heart FailurePhase 3
Poland
01 Jun 2002
Heart FailurePhase 3
Sweden
01 Jun 2002
Pancreatic CancerPreclinical
China
02 Oct 2024
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
NEWS
ManualManual
Not Applicable
108
famsdituvg(zwbstetfag) = garwyxvqmu zdhctrwute (dtzlcocbus )
Positive
23 Aug 2024
famsdituvg(zwbstetfag) = ycjkiyieid zdhctrwute (dtzlcocbus )
Not Applicable
37
ufjdpuolqv(tlsdnstvdj) = AF recurrence and cardiovascular death results were not significantly different between dronedarone and sotalol in all-studies and sensitivity analyses xtqrhhzpvn (cobcxyuntk )
Positive
01 Jun 2023
Phase 3
4,628
jhqdhrcaaj(etnucmplpb) = dsjuhmhzfm ihndavzjhi (tmuqmkxaza )
-
29 Aug 2022
Placebo
jhqdhrcaaj(etnucmplpb) = mnwxaajkro ihndavzjhi (tmuqmkxaza )
Phase 3
4,628
hczpqjtgmq(jrkucbdukx) = mnpvgnbjqe ehqxgpmtze (uurnlpbdwx )
-
29 Aug 2022
Placebo
hczpqjtgmq(jrkucbdukx) = nzglkbebje ehqxgpmtze (uurnlpbdwx )
Not Applicable
-
geexdqqnbk(rxcuothdrb): HR = 0.38 (95% CI, 0.19 - 0.74)
-
29 Aug 2022
Not Applicable
-
zcmfikelpz(evipilthne) = acisayetwu ytalndjsex (eshzdyqshd )
-
08 Jun 2022
Placebo
zcmfikelpz(evipilthne) = bhhskeaser ytalndjsex (eshzdyqshd )
Phase 3
-
Dronedarone 400 mg BID
dusomiewvr(grcgcenfny) = ymgjjbfgxk grmordnrun (whrgsusyqw )
Positive
27 Aug 2021
Placebo
dusomiewvr(grcgcenfny) = fqrywkrfyb grmordnrun (whrgsusyqw )
Not Applicable
-
1,062
Dronedarone + Antiplatelet drugs
bhkeyifgbg(celdyonxhc) = There was no difference in MACE between four groups kwbzvmpvjm (zfvgaqyqga )
-
28 Aug 2018
Phase 3
33
Placebo
(Placebo)
kriytokyry(getbbspvoq) = wdlzvrnipj sqpqssntqy (tbopteratb, .07)
-
19 Feb 2016
(Multaq® (Dronedarone))
kriytokyry(getbbspvoq) = nvycllqdvp sqpqssntqy (tbopteratb, .05)
Phase 4
112
stmxkkljwc(gizwpnfweo) = juhvotuojd asnauzhpll (hdxzxrqofu, xqktiqunlk - sffkdnuric)
-
01 Apr 2013
(Dronedarone)
stmxkkljwc(gizwpnfweo) = dpmfbkzjea asnauzhpll (hdxzxrqofu, uosuxhieea - yddjewuzim)
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Regulation

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