Drugs / Benazepril
Benazepril
Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansion | US (FDA) | LOTENSIN | — | 2004-03-02 | fda.gov ↗ |
| Approved | US (FDA) | LOTENSIN | — | 1991-06-25 | fda.gov ↗ |
Trials 28
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 18 trials · 1 met primary | ||||||
| Phase 1 | NCT00649519 | May 2004 | — | Mylan Pharmaceuticals Inc | Completed | No outcome recorded |
| Phase 1 | NCT00649402 | May → Jun 2004 | — | Mylan Pharmaceuticals Inc | Completed | No outcome recorded |
| Phase 1 | NCT00834977 | Apr → May 2004 | — | Teva Pharmaceuticals USA | Completed | No outcome recorded |
| Phase 1 | NCT00835367 | Mar 2004 | — | Teva Pharmaceuticals USA | Completed | Met primary |
| Phase 1 | NCT00649038 | Dec 2002 | — | Mylan Pharmaceuticals Inc | Completed | No outcome recorded |
| Phase 1 | NCT00649597 | Nov → Dec 2002 | — | Mylan Pharmaceuticals Inc | Completed | No outcome recorded |
| Phase 1 | NCT00836537 | Mar 2001 | — | Teva Pharmaceuticals USA | Completed | No outcome recorded |
| Phase 1 | NCT00836576 | Feb → Mar 2001 | — | Teva Pharmaceuticals USA | Completed | No outcome recorded |
| Phase 22 trials | ||||||
| Phase 2 | NCT01234922 | Feb 2011 → Dec 2013 | cancer of unknown primary site, hypertensive disorder | Wake Forest University Health Sciences | Terminated | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT00309257 | Jan 2004 → Jun 2008 | Alport syndrome | Mario Negri Institute for Pharmacological Research | Completed | No outcome recorded |
| Phase 35 trials · 1 met primary | ||||||
| Phase 3 | NCT01095939 | Apr 2010 → Dec 2015 | — | University Hospital, Geneva | Completed | No outcome recorded |
| Phase 3 | NCT00503152 | May 2007 → Jul 2016 | type 2 diabetes mellitus | Mario Negri Institute for Pharmacological Research | Completed | No outcome recorded |
| Phase 3 | NCT00494715 | May 2007 → Apr 2016 | type 2 diabetes mellitus | Mario Negri Institute for Pharmacological Research | Completed | No outcome recorded |
| Phase 3 | NCT00171366 | Jul 2004 → Jul 2005 | hypertensive disorder | Novartis | Completed | No outcome recorded |
| Phase 3 | NCT00170950 | Oct 2003 → Jan 2008 | hypertensive disorder | Novartis | Terminated | Met primary |
| Phase 48 trials · 3 met primary · 1 missed | ||||||
| Phase 4 | NCT01669434 | Jun 2015 → Nov 2016 | — | University of Nebraska | Completed | Met primary |
| Phase 4 | NCT01375322 | Jun 2007 → Jun 2010 | hypertensive disorder, proteinuria, type 2 diabetes mellitus | TSH Biopharm Corporation Limited | Completed | Met primary |
| Phase 4 | NCT00185120 | Sep 2005 → Sep 2006 | hypertensive disorder | Daiichi Sankyo | Completed | No outcome recorded |
| Phase 4 | NCT01917149 | Mar 2005 → Jul 2013 | dilated cardiomyopathy | Xijing Hospital | Completed | Met primary |
| Phase 4 | NCT00136851 | Dec 2004 → Jul 2005 | hypertensive disorder | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 4 | NCT00139555 | Jul 2004 → Nov 2006 | hypertensive disorder, hypertensive heart disease | Novartis | Completed | Missed primary |
| Phase 4 | NCT00136773 | Apr 2003 → Oct 2005 | proteinuria | Novartis | Completed | No outcome recorded |
| Phase 4 | NCT00367978 | Dec 2001 → Sep 2003 | hypertensive disorder | Novartis | Completed | No outcome recorded |
| Phase not applicable5 trials · 1 met primary · 1 missed | ||||||
| — | NCT01867047 | Jun 2013 → Jun 2016 | hypotensive disorder | Duke University | Terminated | Missed primary |
| — | NCT00721773 | Sep 2008 → Oct 2014 | impaired renal function disease | Sun Yat-sen University | Completed | No outcome recorded |
| — | NCT00907374 | Jul 2005 → Apr 2009 | proteinuria | Charles Drew University of Medicine and Science | Completed | No outcome recorded |
| — | NCT00338091 | Jan 2002 → May 2006 | chronic kidney disease, proteinuria | Southern Medical University, China | Terminated | No outcome recorded |
