Drugs / Sacubitril
Sacubitril
also known as
Sacubitril/Allisartan · AHU377 · Sacubitril component of entresto · sacubitril/valsatran · Sacubitrilo
Small molecule targets MME via inhibition
Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | EU (EMA) | Entresto | — | 2015-11-19 | europa.eu ↗ |
| Approved | US (FDA) | ENTRESTO | — | 2015-07-07 | fda.gov ↗ |
Trials 20
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 01 trial | ||||||
| Phase 0 | NCT03647657 | Dec 2018 → Dec 2021 | medullary thyroid gland carcinoma | University Hospital, Basel, Switzerland | Completed | No outcome recorded |
| Phase 11 trial | ||||||
| Phase 1 | NCT06248112 | May → Jun 2024 | — | Bio-innova Co., Ltd | Unknown | No outcome recorded |
| Phase 24 trials · 1 met primary · 1 missed | ||||||
| Phase 2 | NCT04055428 | Aug 2020 → Dec 2026 expected | cardiovascular disorder, diabetes mellitus | University of Alabama at Birmingham | Recruiting | No outcome recorded |
| Phase 2 | NCT04164732 | Jan 2020 → Aug 2023 | — | Novartis Pharmaceuticals | Completed | Missed primary |
| Phase 2 | NCT01281306 | Jan → Dec 2011 | hypertensive disorder | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 2 | NCT00549770 | Sep 2007 → Jul 2008 | hypertensive disorder | Novartis Pharmaceuticals | Completed | Met primary |
| Phase 2/31 trial | ||||||
| Phase 2/3 | NCT04971720 | Feb 2022 → Jan 2027 expected | hypertensive disorder, obesity disorder | University of Alabama at Birmingham | Recruiting | No outcome recorded |
| Phase 32 trials | ||||||
| Phase 3 | NCT07704684 | Jun 2023 → Aug 2025 | essential hypertension | Shenzhen Salubris Pharmaceuticals Co., Ltd. | Completed | No outcome recorded |
| Phase 3 | NCT04128891 | Feb 2020 | diastolic heart failure | Flinders University | Withdrawn | No outcome recorded Stop: Business |
| Phase 410 trials · 2 missed | ||||||
| Phase 4 | NCT07241338 | Nov 2025 → Nov 2026 expected | essential hypertension | Jing Liu | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT06501651 | Aug 2024 → Apr 2025 overdue | diabetic kidney disease, essential hypertension, type 2 diabetes mellitus | Sichuan Academy of Medical Sciences | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT06035978 | Mar 2024 → Apr 2026 | symptomatic heart failure | University Hospital Ostrava | Unknown | No outcome recorded |
| Phase 4 | NCT05487261 | Dec 2022 → Feb 2025 | heart failure | Clinical Hospital Heliodor Swiecicki of the Medical University of Karol Marcinkowski in Poznań | Unknown | No outcome recorded |
| Phase 4 | NCT05387967 | Jan → Jun 2021 | systolic heart failure | National Institute of Cardiovascular Diseases, Pakistan | Completed | No outcome recorded |
| Phase 4 | NCT04688294 | Jan 2020 → May 2021 | heart failure | Amir Safwat | Completed | No outcome recorded |
| Phase 4 | NCT03893526 | Jan 2019 → Mar 2021 | type 2 diabetes mellitus | University of Copenhagen | Completed | No outcome recorded |
| Phase 4 | NCT03300427 | Jul 2018 → Mar 2022 | heart failure | Novartis Pharmaceuticals | Completed | Missed primary |
| Phase 4 | NCT03168568 | May 2017 → Sep 2020 | heart failure | University of Zurich | Completed | Missed primary |
| Phase 4 | NCT02690974 | Mar 2016 → Jun 2017 | systolic heart failure | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase not applicable1 trial | ||||||
| — | NCT05892146 | May 2021 → Dec 2025 | breast cancer, chemotherapy-induced toxicity, heart failure, lymphoma | National Cheng-Kung University Hospital | Unknown | No outcome recorded |
| Comparator or background therapy5 trials | ||||||
| Phase 1 | NCT07444398 Background | Jan → Mar 2026 overdue | symptomatic heart failure | Khawaja Danish Ali | Recruiting | No outcome recorded |
| Phase 2 | NCT04149990 Comparator | Oct 2018 → Jul 2022 | myocardial infarction | Jacob Moller | Terminated | No outcome recorded Stop: Enrollment |
| Phase 3 | NCT07704697 Background | Nov 2024 → Nov 2025 | essential hypertension | Shenzhen Salubris Pharmaceuticals Co., Ltd. | Completed | No outcome recorded |
| Phase 4 | NCT03717688 Comparator | May 2018 → Feb 2019 | diabetes mellitus, heart failure | Nicolai Jacob Wewer Albrechtsen | Completed | No outcome recorded |
| Phase 4 | NCT02816736 Comparator | Mar 2017 → Sep 2020 | heart failure | Duke University | Completed | No outcome recorded |
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 ↗ |
All press releases naming this drug 2 releases
Evidence & citations 10 cited values
Every value below carries the sentence it was read from. 26 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Sacubitril | “The PARADIGM-HF trial showed that LCZ696, which consists of the neprilysin inhibitor sacubitril and the ARB valsartan, improved morbidity and mortality in patients with chronic...” NCT02816736 ↗18“194 mg sacubitril / 206 mg valstartan (entresto) as one single dose followed by a standardized meal” NCT03893526 ↗ “LCZ696 is a novel combination drug consisting of two antihypertensives, sacubitril and valsartan.” NCT04149990 ↗ “Single dose administration of Entrestro 194 mg sacubitril / 206 mg valstartan” NCT03717688 ↗ “Entresto® was given at a single oral dose, containing 48.6 mg sacubitril.” PMID 38581480 ↗ Apr 2024 “Sacubitril/Valsartan (25/80) mg twice a day for 1 year” NCT05892146 ↗ “sacubitril” NCT04164732 ↗ |
| Known as | AHU377 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT00549770 ↗ |
| Known as | Sacubitril component of entresto | ChEMBL registry synonym — accepted as the source's own label CHEMBL3137301 ↗ |
| Known as | Sacubitril/Allisartan | ClinicalTrials.gov intervention name — accepted as the source's own label NCT07704684 ↗ |
| Known as | sacubitril/valsatran | ClinicalTrials.gov intervention name — accepted as the source's own label NCT03300427 ↗ |
| Known as | Sacubitrilo | ChEMBL registry synonym — accepted as the source's own label CHEMBL3137301 ↗ |
| Action | Inhibit | “the neprilysin inhibitor sacubitril” NCT02816736 ↗1“Neprilysin inhibitor” CHEMBL3137301 ↗ |
| Modality | Small molecule | — CHEMBL3137301 ↗ |
| Route | Oral | “Participants received AHU377 200 mg and matching placebo to LCZ696 and Valsartan (5 tablets and 2 capsules) daily.” NCT00549770 ↗ |
| Target | MME | “Neprilysin inhibitor” CHEMBL3137301 ↗ |