Regulatory milestones approvals, filings & regulatory actions · 8 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | EU (EMA) | Aqumeldi | — | 2023-11-15 | europa.eu ↗ |
| Label expansion | US (FDA) | EPANED KIT | — | 2014-09-04 | fda.gov ↗ |
| Label expansions (5) | US (FDA) | VASOTEC | — | 1988-06-24 – 2001-02-13 | fda.gov ↗ |
| Approved | US (FDA) | VASOTEC | — | 1985-12-24 | fda.gov ↗ |
Trials 64 · started per year
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 15 trials | ||||||
| Phase 1 | NCT02252692 | Aug → Oct 2014 | heart failure | Ethicare GmbH | Unknown | No outcome recorded |
| Phase 1 | NCT01822639 | Apr → May 2013 | hypertensive disorder | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 1 | NCT01117038 | Apr → May 2010 | erectile dysfunction | VIVUS LLC | Completed | No outcome recorded |
| Phase 1 | NCT01115946 | Mar → Apr 2010 | — | Astellas Pharma Inc | Completed | No outcome recorded |
| Phase 1 | NCT00899587 | — | retinal ischemia | Shahid Beheshti University of Medical Sciences | Unknown | No outcome recorded |
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT03179163 | Jul 2016 → Aug 2022 | essential hypertension | Penn State University | Terminated | No outcome recorded Stop: Business |
| Phase 213 trials · 1 missed | ||||||
| Phase 2 | NCT06788314 | Feb 2025 → Dec 2029 expected | congenital vascular malformation | Oslo University Hospital | Recruiting | No outcome recorded |
| Phase 2 | NCT05232370 | Jan 2022 | — | Unidad de Investigacion Medica en Enfermedades Renales | Completed | No outcome recorded |
| Phase 2 | NCT03466333 | Sep 2018 → Sep 2020 | preeclampsia | Manchester University NHS Foundation Trust | 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NCT03005184 | Sep 2017 → Jan 2020 | mild heart failure, moderate heart failure | Vanderbilt University Medical Center | Withdrawn | No outcome recorded |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 | NCT03667131 | Feb → Dec 2017 | rheumatoid arthritis | University of Guadalajara | Completed | No outcome recorded |
| Phase 2 | NCT01705392 | Jan 2013 → Feb 2017 | metastatic melanoma | Haukeland University Hospital | Terminated | No outcome recorded Stop: Business |
| Phase 2 | NCT02281838 | Aug 2011 → Nov 2021 | intracerebral hemorrhage | University of Alberta | Terminated | No outcome recorded |
| Phase 2 | NCT01093807 | Mar 2010 → Mar 2011 | essential hypertension | RECORDATI GROUP | Completed | No outcome recorded |
| Phase 2 | NCT00603590 | Nov 2006 → Jun 2008 | heart disorder, hyperlipidemia, hypertensive disorder | Tehran University of Medical Sciences | Completed | No outcome recorded |
| Phase 2 | NCT00394394 | Feb 2005 → ? | hypertensive disorder | Hospital de Clinicas de Porto Alegre | Completed | No outcome recorded |
| Phase 2 | NCT00143949 | Mar 1997 → Mar 2007 | type 1 diabetes mellitus | Michael Mauer, MD | Completed | Missed primary |
| Phase 2 | NCT00004328 | Dec 1992 → ? | pseudohypoaldosteronism | National Center for Research Resources (NCRR) | Completed | No outcome recorded |
| Phase 2 | NCT00000522 | Aug 1985 → May 1994 | heart disorder, hypertensive disorder | University of Minnesota | Completed | No outcome recorded |
| Phase 2/33 trials · 1 missed | ||||||
| Phase 2/3 | NCT02678312 | Nov 2016 → Jan 2022 | heart failure | Novartis Pharmaceuticals | Completed | Missed primary |
| Phase 2/3 | NCT02654678 | Mar 2016 → Apr 2018 | congenital heart disease, dilated cardiomyopathy, heart failure | Ethicare GmbH | Unknown | No outcome recorded |
| Phase 2/3 | NCT02652728 | Jan 2016 → Jun 2017 | dilated cardiomyopathy, heart failure | Ethicare GmbH | Unknown | No outcome recorded |
| Phase 316 trials · 3 met primary · 2 missed | ||||||
| Phase 3 | NCT07222852 | Nov 2025 → Oct 2027 expected | preeclampsia | Women and Infants Hospital of Rhode Island | Not yet recruiting | No outcome recorded |
