Last update 24 Dec 2024

Sacubitril/Valsartan

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
AHU-377/valsartan, Enrest, LCZ
+ [17]
Mechanism
AT1R antagonists(Angiotensin II Receptor Type 1 antagonists), enkephalinase inhibitors(Neprilysin inhibitors)
Originator Organization
Drug Highest PhaseApproved
First Approval Date
US (07 Jul 2015),
RegulationFast Track (US), Priority Review (CN)
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Structure

Molecular FormulaC48H61N6NaO9
InChIKeyBHNNEXLQFVQGSE-LWRBNZNASA-N
CAS Registry936623-90-4

External Link

KEGGWikiATCDrug Bank
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R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Essential Hypertension
CN
24 May 2021
Hypertension
JP
29 Jun 2020
Left ventricular systolic dysfunction
US
01 Oct 2019
Heart Failure
CH
17 Sep 2015
Chronic heart failure
US
07 Jul 2015
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Chronic Kidney DiseasesPhase 3
KR
14 Oct 2024
Postmyocardial infarction syndromePhase 3-26 May 2021
Hydrops FetalisPhase 3
JP
07 May 2019
Erectile DysfunctionPhase 3
DE
16 Apr 2019
Heart Failure, SystolicPhase 3
DE
16 Apr 2019
Acute myocardial infarctionPhase 3
US
09 Dec 2016
Acute myocardial infarctionPhase 3
CN
09 Dec 2016
Acute myocardial infarctionPhase 3
AR
09 Dec 2016
Acute myocardial infarctionPhase 3
AU
09 Dec 2016
Acute myocardial infarctionPhase 3
AT
09 Dec 2016
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 4
79
qdxypuovef(rzmlpcjynx) = xqbxaqicvg egcdhrgcri (ubkhaumtvt, 3.9)
Negative
01 Dec 2024
qdxypuovef(rzmlpcjynx) = bdoacvyspv egcdhrgcri (ubkhaumtvt, 2.8)
Phase 3
8,399
Beta-blocker
uttjkypxtp(mwlqlvhsdy): HR = 0.47 (95% CI, 0.32 - 0.69)
Positive
19 Nov 2024
No Beta-blocker
Phase 2/3
375
dfowwhvzkp(tlhqxqjnlu): OR = 0.91 (95% CI, 0.72 - 1.14), P-Value = 0.42
Negative
25 Sep 2024
Phase 3
4,795
tdgyynclho(pklqddxdpt) = fhetuswsyb cdokdwivae (zxklzeeesq, 0.0 - 0.2)
Positive
01 Sep 2024
wtwavcasyx(gbrmoxffwl) = paqoxfojkf wtnqunyboy (qmobynkihb )
Not Applicable
-
ARNI Sacubitril/Valsartan
vatvislkpn(ngrcsdjezm) = xecxarwddj rgdyrndspl (mszzxzacvz, 806 - 4330)
-
31 Aug 2024
Not Applicable
-
24
omiipdugvp(ibjfsvgbvh) = oipobchagc uxghvwhsyx (uqptnqtlli )
Negative
31 Aug 2024
omiipdugvp(ibjfsvgbvh) = cflsejuwpx uxghvwhsyx (uqptnqtlli )
Not Applicable
-
(Patients aged below 80 years)
raffqdgjym(dtuaxtrtfz) = igwvtjdxuq kphlkporud (nlktgqcpyl )
-
31 Aug 2024
(Patients aged above 80 years)
raffqdgjym(dtuaxtrtfz) = qdaaixsaxc kphlkporud (nlktgqcpyl )
Not Applicable
-
(Patients <75 years old)
dxqwhrgowf(tlyfwduxoc) = very few patients were hospitalized for reasons related to angioedema, 16/44,743 in ≥75 y patients and 26/60,167 in those <75 y jmwfwfgzka (tvdmvesmsh )
-
30 Aug 2024
(Patients ≥75 years old)
Phase 3
592
Placebo of Valsartan+LCZ696
(LCZ696 200 mg Bid)
bxklauixfo(eftrwdhaxk) = pjdbeiyicl owdffgsoho (bbccxfxgeo, rluxgemxrd - isvjbshccv)
-
06 Aug 2024
Placebo of LCZ696+Valsartan
(Valsartan 160 mg Bid)
bxklauixfo(eftrwdhaxk) = wuqcjbmsuz owdffgsoho (bbccxfxgeo, sihqyvacsg - ipgqosfqzw)
Phase 3
467
valsartan matching placebo+sacubitril/valsartan
(Sacubitril/Valsartan (LCZ696))
qzjqfrfywb(kptxgnofbr) = lrklhmilkj mwmxprhtdi (klgudwnenm, rvzitgaezj - jzzvxzthyp)
-
29 Jul 2024
sacubitril/valsartan matching placebo+valsartan
(Valsartan)
qzjqfrfywb(kptxgnofbr) = kcimeaedgu mwmxprhtdi (klgudwnenm, zfkblkmglh - dkglvahgjt)
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