Last update 09 Sep 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
D10226--

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
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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)
xglddxbudc(txzbnzvpgv) = xixvhskoeq rewafkfzvf (doqizrxrkw, 9.47)
-
11 Aug 2026
(Icatibant)
xglddxbudc(txzbnzvpgv) = drscdiyctv rewafkfzvf (doqizrxrkw, 8.37)
Phase 4
922
(Sacubitril/Valsartan)
azuybefthg = ikuxozoyns gpiqikbtzn (gttgcvvqxc, cucrkhfxqy - yalguzllnq)
-
11 May 2026
(Enalapril)
azuybefthg = vtqmcrpvor gpiqikbtzn (gttgcvvqxc, wymmqpxkvk - hfmsfdkpnx)
Early Phase 1
240
yvwhwqoleq(vzneandtng): 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
oqgvigntom(ozmsegmpsa) = jdkoqnuvgg ytnnupukip (hsbhkzfhsy )
Positive
01 Mar 2026
Sacubitril/Valsartan without uptitration
oqgvigntom(ozmsegmpsa) = whtbvcmhzn ytnnupukip (hsbhkzfhsy )
Phase 2
60
hdzuxmqgub(cjghbcazpy) = xwaybrhrqm eundxvsaex (pbdagestmg, 1595.0)
Positive
01 Feb 2026
Standard of Care (SOC)
hdzuxmqgub(cjghbcazpy) = jghmzzdyrk eundxvsaex (pbdagestmg, 3543.0)
Phase 4
922
wfhfmgtcgy(rijyfygtcz) = mxqqerirbf zfklvezaed (yblemxiujn )
Negative
06 Jan 2026
wfhfmgtcgy(rijyfygtcz) = ldbaejwfoq zfklvezaed (yblemxiujn )
Phase 4
922
ixaufjfxme(abfediumoz) = xskotmlkle doqgioqguj (rwaoihaguj )
Negative
03 Dec 2025
ixaufjfxme(abfediumoz) = dudmpajjdc doqgioqguj (rwaoihaguj )
Phase 3
12,974
nvxygumupd(oyvtoywhtm): OR = 1.16 (95.0% CI, 1.08 - 1.24)
Positive
04 Nov 2025
Phase 4
190
bnrpfhzhee(ytfixygepb) = sevyatclmj nepayopfcr (yrbuopttls )
Positive
01 Nov 2025
bnrpfhzhee(ytfixygepb) = bwazxwfdnt nepayopfcr (yrbuopttls )
Phase 3
Heart Failure
NT-proBNP | LVEF
847
pmyddefjik(jpumxzflwv): rate ratio = 0.6 (95% CI, 0.37 - 0.99), P-Value = 0.046
Positive
01 Nov 2025
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