Drugs / LCZ696
LCZ696
Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | EU (EMA) | Entresto | — | 2015-11-19 | europa.eu ↗ |
| Approved | US (FDA) | ENTRESTO | — | 2015-07-07 | fda.gov ↗ |
Trials 43 · a red edge is where a trial was stopped
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 01 trial | ||||||
| Phase 0 | NCT03771729 | Dec 2018 → May 2019 | chronic kidney disease | The Second Affiliated Hospital of Harbin Medical University | Unknown | No outcome recorded |
| Phase 11 trial | ||||||
| Phase 1 | NCT01569815 | Feb 2009 → Aug 2014 | — | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT03872778 | May 2019 → Jan 2025 | neoplasm | Advanced Accelerator Applications | Completed | No outcome recorded |
| Phase 214 trials | ||||||
| Phase 2 | NCT03928158 | May 2019 → Jun 2023 | essential hypertension, heart failure | National Medical Research Center for Cardiology, Ministry of Health of Russian Federation | Completed | No outcome recorded |
| Phase 2 | NCT01922089 | Nov 2013 → Aug 2014 | symptomatic heart failure | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 2 | NCT01692301 | Dec 2012 → Apr 2015 | hypertensive disorder | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 2 | NCT01631864 | Oct 2012 → Jul 2013 | hypertensive disorder | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 2 | NCT01621633 | Sep 2012 → Jan 2013 | — | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 2 | NCT01601470 | Sep 2012 → Jan 2013 | hypertensive disorder | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 2 | NCT01681576 | Aug 2012 → Oct 2013 | hypertensive disorder | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 2 | NCT01353508 | Mar 2011 → Aug 2012 | hypertensive disorder | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 2 | NCT01281306 | Jan → Dec 2011 | hypertensive disorder | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 2 | NCT01256411 | Nov 2010 → Apr 2012 | essential hypertension | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 2 | NCT01193101 | Aug 2010 → Apr 2011 | essential hypertension | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 2 | NCT00887588 | Nov 2009 → Dec 2011 | heart failure | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 2 | NCT00913653 | May → Jul 2009 | heart failure | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 2 | NCT00549770 | Sep 2007 → Jul 2008 | hypertensive disorder | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 2/31 trial | ||||||
| Phase 2/3 | NCT02678312 | Nov 2016 → Jan 2022 | heart failure | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 317 trials | ||||||
| Phase 3 | NCT06693674 | Feb 2025 → Dec 2026 expected | congenital heart disease | Mayo Clinic | Recruiting | No outcome recorded |
| Phase 3 | NCT03909295 | May → Nov 2019 | diastolic heart failure | Novartis Pharmaceuticals | Terminated | No outcome recorded |
| Phase 3 | NCT03917459 | Apr 2019 → May 2021 | erectile dysfunction, systolic heart failure | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 3 | NCT02900378 | Dec 2016 → Apr 2018 | congestive heart failure | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 3 | NCT02924727 | Dec 2016 → Feb 2021 | acute myocardial infarction | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 3 | NCT02884206 | Nov 2016 → May 2022 | heart failure | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 3 | NCT02468232 | Jun 2015 → Feb 2019 | systolic heart failure | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 3 | NCT02226120 | Oct 2014 → Dec 2017 | congestive heart failure | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 3 | NCT01865188 | Apr 2014 → Apr 2015 | essential hypertension | Novartis Pharmaceuticals | Withdrawn | No outcome recorded |
| Phase 3 | NCT01876368 | Sep 2013 → Aug 2014 | essential hypertension | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 3 | NCT01785472 | Apr 2013 → Aug 2014 | essential hypertension | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 3 | NCT01663233 | Aug 2012 → May 2013 | essential hypertension | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 3 | NCT01615198 | Aug 2012 → Jul 2013 | essential hypertension | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 3 | NCT01646671 | Jul 2012 → Feb 2013 | hypertensive disorder | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 3 | NCT01599104 | Jun 2012 → Apr 2013 | essential hypertension | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 3 | NCT01593787 | May 2012 → Mar 2013 | hypertensive nephropathy | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 3 | NCT01035255 | Dec 2009 → May 2014 | symptomatic heart failure | Novartis Pharmaceuticals | Terminated | No outcome recorded |
| Phase 46 trials | ||||||
| Phase 4 | NCT04649229 | May 2021 → May 2025 | heart failure | Yale University | Completed | No outcome recorded |
