Drugs / Sacubitril/valsartan
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed | Japan (PMDA) | — | congestive heart failure | 2020-03-02 | “Novartis Pharma is currently applying for approval of the drug in Japan with a planned indication for chronic heart failure.” otsuka.co.jp ↗ |
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 4 | NCT03190304 | Jun 2017 → Sep 2020 | heart failure, isoproterenol-mediated vasodilatation | University of Sao Paulo General Hospital | Completed | Missed primary |
News releases announcing trial results or a regulatory action · 1
| Date | Issuer | Release |
|---|---|---|
| 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 use of insulin was also reduced by 29% among patients taking Entresto compared to enalapril-treated patients[1] |
All press releases naming this drug 4 releases
| Date | Issuer | Release |
|---|---|---|
| 2020-03-02 | Otsuka Pharmaceutical Development & Commercialization, Inc. | Otsuka enters into co-promotion agreement for angiotensin receptor neprilysin inhibitor (ARNI) LCZ696 in Japan otsuka.co.jp ↗ |
| 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 ↗ |
| 2017-03-18 | Novartis Pharmaceuticals | New analysis shows Novartis Entresto improves glycemic control in reduced ejection fraction heart failure patients with diabetes 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 2 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 | “Sacubitril/valsartan versus enalapril on exercise capacity in patients with heart failure with reduced ejection fraction: A randomized, double-blind, active-controlled study.” PMID 33992607 ↗ May 2021 |
| Known as | LCZ696 | “Studies with new drugs in the treatment of heart failure (HF), such as the combination of valsartan/sacubitril, also known as LCZ696, have demonstrated important clinical...” NCT03190304 ↗ |