Benazepril
/ Benazepril, Benazepril, Benazepril /, Lotensin, Lotrel (benazepril) is a small molecule pharmaceutical. Benazepril was first approved as Lotensin on 1991-06-25. It is used to treat diabetic nephropathies, heart failure, hypertension, and left ventricular dysfunction in the USA. The pharmaceutical is active against angiotensin-converting enzyme.
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Commercial
Therapeutic Areas
Trade Name
FDA
EMA
Benazepril, Lotensin (discontinued: Benazepril, Lotensin)
CombinationsAmlodipine besylate benazepril, Benazepril hydrochlorothiazide, Lotensin, Lotrel (discontinued: Amlodipine besylate benazepril, Benazepril hydrochlorothiazide, Lotensin)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Benazepril hydrochloride
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| LOTENSIN | Validus Pharmaceuticals | N-019851 RX | 1991-06-25 | 3 products, RLD |
Show 1 discontinued
Benazepril hydrochloride
+
Hydrochlorothiazide
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| LOTENSIN HCT | Validus Pharmaceuticals | N-020033 RX | 1992-05-19 | 3 products, RLD |
Show 1 discontinued
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| amlobenz | ANDA | 2010-04-09 |
| amlodipine and benazepril hydrochloride | ANDA | 2024-10-30 |
| amlodipine and benazepril hydrochloride amlodipine besylate | ANDA | 2021-08-10 |
| amlodipine besylate | ANDA | 2021-01-12 |
| amlodipine besylate and benazepril hcl | ANDA | 2010-03-19 |
| amlodipine besylate and benazepril hydrochloride | ANDA | 2024-09-26 |
| benazepril | ANDA | 2019-01-15 |
| benazepril benazepril hydrochloride | ANDA | 2021-09-20 |
| benazepril hcl | ANDA | 2016-06-23 |
| benazepril hydrochloride | ANDA | 2024-10-14 |
Show 4 more
Indications
FDA
EMA
Agency Specific
FDA
EMA
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Patent Expiration
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ATC Codes
C: Cardiovascular system drugs
— C09: Agents acting on the renin-angiotensin system
— C09A: Ace inhibitors, plain
— C09AA: Ace inhibitors, plain
— C09AA07: Benazepril
— C09B: Ace inhibitors, combinations
— C09BA: Ace inhibitors and diuretics
— C09BA07: Benazepril and diuretics
— C09BB: Ace inhibitors and calcium channel blockers
— C09BB13: Benazepril and amlodipine
HCPCS
No data
Clinical
Clinical Trials
54 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Hypertension | D006973 | EFO_0000537 | I10 | — | 1 | 4 | 11 | 3 | 19 |
| Diabetes mellitus | D003920 | HP_0000819 | E08-E13 | — | — | 3 | 5 | — | 8 |
| Albuminuria | D000419 | EFO_0004285 | R80.9 | — | — | — | 2 | 1 | 3 |
| Type 2 diabetes mellitus | D003924 | EFO_0001360 | E11 | — | — | 1 | 2 | — | 3 |
| Proteinuria | D011507 | HP_0000093 | R80 | — | 1 | — | 1 | 1 | 3 |
| Covid-19 | D000086382 | — | — | — | — | — | 1 | 1 | 2 |
| Hypotension | D007022 | EFO_0005251 | I95 | — | — | — | 1 | 1 | 2 |
| Coronavirus infections | D018352 | EFO_0007224 | B34.2 | — | — | — | 1 | — | 1 |
| Cardiomyopathies | D009202 | EFO_0000318 | I42 | — | — | — | 1 | — | 1 |
| Dilated cardiomyopathy | D002311 | HP_0001644 | I42.0 | — | — | — | 1 | — | 1 |
Show 4 more
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Atherosclerosis | D050197 | EFO_0003914 | I25.1 | — | — | 1 | — | 1 | 2 |
| Cardiovascular diseases | D002318 | HP_0001626 | — | — | — | 1 | — | — | 1 |
| Hypercholesterolemia | D006937 | HP_0003124 | — | — | — | 1 | — | — | 1 |
| Coronary disease | D003327 | — | — | — | — | 1 | — | — | 1 |
| Essential hypertension | D000075222 | — | I10 | — | — | 1 | — | — | 1 |
| Pre-eclampsia | D011225 | EFO_0000668 | O14 | — | — | 1 | — | — | 1 |
| Renal replacement therapy | D017582 | — | — | — | — | 1 | — | — | 1 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Stroke | D020521 | EFO_0000712 | I63.9 | — | 1 | — | — | 2 | 3 |
| Iga vasculitis | D011695 | EFO_1000965 | D69.0 | 1 | 3 | — | — | — | 3 |
| Purpura | D011693 | HP_0000979 | D69.2 | 1 | 3 | — | — | — | 3 |
| Nephritis | D009393 | — | N05 | 1 | 3 | — | — | — | 3 |