| Phase 4 | NCT04113109 | Nov 2019 → Apr 2025 | heart failure | Vanderbilt University Medical Center | Completed | No outcome recorded |
| Phase 4 | NCT02768298 | Jul 2016 → Nov 2019 | symptomatic heart failure | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 4 | NCT02754518 | Apr 2016 → Apr 2019 | heart failure | University of Chicago | Completed | No outcome recorded |
| Phase 4 | NCT02687932 | Mar 2016 → Jan 2018 | left ventricular failure, mitral valve insufficiency | Asan Medical Center | Completed | No outcome recorded |
| Phase 4 | NCT02661217 | Feb 2016 → Feb 2018 | symptomatic heart failure | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase not applicable1 trial | ||||||
| — | NCT03821701 | Jun 2018 → Jan 2021 | heart failure | First Affiliated Hospital Xi'an Jiaotong University | Unknown | No outcome recorded |
| Phase not stated1 trial | ||||||
| — | NCT02389933 | — | systolic heart failure | Novartis Pharmaceuticals | No longer available | No outcome recorded |
Also used as a comparator or background therapy in 2 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 21 trial | ||||||
| Phase 2 | NCT03744975 Comparator | May 2018 → Aug 2025 | diastolic heart failure, type 2 diabetes mellitus | Mayo Clinic | Completed | No outcome recorded |
| Phase 41 trial | ||||||
| Phase 4 | NCT03738878 Comparator | Nov 2018 → Dec 2024 | hypertensive disorder | Vanderbilt University Medical Center | Terminated | No outcome recorded |
Press releases naming this drug 30 releases
| Date | Issuer | Release |
|---|---|---|
| 2025-01-13 | Novartis Pharmaceuticals | Novartis Entresto® US patent upheld by US Court of Appeals novartis.com ↗ |
| 2023-07-07 | Novartis Pharmaceuticals | Novartis will appeal to U.S. Court of Appeals to uphold validity of Entresto® combination patent; maintains 2023 guidance and mid-term outlook novartis.com ↗ |
| 2023-03-31 | Novartis Pharmaceuticals | Novartis Entresto receives positive CHMP opinion for pediatric heart failure novartis.com ↗ |
| 2021-02-16 | Novartis Pharmaceuticals | Novartis Entresto® granted expanded indication in chronic heart failure by FDA novartis.com ↗ |
| 2021-02-16 | Novartis Pharmaceuticals | Novartis Entresto® granted expanded indication in chronic heart failure by FDA novartis.com ↗ |
| 2020-12-16 | Novartis Pharmaceuticals | Novartis announces positive FDA Advisory Committee recommendation for use of Entresto® to treat patients with HFpEF novartis.com ↗ |
| 2020-03-02 | Otsuka Pharmaceutical Development & Commercialization, Inc. | Otsuka enters into co-promotion agreement for angiotensin receptor neprilysin inhibitor (ARNI) LCZ696 in Japan otsuka.co.jp ↗ |
| 2019-11-17 | Novartis Pharmaceuticals | Novartis PARAGON-HF analyses suggest Entresto® benefit beyond HFrEF novartis.com ↗ |
| 2019-09-02 | Novartis Pharmaceuticals | Entresto improved measures of heart structure and function in HFrEF patients in new Novartis study; additional data complement findings novartis.com ↗ |
| 2019-09-01 | Novartis Pharmaceuticals | Novartis PARAGON-HF trial suggests Entresto® benefit in HFpEF patients but narrowly misses primary endpoint novartis.com ↗ |
| 2019-08-19 | Novartis Pharmaceuticals | Novartis to present new Entresto HFpEF and HFrEF data at ESC Congress 2019 novartis.com ↗ |
| 2018-11-11 | Novartis Pharmaceuticals | New Novartis study supports Entresto as foundational HFrEF therapy and in-hospital initiation in appropriate stabilized heart failure patients novartis.com ↗ |
| 2018-08-25 | Novartis Pharmaceuticals | Novartis announces new data that show Entresto® (sacubitril/valsartan) can be initiated early & safely in hospitalized patients after an acute heart failure episode novartis.com ↗ |
| 2018-05-28 | Novartis Pharmaceuticals | Novartis International AG: Patient-reported outcomes tool revealed significant improvement in symptom frequency and quality of life domains with Entresto® novartis.com ↗ |
| 2018-04-16 | Novartis Pharmaceuticals | Novartis announces new analysis demonstrating Entresto helped preserve kidney function in patients with chronic heart failure, especially those with diabetes novartis.com ↗ |
| 2018-04-04 | Novartis Pharmaceuticals | Novartis announces JAMA Cardiology publication of data showing Entresto® improves physical and social activity in HFrEF patients versus enalapril novartis.com ↗ |
| 2017-11-12 | Novartis Pharmaceuticals | New Novartis Entresto® real world evidence data shows beneficial impact on quality of life in people living with heart failure novartis.com ↗ |
| 2017-04-25 | Novartis Pharmaceuticals | Novartis delivered sales growth across all divisions (cc1) as growth drivers, including Cosentyx and Entresto, more than offset generic erosion; innovation momentum continued novartis.com ↗ |
| 2017-03-18 | Novartis Pharmaceuticals | New analysis shows Novartis Entresto improves glycemic control in reduced ejection fraction heart failure patients with diabetes novartis.com ↗ |
