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 22
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT07856043 | Oct 2026 → Jun 2028 expected | cerebrovascular disorder, cognitive impairment with or without cerebellar ataxia, symptomatic heart failure | Stony Brook University | Not yet recruiting | No outcome recorded |
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT05194111 | Aug 2022 → Nov 2028 expected | heart failure | Virginia Commonwealth University | Recruiting | No outcome recorded |
| Phase 25 trials | ||||||
| Phase 2 | NCT05498181 | Oct 2022 → Jan 2026 | — | Brigham and Women's Hospital | Completed | No outcome recorded |
| Phase 2 | NCT04637152 | Nov 2020 → Jul 2022 | resistant hypertension | Hospital Geral Roberto Santos | Completed | No outcome recorded |
| Phase 2 | NCT04153136 | Sep 2020 → Jul 2025 | AIDS, diastolic heart failure | Massachusetts General Hospital | Completed | No outcome recorded |
| Phase 2 | NCT03005184 | Sep 2017 → Jan 2020 | mild heart failure, moderate heart failure | Vanderbilt University Medical Center | Withdrawn | No outcome recorded |
| Phase 2 | NCT04687111 | Dec 2015 → Jun 2021 | cardiac rhythm disease, hypertensive disorder, myocardial disorder, myositis disease | Mark Ledwidge | Unknown | No outcome recorded |
| Phase 33 trials | ||||||
| Phase 3 | NCT06643819 | Oct 2024 → Mar 2026 overdue | essential hypertension | Chong Kun Dang Pharmaceutical | Recruiting | No outcome recorded |
| Phase 3 | NCT05553886 | Dec 2021 → Dec 2025 overdue | symptomatic heart failure | Shenzhen People's Hospital | Recruiting | No outcome recorded |
| Phase 3 | NCT04912167 | Nov 2021 → Mar 2022 | ST-elevation myocardial infarction | West China Hospital | Unknown | No outcome recorded |
| Phase 410 trials · 1 met primary | ||||||
| Phase 4 | NCT06536309 | Aug 2026 | diastolic heart failure | Brigham and Women's Hospital | Withdrawn | No outcome recorded Stop: Enrollment |
| Phase 4 | NCT05465031 | Apr 2024 → Dec 2027 expected | breast cancer, cardiomyopathy, chemotherapy-induced toxicity, heart failure | Silesian Centre for Heart Diseases | Recruiting | No outcome recorded |
| Phase 4 | NCT06357104 | Feb → Mar 2024 | — | Pachankis, Yang I., M.D. | Completed | No outcome recorded |
| Phase 4 | NCT05528419 | Feb 2023 → Jan 2026 | atrial fibrillation, hypertensive disorder | Shanghai Jiao Tong University School of Medicine | Completed | No outcome recorded |
| Phase 4 | NCT05164653 | Dec 2021 → Feb 2024 overdue | heart failure | Saga University | Active not recruiting | No outcome recorded |
| Phase 4 | NCT04103554 | Feb 2021 → Feb 2025 | heart failure | University of Zagreb | Unknown | No outcome recorded |
| Phase 4 | NCT03938389 | Feb 2020 → Feb 2024 overdue | glucose intolerance, hypertensive disorder, obesity disorder, prediabetes syndrome | Ohio State University | Active not recruiting | No outcome recorded |
| Phase 4 | NCT04206865 | Nov 2019 → Sep 2020 | cardiogenic shock | The Cleveland Clinic | Withdrawn | No outcome recorded |
| Phase 4 | NCT04191681 | Nov 2019 → Mar 2022 overdue | advanced heart failure | The Cleveland Clinic | Recruiting | No outcome recorded |
| Phase 4 | NCT02916160 | Sep 2016 → Feb 2020 | heart failure, sleep apnea syndrome | University Hospital, Montpellier | Completed | Met primary |
| Phase not applicable2 trials | ||||||
| — | NCT05053893 | Sep 2021 → Jul 2022 | cardio-renal syndrome | The Affiliated Hospital of Qingdao University | Unknown | No outcome recorded |
| — | NCT03791723 | Jun 2019 → Jan 2021 | atrial fibrillation | The Second Affiliated Hospital of Chongqing Medical University | Unknown | No outcome recorded |
| Comparator or background therapy6 trials | ||||||
| Phase 2 | NCT05212597 Comparator | Jan 2022 → Dec 2023 | aortic valve insufficiency | Samsung Medical Center | Unknown | No outcome recorded |
| Phase 4 | NCT05991284 Comparator | Feb 2024 → Sep 2025 | diastolic heart failure, mitral valve insufficiency | Ziekenhuis Oost-Limburg | Completed | No outcome recorded |
| Phase 4 | NCT05989503 Comparator | Aug 2023 → Jul 2025 | symptomatic heart failure | University of Porto | Completed | No outcome recorded |
| Phase 4 | NCT04575675 Background | May → Nov 2020 | heart failure, hypotensive disorder | Cheng-Hsin General Hospital | Completed | No outcome recorded |
| Phase 4 | NCT03279861 Comparator | Nov 2017 → Nov 2018 | congestive heart failure, hypertensive disorder | University of Maryland, Baltimore | Withdrawn | No outcome recorded |
| — | NCT07341893 Comparator | Aug 2025 → Mar 2026 | heart failure | Damanhour University | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 5
| Date | Issuer | Release |
|---|---|---|
| 2024-03-26 | Otsuka Pharmaceutical Development & Commercialization, Inc. | Regulatory Novartis receives approval in Japan for Entresto Granular Tablets for Pediatric Use, a formulation dedicated for pediatric patients with chronic heart failure® otsuka.co.jp ↗ |
