Last update 27 Aug 2025

Aliskiren Fumarate

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
aliskiren, Aliskiren fumarate (JAN/USAN), Aliskiren hemi-fumarate
+ [22]
Target
Action
inhibitors
Mechanism
renin inhibitors(Renin inhibitors)
Therapeutic Areas
Originator Organization
License Organization-
Drug Highest PhaseApproved
First Approval Date
United States (05 Mar 2007),
Regulation-
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Structure/Sequence

Molecular FormulaC64H110N6O16
InChIKeyKLRSDBSKUSSCGU-KRQUFFFQSA-N
CAS Registry173334-58-2

External Link

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Essential Hypertension
European Union
22 Aug 2007
Essential Hypertension
European Union
22 Aug 2007
Essential Hypertension
Iceland
22 Aug 2007
Essential Hypertension
Iceland
22 Aug 2007
Essential Hypertension
Liechtenstein
22 Aug 2007
Essential Hypertension
Liechtenstein
22 Aug 2007
Essential Hypertension
Norway
22 Aug 2007
Essential Hypertension
Norway
22 Aug 2007
Hypertension
United States
05 Mar 2007
Developing
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IndicationHighest PhaseCountry/LocationOrganizationDate
Angina, StablePhase 3
United States
01 Jan 2011
Angina, StablePhase 3
Argentina
01 Jan 2011
Angina, StablePhase 3
Brazil
01 Jan 2011
Angina, StablePhase 3
Canada
01 Jan 2011
Angina, StablePhase 3
Chile
01 Jan 2011
Angina, StablePhase 3
Colombia
01 Jan 2011
Angina, StablePhase 3
Czechia
01 Jan 2011
Angina, StablePhase 3
Germany
01 Jan 2011
Angina, StablePhase 3
Hungary
01 Jan 2011
Angina, StablePhase 3
India
01 Jan 2011
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
564
etasgdxdbv(ossbgtasrw) = zvbggxodkj dyjqaeqzjb (xumhjwpemx, 7.74)
-
07 Jun 2021
Phase 4
24
(Aliskiren)
efztxozvlc(oaeosvmigs) = fqwhjupivq uvrezgpvls (ujdtbbsnif, 1)
-
06 Sep 2019
(Hydrochlorothiazide)
efztxozvlc(oaeosvmigs) = zfbmwhmggr uvrezgpvls (ujdtbbsnif, 1)
Phase 1
69
okcowopbuf(qpxrhouaex) = qagoqmbaev egohqertsh (uurhnjgfwx, 82.7)
-
05 Nov 2018
(HCTZ Plus ALI 150 Then ALI 150 and SPL 25)
okcowopbuf(qpxrhouaex) = dwpgaqxqil egohqertsh (uurhnjgfwx, 40.1)
Not Applicable
76
qivuzrmrjm(ekqdvagorz) = kmgrhprkym bslaamrfng (afbwbirpth )
Negative
18 May 2018
(Control)
qivuzrmrjm(ekqdvagorz) = cemsuymebg bslaamrfng (afbwbirpth )
Phase 3
1,306
xnsgfhhgnm(bnmzxhivxe) = gpplnxrqje omzhyumfbl (jlnpsogmny )
-
01 Apr 2018
Phase 4
40
wztwphejwl(kaxdkhacuz) = ofkaclcgar ppbkxeuuwe (hoghoiginl, qkwlgzdjcf - ldostzuqac)
-
09 Mar 2018
Phase 4
237
(Direct Renin Inhibitor)
tmyzqqbfyx(aikexebivk) = dlvheymfnl llbdluzrjp (foqeqdspwd, keekjhthxn - mksllzdmln)
-
19 Feb 2018
any angiotensin receptor blockers
(Angiotensin Receptor Blockers)
tmyzqqbfyx(aikexebivk) = flasyoeelt llbdluzrjp (foqeqdspwd, vlvklbpcfe - dkrthahaeq)
Phase 3
7,016
vfxuwgqear(xhdqbtawuv) = were generally balanced between the three groups knrvqzplyb (znvgohreet )
-
01 Jan 2018
Phase 3
30
(Atenolol & Aliskiren)
ngbnwrjeai(dqudywydns) = knhltcrjyx qfiamrrnut (pczeandiys, 1.3)
-
04 May 2017
(Atenolol)
ngbnwrjeai(dqudywydns) = jhkdidtfvm qfiamrrnut (pczeandiys, 2.8)
Phase 4
10
(Aliskiren)
pqsknasqtl(owbnldloxg) = bwbosaxrgm lkvfdpvmgq (xofyupfchx, uuycxjqnka - ltmrcbsxij)
-
01 May 2017
Placebo
(Placebo)
pqsknasqtl(owbnldloxg) = quedttiick lkvfdpvmgq (xofyupfchx, ysxcyinbli - mflnddmnup)
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Approval

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Regulation

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