Overview
Ramipril is a prodrug belonging to the angiotensin-converting enzyme (ACE) inhibitor class of medications. It is metabolized to ramiprilat in the liver and, to a lesser extent, kidneys. Ramiprilat is a potent, competitive inhibitor of ACE, the enzyme responsible for the conversion of angiotensin I (ATI) to angiotensin II (ATII). ATII regulates blood pressure and is a key component of the renin-angiotensin-aldosterone system (RAAS). Ramipril may be used in the treatment of hypertension, congestive heart failure, nephropathy, and to reduce the rate of death, myocardial infarction and stroke in individuals at high risk of cardiovascular events.
Indication
For the management of mild to severe hypertension. May be used to reduce cardiovascular mortality following myocardial infarction in hemodynamically stable individuals who develop clinical signs of congestive heart failure within a few days following myocardial infarction. To reduce the rate of death, myocardial infarction and stroke in individuals at high risk of cardiovascular events. May be used to slow the progression of renal disease in individuals with hypertension, diabetes mellitus and microalubinuria or overt nephropathy.
Associated Conditions
- Cardiovascular Events
- Diabetic Nephropathy
- Heart Failure
- Hearth Failure With Reduced Ejection Fraction (HFrEF)
- Hypertension
- Myocardial Infarction
- Nondiabetic proteinuric chronic kidney disease
- Stroke
- High risk cardiovascular event
Research Report
An Expert Report on the Pharmacological and Clinical Profile of Ramipril (DB00178)
Introduction and Drug Profile
Executive Summary
Ramipril is a long-acting, small-molecule medication that holds a cornerstone position in modern cardiovascular pharmacotherapy.[1] It belongs to the angiotensin-converting enzyme (ACE) inhibitor class of drugs and functions as an inactive prodrug, which undergoes metabolic activation in the body to yield its potent active form, ramiprilat.[1] The therapeutic efficacy of ramipril is rooted in its ability to modulate the renin-angiotensin-aldosterone system (RAAS), a critical physiological pathway that regulates blood pressure and fluid balance.[5] By inhibiting ACE, ramipril effectively reduces the production of angiotensin II, a powerful vasoconstrictor, and prevents the degradation of bradykinin, a vasodilator, thereby lowering blood pressure and reducing cardiac workload.[5]
The clinical applications of ramipril are extensive and well-established. It is indicated for the management of hypertension, the treatment of heart failure following myocardial infarction, and the management of diabetic kidney disease.[1] Perhaps its most significant contribution to clinical practice stems from landmark evidence demonstrating its efficacy in the broad secondary prevention of major cardiovascular events. Ramipril is proven to reduce the rate of death, myocardial infarction, and stroke in a wide range of high-risk individuals, a role that extends beyond its blood-pressure-lowering effects.[1] Ramipril is available by prescription only and is marketed globally under various trade names, with Altace being one of the most widely recognized.[7]
Therapeutic Classification and Role
Ramipril is formally classified based on its mechanism and clinical use:
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
---|---|---|---|---|---|
2025/06/15 | Phase 2 | Completed | National Heart Institute, Egypt | ||
2024/08/20 | Phase 4 | Recruiting | Vastra Gotaland Region | ||
2024/03/12 | Phase 1 | Not yet recruiting | Arab Contractors Medical Centre | ||
2023/10/27 | Phase 4 | Completed | |||
2023/05/09 | Phase 3 | Completed | |||
2023/01/17 | Phase 1 | Completed | |||
2024/12/16 | Phase 3 | Recruiting | |||
2022/06/29 | Phase 1 | Completed | |||
2021/11/24 | Not Applicable | Not yet recruiting | |||
2020/10/09 | Phase 2 | Completed |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
---|---|---|---|---|---|
Zydus Pharmaceuticals USA Inc. | 68382-144 | ORAL | 1.25 mg in 1 1 | 11/7/2023 | |
Zydus Pharmaceuticals USA Inc. | 68382-145 | ORAL | 2.5 mg in 1 1 | 11/7/2023 | |
Accord Healthcare Inc. | 16729-154 | ORAL | 5 mg in 1 1 | 5/14/2021 | |
Chartwell RX, LLC. | 62135-271 | ORAL | 1.25 mg in 1 1 | 11/3/2023 | |
BluePoint Laboratories | 68001-431 | ORAL | 10 mg in 1 1 | 9/17/2021 | |
St. Mary's Medical Park Pharmacy | 60760-571 | ORAL | 10 mg in 1 1 | 3/26/2019 | |
A-S Medication Solutions | 50090-3873 | ORAL | 2.5 mg in 1 1 | 9/13/2019 | |