| 2024-02-09 | Otsuka Pharmaceutical Development & Commercialization, Inc. | Regulatory Novartis Obtains Approval for Additional Indication of Pediatric Chronic Heart Failure for Angiotensin Receptor Neprilysin Inhibitor (ARNI) Entresto Tablet® otsuka.co.jp ↗
This drug is the first in Japan to receive dosage and administration approval for the indication of chronic heart failure in pediatric patients. |
| 2021-09-27 | Otsuka Pharmaceutical Development & Commercialization, Inc. | Regulatory Otsuka announces that Novartis Pharma's ENTRESTO received a new indication for treatment of hypertension in Japan® otsuka.co.jp ↗
Otsuka Pharmaceutical Co., Ltd. (Otsuka), announces that Novartis Pharma K.K. (Novartis Pharma) has obtained approval in Japan for ENTRESTO 100 mg and 200 mg Tablets (generic name: sacubitril valsartan sodium hydrate) for the new indication of hypertension. |
| 2020-06-29 | Otsuka Pharmaceutical Development & Commercialization, Inc. | Regulatory Novartis Pharma obtains manufacturing and marketing approval in Japan for Entresto tablet as angiotensin receptor neprilysin inhibitor (ARNI) for chronic heart failure® otsuka.co.jp ↗
Manufacturing and marketing approval was granted in Japan |
| 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 27 releases
Evidence & citations 10 cited values
Every value below carries the sentence it was read from. 31 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | sacubitril/valsartan | “The sacubitril/valsartan molecule (LCZ696) or Entresto® is a molecular complex composed of the sacubitril prodrug activated after ingestion in sacubitrilate - neprilysin...” NCT04637152 ↗34“This study investigated the effect of uptitration of sacubitril/valsartan (Sac/Val) compared with angiotensin-converting enzyme inhibitors or angiotensin receptor blockers...” PMID 40389107 ↗ May 2025 “The angiotensin receptor blocker-neprilysin inhibitor sacubitril-valsartan (Entresto) is a potent anti-hypertensive mediation that was recently approved by the Food and Drug...” NCT03279861 ↗ “Sacubitril/valsartan and SGLT2i reduced HF hospitalizations and mortality in patients with heart failure and a reduced ejection fraction with a rapid onset of action, but the...” NCT05989503 ↗ “Sacubitril/valsartan is an angiotensin receptor-neprilysin inhibitor indicated for the treatment of patients with chronic heart failure (HF) with reduced ejection fraction” PMID 29754651 ↗ Feb 2018 “Sacubitril/valsartan (Entresto®) administered in the target dose of 200 mg b.i.d. (97/103 mg of sacubitril and valsartan respectively) for the period of 24 months.” NCT05465031 ↗ “assigned 84 patients with symptomatic HFpEF and at least moderate AFMR within the previous year to sacubitril/valsartan (n=41) or standard-of-care (SOC; n=43).” PMID 42104906 ↗ May 2026 “Following baseline studies, participants will either receive a medication called sacubitril/valsartan or placebo for 6 months.” NCT04153136 ↗ “they will receive sacubitril/valsartan (LCZ696) 200 mg bid for seven days.” NCT03005184 ↗ |
| Known as | CKD-202A | “CKD-202A(Sacubitril∙Valsartan) 100mg” NCT06643819 ↗ |
| Known as | Entresto | “The sacubitril/valsartan molecule (LCZ696) or Entresto® is a molecular complex composed of the sacubitril prodrug activated after ingestion in sacubitrilate - neprilysin...” NCT04637152 ↗3“The angiotensin receptor blocker-neprilysin inhibitor sacubitril-valsartan (Entresto) is a potent anti-hypertensive mediation that was recently approved by the Food and Drug...” NCT03279861 ↗ “This study tests the hypothesis that endogenous bradykinin contributes to effects of a combined angiotensin receptor blocker/neprilysin inhibitor (LCZ696 or Entresto)” NCT03005184 ↗ “Sacubitril/valsartan (Entresto®) administered in the target dose of 200 mg b.i.d. (97/103 mg of sacubitril and valsartan respectively) for the period of 24 months.” NCT05465031 ↗ |
| Known as | LCZ696 | “The sacubitril/valsartan molecule (LCZ696) or Entresto® is a molecular complex composed of the sacubitril prodrug activated after ingestion in sacubitrilate - neprilysin...” NCT04637152 ↗1“they will receive sacubitril/valsartan (LCZ696) 200 mg bid for seven days.” NCT03005184 ↗ |
| Known as | LCZ696, ENTRESTO | “LCZ696, ENTRESTO®” NCT02916160 ↗ |
| Known as | Sac/Val | “This study investigated the effect of uptitration of sacubitril/valsartan (Sac/Val) compared with angiotensin-converting enzyme inhibitors or angiotensin receptor blockers...” PMID 40389107 ↗ May 2025 |
| Known as | Sacubitril valsartan sodium | “Sacubitril valsartan sodium tablets,50mg,100mg” NCT05553886 ↗ |
| Known as | Sacubitril Valsartan Sodium Tablets | “The initial dose of Sacubitril Valsartan Sodium Tablets(Novartis, China) is 50mg, once a day, taken on an empty stomach in the morning, and gradually titrated from the minimum...” NCT05053893 ↗ |
| Action | Inhibit | “It combines inhibitory prodrug neprilysin and valsartan.” NCT02916160 ↗ |
| Route | Oral | “Sacubitril/valsartan is an oral medication taken twice daily” NCT04153136 ↗ |