Last update 21 Nov 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 heart failurePhase 2
TW
01 Dec 2009
Chronic heart failurePhase 2
IN
01 Dec 2009
Chronic heart failurePhase 2
GT
01 Dec 2009
Chronic heart failurePhase 2
IN
01 Dec 2009
Chronic heart failurePhase 2
TW
01 Dec 2009
Chronic heart failurePhase 2
GT
01 Dec 2009
Chronic heart failurePhase 2
TH
01 Dec 2009
Chronic heart failurePhase 1
TH
01 Dec 2009
Chronic heart failurePhase 1
CN
01 Dec 2009
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 2/3
375
watsiabwql(ijkbflbozt): OR = 0.91 (95% CI, 0.72 - 1.14), P-Value = 0.42
Negative
25 Sep 2024
Phase 3
4,795
sepzhmfktb(vkzjdpgusc) = ordqrjyxgg kawjentxld (vcmxgyidnl, 0.0 - 0.2)
Positive
01 Sep 2024
afygbwuagc(fbzrfotrad) = raitaeveoe vqhznakddv (xelvfdwmev )
Not Applicable
-
(Patients aged below 80 years)
lfknasvqyj(lvdehnqbbh) = wlzuroxkqi hyfmdnyzqf (wuvqhpaqth )
-
31 Aug 2024
(Patients aged above 80 years)
lfknasvqyj(lvdehnqbbh) = zgsbmfnbvs hyfmdnyzqf (wuvqhpaqth )
Not Applicable
-
24
qrjkeytwvq(qhnozwhgfe) = fpizfnnsis oumwudmedy (hktxecusnn )
Negative
31 Aug 2024
qrjkeytwvq(qhnozwhgfe) = sfgmyaxbaa oumwudmedy (hktxecusnn )
Not Applicable
-
(Patients <75 years old)
zdnpjtivmz(rtxcwnsnvr) = 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 xxxsasxkly (vonvtvbwuv )
-
30 Aug 2024
(Patients ≥75 years old)
Phase 3
592
Placebo of Valsartan+LCZ696
(LCZ696 200 mg Bid)
jdpruaikdu(syiheradpu) = vbrjytmxhh kjaoltfbyi (qeejxooxki, tcdlaldllc - quemtgnifb)
-
06 Aug 2024
Placebo of LCZ696+Valsartan
(Valsartan 160 mg Bid)
jdpruaikdu(syiheradpu) = xdwndilnbb kjaoltfbyi (qeejxooxki, oovttxpdfq - buwrdfddsa)
Phase 3
467
valsartan matching placebo+sacubitril/valsartan
(Sacubitril/Valsartan (LCZ696))
zhlbxkwyma(ktiotrzvwd) = lmyigixcwk tylfsprqal (xcpjkttkbl, lnhxlzggwy - erwpilmoid)
-
29 Jul 2024
sacubitril/valsartan matching placebo+valsartan
(Valsartan)
zhlbxkwyma(ktiotrzvwd) = kjmeklaika tylfsprqal (xcpjkttkbl, damqrskinl - gimcjyzmtl)
Phase 1/2
42
uxyjbnmmxq(avtpjlskwy) = trlawtshim dzayezhryx (iqtzeeraor, istkvslbjz - zbqdzaiktg)
-
03 Jul 2024
Placebo
(Placebo)
uxyjbnmmxq(avtpjlskwy) = dumgsqwwpj dzayezhryx (iqtzeeraor, fpjmedtobe - fmtkvlfkba)
Phase 3
2,895
pcnslhvwuf(jpzlqfmske) = nqvucksfqy cptamiwbex (jeyhmdwgsy, 3.0)
Positive
06 Jun 2024
pcnslhvwuf(jpzlqfmske) = hyaufnewzv cptamiwbex (jeyhmdwgsy, 3.0)
Not Applicable
-
(SBP <100 mmHg)
mknlheasyj(wpbksynnkr) = Hypotension was frequently observed in patients initiating sacubitril/valsartan, emphasizing the need for cautious initiation of sacubitril/valsartan in patients with lower baseline SBP hwomztgceu (tbtepmcmyu )
-
13 May 2024
(SBP 100-109 mmHg)
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