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benazepril

Trade name: lotensin

Small moleculeapproved

Approved

Jun 25, 1991

Benazepril is a prodrug which is metabolized by the liver into its active form benazeprilat via cleavage of the drug's ester group. Benazepril and Benazeprilat inhibit angiotensin-converting enzyme (ACE) in human subjects and animals. Benazeprilat has much greater ACE inhibitory activity than does Benazepril. It is indicated for the treatment of hypertension. It may be used alone or in combination with thiazide diuretics. Adverse reactions reported in controlled clinical trials and rarer events seen in post-marketing experience, include the following: Stevens-Johnson syndrome, pemphigus, apparent hypersensitivity reactions (manifested by dermatitis, pruritus, or rash), photosensitivity, and flushing, nausea, pancreatitis, constipation, gastritis, vomiting, and melena, thrombocytopenia and hemolytic anemia, anxiety, decreased libido, hypertonia, insomnia, nervousness, and paresthesia. Patients on diuretics, especially those in whom diuretic therapy was recently instituted, may occasionally experience an excessive reduction of blood pressure after initiation of therapy with Benazepril. Increased serum lithium levels and symptoms of lithium toxicity have been reported in patients receiving ACE inhibitors (including benazepril) during therapy with lithium. — NCATS

Clinical trial activity

43 trials · 49 clinical orgs · 31 marketing orgs

Phase 1
13
Phase 2
13
Phase 3
7
Phase 4
11

Earliest trial started Sep 1, 1999 (NCT00000620)

Timeline

1990s

  1. Jun 25, 1991

    Earliest FDA Approval

  2. Jun 25, 1991

    Validus Pharmaceuticals — NDA Secondary Org

  3. Mar 3, 1995

    Novartis — Marketing Organization

  4. Mar 3, 1995

    Novartis — NDA Secondary Org

  5. Jan 1, 1999

    Earliest Phase 3 Sponsor(trial)

2000s

  1. Jan 1, 2001

    Teva — Earliest Phase 1 Sponsor(trial)

  2. Jan 1, 2004

    Earliest Phase 2 Sponsor(trial)