| Phase 3 | NCT04591210 | Jan 2021 → Dec 2024 | COVID-19, cardiovascular disorder | Ottawa Heart Institute Research Corporation | Completed | No outcome recorded |
| Phase 3 | NCT04345406 | Apr 2020 → Dec 2029 expected | COVID-19 | Tanta University | Not yet recruiting | No outcome recorded |
| Phase 3 | NCT03265574 | Oct 2017 → Aug 2023 | breast cancer, non-Hodgkin lymphoma | South Tees Hospitals NHS Foundation Trust | Completed | Missed primary |
| Phase 3 | NCT03066804 | Aug 2017 → Oct 2019 | diastolic heart failure | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 3 | NCT02735707 | Apr 2016 → Feb 2026 overdue | pneumonia | UMC Utrecht | Recruiting | Mixed |
| Phase 3 | NCT03459560 | Dec 2015 → Mar 2022 | cardiovascular disorder | Tehran University of Medical Sciences | Unknown | Met primary |
| Phase 3 | NCT01968200 | Dec 2012 → Dec 2019 | cancer | European Institute of Oncology | Unknown | No outcome recorded |
| Phase 3 | NCT02432885 | Jun 2009 → Jun 2012 | cardiovascular disorder, muscular dystrophy | InCor Heart Institute | Completed | Met primary |
| Phase 3 | NCT00853658 | Mar 2009 → Oct 2015 | heart failure | Novartis Pharmaceuticals | Completed | Missed primary |
| Phase 3 | NCT01110824 | Apr 2008 → Dec 2011 | acute myeloid leukemia, plasma cell myeloma, precursor lymphoblastic lymphoma/leukemia | Hospital Clinic of Barcelona | Completed | Met primary |
| Phase 3 | NCT00446511 | Jun 2007 → Jun 2009 | hypertensive disorder | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 3 | NCT00003070 | Sep 2000 → Jul 2003 | chemotherapy-induced toxicity, childhood malignant neoplasm | Children's Oncology Group | Completed | No outcome recorded |
| Phase 3 | NCT00274118 | Jul 1997 → Jan 2004 | hypertensive disorder, type 2 diabetes mellitus | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 3 | NCT00000547 | Apr 1994 → Feb 2001 | heart failure, myocardial disorder | National Heart, Lung, and Blood Institute (NHLBI) | Completed | No outcome recorded |
| Phase 3 | NCT00000516 | Jul 1985 → May 1990 | coronary artery disorder, heart failure, hypertensive disorder, myocardial ischemia | National Heart, Lung, and Blood Institute (NHLBI) | Completed | No outcome recorded |
| Phase 414 trials · 1 met primary · 1 missed | ||||||
| Phase 4 | NCT07023003 | Jul 2025 → Jul 2028 expected | hypertension, pregnancy-induced | Nebraska Methodist Health System | Recruiting | No outcome recorded |
| Phase 4 | NCT05711810 | Jan 2023 | Orthocoronavirinae infectious disease, myocarditis | Yang I. Pachankis | Completed | No outcome recorded |
| Phase 4 | NCT05637853 | Oct 2022 → Aug 2024 overdue | symptomatic heart failure | Göteborg University | Active not recruiting | No outcome recorded |
| Phase 4 | NCT02817360 | Feb 2016 → Dec 2025 overdue | heart disorder, type 2 diabetes mellitus | Martin Huelsmann | Recruiting | No outcome recorded |
| Phase 4 | NCT01669434 | Jun 2015 → Nov 2016 | — | University of Nebraska | Completed | Met primary |
| Phase 4 | NCT02135263 | Apr 2012 → May 2014 | butyrylesterase 1 | Bispebjerg Hospital | Completed | No outcome recorded |
| Phase 4 | NCT01211314 | Jan → Dec 2011 | hypertensive disorder | Meir Medical Center | Terminated | No outcome recorded Stop: Business |
| Phase 4 | NCT01069042 | Feb → Aug 2010 | heart failure | National Cheng-Kung University Hospital | Unknown | No outcome recorded |
| Phase 4 | NCT00734123 | Apr 2008 → Apr 2009 | atherosclerosis | Hospital Arnau de Vilanova | Unknown | No outcome recorded |
| Phase 4 | NCT00456963 | Sep 2007 → Mar 2010 | diabetes mellitus, hypertensive disorder | Istituto Auxologico Italiano | Terminated | No outcome recorded |
| Phase 4 | NCT00419835 | May 2005 → Sep 2007 | diabetic kidney disease | University of Sao Paulo | Completed | No outcome recorded |
