Drugs / LCZ696
LCZ696
Regulatory milestones approvals, filings & regulatory actions · 4 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed symptomatic heart failure 2 milestones | |||||
| Filed | EU (EMA) | — | symptomatic heart failure | 2015-01-27 | “Regulatory applications have been submitted in both the US and EU for LCZ696 as a treatment for patients with heart failure with reduced ejection fraction (HFrEF).” novartis.com ↗ |
| Filed | US (FDA) | — | symptomatic heart failure | 2015-01-27 | “Regulatory applications have been submitted in both the US and EU for LCZ696 as a treatment for patients with heart failure with reduced ejection fraction (HFrEF).” novartis.com ↗ |
| Approved Indication not stated 2 milestones | |||||
| Approved | EU (EMA) | Entresto | — | 2015-11-19 | europa.eu ↗ |
| Approved | US (FDA) | ENTRESTO | — | 2015-07-07 | fda.gov ↗ |
Trials 43
| 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 · 4 met primary | ||||||
| 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 | Met primary |
| Phase 2 | NCT01631864 | Oct 2012 → Jul 2013 | hypertensive disorder | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 2 | NCT01601470 | Sep 2012 → Jan 2013 | hypertensive disorder | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 2 | NCT01621633 | Sep 2012 → Jan 2013 | — | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 2 | NCT01681576 | Aug 2012 → Oct 2013 | hypertensive disorder | Novartis Pharmaceuticals | Completed | Met primary |
| 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 | Met primary |
| 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 | Met primary |
| Phase 2/31 trial · 1 missed | ||||||
| Phase 2/3 | NCT02678312 | Nov 2016 → Jan 2022 | heart failure | Novartis Pharmaceuticals | Completed | Missed primary |
| Phase 317 trials · 3 met primary · 4 missed | ||||||
| Phase 3 | NCT06693674 | Feb 2025 → Aug 2028 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 | Missed primary |
| Phase 3 | NCT02900378 | Dec 2016 → Apr 2018 | congestive heart failure | Novartis Pharmaceuticals | Completed | Missed primary |
| Phase 3 | NCT02924727 | Dec 2016 → Feb 2021 | acute myocardial infarction | Novartis Pharmaceuticals | Completed | Missed primary |
| 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 | Missed primary |
| 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 | Met primary |
| Phase 3 | NCT01785472 | Apr 2013 → Aug 2014 | essential hypertension | Novartis Pharmaceuticals | Completed | Met primary |
| 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 | Met primary |
| Phase 46 trials · 1 met primary · 2 missed | ||||||
| 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 | Missed primary |
| Phase 4 | NCT02754518 | Apr 2016 → Apr 2019 | heart failure | University of Chicago | Completed | Mixed |
| Phase 4 | NCT02687932 | Mar 2016 → Jan 2018 | left ventricular failure, mitral valve insufficiency | Asan Medical Center | Completed | Met primary |
| Phase 4 | NCT02661217 | Feb 2016 → Feb 2018 | symptomatic heart failure | Novartis Pharmaceuticals | Completed | Missed primary |
| 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 |
| Comparator or background therapy2 trials | ||||||
| Phase 2 | NCT03744975 Comparator | May 2018 → Aug 2025 | diastolic heart failure, type 2 diabetes mellitus | Mayo Clinic | Completed | No outcome recorded |
| Phase 4 | NCT03738878 Comparator | Nov 2018 → Dec 2024 | hypertensive disorder | Vanderbilt University Medical Center | Terminated | No outcome recorded |
News releases announcing trial results or a regulatory action · 25
| Date | Issuer | Release |
|---|---|---|
| 2023-03-31 | Novartis Pharmaceuticals | Regulatory Novartis Entresto receives positive CHMP opinion for pediatric heart failure novartis.com ↗
In this new indication the CHMP concluded that Entresto brings an important contribution to patient care and therefore fulfills the criteria of significant clinical benefit; if approved, this would support extension of the regulatory data protection to November 2026 |
| 2021-02-16 | Novartis Pharmaceuticals | Regulatory Novartis Entresto® granted expanded indication in chronic heart failure by FDA novartis.com ↗
Basel, February 16, 2021 — Novartis today announced that the US Food and Drug Administration (FDA) has approved the following expanded indication for Entresto ® (sacubitril/valsartan): to reduce the risk of cardiovascular death and hospitalization for heart failure in adult patients with chronic heart failure 1 . |
