Overview
Benazepril, brand name Lotensin, is a medication used to treat high blood pressure (hypertension), congestive heart failure, and chronic renal failure. Upon cleavage of its ester group by the liver, benazepril is converted into its active form benazeprilat, a non-sulfhydryl angiotensin-converting enzyme (ACE) inhibitor.
Indication
Benazepril is indicated for the treatment of hypertension. It may be used alone or in combination with thiazide diuretics.
Associated Conditions
- Diabetic Nephropathy
- Heart Failure
- Hypertension
- Non-diabetic Nephropathy
Research Report
Published: Sep 6, 2025
A Comprehensive Monograph on Benazepril (DrugBank ID: DB00542)
Section 1: Drug Profile and Chemical Characteristics
Benazepril is a second-generation angiotensin-converting enzyme (ACE) inhibitor widely utilized in cardiovascular medicine. A thorough understanding of its chemical identity, physicochemical properties, and available formulations is fundamental to appreciating its pharmacological behavior and clinical application.
1.1 Identification and Nomenclature
To ensure unambiguous identification across global databases and regulatory frameworks, Benazepril is cataloged under multiple identifiers.
- Generic Name: The universally recognized generic name is Benazepril.[1] International non-proprietary names include the French Bénazépril and the Latin Benazeprilum.[1]
- Systematic Chemical Name: According to IUPAC nomenclature, the compound is named (3S)-3-amino]-2,3,4,5-tetrahydro-2-oxo-1H-1-benzazepine-1-acetic acid hydrochloride.[2] An alternate chemical name is 2-amino]-2-oxo-4,5-dihydro-3H-1-benzazepin-1-yl]acetic acid.[3]
- Database and Registry Identifiers: The drug is assigned unique codes in various scientific and regulatory databases, including:
- DrugBank ID: DB00542 [1]
- CAS Numbers: A distinction is made between the active moiety and its pharmaceutically relevant salt form. The CAS number for the benazepril free base is 86541-75-5 [4], while the clinically utilized benazepril hydrochloride salt is identified by CAS number 86541-74-4.[2]
- Other Identifiers: Additional identifiers include UNII PX47FSF9B3, ChEBI ID CHEBI:3011, ChEMBL ID CHEMBL838, and the research code CGS-14824A.[1]
1.2 Physicochemical Properties
The molecular structure and physical properties of benazepril govern its absorption, distribution, and interaction with its biological target.
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2021/06/24 | Phase 2 | Recruiting | |||
2020/07/24 | Phase 2 | Active, not recruiting | |||
2018/07/19 | Phase 1 | UNKNOWN | Henan University of Traditional Chinese Medicine | ||
2013/08/06 | Phase 4 | Completed | Xijing Hospital | ||
2012/05/23 | Phase 4 | Completed | Hospital Universitario Pedro Ernesto | ||
2010/11/04 | Phase 2 | Terminated | |||
2010/03/30 | Phase 3 | Completed | |||
2009/05/22 | Not Applicable | Completed | |||
2009/02/04 | Phase 1 | Completed | |||
2009/02/04 | Phase 1 | Completed |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Amneal Pharmaceuticals LLC | 65162-751 | ORAL | 5 mg in 1 1 | 2/18/2019 | |
| A-S Medication Solutions | 50090-5137 | ORAL | 20 mg in 1 1 | 2/20/2020 | |
| Amneal Pharmaceuticals of New York LLC | 53746-751 | ORAL | 5 mg in 1 1 | 9/1/2021 | |
| Carilion Materials Management | 68151-1363 | ORAL | 10 mg in 1 1 | 6/26/2013 | |
| Zydus Lifesciences Limited | 70771-1151 | ORAL | 40 mg in 1 1 | 11/5/2022 | |
| PD-Rx Pharmaceuticals, Inc. | 72789-502 | ORAL | 20 mg in 1 1 | 5/7/2025 | |
| Physicians Total Care, Inc. | 54868-5783 | ORAL | 40 mg in 1 1 | 3/2/2012 | |
| RPK Pharmaceuticals, Inc. | 53002-1802 | ORAL | 40 mg in 1 1 | 12/23/2022 | |
| NuCare Pharmaceuticals,Inc. | 68071-4890 | ORAL | 40 mg in 1 1 | 2/17/2021 | |
| Northwind Pharmaceuticals, LLC | 51655-617 | ORAL | 40 mg in 1 1 | 1/1/2024 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
| No EMA approvals found for this drug. | |||
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No HSA approvals found for this drug. | |||||
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| No NMPA approvals found for this drug. | |||||
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| No TGA approvals found for this drug. | |||||
Health Canada Drug Approvals
Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
|---|---|---|---|---|---|
| LOTENSIN 10MG | novartis pharmaceuticals canada inc | 00885843 | Tablet - Oral | 10 MG | 12/31/1993 |
| BENAZEPRIL | aa pharma inc | 02273918 | Tablet - Oral | 20 MG | 3/24/2006 |
| LOTENSIN 5MG | novartis pharmaceuticals canada inc | 00885835 | Tablet - Oral | 5 MG | 12/31/1993 |
| PMS-BENAZEPRIL | 02231548 | Tablet - Oral | 5 MG | N/A | |
| BENAZEPRIL | aa pharma inc | 02290340 | Tablet - Oral | 10 MG | 5/15/2007 |
| LOTENSIN 20MG | novartis pharmaceuticals canada inc | 00885851 | Tablet - Oral | 20 MG | 12/31/1993 |
| PMS-BENAZEPRIL | 02231551 | Tablet - Oral | 20 MG | N/A | |
| PMS-BENAZEPRIL | 02231550 | Tablet - Oral | 10 MG | N/A |
CIMA AEMPS Drug Approvals
Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
|---|---|---|---|---|---|
| No CIMA AEMPS (Spain) approvals found for this drug. | |||||
Philippines FDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Philippines FDA approvals found for this drug. | |||||
Saudi SFDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Saudi SFDA approvals found for this drug. | |||||
Malaysia NPRA Drug Approvals
Approved Product | Company | Registration Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Malaysia NPRA approvals found for this drug. | |||||
UK EMC Drug Information
Medicine Name | MA Holder | MA Number | Pharmaceutical Form | Active Ingredient | Authorization Date |
|---|---|---|---|---|---|
| No UK EMC drug information found for this drug. | |||||
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