CDEK
← All drugs Report issue

lisinopril

Trade name: zestril

Small moleculeapproved

Approved

Dec 29, 1987

Lisinopril is a potent, competitive inhibitor of angiotensin-converting enzyme (ACE). Lisinopril is marketed under the brand name ZESTRIL. ZESTRIL is indicated for the treatment of hypertension. It may be used alone as initial therapy or concomitantly with other classes of antihypertensive agents. It is also indicated as adjunctive therapy in the management of heart failure in patients who are not responding adequately to diuretics and digitalis. Lisinopril inhibits angiotensin-converting enzyme (ACE) in human subjects and animals. ACE is a peptidyl dipeptidase that catalyzes the conversion of angiotensin I to the vasoconstrictor substance, angiotensin II. Angiotensin II also stimulates aldosterone secretion by the adrenal cortex. The beneficial effects of lisinopril in hypertension and heart failure appear to result primarily from suppression of the renin-angiotensin-aldosterone system. Inhibition of ACE results in decreased plasma angiotensin II which leads to decreased vasopressor activity and to decreased aldosterone secretion. While the mechanism through which ZESTRIL lowers blood pressure is believed to be primarily suppression of the renin-angiotensin-aldosterone system, ZESTRIL is antihypertensive even in patients with low-renin hypertension. — NCATS

Clinical trial activity

117 trials · 138 clinical orgs · 37 marketing orgs

Phase 1
28
Phase 2
40
Phase 3
22
Phase 4
25

Earliest trial started Mar 1, 1993 (NCT00311870)

Timeline

1980s

  1. Dec 29, 1987

    Merck — Earliest FDA Approval

  2. Dec 29, 1987

    Merck — NDA Organization

  3. May 19, 1988

    Alvogen — NDA Secondary Org

  4. May 19, 1988

    Alvogen — Marketing Organization

  5. May 19, 1988

    TWi Biotechnology, Inc. — Marketing Organization

1990s

  1. Jan 1, 1993

    Earliest Phase 3 Sponsor(trial)

  2. Jan 1, 1998

    Earliest Phase 2 Sponsor(trial)

  3. Jan 1, 1999

    Earliest Phase 1 Sponsor(trial)

