Drugs / Quinapril

Regulatory milestones approvals, filings & regulatory actions · 2 recorded

MilestoneJurisdictionBrandIndicationDateSentence it was read from
Label expansion US (FDA) ACCUPRIL — 1993-10-29 fda.gov ↗
Approved US (FDA) ACCUPRIL — 1991-11-19 fda.gov ↗

Trials 14

PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 14 trials
Phase 1 NCT00648011 Aug 2003 — Mylan Pharmaceuticals Inc Completed No outcome recorded
Phase 1 NCT00649441 Aug → Sep 2003 — Mylan Pharmaceuticals Inc Completed No outcome recorded
Phase 1 NCT00649649 Dec 2002 — Mylan Pharmaceuticals Inc Completed No outcome recorded
Phase 1 NCT00649103 Dec 2002 — Mylan Pharmaceuticals Inc Completed No outcome recorded
Phase 48 trials · 1 met primary
Phase 4 NCT05713396 Jan 2017 → Jun 2022 diabetes mellitus AHEPA University Hospital Completed 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 NCT00313547 Apr 2006 → Apr 2007 hypertensive disorder Montreal Heart Institute Terminated No outcome recorded Stop: Enrollment
Phase 4 NCT00147524 Oct 2003 → May 2005 hypertensive disorder Pfizer Completed No outcome recorded
Phase 4 NCT00188188 Mar 2002 → ? systemic lupus erythematosus University Health Network, Toronto Unknown No outcome recorded
Phase 4 NCT00269243 Nov 1999 → May 2005 — Montreal Heart Institute Completed No outcome recorded
Phase 4 NCT03031834 Jan 1999 → May 2001 diabetic autonomic neuropathy Aristotle University Of Thessaloniki Completed No outcome recorded
Phase not applicable2 trials · 1 missed
— NCT01867047 Jun 2013 → Jun 2016 hypotensive disorder Duke University Terminated Missed primary
— NCT00154050 May 2004 → Jul 2006 peripheral arterial disease Technical University Dresden Completed No outcome recorded
Comparator or background therapy10 trials
Phase 3 NCT01581476 Comparator Jan 2009 → Apr 2017 type 1 diabetes mellitus University of Cambridge 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 NCT04330300 Comparator Apr 2020 → Jul 2021 COVID-19, essential hypertension National University of Ireland, Galway, Ireland Suspended No outcome recorded Stop: Business
Phase 4 NCT00438113 Comparator Dec 2009 → Sep 2016 atrial fibrillation Nova Scotia Health Authority Completed 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

News releases announcing trial results or a regulatory action · 4

DateIssuerRelease
2009-06-19 Sun Pharmaceutical Industries, Inc. Regulatory Sun Pharma announces USFDA approval for generic Accupril® tablets sunpharma.com ↗
Sun Pharma announces USFDA approval for generic Accupril® tablets
2007-08-27 Teva Branded Pharmaceutical Products R&D, Inc. Regulatory Teva Announces Approval Of Generic Accupril® Tablets tevapharm.com ↗
the U.S. Food and Drug Administration has granted final approval
2003-06-02 Teva Branded Pharmaceutical Products R&D, Inc. Regulatory Teva Announces Final Approval for Quinapril Hydrochloride Tablets tevapharm.com ↗
Jerusalem, Israel, June 2, 2003 - 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 Quinapril HCl Tablets, 5 mg, 10 mg, 20 mg and 40 mg.
2002-02-11 Teva Branded Pharmaceutical Products R&D, Inc. Regulatory Teva Announces Tentative Approval for Quinapril HCl Tablets tevapharm.com ↗
Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA) announced today that the U.S. Food and Drug Administration (FDA) has granted tentative approval for Quinapril HCL 5, 10, 20 and 40 mg tablets.

All press releases naming this drug 6 releases

DateIssuerRelease

Evidence & citations 15 cited values

Every value below carries the sentence it was read from. 25 sources stand behind the page.

FieldValueCited text
Known as Quinapril “Examples of possible ACE-I drugs include: benazepril (Lotensin), captopril (Capoten), enalapril (Vasotec, Epaned), fosinopril (Monopril), lisinopril (Prinivil, Zestril),...” NCT01867047 ↗
21

“We will then attempt to reverse abnormalities in endothelial function and myocardial perfusion by therapy with an ACE inhibitor(Quinapril).” NCT00188188 ↗

“Benazepril, captopril, enalapril, fosinopril, lisinopril, perindopril, quinapril, ramipril, trandolapril” NCT04330300 ↗

“moexipril, perindopril, quinapril, ramipril, trandolapril” NCT00684489 ↗

“Quinapril 40mg/d” NCT02817360 ↗

“Quinapril” NCT01581476 ↗

“Quinapril” NCT00741585 ↗

“quinapril” NCT01669434 ↗

NCT00649649 ↗

NCT00313547 ↗

NCT00649103 ↗

Show 11 more sources

Known as Accupril “Examples of possible ACE-I drugs include: benazepril (Lotensin), captopril (Capoten), enalapril (Vasotec, Epaned), fosinopril (Monopril), lisinopril (Prinivil, Zestril),...” NCT01867047 ↗
2

“Step 1 - Accupril, titrated to maximum tolerated dose, beginning at 20 mg po od followed by 40 mg successively Step 2 - combination of Accupril with Hydrochlorothiazide 12.5 mg po od.” NCT00438113 ↗

NCT07547878 ↗

Known as Accupro ChEMBL registry synonym — accepted as the source's own label CHEMBL1592 ↗
Known as C09AA06 ChEMBL registry synonym — accepted as the source's own label CHEMBL1592 ↗
Known as CI 906 ChEMBL registry synonym — accepted as the source's own label CHEMBL1592 ↗
Known as NSC-758222 ChEMBL registry synonym — accepted as the source's own label CHEMBL1592 ↗
Known as Quinapril HCl “Quinapril HCl and Hydrochlorothiazide Tablets 20 mg/25 mg” NCT00648011 ↗
Known as Quinapril Hydrochloride “Quinapril Hydrochloride Tablets 40 mg” NCT00649103 ↗
1

“Quinapril Hydrochloride Tablets 40 mg” NCT00649649 ↗

Known as Quinapril hydrochloride component of accuretic ChEMBL registry synonym — accepted as the source's own label CHEMBL1592 ↗
Known as Quinapril hydrochloride component of quinaretic ChEMBL registry synonym — accepted as the source's own label CHEMBL1592 ↗
Known as Quinil ChEMBL registry synonym — accepted as the source's own label CHEMBL1592 ↗
Action Inhibit “Quinapril is an effective and well-tolerated ACE-I” NCT00147524 ↗
Modality Small molecule — CHEMBL1592 ↗
Route Oral “Medication A(oral Quinapril or Placebo)” NCT00188188 ↗
Target ACE “These effects are mediated through the binding of quinaprilat to both tissue and plasma-ACE.” NCT00147524 ↗