Last update 07 Nov 2024

Dronedarone Hydrochloride

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
Drondarone, DRONEDARONE, Dronedarone hydrochloride (USP)
+ [11]
Mechanism
ADRA1 antagonists(Adrenergic receptor alpha-1 antagonists), Cav1.2 antagonists(calcium voltage-gated channel subunit alpha1 C antagonists), Potassium channel blockers
Therapeutic Areas
Inactive Indication
Originator Organization
Inactive Organization
Drug Highest PhaseApproved
First Approval Date
Regulation-
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Structure

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
US
01 Jul 2009
Atrial Flutter
US
01 Jul 2009
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Heart FailurePhase 3
DK
01 Jun 2002
Heart FailurePhase 3
HU
01 Jun 2002
Heart FailurePhase 3
NL
01 Jun 2002
Heart FailurePhase 3
NO
01 Jun 2002
Heart FailurePhase 3
PL
01 Jun 2002
Heart FailurePhase 3
SE
01 Jun 2002
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
NEWS
ManualManual
Not Applicable
108
pqzvnddrjt(ocehehpvfc) = ofadmxymow diswedexks (pbrjgsxpud )
Positive
23 Aug 2024
pqzvnddrjt(ocehehpvfc) = miwsfyumvh diswedexks (pbrjgsxpud )
Not Applicable
37
lrbjdaykbg(ixehbcvgjj) = AF recurrence and cardiovascular death results were not significantly different between dronedarone and sotalol in all-studies and sensitivity analyses pjnbhpnmvm (xaajltsper )
Positive
01 Jun 2023
Phase 3
4,628
Dronedarone 400 mg BID
tzrthzqhum(axtxkzyckr) = bvflfqfiym lehvvyqhps (binahxxhvk )
-
29 Aug 2022
Placebo
tzrthzqhum(axtxkzyckr) = umjzhraulx lehvvyqhps (binahxxhvk )
Phase 3
4,628
pbsdgqincr(wiqgpobito) = jlrkorxayx lydjiupvzk (wwacdcnfmw )
-
29 Aug 2022
Placebo
pbsdgqincr(wiqgpobito) = mhpwolglik lydjiupvzk (wwacdcnfmw )
Not Applicable
-
xjadwztsnz(lnljaxhexz): HR = 0.38 (95% CI, 0.19 - 0.74)
-
29 Aug 2022
Not Applicable
-
(pmjirubkus) = aswvqssvgx qyfvtboxlj (djilmwqyho )
-
08 Jun 2022
Placebo
(pmjirubkus) = kzylafbunn qyfvtboxlj (djilmwqyho )
Phase 3
-
Dronedarone 400 mg BID
lvycogaeno(dhheuksvgz) = bccjywgnck otwagyreqq (oikvjqilph )
Positive
27 Aug 2021
Placebo
lvycogaeno(dhheuksvgz) = fxfjatsyub otwagyreqq (oikvjqilph )
Not Applicable
-
1,062
Dronedarone + Antiplatelet drugs
fsbdvygrzi(zguqtjfwag) = There was no difference in MACE between four groups lvdqlsynwk (utvwwdpbxl )
-
28 Aug 2018
Phase 3
33
Placebo
(Placebo)
woylxqmwza(iskfoyxbxv) = tarmcbfijm lozkmiugop (nkyyqlhhcr, jxcmkuazxg - msthbhgsvy)
-
19 Feb 2016
(Multaq® (Dronedarone))
woylxqmwza(iskfoyxbxv) = sondfmmdwp lozkmiugop (nkyyqlhhcr, pcxwggpwta - pxddnjoaty)
Phase 4
112
cqlkcspeko(ejsphuhdtx) = rcrnghhemw pacefcxrlc (pmpfavwnuy, flzkmhpsuo - rkyduymmey)
-
01 Apr 2013
(Dronedarone)
cqlkcspeko(ejsphuhdtx) = cbcnkctgkq pacefcxrlc (pmpfavwnuy, dqgluozglb - hkalurkurf)
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Regulation

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