Drugs / Fosinopril
Fosinopril
also known as
Monopril · C09AA09 · Fosenopril · Fosenopril sodium · fosinopril or Newace · FOSINOPRIL SODIUM · Fosinopril sodium component of monopril hct · Fosinopril sodium salt · +4 more
Small molecule targets ACE via inhibition
Regulatory milestones approvals, filings & regulatory actions · 3 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansions (2) | US (FDA) | MONOPRIL | — | 1995-05-02 – 2003-05-27 | fda.gov ↗ |
| Approved | US (FDA) | MONOPRIL | — | 1991-05-16 | fda.gov ↗ |
Trials 5
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 21 trial | ||||||
| Phase 2 | NCT00051389 | Feb 2002 → Jan 2007 | heart disorder, hypertensive disorder | National Heart, Lung, and Blood Institute (NHLBI) | Completed | No outcome recorded |
| Phase 31 trial | ||||||
| Phase 3 | NCT03073018 | Apr 1998 → Jun 2003 | cardiovascular disorder, proteinuria | University Medical Center Groningen | Completed | No outcome recorded |
| Phase 42 trials · 1 met primary | ||||||
| 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 not applicable1 trial · 1 missed | ||||||
| — | NCT01867047 | Jun 2013 → Jun 2016 | hypotensive disorder | Duke University | Terminated | Missed primary |
| Comparator or background therapy8 trials | ||||||
| Phase 2 | NCT00315016 Comparator | Jan 2007 → Jul 2011 | diabetic kidney disease | Radboud University Medical Center | 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 | NCT02646397 Background | Feb 2016 → Dec 2017 | chronic kidney disease | Shanghai Changzheng Hospital | Unknown | No outcome recorded |
| Phase 4 | NCT01014338 Comparator | Oct 2009 → Sep 2012 | chronic obstructive pulmonary disease | Imperial College London | Completed | No outcome recorded |
| — | NCT01342614 Comparator | May 2006 → Aug 2009 | diabetes mellitus, essential hypertension | China-Japan Friendship Hospital | Completed | No outcome recorded |
| — | NCT00565396 Comparator | Sep 2004 → Jul 2008 | chronic kidney disease, proteinuria | Shanghai Municipal Health Bureau | Unknown | 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 · 2
| Date | Issuer | Release |
|---|---|---|
| 2003-11-25 | Teva Branded Pharmaceutical Products R&D, Inc. | Regulatory Teva Announces Approval of Fosinopril Sodium Tablets 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 of the company's ANDA for Fosinopril Sodium Tablets, 10 mg, 20 mg and 40 mg. |
| 2003-07-10 | Teva Branded Pharmaceutical Products R&D, Inc. | Regulatory Teva Announces Tentative Approval of Fosinopril Sodium Tablets tevapharm.com ↗
Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA) announced today that the U. S. Food and Drug Administration has granted tentative approval of the company's ANDA for Fosinopril Sodium Tablets, 10 mg, 20 mg and 40 mg. |
All press releases naming this drug 4 releases
| Date | Issuer | Release |
|---|---|---|
| 2013-02-13 | Sobi, Inc. | Sobi gains distribution rights for Megace®, Monopril®, Cefzil® and Duricef® from PharmaSwiss sobi.com ↗ |
| 2003-11-25 | Teva Branded Pharmaceutical Products R&D, Inc. | Teva Announces Approval of Fosinopril Sodium Tablets 10 Mg, 20 Mg, And 40 Mg tevapharm.com ↗ |
| 2003-10-27 | Teva Branded Pharmaceutical Products R&D, Inc. | Teva Receives Favorable Court Ruling On Fosinopril Sodium Tablets tevapharm.com ↗ |
| 2003-07-10 | Teva Branded Pharmaceutical Products R&D, Inc. | Teva Announces Tentative Approval of Fosinopril Sodium Tablets tevapharm.com ↗ |
Evidence & citations 17 cited values
Every value below carries the sentence it was read from. 14 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | fosinopril | “Examples of possible ACE-I drugs include:
benazepril (Lotensin), captopril (Capoten), enalapril (Vasotec, Epaned), fosinopril (Monopril), lisinopril (Prinivil, Zestril),...” NCT01867047 ↗11“Benazepril, captopril, enalapril, fosinopril, lisinopril, perindopril, quinapril, ramipril, trandolapril” NCT04330300 ↗ “enalapril, fosinopril, lisinopril, moexipril, perindopril” NCT00684489 ↗ “Fosinopril 40mg/d” NCT02817360 ↗ “fosinopril” NCT01669434 ↗ |
| Known as | C09AA09 | ChEMBL registry synonym — accepted as the source's own label CHEMBL3039598 ↗ |
| Known as | Fosenopril | ChEMBL registry synonym — accepted as the source's own label CHEMBL3039598 ↗ |
| Known as | Fosenopril sodium | ChEMBL registry synonym — accepted as the source's own label CHEMBL3039598 ↗ |
| Known as | fosinopril or Newace | “fosinopril or Newace” NCT00315016 ↗ |
| Known as | FOSINOPRIL SODIUM | ChEMBL registry synonym — accepted as the source's own label CHEMBL3039598 ↗ |
| Known as | Fosinopril sodium component of monopril hct | ChEMBL registry synonym — accepted as the source's own label CHEMBL3039598 ↗ |
| Known as | Fosinopril sodium salt | ChEMBL registry synonym — accepted as the source's own label CHEMBL3039598 ↗ |
| Known as | Fositens | ChEMBL registry synonym — accepted as the source's own label CHEMBL3039598 ↗ |
| Known as | Fozitec | ChEMBL registry synonym — accepted as the source's own label CHEMBL3039598 ↗ |
| Known as | Monopril | “Examples of possible ACE-I drugs include: benazepril (Lotensin), captopril (Capoten), enalapril (Vasotec, Epaned), fosinopril (Monopril), lisinopril (Prinivil, Zestril),...” NCT01867047 ↗ |
| Known as | SQ 28555 | ChEMBL registry synonym — accepted as the source's own label CHEMBL3039598 ↗ |
| Known as | Staril | ChEMBL registry synonym — accepted as the source's own label CHEMBL3039598 ↗ |
| Action | Inhibit | “ACE inhibition” NCT00051389 ↗ |
| Modality | Small molecule | — CHEMBL3039598 ↗ |
| Route | Oral | “Fosinopril 10mg/day(oral)” NCT00565396 ↗ |
| Target | ACE | “ACE inhibition” NCT00051389 ↗ |