2000s

  1. Jul 1, 2002

    Invatech — Marketing Organization

  2. Jul 1, 2002

    Chartwell Pharmaceuticals — Marketing Organization

  3. Jul 1, 2002

    Epic Pharma Llc — Marketing Organization

  4. Jul 1, 2002

    Graviti Pharmaceuticals — Marketing Organization

  5. Jul 1, 2002

    Strides Pharma Science — Marketing Organization

  6. Jul 1, 2002

    Ascent Pharmahealth — Marketing Organization

  7. Jul 1, 2002

    CASI Pharmaceuticals, Inc. — Marketing Organization

  8. Jul 1, 2002

    Heritage Pharma — Marketing Organization

  9. Jul 1, 2002

    Hikma — Marketing Organization

  10. Jul 1, 2002

    Mylan — Marketing Organization

  11. Jul 1, 2002

    Prinston Inc — Marketing Organization

  12. Jul 1, 2002

    Sandoz — Marketing Organization

  13. Jul 1, 2002

    Sun Pharmaceuticals — Marketing Organization

  14. Jul 1, 2002

    Teva — Marketing Organization

  15. Jul 1, 2002

    Watson Pharmaceuticals — Marketing Organization

  16. Jul 1, 2002

    Pharmgen — Marketing Organization

  17. Jul 1, 2002

    Rising Pharmaceuticals — Marketing Organization

  18. Jul 1, 2002

    Novartis — Marketing Organization

  19. Jul 1, 2002

    AiPing Pharm Inc — Marketing Organization

  20. Jul 1, 2002

    Annora Pharma — Marketing Organization

  21. Jul 1, 2002

    PHARMOBEDIENT — Marketing Organization

  22. Sep 30, 2002

    Apotex — Marketing Organization

  23. Sep 30, 2002

    Corepharma — Marketing Organization

  24. Sep 9, 2005

    Lupin — Marketing Organization

  25. Feb 22, 2006

    Aurobindo Pharma — Marketing Organization

  26. Apr 19, 2007

    Wockhardt — Marketing Organization

  27. Apr 19, 2007

    Atlantide Pharmaceuticals — Marketing Organization

2010s

  1. Jul 30, 2013

    Accord Research — Marketing Organization

  2. Oct 29, 2013

    Invagen Pharms — Marketing Organization

  3. Jul 29, 2016

    Silvergate Pharmaceuticals — NDA Secondary Org

  4. Jul 29, 2016

    Azurity — Marketing Organization

  5. Jul 29, 2016

    Azurity — NDA Secondary Org

  6. May 23, 2017

    Cipla — Marketing Organization

2020s

  1. Sep 15, 2020

    Yiling Pharmaceutical Inc. — Marketing Organization

  2. Sep 15, 2020

    Sciegen Pharmaceticals — Marketing Organization

Indications

Approved for

Studied for

Mechanism of action

Combination products

Approval history

  • approvedDec 29, 1987

Chemistry & pharmacology

Loading structure…

SMILES

N/N=c1\[nH][nH]/c(=N\N)c2ccccc12
Mol. weight
190.21 g/mol
Lipinski Ro5
Pass
Rule of 3
No
Chirality
Achiral Molecule
Inorganic
No
Polymer
No
Availability
Prescription Only

Oral

No

Parenteral

No

Topical

No

Sources

Also known as

  • 6-acetamidocaproic acid
  • 6-acetamidohexanoic acid
  • 6-(acetylamino)hexanoic acid
  • acemin
  • acemin
  • acetaminocaproic acid
  • acexamic acid
  • anhydrous lisinopril
  • calcium acexamate
  • carace
  • carace
  • cy168e
  • dihydralazin
  • dihydralazine
  • dihydralazine
  • dihydralazine
  • dihydralazine
  • dihydralazine
  • dihydralazine
  • dihydralazine
  • dihydralazine
  • dihydralazine sulfate
  • dihydrallazine
  • dihydrazinophthalazine
  • diroton
  • diroton
  • epsilon-acetamidocaproic acid
  • hypopresol
  • linopril
  • lisinopril
  • lisinopril
  • lisinopril
  • lisinopril
  • lisinopril
  • lisinopril
  • lisinopril
  • lisinopril
  • lisinopril
  • lisinopril
  • lisinopril
  • lisinopril anhydrous
  • lisinopril anhydrous
  • lisinopril dihydrate
  • lisinopril hydrate
  • lisinopril hydrate
  • lisinopril hydrate
  • lisinoprilum
  • lisinoprilum
  • lisonopril
  • lisopress
  • mk-521
  • mk-521
  • [n2-[(s)-1-carboxy-3-phenylpropyl]-l-lysyl-l-proline
  • [n2-[(s)-1-carboxy-3-phenylpropyl]-l-lysyl-l-proline
  • nanopril
  • nepresol
  • nepresolin
  • nepressol
  • ophthazin
  • prinivil
  • prinivil
  • prinivil
  • (s)-1-(n(2)-(1-carboxy-3-phenylpropyl)-l-lysyl)-l-proline
  • (s)-1-(n(2)-(1-carboxy-3-phenylpropyl)-l-lysyl)-l-proline
  • sodium acexamate
  • tonolysin
  • zestril
  • zestril
  • zestril
  • zinc acexamate
  • zinc acexamate
  • zinc acexamate
  • zinc acexamate

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT06772779Phase 1Apr 1, 2024Merck
NCT06187493N/AJan 1, 2024Assiut University
NCT05530655Early Phase 1 (Phase 1)Jan 15, 2023Medical College of Wisconsin, University of Rochester
NCT05644769Phase 4Nov 15, 2022Trinity Hypertension & Metabolic Research Institute, Wake Forest University
NCT05230901Phase 3Feb 23, 2022University of Goettingen
NCT05061901Phase 1Oct 6, 2021CRO ClinPharmInvest, Pharmtechnology LLC
NCT05056727Phase 3Sep 30, 2021AstraZeneca, Stanford University
NCT04486118Phase 2Feb 1, 2021Feinstein Institute for Medical Research, Lupus Research Alliance, Northwell Health
NCT04550481Phase 2Jan 1, 2021National Cancer Institute (NCI), Northwestern University
NCT04401267Phase 2Jun 30, 2020National Cancer Institute (NCI), St. Jude Children's Hospital
NCT04190433Phase 2Jan 1, 2020Mayo Clinic
NCT03599466Phase 1Oct 31, 2018Bright Future Pharmaceuticals Factory, Chinese University of Hong Kong
NCT04885660Phase 1Oct 12, 2018Qingdao University
NCT03422705Phase 2Jul 1, 2018University of Leeds
NCT03461003Phase 4Apr 2, 2018University of Texas at Houston
NCT03392740Phase 4Mar 15, 2018Genesys Regional Medical Center
NCT03417388Phase 4Feb 9, 2018Department of Defense, University of Florida
NCT03201939Phase 2Nov 1, 2017Aminu Kano Teaching Hospital, National Cancer Institute (NCI), National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Vanderbilt University
NCT02847338Phase 4Nov 1, 2016Medical Research Council, University of Cambridge
NCT02774460Phase 4Nov 1, 2016Uppsala University
Showing 20 of 117 trials
Page 1 / 6