| Phase 4 | NCT01557140 | May 2003 → Mar 2004 | Chagas cardiomyopathy, dilated cardiomyopathy, heart failure | Federal University of Minas Gerais | Completed | Missed primary |
| Phase 4 | NCT00292526 | Nov 2000 → Nov 2011 | chemotherapy-induced toxicity | European Institute of Oncology | Completed | No outcome recorded |
| Phase 4 | NCT00367562 | Jan 1996 → Dec 2005 | IgA glomerulonephritis | Hospital Britanico | Completed | No outcome recorded |
| Phase not applicable12 trials · 1 missed | ||||||
| — | NCT07363343 | Mar 2026 → Dec 2029 expected | preeclampsia | The Cleveland Clinic | Recruiting | No outcome recorded |
| — | NCT06187493 | Jan 2024 → Jan 2025 | diabetic kidney disease | Assiut University | Unknown | No outcome recorded |
| — | NCT06710600 | Sep 2022 → Apr 2024 | photosensitivity disease | Medical University of Vienna | Completed | No outcome recorded |
| — | NCT04092309 | Sep 2019 → Sep 2020 | disease related to hematopoietic stem cell transplant, poisoning | University of Athens | Unknown | No outcome recorded |
| — | NCT03949075 | May → Dec 2019 | — | University of Copenhagen | Completed | No outcome recorded |
| — | NCT01867047 | Jun 2013 → Jun 2016 | hypotensive disorder | Duke University | Terminated | Missed primary |
| — | NCT01364675 | Jan 2012 → Jul 2016 | hypertensive disorder, prediabetes syndrome | Ramathibodi Hospital | Unknown | No outcome recorded |
| — | NCT01096121 | Jun 2010 → Jan 2012 | sickle cell disease | Assistance Publique - Hôpitaux de Paris | Terminated | No outcome recorded |
| — | NCT00895414 | Apr 2009 → Apr 2014 | breast cancer | Masonic Cancer Center, University of Minnesota | Completed | No outcome recorded |
| — | NCT00141583 | Apr 2004 → Oct 2006 | essential hypertension | St George's, University of London | Terminated | No outcome recorded Stop: Enrollment |
| — | NCT00484068 | Jan 2003 → Jun 2006 | diabetic kidney disease, proteinuria | Hospital de Clinicas de Porto Alegre | Completed | No outcome recorded |
| — | NCT00006137 | May 2000 → ? | IgA glomerulonephritis | National Center for Research Resources (NCRR) | Completed | No outcome recorded |
| Comparator or background therapy69 trials | ||||||
| Phase 0 | NCT02879721 Comparator | Oct 2009 → Dec 2012 | Barrett esophagus | Göteborg University | Completed | No outcome recorded |
| Phase 1 | NCT02623036 Comparator | Nov 2015 → Apr 2018 | resistant hypertension | Memorial Health University Medical Center | Unknown | No outcome recorded |
| Phase 1 | NCT00270153 Comparator | Sep 2004 → Dec 2009 | — | Montefiore Medical Center | Completed | No outcome recorded |
| Phase 1/2 | NCT01624064 Comparator | Aug → Oct 2012 | chronic kidney disease | Ministry of Health, Sri Lanka | Unknown | No outcome recorded |
| Phase 2 | NCT04484350 Background | Oct 2020 → Feb 2023 | hypertensive disorder, ischemic stroke, vascular occlusion disorder | Hamilton Health Sciences Corporation | Completed | No outcome recorded |
| Phase 2 | NCT04183101 Comparator | Oct 2020 → Dec 2029 expected | C3 glomerulonephritis, dense deposit disease, membranoproliferative glomerulonephritis | Region Skane | Recruiting | No outcome recorded |
| Phase 2 | NCT01754909 Comparator | Nov 2013 → Apr 2018 | lung cancer, radiation pneumonitis | VA Office of Research and Development | Completed | No outcome recorded |
| Phase 2 | NCT00543413 Comparator | Oct 2007 → Jun 2008 | hypertensive disorder | Merck Sharp & Dohme LLC | Completed | Missed primary |
| Phase 2 | NCT00963976 Background | Jan 2007 → Dec 2011 | intracerebral hemorrhage | University of Alberta | Completed | No outcome recorded |
| Phase 2 | NCT00396721 Comparator | Jan 2006 → Oct 2009 | IgA glomerulonephritis | Josep m Cruzado | Completed | No outcome recorded |
| Phase 2 | NCT00520247 Background | Sep 2005 → Feb 2006 | hyperhomocysteinemia, hypertensive disorder | Anhui Medical University | Completed | No outcome recorded |
