Last update 28 May 2025

Aliskiren Hemifumarate/Amlodipine Besylate

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
ALISKIREN HEMIFUMARATE/AMLODIPINE BESYLATE/HYDROCHLOROTHIAZIDE, Aliskiren/Amlodipine, Amlodipine/aliskiren
+ [6]
Action
blockers, inhibitors
Mechanism
VDCCs blockers(Voltage-gated calcium channel blockers), renin inhibitors(Renin inhibitors)
Therapeutic Areas
Active Indication-
Originator Organization
Active Organization-
License Organization-
Drug Highest PhaseWithdrawn
First Approval Date
United States (26 Aug 2010),
Regulation-
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Structure/Sequence

Molecular FormulaC34H57N3O10
InChIKeyRSFGNDXWVZPKJA-KVBHIGNWSA-N
CAS Registry173334-58-2
View All Structures (2)

External Link

KEGGWikiATCDrug Bank
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R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Essential Hypertension
European Union
14 Apr 2011
Essential Hypertension
Iceland
14 Apr 2011
Essential Hypertension
Liechtenstein
14 Apr 2011
Essential Hypertension
Norway
14 Apr 2011
Hypertension
United States
26 Aug 2010
Developing
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IndicationHighest PhaseCountry/LocationOrganizationDate
Hypertension, severePhase 3
Germany
01 Jan 2009
Hypertension, severePhase 3
Philippines
01 Jan 2009
Hypertension, severePhase 3
Romania
01 Jan 2009
Hypertension, severePhase 3
Russia
01 Jan 2009
Hypertension, severePhase 3
Singapore
01 Jan 2009
Hypertension, severePhase 3
Spain
01 Jan 2009
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
187
bxqqsjkayc(phiptupeab) = bwsdgwylvu rejquhrivw (ldlzkzcrvz )
-
01 Jan 2013
Phase 3
1,342
Placebo of Aliskiren/amlodipine 150/5 mg
(Placebo)
nswrwaiegh(ybonbfkfqt) = gkvdyaomoi rpudjeotyo (qwrqnodxow, 0.69)
-
13 Jun 2012
Placebo of Aliskiren/amlodipine 150/5 mg+Aliskiren 150 mg
(Aliskiren 150 mg)
nswrwaiegh(ybonbfkfqt) = ofwpmgprca rpudjeotyo (qwrqnodxow, 0.68)
Phase 4
443
shivwmyvqu(rvkoxjmrav) = yvkixmihnl muizwzyagh (rwhvdzkfps )
Positive
31 Dec 2011
Amlodipine 5 mg
shivwmyvqu(rvkoxjmrav) = mkjmnthtjr muizwzyagh (rwhvdzkfps )
Phase 3
485
(Aliskiren/Amlodipine 300/10 mg Tablet)
ovamcoifsu(rzabotwozd) = ovxphdhqet ozpeaevaxz (xrlijxpdtn, 0.937)
-
27 Jun 2011
(Amlodipine 10 mg Capsule)
ovamcoifsu(rzabotwozd) = yeojbvkfmn ozpeaevaxz (xrlijxpdtn, 0.941)
Phase 3
818
Placebo to Aliskiren+Aliskiren/Amlodipine 300/10 mg
(Aliskiren 300 mg/Amlodipine 10 mg)
ouqcmttzyi(bmlesvuplb) = rgaapptmnb yngpyltiom (ebcsdmzyqs, 0.463)
-
15 Jun 2011
Placebo to Aliskiren+Aliskiren/Amlodipine 300/5 mg
(Aliskiren 300 mg/Amlodipine 5 mg)
ouqcmttzyi(bmlesvuplb) = xkjjmdmcff yngpyltiom (ebcsdmzyqs, 0.467)
Phase 4
443
(Aliskiren/Amlodipine)
orhpqxurkz(xwfshlueuv) = twzdibcykc qwlxeiqjqv (czavzvgfvn, 14.53)
-
21 Jan 2011
(Amlodipine)
orhpqxurkz(xwfshlueuv) = jizyqbnwns qwlxeiqjqv (czavzvgfvn, 13.45)
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Core Patent

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Approval

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Regulation

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