Drugs / Sacubitril/Valsartan
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 2 | NCT03415906 | Dec 2017 → Sep 2018 | heart failure | Hannover Medical School | Withdrawn | No outcome recorded Stop: Enrollment |
News releases announcing trial results or a regulatory action · 16
| Date | Issuer | Release |
|---|---|---|
| 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) |
| 2019-09-02 | 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]. |
| 2018-05-28 | 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. |
| 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 |
| 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] |
| 2016-04-21 | The Medicines Company | Results Novartis erzielt im ersten Quartal trotz Verlust der Exklusivrechte an Gleevec solide Ergebnisse und investiert in Neueinführungen zugunsten langfristigen Wachstums novartis.com ↗
Neue Analysen der Studie PARADIGM-HF zeigten, dass Entresto (Sacubitril/Valsartan) herzkreislaufbedingte Todesfälle und Klinikeinweisungen wegen Herzinsuffizienz im Vergleich zum ACE-Hemmer Enalapril um 20% reduzierte - unabhängig von der Hintergrundtherapie sowie bei als klinisch stabil geltenden Patienten. |
| 2015-11-24 | Novartis Pharmaceuticals | Regulatory Novartis' heart failure medicine Entresto(TM) receives EU approval novartis.com ↗
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 ↗
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 28 releases
Evidence & citations 3 cited values
Every value below carries the sentence it was read from. 1 source stands behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Sacubitril/Valsartan | “With Sacubitril/Valsartan (ENTRESTO®) on Centrally Generated Sympathetic Activity in Heart Failure Patients” NCT03415906 ↗ |
| Known as | ENTRESTO | “With Sacubitril/Valsartan (ENTRESTO®) on Centrally Generated Sympathetic Activity in Heart Failure Patients” NCT03415906 ↗ |
| Action | Inhibit | “Combined angiotensin receptor + neprilysin inhibition” NCT03415906 ↗ |