| Phase 2 | NCT02088450 Comparator | Feb 1990 → Feb 1997 | — | KU Leuven | Terminated | No outcome recorded |
| Phase 2/3 | NCT05373004 Comparator | Mar 2023 → Mar 2024 | diabetic kidney disease | Omar Tarek Elfarargi | Unknown | No outcome recorded |
| Phase 2/3 | NCT02575092 Background | Nov 2015 → Feb 2019 | coronary artery disorder, hyperhomocysteinemia, hypertensive disorder | Fuling Central Hospital of Chongqing City | Completed | No outcome recorded |
| Phase 2/3 | NCT01007994 Comparator | Nov 2009 → Jan 2020 | secondary hypertension | Northwell Health | Completed | No outcome recorded |
| Phase 3 | NCT04912167 Comparator | Nov 2021 → Mar 2022 | ST-elevation myocardial infarction | West China Hospital | Unknown | No outcome recorded |
| Phase 3 | NCT04853758 Comparator | May 2021 → Dec 2024 | Chagas cardiomyopathy | University of Sao Paulo General Hospital | Unknown | No outcome recorded |
| Phase 3 | NCT03917459 Comparator | Apr 2019 → May 2021 | erectile dysfunction, systolic heart failure | Novartis Pharmaceuticals | Completed | Missed primary |
| Phase 3 | NCT02900378 Comparator | Dec 2016 → Apr 2018 | congestive heart failure | Novartis Pharmaceuticals | Completed | Missed primary |
| Phase 3 | NCT02468232 Comparator | Jun 2015 → Feb 2019 | systolic heart failure | Novartis Pharmaceuticals | Completed | Missed primary |
| Phase 3 | NCT01437371 Background | Aug 2011 → Jun 2014 | heart failure | University Hospital, Clermont-Ferrand | Completed | No outcome recorded |
| Phase 3 | NCT01271985 Comparator | Feb 2011 → Jan 2019 | cardiovascular disorder | Tehran University of Medical Sciences | Completed | No outcome recorded |
| Phase 3 | NCT01151410 Comparator | Aug 2010 → Aug 2015 | hypertensive disorder | Novartis Pharmaceuticals | Completed | Met primary |
| Phase 3 | NCT01035255 Comparator | Dec 2009 → May 2014 | symptomatic heart failure | Novartis Pharmaceuticals | Terminated | Met primary |
| Phase 3 | NCT00568178 Comparator | Jun 2007 → Sep 2008 | proteinuria | Organon and Co | Completed | Met primary |
| Phase 3 | NCT00433836 Comparator | Jan 2007 → Feb 2009 | hypertensive disorder | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 3 | NCT00113698 Comparator | Dec 2004 → Nov 2005 | congestive heart failure, ventricular septal defect | University of Utah | Terminated | No outcome recorded Stop: Enrollment |
| Phase 3 | NCT00113087 Comparator | Aug 2003 → Jul 2008 | congenital heart disease, congestive heart failure | National Heart, Lung, and Blood Institute (NHLBI) | Completed | No outcome recorded |
| Phase 3 | NCT01411735 Comparator | Jul 2003 → Jun 2004 | diastolic heart failure | Wake Forest University | Completed | No outcome recorded |
| Phase 3 | NCT02177448 Comparator | Sep 1998 → Sep 1999 | hypertensive disorder | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 3 | NCT00882440 Comparator | Dec 1990 → Aug 1991 | hypertensive disorder | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 4 | NCT07547878 Comparator | Apr 2026 → Mar 2029 expected | chronic kidney disease, type 2 diabetes mellitus | Baylor Research Institute | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT07513883 Background | Mar 2026 → Sep 2028 expected | heart failure | Ziekenhuis Oost-Limburg | Recruiting | No outcome recorded |
| Phase 4 | NCT05487261 Comparator | 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 | NCT04330300 Comparator | Apr 2020 → Jul 2021 | COVID-19, essential hypertension | National University of Ireland, Galway, Ireland | Suspended | No outcome recorded Stop: Business |
| Phase 4 | NCT04236258 Comparator | Jan 2020 → Jun 2021 | puerperal disorder, severe pre-eclampsia | Brigham and Women's Hospital | Completed | No outcome recorded |
