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
Lotensin (generic drugs available since 2004-02-11)
CombinationsLotensin, Lotrel (generic drugs available since 2004-02-11)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Amlodipine besylate
+
Benazepril hydrochloride
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 | 2024-01-08 |
| 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 | 2024-01-29 |
| benazepril | ANDA | 2019-01-15 |
| benazepril benazepril hydrochloride | ANDA | 2021-09-20 |
| benazepril hcl | ANDA | 2016-06-23 |
| benazepril hydrochloride | ANDA | 2024-01-15 |
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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 |
| Covid-19 | D000086382 | — | U07.1 | — | — | — | 1 | 1 | 2 |
| Diabetes mellitus | D003920 | HP_0000819 | E08-E13 | — | — | 1 | 1 | — | 2 |
| Albuminuria | D000419 | EFO_0004285 | R80.9 | — | — | — | 2 | — | 2 |
| Type 2 diabetes mellitus | D003924 | EFO_0001360 | E11 | — | — | 1 | 1 | — | 2 |
| Proteinuria | D011507 | HP_0000093 | R80 | — | — | — | 1 | 1 | 2 |
| Hypotension | D007022 | EFO_0005251 | I95 | — | — | — | 1 | 1 | 2 |
| Dilated cardiomyopathy | D002311 | HP_0001644 | I42.0 | — | — | — | 1 | — | 1 |
| Diabetic nephropathies | D003928 | EFO_0000401 | — | — | — | — | 1 | — | 1 |
| Left ventricular hypertrophy | D017379 | EFO_0003896 | — | — | — | — | 1 | — | 1 |
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 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Iga vasculitis | D011695 | EFO_1000965 | D69.0 | 1 | 3 | — | — | — | 3 |
| Hereditary nephritis | D009394 | EFO_0004128 | Q87.81 | — | 2 | — | — | — | 2 |
| Neoplasms | D009369 | — | C80 | — | 1 | — | — | — | 1 |
| Systemic lupus erythematosus | D008180 | HP_0002725 | M32 | — | 1 | — | — | — | 1 |
| Ischemic stroke | D000083242 | — | — | — | 1 | — | — | — | 1 |
| Blood pressure | D001794 | EFO_0004325 | — | — | 1 | — | — | — | 1 |
| Individuation | D007207 | — | — | — | 1 | — | — | — | 1 |
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Healthy volunteers/patients | — | — | — | 9 | — | — | — | 2 | 11 |
| 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 | — | — | — | — | 2 | 2 |
| Stroke | D020521 | EFO_0000712 | I63.9 | — | — | — | — | 2 | 2 |
| 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 | N18.6 | — | — | — | — | 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
No data
Variants
No data
Financial
Revenue by drug
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Estimated US medical usage
Benazepril
+
Amlodipine
Total medical expenditures per year (USD, in millions)
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Price per prescription (USD)
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Benazepril
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Benazepril
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Hydrochlorothiazide
Total medical expenditures per year (USD, in millions)
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Number of persons purchased
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Number of purchases
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Trends
PubMed Central
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Additional graphs summarizing 3,295 documents
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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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4,101 adverse events reported
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