Last update 14 Aug 2026

Sacubitril/Valsartan

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
AHU-377/valsartan, Enrest, LCZ
+ [20]
Action
antagonists, inhibitors
Mechanism
AT1R antagonists(Angiotensin II Receptor Type 1 antagonists), enkephalinase inhibitors(Neprilysin inhibitors)
Therapeutic Areas
Originator Organization
Drug Highest PhaseApproved
First Approval Date
United States (07 Jul 2015),
RegulationFast Track (United States), Priority Review (China)
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Structure/Sequence

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
China
24 May 2021
Hypertension
Japan
29 Jun 2020
Left ventricular systolic dysfunction
United States
01 Oct 2019
Reduced ejection fraction co-occurrent and due to chronic heart failure
European Union
19 Nov 2015
Reduced ejection fraction co-occurrent and due to chronic heart failure
Iceland
19 Nov 2015
Reduced ejection fraction co-occurrent and due to chronic heart failure
Liechtenstein
19 Nov 2015
Reduced ejection fraction co-occurrent and due to chronic heart failure
Norway
19 Nov 2015
Heart Failure
Switzerland
17 Sep 2015
Chronic heart failure
United States
07 Jul 2015
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Postmyocardial infarction syndromePhase 3-26 May 2021
Erectile DysfunctionPhase 3
Germany
16 Apr 2019
Heart Failure, SystolicPhase 3
Germany
16 Apr 2019
Acute myocardial infarctionPhase 3
United States
09 Dec 2016
Acute myocardial infarctionPhase 3
China
09 Dec 2016
Acute myocardial infarctionPhase 3
Argentina
09 Dec 2016
Acute myocardial infarctionPhase 3
Australia
09 Dec 2016
Acute myocardial infarctionPhase 3
Austria
09 Dec 2016
Acute myocardial infarctionPhase 3
Belgium
09 Dec 2016
Acute myocardial infarctionPhase 3
Brazil
09 Dec 2016
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Clinical Result

Indication
Phase
Evaluation
View All Results
Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 4
46
placebo+valsartan+sacubitril
(Placebo)
xqyblkarpl(cfzctrgpkk) = hmsuzaqgrg pewdzbdkil (jvvksrlumk, 9.47)
-
11 Aug 2026
(Icatibant)
xqyblkarpl(cfzctrgpkk) = xiwjkfzxec pewdzbdkil (jvvksrlumk, 8.37)
Phase 4
922
(Sacubitril/Valsartan)
gxtzyrddzf = halzzsqdtk ergqlyhqaj (zdqpranceq, uloaelixhs - vopxhewzpm)
-
11 May 2026
(Enalapril)
gxtzyrddzf = tfelilzxdf ergqlyhqaj (zdqpranceq, avjtbakank - xeyijiydkw)
Early Phase 1
240
kfmkkrmrzi(oamwhrbiam): adjusted mean difference = -1.9 (95.0% CI, -3.2 to -0.5), P-Value = 0.02
Positive
01 Apr 2026
Placebo
Phase 4
376
Sacubitril/Valsartan with uptitration
ypgaknkrnq(nsgyzznsgw) = tmlryolncl nvmjbgsuym (pthzxwtupn )
Positive
01 Mar 2026
Sacubitril/Valsartan without uptitration
ypgaknkrnq(nsgyzznsgw) = zqhcyokefo nvmjbgsuym (pthzxwtupn )
Phase 2
60
btzgzmnrae(yblyzokpzv) = prwjbobwel pxygvanjeq (txdzsxjsmg, 1595.0)
Positive
01 Feb 2026
Standard of Care (SOC)
btzgzmnrae(yblyzokpzv) = sazbhsyjma pxygvanjeq (txdzsxjsmg, 3543.0)
Phase 4
922
kdivawbtcr(txcfvoxgss) = qqbevymlhk sqrbwqrruq (ijcnooarpr )
Negative
06 Jan 2026
kdivawbtcr(txcfvoxgss) = fchmtcrsmx sqrbwqrruq (ijcnooarpr )
Phase 4
922
nkcqukcfmq(fulixovosr) = yzpkfymhlt twpyxdhapn (tncxkkcfrr )
Negative
03 Dec 2025
nkcqukcfmq(fulixovosr) = eijoeeaqwh twpyxdhapn (tncxkkcfrr )
Phase 3
12,974
dybhvrcahj(ywtowhnock): OR = 1.16 (95.0% CI, 1.08 - 1.24)
Positive
04 Nov 2025
Phase 3
Heart Failure
NT-proBNP | LVEF
847
lvzjdmqpxl(dhspxkwmgp): rate ratio = 0.6 (95% CI, 0.37 - 0.99), P-Value = 0.046
Positive
01 Nov 2025
Phase 4
190
vzeiyecmfe(myqsxjqhrl) = pyscezzgpe gssxtehavw (kmrsyaxagh )
Positive
01 Nov 2025
vzeiyecmfe(myqsxjqhrl) = tirqmgpmgg gssxtehavw (kmrsyaxagh )
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