| Phase 4 | NCT04023227 Comparator | Dec 2019 → Mar 2025 | Chagas disease, heart failure | Novartis Pharmaceuticals | Completed | Met primary |
| Phase 4 | NCT03502031 Comparator | Oct 2018 → Oct 2022 | diabetic kidney disease | James A. Tumlin, MD | Unknown | No outcome recorded |
| Phase 4 | NCT03472508 Comparator | Mar 2018 → Mar 2019 | hypertensive disorder | Shenzhen Ausa Pharmed Co.,Ltd | Unknown | No outcome recorded |
| Phase 4 | NCT03190304 Comparator | Jun 2017 → Sep 2020 | heart failure, isoproterenol-mediated vasodilatation | University of Sao Paulo General Hospital | Completed | Missed primary |
| Phase 4 | NCT03119623 Comparator | Jun 2017 → Aug 2019 | symptomatic heart failure | Brigham and Women's Hospital | Withdrawn | No outcome recorded Stop: Business |
| Phase 4 | NCT03051282 Comparator | Apr 2017 → Jan 2026 | — | University of Michigan | Completed | No outcome recorded |
| Phase 4 | NCT02970669 Comparator | Dec 2016 → Mar 2018 | heart failure | Novartis Pharmaceuticals | Completed | Missed primary |
| Phase 4 | NCT02874794 Comparator | Aug 2016 → Dec 2018 | heart failure | Novartis Pharmaceuticals | Completed | Missed primary |
| Phase 4 | NCT02768298 Comparator | Jul 2016 → Nov 2019 | symptomatic heart failure | Novartis Pharmaceuticals | Completed | Missed primary |
| Phase 4 | NCT02554890 Comparator | Apr 2016 → Jun 2018 | heart failure | Novartis Pharmaceuticals | Completed | Met primary |
| Phase 4 | NCT02817503 Background | Dec 2015 → Dec 2016 | hyperhomocysteinemia, hypertensive disorder | Second Affiliated Hospital of Nanchang University | Unknown | No outcome recorded |
| Phase 4 | NCT02214498 Comparator | May 2015 → May 2017 | essential hypertension | Erasmus Medical Center | Unknown | No outcome recorded |
| Phase 4 | NCT02200822 Comparator | Jul 2014 → Feb 2019 | heart failure | Hasselt University | Completed | No outcome recorded |
| Phase 4 | NCT02571842 Comparator | Jan 2012 → Dec 2016 | IgA glomerulonephritis | Chulalongkorn University | Unknown | No outcome recorded |
| Phase 4 | NCT01305850 Comparator | Jul 2010 → Aug 2011 | — | Chulalongkorn University | Unknown | No outcome recorded |
| Phase 4 | NCT01041963 Comparator | Jun 2009 → Jun 2010 | — | Chulalongkorn University | Unknown | No outcome recorded |
| Phase 4 | NCT00741585 Comparator | Sep 2008 → Jun 2018 | chronic kidney disease, essential hypertension, stroke disorder | University of Vigo | Completed | No outcome recorded |
| Phase 4 | NCT01871740 Comparator | May 2008 → Jun 2014 | essential hypertension, hyperhomocysteinemia | Shenzhen Ausa Pharmed Co.,Ltd | Withdrawn | No outcome recorded |
| Phase 4 | NCT00794885 Comparator | May 2008 → Aug 2013 | essential hypertension | Shenzhen Ausa Pharmed Co.,Ltd | Completed | Met primary |
| Phase 4 | NCT00666848 Comparator | Mar 2008 → Aug 2009 | hypertensive disorder, metabolic syndrome X | Vanderbilt University | Completed | No outcome recorded |
| Phase 4 | NCT00391846 Background | Oct 2006 → Jan 2009 | left ventricular failure | AstraZeneca | Completed | No outcome recorded |
| Phase 4 | NCT00235287 Comparator | Sep 2005 → ? | cardiovascular disorder, chronic kidney disease | Herlev Hospital | Unknown | No outcome recorded |
| Phase 4 | NCT00302705 Comparator | Jan 2005 → Mar 2007 | essential hypertension | University of Vigo | Completed | No outcome recorded |
| Phase 4 | NCT02177461 Comparator | Apr 2000 → Aug 2002 | hypertensive disorder | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 4 | NCT00295542 Comparator | Mar 2000 → Apr 2009 | hypertensive disorder | University of Vigo | Completed | No outcome recorded |
| — | NCT07568574 Background | Mar 2026 → May 2028 expected | — | Enhanced Emirates Limited | Enrolling by invitation | No outcome recorded |
| — | NCT05479097 Background | Feb → Aug 2023 | hypertensive disorder | University of Wisconsin, Madison | Completed | No outcome recorded |