REMEDYREPACK INC. | 70518-3038 | ORAL | 10 mg in 1 1 | 3/11/2024 | |
Camber Pharmaceuticals | 31722-271 | ORAL | 1.25 mg in 1 1 | 8/26/2011 | |
Exelan Pharmaceuticals, Inc. | 76282-673 | ORAL | 10 mg in 1 1 | 10/1/2021 |
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 |
---|---|---|---|---|---|
TRITACE 5 TABLET 5 mg | SIN09592P | TABLET | 5 mg | 12/22/1997 | |
TRITACE 2.5 TABLET 2.5 mg | SIN09591P | TABLET | 2.5 mg | 12/22/1997 | |
TRINOMIA HARD CAPSULES 100mg/ 20mg/ 10mg | SIN15646P | CAPSULE | 10mg | 3/19/2019 | |
TRINOMIA HARD CAPSULES 100mg/ 20mg/ 5mg | SIN15648P | CAPSULE | 5mg | 3/19/2019 | |
TRINOMIA HARD CAPSULES 100mg/ 20mg/ 2.5mg | SIN15647P | CAPSULE | 2.5mg | 3/19/2019 |
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 |
---|---|---|---|---|---|
TRIASYN 5.0/5.0 tablet blister pack | 67183 | Medicine | A | 12/18/1998 | |
RAMIPRIL WINTHROP ramipril 10mg capsule hard blister pack | 128853 | Medicine | A | 10/31/2006 | |
RAMIPRIL AN ramipril 10 mg capsule bottle | 203704 | Medicine | A | 8/14/2013 | |
APX-RAMIPRIL ramipril 10 mg capsule bottle | 343102 | Medicine | A | 10/12/2020 | |
RAMIPRIL-WGR ramipril 10 mg capsule bottle | 343107 | Medicine | A | 10/12/2020 | |
AURO-RAMIPRIL CAPS 5 ramipril 5 mg capsule blister pack | 203710 | Medicine | A | 8/14/2013 | |
TRYZAN CAPS 1.25 ramipril 1.25mg capsules blister pack | 127085 | Medicine | A | 6/28/2007 | |
RAMIPRIL AN ramipril 1.25 mg capsule bottle | 203701 | Medicine | A | 8/14/2013 | |
TRYZAN CAPS 5 ramipril 5mg capsules blister pack | 127152 | Medicine | A | 6/28/2007 | |
APOTEX-RAMIPRIL ramipril 2.5mg capsule blister pack | 179018 | Medicine | A | 9/27/2011 |
Health Canada Drug Approvals
Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
---|---|---|---|---|---|
RAMIPRIL-HCTZ | PRO DOC LIMITEE | 02415909 | Tablet - Oral | 10 MG | 11/28/2013 |
PRIVA-RAMIPRIL | pharmapar inc | 02483440 | Capsule - Oral | 15 MG | N/A |
APO-RAMIPRIL | 02251574 | Capsule - Oral | 5 MG | 12/12/2006 | |
MAR-RAMIPRIL | marcan pharmaceuticals inc | 02420481 | Capsule - Oral | 10.0 MG | 1/9/2015 |
MAR-RAMIPRIL | marcan pharmaceuticals inc | 02420473 | Capsule - Oral | 5.0 MG | 1/9/2015 |
ACH-RAMIPRIL | 02439808 | Capsule - Oral | 5 MG | N/A | |
ALTACE PLUS FELODIPINE 5MG + 5MG | sanofi-aventis canada inc | 02240306 | Tablet - Oral | 5 MG | 6/27/2006 |
APO-RAMIPRIL/HCTZ | 02354039 | Tablet - Oral | 10 MG | N/A | |
TEVA-RAMIPRIL | teva canada limited | 02247945 | Capsule - Oral | 2.5 MG | 5/2/2007 |
TEVA-RAMIPRIL | teva canada limited | 02306654 | Capsule - Oral | 15 MG | N/A |
CIMA AEMPS Drug Approvals
Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
---|---|---|---|---|---|
RAMIPRIL ARISTO 5 mg COMPRIMIDOS EFG | Aristo Pharma Iberia S.L. | 67879 | COMPRIMIDO | Medicamento Sujeto A Prescripción Médica. Tratamiento De Larga Duración | Not Commercialized |
RAMIPRIL TARBIS 5 mg COMPRIMIDOS EFG | Tarbis Farma S.L. | 73532 | COMPRIMIDO | Medicamento Sujeto A Prescripción Médica. Tratamiento De Larga Duración | Commercialized |
AMLODIPINO/RAMIPRIL ARISTO 10 MG/5 MG CAPSULAS DURAS | 82689 | CÁPSULA DURA | Medicamento Sujeto A Prescripción Médica | Commercialized | |
RAMIPRIL NORMON 5 mg COMPRIMIDOS EFG | Laboratorios Normon S.A. | 68275 | COMPRIMIDO | Medicamento Sujeto A Prescripción Médica. Tratamiento De Larga Duración | Commercialized |
RAMIPRIL COMBIX 10 mg COMPRIMIDOS EFG | Laboratorios Combix S.L.U. | 73787 | COMPRIMIDO | Medicamento Sujeto A Prescripción Médica. Tratamiento De Larga Duración | Not Commercialized |
RAMIPRIL SANDOZ 5 mg COMPRIMIDOS EFG | Sandoz Farmaceutica S.A. | 65825 | COMPRIMIDO | Medicamento Sujeto A Prescripción Médica. Tratamiento De Larga Duración | Commercialized |
RABIDUX 2,5 MG/2,5 MG CAPSULAS DURAS | Adamed Laboratorios S.L.U. | 87203 | CÁPSULA DURA | Medicamento Sujeto A Prescripción Médica | Commercialized |
RAMIPRIL KRKA 2,5 MG COMPRIMIDOS EFG | Krka D.D. Novo Mesto | 80774 | COMPRIMIDO | Medicamento Sujeto A Prescripción Médica. Tratamiento De Larga Duración | Commercialized |
RAMIPRIL RATIOPHARM 10 mg COMPRIMIDOS | Teva Pharma S.L.U. | 66448 | COMPRIMIDO | Medicamento Sujeto A Prescripción Médica. Tratamiento De Larga Duración | Commercialized |
TRICUAL 20 MG/5 MG/10 MG COMPRIMIDOS | Laboratorios Bial S.A. | 89882 | COMPRIMIDO | Medicamento Sujeto A Prescripción Médica | Not Commercialized |
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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