| Hereditary nephritis | D009394 | EFO_0004128 | Q87.81 | — | 2 | — | — | — | 2 |
| Syndrome | D013577 | — | — | — | 2 | — | — | — | 2 |
| Ischemic stroke | D000083242 | — | — | — | 1 | — | — | 1 | 2 |
| Neoplasms | D009369 | — | C80 | — | 1 | — | — | — | 1 |
| Systemic lupus erythematosus | D008180 | HP_0002725 | M32 | — | 1 | — | — | — | 1 |
| Blood pressure | D001794 | EFO_0004325 | — | — | 1 | — | — | — | 1 |
Show 4 more
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Healthy volunteers/patients | — | — | — | 9 | — | — | — | 2 | 11 |
| Malnutrition | D044342 | EFO_0008572 | E40-E46 | 2 | — | — | — | — | 2 |
| Fasting | D005215 | EFO_0002756 | — | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Chronic renal insufficiency | D051436 | — | N18 | — | — | — | — | 3 | 3 |
| Renal insufficiency | D051437 | HP_0000083 | N19 | — | — | — | — | 3 | 3 |
| Disease progression | D018450 | — | — | — | — | — | — | 1 | 1 |
| Drug dose-response relationship | D004305 | — | — | — | — | — | — | 1 | 1 |
| Transient ischemic attack | D002546 | EFO_0003764 | G45.9 | — | — | — | — | 1 | 1 |
| Pathologic constriction | D003251 | — | — | — | — | — | — | 1 | 1 |
| Stents | D015607 | — | — | — | — | — | — | 1 | 1 |
| Chronic kidney failure | D007676 | EFO_0003884 | N18.9 | — | — | — | — | 1 | 1 |
| Obesity | D009765 | EFO_0001073 | E66.9 | — | — | — | — | 1 | 1 |
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Benazepril |
| INN | benazepril |
| Description | Benazepril is a benzazepine that is benazeprilat in which the carboxy group of the 2-amino-4-phenylbutanoic acid moiety has been converted to the corresponding ethyl ester. It is used (generally as its hydrochloride salt) as a prodrug for the angiotensin-converting enzyme inhibitor benazeprilat in the treatment of hypertension and heart failure. It has a role as an EC 3.4.15.1 (peptidyl-dipeptidase A) inhibitor and a prodrug. It is a benzazepine, a dicarboxylic acid monoester, an ethyl ester and a lactam. It is functionally related to a benazeprilat. It is a conjugate base of a benazepril(1+). |
| Classification | Small molecule |
| Drug class | antihypertensives (ACE inhibitors) |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | CCOC(=O)[C@H](CCc1ccccc1)N[C@H]1CCc2ccccc2N(CC(=O)O)C1=O |
Identifiers
| PDB | — |
| CAS-ID | 86541-75-5 |
| RxCUI | — |
| ChEMBL ID | CHEMBL838 |
| ChEBI ID | 3011 |
| PubChem CID | 5362124 |
| DrugBank | DB00542 |
| UNII ID | UDM7Q7QWP8 (ChemIDplus, GSRS) |
Target
Agency Approved
ACE
ACE
Organism
Homo sapiens
Gene name
ACE
Gene synonyms
DCP, DCP1
NCBI Gene ID
Protein name
angiotensin-converting enzyme
Protein synonyms
angiotensin I converting enzyme (peptidyl-dipeptidase A) 1, carboxycathepsin, CD143, CD143 antigen, dipeptidyl carboxypeptidase 1, Dipeptidyl carboxypeptidase I, Kininase II, peptidase P
Uniprot ID
Mouse ortholog
Ace (11421)
angiotensin-converting enzyme (P09470)
Alternate
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Variants
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Financial
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Estimated US medical usage
Benazepril
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Amlodipine
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Benazepril
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Benazepril
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Hydrochlorothiazide
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Trends
PubMed Central
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Safety
Black-box Warning
Black-box warning for: Amlobenz, Amlodipine and benazepril hydrochloride, Amlodipine besylate and benazepril hcl, Amlodipine besylate and benazepril hydrochloride, Benazepril hydrochloride, Benazepril hydrochloride and hydrochlorothiazide, Lotensin, Lotensin hct, Lotrel
Adverse Events
Top Adverse Reactions
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4,512 adverse events reported
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