Drugs / sacubitril/valsartan
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 4 | NCT03506412 | Jun 2018 → Mar 2021 | diastolic heart failure | Mayo Clinic | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 15
| Date | Issuer | Release |
|---|---|---|
| 2021-02-16 | Novartis Pharmaceuticals | Regulatory Novartis Entresto® granted expanded indication in chronic heart failure by FDA novartis.com ↗
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 . |
| 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). |
| 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] |
| 2018-04-16 | 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 ↗ |
| 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). |
| 2017-03-18 | Novartis Pharmaceuticals | Results New analysis shows Novartis Entresto improves glycemic control in reduced ejection fraction heart failure patients with diabetes novartis.com ↗
New post-hoc analysis of PARADIGM-HF data demonstrates Entresto lowered levels of HbA1c (a measure of glycemic control) by 0.26% vs. 0.16% for ACE-inhibitor enalapril in heart failure with reduced ejection fraction (HFrEF) patients who also had diabetes |
| 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 ↗
A new analysis published today in JAMA Cardiology has found that timely and broad adoption of Entresto® (sacubitril/valsartan) by all eligible heart failure patients with reduced ejection fraction (HFrEF) could prevent or postpone more than 28,000 deaths each year in the US alone. |
| 2016-04-21 | Novartis Pharmaceuticals | Results Novartis delivered solid Q1 despite Gleevec loss of exclusivity; investing behind new launches for long-term growth novartis.com ↗
New analyses from the PARADIGM-HF trial showed Entresto (sacubitril/valsartan) reduces cardiovascular death and heart failure hospitalizations by 20% compared to ACE inhibitor enalapril, regardless of background therapy and in patients considered clinically stable. |
| 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 ↗
Novartis announced today new analyses of the data from PARADIGM-HF showing that Entresto (TM) (sacubitril/valsartan) consistently demonstrated benefit among heart failure patients with reduced ejection fraction (HFrEF), even when patients are considered clinically stable and regardless of background therapy. |
| 2015-10-27 | Novartis Pharmaceuticals | Results Novartis delivered strong core margin expansion (cc) and continued to strengthen the pipeline in Q3; on track for full-year guidance novartis.com ↗
Data from an extension study showed that Cosentyx provides high levels of skin clearance and sustained efficacy in patients with moderate-to-severe plaque psoriasis while maintaining a favorable safety profile over three years. |
| 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 | “Entresto™ 49/51 mg (sacubitril/valsartan) twice-daily for a total duration of up to 5 weeks of treatment.” NCT03506412 ↗ |
| Known as | Entresto | “Entresto™ 49/51 mg (sacubitril/valsartan) twice-daily for a total duration of up to 5 weeks of treatment.” NCT03506412 ↗ |
| Route | Oral | “Entresto™ 49Mg-51 mg will be given twice daily orally for 5 weeks” NCT03506412 ↗ |