| — | NCT00270426 | — | chronic renal failure syndrome | Southern Medical University, China | Terminated | Met primary |
| Comparator or background therapy15 trials | ||||||
| Phase 1/2 | NCT03591471 Comparator | Sep 2014 → Dec 2018 | immunoglobulin A vasculitis | Henan University of Traditional Chinese Medicine | Unknown | No outcome recorded |
| Phase 2 | NCT05670028 Background | Jun 2023 → Jan 2026 | ischemic stroke, vascular insufficiency disorder | Beijing Tiantan Hospital | Unknown | No outcome recorded |
| Phase 2 | NCT04486118 Comparator | Oct 2021 → Jun 2025 overdue | systemic lupus erythematosus | Northwell Health | Active not recruiting | No outcome recorded |
| Phase 2 | NCT04937907 Background | Sep 2021 → Dec 2024 | X-linked Alport syndrome | Shanghai Children's Hospital | Completed | No outcome recorded |
| Phase 3 | NCT00367094 Background | Jul 2006 → ? | essential hypertension | Novartis | Completed | No outcome recorded |
| Phase 3 | NCT00000620 Background | Sep 1999 → Jun 2009 | atherosclerosis, coronary artery disorder, hyperlipoproteinemia, hypertensive disorder +1 | National Heart, Lung, and Blood Institute (NHLBI) | Completed | Missed primary |
| 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 | NCT04330300 Comparator | Apr 2020 → Jul 2021 | COVID-19, essential hypertension | National University of Ireland, Galway, Ireland | Suspended | No outcome recorded Stop: Business |
| Phase 4 | NCT03682692 Background | Jun 2018 → Jun 2021 | hypertensive disorder | Shanghai Jiao Tong University School of Medicine | Completed | Missed primary |
| Phase 4 | NCT01603940 Comparator | May 2012 → Jan 2015 | hypertensive disorder, type 2 diabetes mellitus | Hospital Universitario Pedro Ernesto | Completed | No outcome recorded |
| Phase 4 | NCT00234871 Comparator | Jan 2004 → Mar 2005 | diabetes mellitus, hypertensive disorder, proteinuria | Abbott | Completed | No outcome recorded |
| — | NCT00691314 Comparator | Jun 2008 → Sep 2010 | atherosclerosis, transient ischemic attack | Peking Union Medical College Hospital | Completed | No outcome recorded |
| — | NCT00664846 Background | Apr 2008 → Dec 2010 | ischemic stroke | Peking Union Medical College Hospital | Completed | No outcome recorded |
| — | NCT00630708 Comparator | Feb 2008 → Mar 2014 | chronic kidney disease | Nanfang Hospital, Southern Medical University | Terminated | 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 · 4
| Date | Issuer | Release |
|---|---|---|
| 2007-05-20 | Teva Branded Pharmaceutical Products R&D, Inc. | Regulatory Teva Provides Update On Generic Lotrel ® tevapharm.com ↗
the U. S. Food and Drug Administration granted to Teva final approval of its amlodipine besylate/ benazepril products |
| 2006-07-12 | Teva Branded Pharmaceutical Products R&D, Inc. | Regulatory Teva Announces Tentative Approval of Generic Lotrel® tevapharm.com ↗
Teva Pharm aceutical Industries Ltd.(Nasdaq:TEVA) announced today that the U.S.Food and Drug Administration has granted tentative approval for the Company's Abbreviated New Drug Application (ANDA) |
| 2004-02-11 | Teva Branded Pharmaceutical Products R&D, Inc. | Regulatory Teva Announces Final Approval Of Benazepril Hcl Tablets, 5 Mg, 10 Mg, 20 Mg, And 40 Mg tevapharm.com ↗
Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA) announced today that the U.S. Food and Drug Administration has granted final approval for the Company's ANDA for Benazepril Hydrochloride Tablets, 5 mg, 10 mg, 20 mg and 40 mg. |
| 2003-11-07 | Teva Branded Pharmaceutical Products R&D, Inc. | Regulatory Teva Announces Tentative Approval Of Benazepril Hcl Tablets, 5 Mg, 10 Mg, 20 Mg, And 40 Mg tevapharm.com ↗
Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA) announced today that the U.S. Food and Drug Administration has granted tentative approval for the company's ANDA for Benazepril Hydrochloride Tablets, 5 mg, 10 mg, 20 mg and 40 mg. |
All press releases naming this drug 4 releases
| Date | Issuer | Release |
|---|---|---|
| 2007-05-20 | Teva Branded Pharmaceutical Products R&D, Inc. | Teva Provides Update On Generic Lotrel ® tevapharm.com ↗ |
| 2006-07-12 | Teva Branded Pharmaceutical Products R&D, Inc. | Teva Announces Tentative Approval of Generic Lotrel® tevapharm.com ↗ |
| 2004-02-11 | Teva Branded Pharmaceutical Products R&D, Inc. | Teva Announces Final Approval Of Benazepril Hcl Tablets, 5 Mg, 10 Mg, 20 Mg, And 40 Mg tevapharm.com ↗ |
| 2003-11-07 | Teva Branded Pharmaceutical Products R&D, Inc. | Teva Announces Tentative Approval Of Benazepril Hcl Tablets, 5 Mg, 10 Mg, 20 Mg, And 40 Mg tevapharm.com ↗ |
Evidence & citations 8 cited values
Every value below carries the sentence it was read from. 44 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Benazepril | “Examples of possible ACE-I drugs include:
benazepril (Lotensin), captopril (Capoten), enalapril (Vasotec, Epaned), fosinopril (Monopril), lisinopril (Prinivil, Zestril),...” NCT01867047 ↗40“To manipulate the blood pressure within a certain range with hypotensive drugs (e.g. nifedipine, benidipine, captopril, benazepril, irbesartan, labetalol, urapidil) and/or...” NCT05670028 ↗ “During the run-in period, all patients take benazepril 10 mg daily, and have an office visit every two weeks.” NCT03682692 ↗ “Benazepril, captopril, enalapril, fosinopril, lisinopril, perindopril, quinapril, ramipril, trandolapril” NCT04330300 ↗ “antihypertension agents:Amlodipine 5mg/day or Benazepril 10mg/day” NCT00664846 ↗ “antihypertension agents:Amlodipine 5mg/day or Benazepril 10mg/day” NCT00691314 ↗ “carvedilol, labetalol, benazepril, captopril, enalapril” NCT00684489 ↗ “benazepril (Lotensin, Zestril, Altace)” NCT00000620 ↗ “benazepril” NCT01669434 ↗ |
| Known as | benazepril (Lotensin, Zestril, Altace) | “benazepril (Lotensin, Zestril, Altace)” NCT00000620 ↗ |
| Known as | Benazepril HCl | “The objective of this study was to investigate the bioequivalence of Mylan benazepril HCl and hydrochlorothiazide 20 mg/25 mg to Novartis Lotensin HCT® 20 mg/25 mg combination...” NCT00649597 ↗4“Benazepril HCl and Hydrochlorothiazide Tablets 20 mg/25 mg” NCT00649038 ↗ “Amlodipine and Benazepril HCl Capsules 10 mg/20 mg” NCT00649402 ↗ “Amlodipine and Benazepril HCl Capsules 10 mg/20 mg” NCT00649519 ↗ “Benazepril HCl 40 mg Tablets” NCT00836537 ↗ |
| Known as | Benazepril hydrochloride | “This study will compare the relative bioavailability (rate and extent of absorption) of 40 mg Benazepril Hydrochloride Tablets by TEVA Pharmaceuticals Industries, Ltd. with...” NCT00836537 ↗3“amlodipine besylate/benazepril hydrochloride” NCT00136851 ↗ “Drug: Benazepril hydrochloride” NCT01095939 ↗ |
| Known as | Benazepril hydrochloride (HCl) | “Benazepril hydrochloride (HCl)/amlodipine besylate 10/5 mg capsules for oral administration once daily.” NCT00170950 ↗ |
| Known as | Lotensin | “This study will compare the relative bioavailability (rate and extent of absorption) of 40 mg Benazepril Hydrochloride Tablets by TEVA Pharmaceuticals Industries, Ltd. with...” NCT00836537 ↗3“Examples of possible ACE-I drugs include: benazepril (Lotensin), captopril (Capoten), enalapril (Vasotec, Epaned), fosinopril (Monopril), lisinopril (Prinivil, Zestril),...” NCT01867047 ↗ “commercially available benazepril HCl (Lotensin®, Novartis Pharmaceuticals Corporation)” NCT00836576 ↗ |
| Action | Inhibit | “an angiotensin-converting-enzyme (ACE) inhibitor” PMID 19052124 ↗ Dec 2008 |
| Route | Oral | “Benazepril hydrochloride (HCl)/amlodipine besylate 10/5 mg capsules for oral administration once daily.” NCT00170950 ↗ |