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 | — | “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 | NCT02970669 | Dec 2016 → Mar 2018 | heart failure | Novartis Pharmaceuticals | Completed | Missed primary |
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 ↗ |
| 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 ↗ |
| 2015-02-13 | Novartis Pharmaceuticals | Novartis' heart failure medicine LCZ696 granted FDA priority review 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 NCT02970669 ↗ |
| Known as | LCZ696 | “sacubitril/valsartan (LCZ696)” NCT02970669 ↗ |
| Route | Oral | “sacubitril/valsartan tablet taken orally.” NCT02970669 ↗ |