| 2020-12-16 | Novartis Pharmaceuticals | Regulatory Novartis announces positive FDA Advisory Committee recommendation for use of Entresto® to treat patients with HFpEF novartis.com ↗
The Committee voted 12 to 1 that the data presented support the use of Entresto in treatment of patients with heart failure with preserved ejection fraction (HFpEF) |
| 2020-06-29 | Novartis Pharmaceuticals | Regulatory Novartis receives simultaneous approval for five new products from Japanese Ministry of Health, Labour and Welfare, offering Japanese patients a broad range of novel treatment options novartis.com ↗ |
| 2019-11-17 | Novartis Pharmaceuticals | Results Novartis PARAGON-HF analyses suggest Entresto® benefit beyond HFrEF novartis.com ↗
The data suggest that, in specific subgroups, treatment with Entresto may result in greater reductions in heart failure hospitalizations and cardiovascular death, as compared to valsartan. |
| 2019-09-02 | Novartis Pharmaceuticals | Results Entresto improved measures of heart structure and function in HFrEF patients in new Novartis study; additional data complement findings novartis.com ↗
Novartis announced today results from two new clinical trials evaluating improvement in heart structure and function and long-term safety of Entresto ® (sacubitril/valsartan) in patients with heart failure with reduced ejection fraction (HFrEF). |
| 2019-09-01 | Novartis Pharmaceuticals | Results Novartis PARAGON-HF trial suggests Entresto® benefit in HFpEF patients but narrowly misses primary endpoint novartis.com ↗
Novartis announced today full results from its global Phase III PARAGON-HF study, investigating the efficacy and safety of Entresto (sacubitril/valsartan) versus the active comparator valsartan in heart failure patients with preserved ejection fraction (HFpEF). |
| 2019-07-29 | Novartis Pharmaceuticals | Results Novartis provides update on Phase III PARAGON-HF trial in heart failure patients with preserved ejection fraction (HFpEF) novartis.com ↗
Novartis today announced topline results from the global Phase III PARAGON-HF study, investigating the safety and efficacy of sacubitril/valsartan versus the active comparator valsartan in HFpEF patients[1]. |
| 2018-11-11 | Novartis Pharmaceuticals | Results New Novartis study supports Entresto as foundational HFrEF therapy and in-hospital initiation in appropriate stabilized heart failure patients novartis.com ↗
Patients on Entresto in PIONEER-HF had a 29% greater reduction in time-averaged N-terminal pro-B-type natriuretic peptide (NT-proBNP) at weeks 4 and 8 (the primary endpoint) compared to enalapril patients (95% CI: 0.63, 0.81; P<0.0001)[1]. |
| 2018-08-25 | Novartis Pharmaceuticals | Results 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 ↗
TRANSITION shows that Entresto can be safely initiated shortly after an acute heart failure episode, both in the hospital and in an out-patient setting and in a wide range of stabilized patients[1] |
| 2018-05-28 | Novartis Pharmaceuticals | Results Novartis International AG: Patient-reported outcomes tool revealed significant improvement in symptom frequency and quality of life domains with Entresto® novartis.com ↗
This pre-specified analysis of an interim data cut from the CHAMP-HF registry showed that chronic heart failure (HF) patients with reduced ejection fraction (HFrEF) taking Entresto reported early, statistically significant improvement in health status, as measured by the KCCQ-12 overall summary score (KCCQ-OS). |
| 2018-04-16 | Novartis Pharmaceuticals | Results Novartis announces new analysis demonstrating Entresto helped preserve kidney function in patients with chronic heart failure, especially those with diabetes novartis.com ↗
HFrEF patients treated with Entresto had a slower rate of decline in eGFR than those treated with ACE inhibitor enalapril.[1] |
| 2018-04-04 | Novartis Pharmaceuticals | Results Novartis announces JAMA Cardiology publication of data showing Entresto® improves physical and social activity in HFrEF patients versus enalapril novartis.com ↗
Post-hoc analysis of PARADIGM-HF published in JAMA Cardiology shows heart failure patients treated with Entresto experience significant improvements in physical and social activities compared to those taking enalapril[1] |
| 2017-11-12 | Novartis Pharmaceuticals | Results New Novartis Entresto® real world evidence data shows beneficial impact on quality of life in people living with heart failure novartis.com ↗
Novartis today announced new results from a real-world database study of patients in Germany prescribed Entresto ® (sacubitril/valsartan) for heart failure with reduced ejection fraction (HFrEF). |