| — | NCT03526042 Comparator | Sep 2017 → Jul 2019 | atherosclerosis, lupus nephritis | National Institute of Medical Sciences and Nutrition Salvador Zubiran | Unknown | No outcome recorded |
| — | NCT01891292 Comparator | Jul 2013 → Aug 2014 | proteinuria, sickle cell disease | The University of The West Indies | Unknown | No outcome recorded |
| — | NCT01839253 Comparator | Aug 2012 → Mar 2014 | — | Yonsei University | Completed | No outcome recorded |
| — | NCT01015937 Comparator | Mar 2008 → Jun 2009 | diabetic kidney disease, proteinuria | Shaheed Faghihi Hospital | Completed | No outcome recorded |
| — | NCT00292162 Comparator | Jan 2007 → Jul 2009 | atrial fibrillation, heart failure | NHS Greater Glasgow and Clyde | Completed | No outcome recorded |
| — | NCT00684489 Comparator | Sep 2003 → Mar 2005 | essential hypertension | Medical University of South Carolina | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 9
| Date | Issuer | Release |
|---|---|---|
| 2019-09-02 | Novartis Pharmaceuticals | Results Entresto improved measures of heart structure and function in HFrEF patients in new Novartis study; additional data complement findings novartis.com ↗
The study, also presented at ESC Congress 2019, showed that neither Entresto nor enalapril improved the primary endpoint of change in aortic impedance (a measure of vascular stiffness)[2]. |
| 2018-11-11 | Novartis Pharmaceuticals | Results New Novartis study supports Entresto as foundational HFrEF therapy and in-hospital initiation in appropriate stabilized heart failure patients novartis.com ↗
Entresto ® (sacubitril/valsartan) outperformed commonly used heart failure medicine enalapril in landmark study; delivered significantly greater and more rapid reductions in an established biomarker for heart failure severity and prognosis[1] |
| 2018-04-16 | Novartis Pharmaceuticals | Results Novartis announces new analysis demonstrating Entresto helped preserve kidney function in patients with chronic heart failure, especially those with diabetes novartis.com ↗
HFrEF patients treated with Entresto had a slower rate of decline in eGFR than those treated with ACE inhibitor enalapril.[1] |
| 2018-04-04 | Novartis Pharmaceuticals | Results Novartis announces JAMA Cardiology publication of data showing Entresto® improves physical and social activity in HFrEF patients versus enalapril novartis.com ↗
Post-hoc analysis of PARADIGM-HF published in JAMA Cardiology shows heart failure patients treated with Entresto experience significant improvements in physical and social activities compared to those taking enalapril |
| 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] |
| 2016-11-15 | Novartis Pharmaceuticals | Results New analysis of Novartis' Entresto® data shows long-term benefits on heart failure readmissions and total cardiovascular deaths novartis.com ↗
Entresto reduced the risk of first and subsequent events of heart failure hospitalizations and cardiovascular deaths following heart failure hospitalization by 20%-24% compared to enalapril[1] |
| 2016-09-19 | Novartis Pharmaceuticals | Results Important new analysis shows that Novartis' Entresto® is associated with higher relative health-related quality of life scores among HFrEF patients novartis.com ↗
New analysis of PARADIGM-HF data shows that among patients who had been hospitalized for heart failure, those on Entresto reported higher relative health-related quality of life (HRQL) scores compared to those taking ACE inhibitor enalapril[1] |
| 2016-04-21 | Novartis Pharmaceuticals | Results Novartis delivered solid Q1 despite Gleevec loss of exclusivity; investing behind new launches for long-term growth novartis.com ↗
Results from the ATMOSPHERE trial demonstrated no benefit from adding aliskiren, a renin inhibitor, to enalapril. |