  3. Feb 11, 2004

    Chartwell Pharmaceuticals — Marketing Organization

  4. Feb 11, 2004

    Ani Pharmaceuticals — Marketing Organization

  5. Feb 11, 2004

    Actavis — Marketing Organization

  6. Feb 11, 2004

    CASI Pharmaceuticals, Inc. — Marketing Organization

  7. Feb 11, 2004

    Genpharm — Marketing Organization

  8. Feb 11, 2004

    Heritage Pharma — Marketing Organization

  9. Feb 11, 2004

    Teva — Marketing Organization

  10. Feb 11, 2004

    Mylan — Marketing Organization

  11. Feb 11, 2004

    Prinston Inc — Marketing Organization

  12. Feb 11, 2004

    Sandoz — Marketing Organization

  13. Feb 11, 2004

    Sun Pharmaceuticals — Marketing Organization

  14. Feb 11, 2004

    Rising Pharmaceuticals — Marketing Organization

  15. Feb 11, 2004

    Medarex — Marketing Organization

  16. Feb 3, 2006

    Amneal Pharmaceuticals — Marketing Organization

  17. Mar 8, 2006

    Corepharma — Marketing Organization

  18. Mar 8, 2006

    Annora Pharma — Marketing Organization

  19. Mar 8, 2006

    Apotex — Marketing Organization

  20. Mar 8, 2006

    Impax Laboratories — Marketing Organization

  21. Sep 15, 2006

    Dr. Reddy's Laboratories — NDA Secondary Org

  22. May 22, 2008

    Aurobindo Pharma — Marketing Organization

  23. May 23, 2008

    Cadila Healthcare — Marketing Organization

2010s

  1. Feb 5, 2010

    Lupin — Marketing Organization

  2. Apr 15, 2010

    Dr. Reddy's Laboratories — Marketing Organization

  3. Jul 29, 2010

    Par Pharmaceuticals — Marketing Organization

  4. Jul 29, 2010

    Strides Pharma Science — Marketing Organization

  5. Oct 14, 2010

    Watson Pharmaceuticals — Marketing Organization

  6. Jul 5, 2011

    PHARMOBEDIENT — Marketing Organization

  7. Mar 28, 2013

    Zydus Discovery DMCC — Marketing Organization

  8. Dec 7, 2018

    Cipla — Marketing Organization

Indications

Approved for

Studied for

Mechanism of action

Combination products

Approval history

  • approvedJun 25, 1991

Chemistry & pharmacology

Loading structure…

SMILES

CCOC(=O)[C@H](CCc1ccccc1)N[C@H]1CCc2ccccc2N(CC(=O)O)C1=O
Mol. weight
424.5 g/mol
Lipinski Ro5
Pass
Rule of 3
No
Chirality
Single Stereoisomer
Inorganic
No
Polymer
No
Delivery
Oral
Availability
Prescription Only

Oral

Yes

Parenteral

No

Topical

No

Black box warningProdrug

Sources

Also known as

  • 1h-1-benzazepine-1-acetic acid, 3-((1-(ethoxycarbonyl)-3-phenylpropyl)amino)-2,3,4,5-tetrahydro-2-oxo-, (s-(r*,r*))-
  • benazapril
  • benazepril
  • benazepril
  • benazepril
  • benazepril
  • benazepril
  • benazepril
  • benazepril
  • benazepril
  • benazepril
  • benazepril
  • benazepril hcl
  • benazepril hcl
  • benazepril hcl
  • benazepril hydrochloride
  • benazepril hydrochloride
  • benazepril hydrochloride
  • benazepril hydrochloride
  • benazepril hydrochloride
  • benazepril hydrochloride
  • benazeprilum
  • benazeprilum
  • benzazepril
  • briem
  • cgs-14824a
  • cgs-14824a
  • cgs-14824a
  • cgs-14824-a
  • cgs-14824a hcl
  • cgs-14824a hcl
  • cibacen
  • cibacen
  • cibacen
  • cibacen
  • cibacène
  • labopal
  • lotensin
  • lotensin
  • lotensin
  • lotensin
  • lotensin
  • lotrel

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT04937907Phase 2Sep 8, 2021Jiao Tong University
NCT04486118Phase 2Feb 1, 2021Feinstein Institute for Medical Research, Lupus Research Alliance, Northwell Health
NCT03682692Phase 4Jun 1, 2018Jiao Tong University
NCT02532777Phase 2Aug 1, 2015Nanjing Medical University
NCT01669434Phase 4Jun 1, 2015University of Nebraska
NCT03591471Phase 1/Phase 2 (Phase 2)Sep 30, 2014Chengdu University of Traditional Chinese Medicines, Fudan University, Henan University of Traditional Chinese Medicine, Jiao Tong University, Peking University, Yunnan University of Traditional Chinese Medicine
NCT01603940Phase 4May 1, 2012Rio de Janeiro State University
NCT01234922Phase 2Feb 1, 2011Wake Forest University
NCT01095939Phase 3Apr 1, 2010University of Geneva
NCT00721773N/ASep 1, 2008Anhui Medical University, Central South University, Guangxi Medical University, Guangzhou Medical University, Huazhong University of Science and Technology, Peking University, Shenzhen University, Sichuan University, Sun Yat-Sen University, Tsinghua University
NCT00630708N/AFeb 1, 2008Southern Medical University
NCT01375322Phase 4Jun 1, 2007Taichung Veterans General Hospital, TSH Biopharm Corporation Limited
NCT00503152Phase 3May 1, 2007Agenzia Italiana del Farmaco, Mario Negri Institute
NCT00494715Phase 3May 1, 2007Agenzia Italiana del Farmaco, Mario Negri Institute
NCT01505998Phase 1Mar 1, 2007Dr. Reddy's Laboratories, Vimta Labs Ltd.
NCT01506011Phase 1Mar 1, 2007Dr. Reddy's Laboratories, Vimta Labs Ltd.
NCT00367094Phase 3Jul 1, 2006Novartis
NCT00270426N/ADec 23, 2005Southern Medical University
NCT00185120Phase 4Sep 1, 2005Daiichi Sankyo
NCT00907374N/AJul 1, 2005Charles Drew University
Showing 20 of 43 trials
Page 1 / 3