Organizations

Research & Development (138)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
GlaxoSmithKlineFor profit11842005
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Government8341993
Mayo ClinicAcademic/Hospital6442006
National Cancer Institute (NCI)Government5122010
Accutest Research Laboratories (I) Pvt. Ltd.For profit4012012
IPCA Laboratories Ltd.For profit4412012
NovartisFor profit4422004
Wake Forest UniversityAcademic/Hospital4232009
AstraZenecaFor profit3332005
Emory UniversityAcademic/Hospital3112006
Harvard UniversityAcademic/Hospital3212007
Isfahan UniversityAcademic/Hospital3322006
MerckFor profit3122006
New York UniversityAcademic/Hospital3232008
University of BirminghamAcademic/Hospital3022006
University of MinnesotaAcademic/Hospital3132007
University of PittsburghAcademic/Hospital3122002
University of RochesterAcademic/Hospital3122008
Utrecht UniversityAcademic/Hospital3122010
Aarhus UniversityAcademic/Hospital2222006
138 organizations
Page 1 / 7

Marketing (44)

OrganizationOrg typeRelationshipDate
Accord ResearchFor profitMKTGJul 30, 2013
AiPing Pharm IncFor profitMKTGJul 1, 2002
AlvogenFor profitNDA2May 19, 1988
AlvogenFor profitMKTGMay 19, 1988
AlvogenFor profitSYNMay 19, 1988
Annora PharmaFor profitMKTGJul 1, 2002
ApotexFor profitMKTGSep 30, 2002
ApotexFor profitSYNOct 5, 2004
Ascent PharmahealthFor profitMKTGJul 1, 2002
Atlantide PharmaceuticalsFor profitMKTGApr 19, 2007
Aurobindo PharmaFor profitMKTGFeb 22, 2006
AzurityFor profitMKTGJul 29, 2016
AzurityFor profitNDA2Jul 29, 2016
CASI Pharmaceuticals, Inc.For profitMKTGJul 1, 2002
Chartwell PharmaceuticalsFor profitMKTGJul 1, 2002
CiplaFor profitMKTGMay 23, 2017
CorepharmaFor profitMKTGSep 30, 2002
Epic Pharma LlcFor profitMKTGJul 1, 2002
Epic Pharma LlcFor profitSYNJul 1, 2002
Graviti PharmaceuticalsFor profitMKTGJul 1, 2002
Heritage PharmaFor profitMKTGJul 1, 2002
HikmaFor profitMKTGJul 1, 2002
Invagen PharmsFor profitMKTGOct 29, 2013
InvatechFor profitMKTGJul 1, 2002
LupinFor profitMKTGSep 9, 2005
MerckFor profitNDADec 29, 1987
MylanFor profitMKTGJul 1, 2002
NovartisFor profitMKTGJul 1, 2002
PHARMOBEDIENTFor profitMKTGJul 1, 2002
PharmgenFor profitMKTGJul 1, 2002
Prinston IncFor profitMKTGJul 1, 2002
Rising PharmaceuticalsFor profitMKTGJul 1, 2002
SandozFor profitMKTGJul 1, 2002
Sciegen PharmaceticalsFor profitMKTGSep 15, 2020
Silvergate PharmaceuticalsFor profitNDA2Jul 29, 2016
Strides Pharma ScienceFor profitMKTGJul 1, 2002
Sun PharmaceuticalsFor profitMKTGJul 1, 2002
TWi Biotechnology, Inc.For profitMKTGMay 19, 1988
TevaFor profitMKTGJul 1, 2002
Watson PharmaceuticalsFor profitMKTGJul 1, 2002
WockhardtFor profitSYNApr 19, 2007
WockhardtFor profitMKTGApr 19, 2007
Yiling Pharmaceutical Inc.For profitMKTGSep 15, 2020
Yiling Pharmaceutical Inc.For profitSYNSep 15, 2020