Drugs / sacubitril/valsartan
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 4 | NCT02554890 | Apr 2016 → Jun 2018 | heart failure | Novartis Pharmaceuticals | Completed | Met primary |
News releases announcing trial results or a regulatory action · 21
| 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) |
| 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). |
| 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. |
All press releases naming this drug 21 releases
Evidence & citations 3 cited values
Every value below carries the sentence it was read from. 2 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | sacubitril/valsartan | ClinicalTrials.gov intervention name — accepted as the source's own label NCT02554890 ↗ |
| Action | Inhibit | “sacubitril/valsartan, an angiotensin receptor-neprilysin inhibitor, is unclear.” PMID 32919915 ↗ Sep 2020 |
| Route | Oral | “sacubitril/valsartan (LCZ696) tablet with minimum dose 24/26 mg, maximum dose 97/103 mg twice daily administered orally.” NCT02554890 ↗ |