Organizations

Research & Development (49)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
NovartisFor profit7722001
Dr. Reddy's LaboratoriesFor profit4412004
MylanFor profit4412002
PRACSFor profit4012001
TevaFor profit4412001
Jiao Tong UniversityAcademic/Hospital3222014
Mario Negri InstituteAcademic/Hospital3322004
Southern Medical UniversityAcademic/Hospital3312002
Agenzia Italiana del FarmacoGovernment2012007
Kendle International Inc.For profit2012004
MDS PharmaFor profit2012004
Peking UniversityAcademic/Hospital2022008
RanbaxyFor profit2212004
SFBC AnapharmFor profit2012004
Vimta Labs Ltd.For profit2012007
Wake Forest UniversityAcademic/Hospital2121999
AbbottFor profit1112004
Anhui Medical UniversityAcademic/Hospital1012008
Centers for Disease Control and Prevention (CDC)Government1011999
Central South UniversityAcademic/Hospital1012008
49 organizations
Page 1 / 3

Marketing (48)

OrganizationOrg typeRelationshipDate
ActavisFor profitMKTGFeb 11, 2004
Amneal PharmaceuticalsFor profitMKTGFeb 3, 2006
Amneal PharmaceuticalsFor profitSYNDec 7, 2018
Ani PharmaceuticalsFor profitMKTGFeb 11, 2004
Ani PharmaceuticalsFor profitSYNFeb 11, 2004
Annora PharmaFor profitMKTGMar 8, 2006
ApotexFor profitSYNMar 8, 2006
ApotexFor profitMKTGMar 8, 2006
Aurobindo PharmaFor profitMKTGMay 22, 2008
Aurobindo PharmaFor profitSYNSep 5, 2012
Aurobindo PharmaFor profitMKTGFeb 11, 2004
CASI Pharmaceuticals, Inc.For profitMKTGFeb 11, 2004
Cadila HealthcareFor profitMKTGMay 23, 2008
Chartwell PharmaceuticalsFor profitMKTGFeb 11, 2004
Ciba-GeigyFor profitNDA—
CiplaFor profitMKTGDec 7, 2018
CorepharmaFor profitMKTGMar 8, 2006
Dr. Reddy's LaboratoriesFor profitMKTGApr 15, 2010
Dr. Reddy's LaboratoriesFor profitSYNSep 15, 2006
Dr. Reddy's LaboratoriesFor profitNDA2Sep 15, 2006
GenpharmFor profitMKTGFeb 11, 2004
Heritage PharmaFor profitMKTGFeb 11, 2004
Heritage PharmaFor profitSYNDec 30, 2013
Impax LaboratoriesFor profitMKTGMar 8, 2006
LupinFor profitMKTGFeb 5, 2010
MedarexFor profitMKTGFeb 11, 2004
MylanFor profitMKTGFeb 11, 2004
MylanFor profitSYNFeb 11, 2004
NovartisFor profitMKTGMar 3, 1995
NovartisFor profitNDA2Mar 3, 1995
PHARMOBEDIENTFor profitMKTGJul 5, 2011
Par PharmaceuticalsFor profitMKTGJul 29, 2010
Prinston IncFor profitMKTGFeb 11, 2004
Rising PharmaceuticalsFor profitSYNFeb 11, 2004
Rising PharmaceuticalsFor profitMKTGFeb 11, 2004
SandozFor profitMKTGFeb 11, 2004
Strides Pharma ScienceFor profitMKTGJul 29, 2010
Sun PharmaceuticalsFor profitMKTGFeb 11, 2004
TevaFor profitMKTGFeb 11, 2004
TevaFor profitSYNFeb 11, 2004
TevaFor profitSYNMay 18, 2007
Validus PharmaceuticalsFor profitSYNJun 25, 1991
Validus PharmaceuticalsFor profitNDA2Jun 25, 1991
Watson PharmaceuticalsFor profitMKTGOct 14, 2010
Watson PharmaceuticalsFor profitSYNJul 5, 2011
Zydus Discovery DMCCFor profitSYNMay 23, 2008
Zydus Discovery DMCCFor profitMKTGMar 28, 2013
Zydus Discovery DMCCFor profitSYNMay 23, 2008