| 2000-08-23 | Teva Branded Pharmaceutical Products R&D, Inc. | Regulatory Teva Received Two Approvals:Final Approval for Enalapril to be Shipped Immediately Tentative Approval for Loratadine tevapharm.com ↗
Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA) announced today that it has received from the U.S. FDA final approval to manufacture and market Enalapril Maleate 2.5, 5, 10 and 20mg Tablets. |
All press releases naming this drug 9 releases
Evidence & citations 10 cited values
Every value below carries the sentence it was read from. 134 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Enalapril | “Examples of possible ACE-I drugs include:
benazepril (Lotensin), captopril (Capoten), enalapril (Vasotec, Epaned), fosinopril (Monopril), lisinopril (Prinivil, Zestril),...” NCT01867047 ↗129“In the second week, RAASi will be introduced with either angiotensin converting enzyme inhibitor (ACEi)(Ramipril or Enalapril) or angiotensin receptor neprilisyn inhibitor...” NCT05637853 ↗ “If necessary, the dihydropyridine calcium-channel blocker was combined with or replaced by enalapril maleate (5-20 mg/day), hydrochlorothiazide (12.5-25 mg/day), or both drugs.” NCT02088450 ↗ “We randomized 90 patients with preserved left ventricular ejection fraction (LVEF) after BMT to sacubitril/valsartan, enalapril, or no cardioprotective medication (controls).” PMID 39983618 ↗ Feb 2025 “A combination tablet containing Aspirin 81 mg, enalapril 5 mg (or valsartan 40 mg), atorvastatin 20 mg and hydrochlorothiazide 12.5 mg taken once daily” NCT01271985 ↗ “sirolimus starting at 1 mg/d (target 3-6 ng/ml) plus enalapril starting at 5 mg/d to control blood pressure plus atorvastatin starting at 10 mg/d” NCT00396721 ↗ “RAAS (Lisinopril, Enalapril, Perindopril, Losartan, and Valsartan taken each day at maximum tolerated dose that will different for each subject)” NCT03502031 ↗ “The study recommends physicians to select an ACEi with proven benefit in cardiovascular diseases such as perindopril, ramipril or enalapril.” NCT04591210 ↗ “The polypill comprises hydrochlorothiazide 12.5 mg, aspirin 81 mg, atorvastatin 20 mg, and either enalapril 5 mg or valsartan 40 mg.” PMID 32894967 ↗ Aug 2020 “The combined use of enalapril and folic acid, compared with enalapril alone, significantly reduced the risk of first stroke.” NCT02817503 ↗ “Fixed dose combination therapy - aspirin 81mg, hydrochlorothiazide 12.5mg, enalapril 2.5mg and atorvastatin 20mg Once daily” NCT00603590 ↗ |
| Known as | Corodil | “Initially 5 mg Corodil® 'Enalapril' daily followed by up to 20 mg daily dependent on the blood pressure response” NCT03949075 ↗ |
| Known as | Enalapril "ratiopharm" | “enalapril (Enalapril "ratiopharm") 10mg” NCT06710600 ↗ |
| Known as | enalapril maleate | “The PROACT trial will establish the effectiveness of the ACE inhibitor enalapril maleate (enalapril) in preventing cardiotoxicity in patients with breast cancer and...” PMID 36585130 ↗ Dec 2022 |
| Known as | Epaned | “Examples of possible ACE-I drugs include: benazepril (Lotensin), captopril (Capoten), enalapril (Vasotec, Epaned), fosinopril (Monopril), lisinopril (Prinivil, Zestril),...” NCT01867047 ↗ |
| Known as | Vasotec | “Examples of possible ACE-I drugs include: benazepril (Lotensin), captopril (Capoten), enalapril (Vasotec, Epaned), fosinopril (Monopril), lisinopril (Prinivil, Zestril),...” NCT01867047 ↗ |
| Action | Inhibit | “SOLVD was initiated in 1986 primarily to evaluate the effects of enalapril, an angiotensin-converting enzyme (ACE) inhibitor.” NCT00000516 ↗ |
| Modality | Other / unclassified | “an ACE Inhibitor” NCT03119623 ↗ |
| Route | Oral | “Patients are administered enalapril or placebo by mouth bid.” NCT00003070 ↗ |
| Target | ACE | “SOLVD was initiated in 1986 primarily to evaluate the effects of enalapril, an angiotensin-converting enzyme (ACE) inhibitor.” NCT00000516 ↗ |