Sacubitril / Valsartan

also known as Entresto

Developed for: COVID-19
Investigated by: Duke University · Novartis Pharmaceuticals

Regulatory milestones approvals, filings & regulatory actions · 3 recorded

Milestone	Jurisdiction	Brand	Indication	Date	Sentence it was read from
Filed	US (FDA)	Entresto	symptomatic heart failure	2020-07-21	“Additionally we submitted regulatory filings for several major drugs, including Leqvio , Kesimpta and Entresto (HFpEF).” novartis.com ↗ “Entresto HFpEF File accepted in the US.” novartis.com ↗
Filed	EU (EMA)	Entresto	symptomatic heart failure	—	“Filed with EMA in Q2 2019 and in Japan in Q3 2019.” novartis.com ↗
Filed	Japan (PMDA)	Entresto	symptomatic heart failure	—	“Filed with EMA in Q2 2019 and in Japan in Q3 2019.” novartis.com ↗

Trials 1

today NCT04883528 · Ph 1/2

20222023202420252026

Phase	Registry id	Dates	Indication	Sponsor	Status	Outcome
Phase 1/2	NCT04883528	Aug 2021 → Jun 2023	COVID-19	Duke University	Completed	Missed primary

News releases announcing trial results or a regulatory action · 1

Date	Issuer	Release
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 ↗ The simultaneous approval of five new products is remarkable for Japan and our industry.

All press releases naming this drug 29 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 ↗
2020-06-29	Novartis Pharmaceuticals	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	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 ↗

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	ClinicalTrials.gov intervention name — accepted as the source's own label NCT04883528 ↗
Known as	Entresto	“Drug: Sacubitril / Valsartan Oral Tablet [Entresto]” NCT04883528 ↗
Route	Oral	“administered orally” NCT04883528 ↗