| 2017-03-22 | Novartis Pharmaceuticals | Results Novartis provides update on Phase III study of RLX030 (serelaxin) in patients with acute heart failure novartis.com ↗
RELAX-AHF-2 did not meet its primary endpoints of reduction in cardiovascular death through Day 180 or reduced worsening heart failure through Day five when added to standard therapy in patients with AHF. |
| 2017-03-18 | Novartis Pharmaceuticals | Results New analysis shows Novartis Entresto improves glycemic control in reduced ejection fraction heart failure patients with diabetes novartis.com ↗
Entresto lowered HbA1c levels - a measure of average blood glucose levels for the past two to three months - after one year of treatment for HF, and this effect was sustained over three years of study follow-up[1]. |
| 2016-11-15 | Novartis Pharmaceuticals | Results New analysis of Novartis' Entresto® data shows long-term benefits on heart failure readmissions and total cardiovascular deaths novartis.com ↗
Entresto reduced the risk of first and subsequent events of heart failure hospitalizations and cardiovascular deaths following heart failure hospitalization by 20%-24% compared to enalapril[1] |
| 2016-09-19 | Novartis Pharmaceuticals | Results Important new analysis shows that Novartis' Entresto® is associated with higher relative health-related quality of life scores among HFrEF patients novartis.com ↗
New analysis of PARADIGM-HF data shows that among patients who had been hospitalized for heart failure, those on Entresto reported higher relative health-related quality of life (HRQL) scores compared to those taking ACE inhibitor enalapril[1] |
| 2016-06-22 | Novartis Pharmaceuticals | Results 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 ↗
This new analysis estimates that as many as 28,484 deaths in HFrEF patients annually could be prevented or postponed with optimal use of Entresto (with sensitivity analyses demonstrating a range of 18,230 to 41,017) . |
| 2016-04-02 | Novartis Pharmaceuticals | Results New analyses show Novartis' Entresto(TM) reduced cardiovascular death or hospitalization for heart failure, consistently benefitting patients with reduced ejection fraction regardless... novartis.com ↗
In a second analysis, patients taking Entresto had about a 20% reduction in CV death or heart failure hospitalization compared to those taking enalapril, regardless of background therapy[1],[2] |
| 2015-11-24 | Novartis Pharmaceuticals | Regulatory Novartis' heart failure medicine Entresto(TM) receives EU approval novartis.com ↗
Basel, November 24, 2015 - Novartis announced today that the European Commission (EC) has approved Entresto TM (sacubitril/valsartan) for the treatment of adult patients with symptomatic chronic heart failure with reduced ejection fraction (HFrEF). |
| 2015-09-25 | Novartis Pharmaceuticals | Regulatory Novartis' new heart failure medicine Entresto(TM) recommended by CHMP for EU approval novartis.com ↗
Novartis announced today that the Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for Entresto(TM) (sacubitril/valsartan), marking an important milestone towards becoming available in the EU. |
| 2015-09-18 | Novartis Pharmaceuticals | Regulatory Swissmedic approves Novartis' new heart failure medicine Entresto(TM) novartis.com ↗
Novartis announced today that Swissmedic has approved Entresto(TM) (sacubitril/valsartan), previously known as LCZ696, to reduce the risk of cardiovascular mortality and morbidity in patients with heart failure with reduced ejection fraction (HFrEF). |
| 2015-07-07 | Novartis Pharmaceuticals | Regulatory 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 ↗
Basel, July 7, 2015 - Novartis announced today that the US Food and Drug Administration (FDA) has approved Entresto(TM) (sacubitril/valsartan) tablets, previously known as LCZ696, for the treatment of heart failure with reduced ejection fraction. |
| 2015-02-13 | Novartis Pharmaceuticals | Regulatory Novartis' heart failure medicine LCZ696 granted FDA priority review novartis.com ↗
Basel, February 13, 2015 - Novartis announced today that the US Food and Drug Administration (FDA) has granted priority review designation to LCZ696, an investigational medicine for the treatment of heart failure with reduced ejection fraction (HFrEF). |
All press releases naming this drug 33 releases
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 ↗ |
| 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 ↗ |