| 2016-11-15 | Novartis Pharmaceuticals | New analysis of Novartis' Entresto® data shows long-term benefits on heart failure readmissions and total cardiovascular deaths novartis.com ↗ |
| 2016-09-19 | Novartis Pharmaceuticals | Important new analysis shows that Novartis' Entresto® is associated with higher relative health-related quality of life scores among HFrEF patients novartis.com ↗ |
| 2016-06-22 | Novartis Pharmaceuticals | Timely use of Novartis' Entresto could prevent or postpone over 28,000 US deaths per year among HFrEF patients, according to an expert analysis in JAMA Cardiology novartis.com ↗ |
| 2016-05-21 | Novartis Pharmaceuticals | Novartis' Entresto® given strong Class I recommendation in both US and EU heart failure guidelines, less than a year after regulatory approvals novartis.com ↗ |
| 2016-05-19 | Novartis Pharmaceuticals | Novartis announces investment in FortiHFy clinical program of Entresto® and heart failure novartis.com ↗ |
| 2016-04-02 | Novartis Pharmaceuticals | New analyses show Novartis' Entresto(TM) reduced cardiovascular death or hospitalization for heart failure, consistently benefitting patients with reduced ejection fraction regardless... novartis.com ↗ |
| 2015-11-24 | Novartis Pharmaceuticals | Novartis' heart failure medicine Entresto(TM) receives EU approval novartis.com ↗ |
| 2015-09-25 | Novartis Pharmaceuticals | Novartis' new heart failure medicine Entresto(TM) recommended by CHMP for EU approval novartis.com ↗ |
| 2015-09-18 | Novartis Pharmaceuticals | Swissmedic approves Novartis' new heart failure medicine Entresto(TM) novartis.com ↗ |
| 2015-07-07 | Novartis Pharmaceuticals | Novartis' new heart failure medicine LCZ696, now called Entresto(TM), approved by FDA to reduce risk of cardiovascular death and heart failure hospitalization novartis.com ↗ |
| 2015-02-13 | Novartis Pharmaceuticals | Novartis' heart failure medicine LCZ696 granted FDA priority review novartis.com ↗ |
Evidence & citations 8 cited values
Every value below carries the sentence it was read from. 55 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | LCZ696 | “Sacubitril/Valsartan (LCZ696) in Patients With Advanced Hypertensive Left Ventricular Hypertrophy and Heart Failure With Preserved Ejection Fraction: Clinical, Haemodynamic and...” NCT03928158 ↗42 |
| Known as | Entresto | ClinicalTrials.gov intervention name — accepted as the source's own label NCT06693674 ↗ |
| Known as | Sacubitril Valsartan Sodium Tablets | “Sacubitril Valsartan Sodium Tablets, 100mg bid, among whole study” NCT03821701 ↗ |
| Known as | sacubitril/valsartan | “Sacubitril/Valsartan (LCZ696) in Patients With Advanced Hypertensive Left Ventricular Hypertrophy and Heart Failure With Preserved Ejection Fraction: Clinical, Haemodynamic and...” NCT03928158 ↗10“The purpose of this study was to determine the effect of sacubitril/valsartan (LCZ696) vs. Enalapril on improvement in erectile function and ability in male patients with...” NCT03917459 ↗ “AIMS: To assess the tolerability of initiating/uptitrating sacubitril/valsartan (LCZ696) from 50 to 200 mg twice daily (target dose) over 3 and 6 weeks in heart failure (HF)...” PMID 27170530 ↗ May 2016 “Sacubitril/valsartan (LCZ696) was hypothesized to increase natriuresis and diuresis and result in superior blood pressure control compared with valsartan in Asian patients with SSH.” PMID 27849566 ↗ Nov 2016 “Sacubitril/valsartan (LCZ696), a novel angiotensin receptor-neprilysin inhibitor, was recently approved for the treatment of heart failure with reduced ejection fraction.” PMID 29180454 ↗ Nov 2017 “Pharmacodynamic and Pharmacokinetic Profiles of Sacubitril/Valsartan (LCZ696) in Patients with Heart Failure and Reduced Ejection Fraction.” PMID 26990595 ↗ Aug 2016 “Sacubitril/valsartan (LCZ696) is indicated for the treatment of patients with heart failure and reduced ejection fraction (HFrEF).” PMID 28599060 ↗ Nov 2017 “LCZ696 (sacubitril/valsartan) tablet will be available in 24/26 mg, 49/51 mg and 97/103 mg, respectively” NCT02924727 ↗ “Efficacy and safety of LCZ696 (sacubitril-valsartan) according to age: insights from PARADIGM-HF.” PMID 26231885 ↗ Jul 2015 “The first dose of sacubitril/valsartan (50 mg) significantly lowered MAP” PMID 42028604 ↗ Apr 2026 “LCZ696 (Sacubitril/Valsartan)” NCT02900378 ↗ |
| Known as | sucabitril valsartan sodium hydrate | “LCZ696 (Japanese adopted name: sucabitril valsartan sodium hydrate)” PMID 24446062 ↗ Jan 2014 |
| Known as | valsartan/sacubitril | “newly invented dual-acting drug valsartan/sacubitril (LCZ696)” PMID 26280447 ↗ Sep 2015 |
| Action | Inhibit | “LCZ696 is a first-in-class inhibitor of the angiotensin II receptor and neprilysin.” PMID 20236700 ↗ Mar 2010 |
| Route | Oral | “Participants received LCZ696 100 mg and matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily.” NCT00549770 ↗ |