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
Also used as a comparator or background therapy in 69 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 01 trial | ||||||
| Phase 0 | NCT02879721 Comparator | Oct 2009 → Dec 2012 | Barrett esophagus | Göteborg University | Completed | No outcome recorded |
| Phase 12 trials | ||||||
| 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 1/21 trial | ||||||
| Phase 1/2 | NCT01624064 Comparator | Aug → Oct 2012 | chronic kidney disease | Ministry of Health, Sri Lanka | Unknown | No outcome recorded |
| Phase 28 trials | ||||||
| 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 | No outcome recorded |
| 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 2/33 trials | ||||||
| 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 316 trials | ||||||
| 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 | No outcome recorded |
| Phase 3 | NCT02900378 Comparator | Dec 2016 → Apr 2018 | congestive heart failure | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 3 | NCT02468232 Comparator | Jun 2015 → Feb 2019 | systolic heart failure | Novartis Pharmaceuticals | Completed | No outcome recorded |
| 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 | No outcome recorded |
| Phase 3 | NCT01035255 Comparator | Dec 2009 → May 2014 | symptomatic heart failure | Novartis Pharmaceuticals | Terminated | No outcome recorded |
| Phase 3 | NCT00568178 Comparator | Jun 2007 → Sep 2008 | proteinuria | Organon and Co | Completed | No outcome recorded |
| 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 |
| 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 430 trials | ||||||
| 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 |
| 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 | No outcome recorded |
| 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 | No outcome recorded |
| Phase 4 | NCT03119623 Comparator | Jun 2017 → Aug 2019 | symptomatic heart failure | Brigham and Women's Hospital | Withdrawn | No outcome recorded |
| 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 | No outcome recorded |
| Phase 4 | NCT02874794 Comparator | Aug 2016 → Dec 2018 | heart failure | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 4 | NCT02768298 Comparator | Jul 2016 → Nov 2019 | symptomatic heart failure | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 4 | NCT02554890 Comparator | Apr 2016 → Jun 2018 | heart failure | Novartis Pharmaceuticals | Completed | No outcome recorded |
| 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 | No outcome recorded |
| 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 |
| Phase not applicable8 trials | ||||||
| — | 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 |
Press releases naming this drug 2 releases
| Date | Issuer | Release |
|---|---|---|
| 2018-04-04 | Novartis Pharmaceuticals | Novartis announces JAMA Cardiology publication of data showing Entresto® improves physical and social activity in HFrEF patients versus enalapril novartis.com ↗ |
| 2000-08-23 | Teva Branded Pharmaceutical Products R&D, Inc. | Teva Received Two Approvals:Final Approval for Enalapril to be Shipped Immediately Tentative Approval for Loratadine tevapharm.com ↗ |
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 ↗ “Benazepril, captopril, enalapril, fosinopril, lisinopril, perindopril, quinapril, ramipril, trandolapril” NCT04330300 ↗ “All patients received enalapril (up-titrated to 20 mg BID) and spironolactone (25 mg QD).” NCT01557140 ↗ “prescription of antihypertensives (amlodipine and/or losartan OR enalapril)” NCT05479097 ↗ “ACE inhibitor: enalapril, lisinopril, ramipril, captopril or trandolapril” NCT07513883 ↗ “enalapril: 10 mg bid→5 mg bid→2,5 mg bid→1,25 mg bid→stop” NCT02200822 ↗ “benazepril, captopril, enalapril, fosinopril, lisinopril” NCT00684489 ↗ “Other Name: Enalapril, Lorsartan, Prednisolone” NCT02571842 ↗ “enalapril (Enalapril "ratiopharm") 10mg” NCT06710600 ↗ “Captopril or enalapril” NCT04345406 ↗ “Enalapril 40mg/d” NCT02817360 ↗ “enalapril” NCT01669434 ↗ “Enalapril” NCT01839253 ↗ “Enalapril” NCT00741585 ↗ “Enalapril” NCT02735707 ↗ “Enalapril” NCT05232370 ↗ “enalapril” NCT01015937 ↗ |
| 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 ↗ |