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
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Title | Posted | Study ID | Phase | Status | Sponsor |
---|---|---|---|---|---|
2018/02/22 | N/A | Recruiting | |||
2018/01/30 | Phase 1 | Completed | |||
2017/06/28 | Phase 4 | UNKNOWN | |||
2017/04/04 | Phase 4 | Completed | |||
2017/01/05 | Phase 4 | Completed | |||
2016/10/05 | Phase 3 | Completed | |||
2016/09/15 | Phase 4 | Completed | |||
2016/07/22 | Phase 4 | Recruiting | |||
2016/07/14 | Phase 4 | Completed | Sao Jose do Rio Preto Medical School | ||
2016/06/07 | Phase 2 | UNKNOWN |
FDA Drug Approvals
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Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
---|---|---|---|---|---|
Carilion Materials Management | 68151-0681 | ORAL | 1.25 mg in 1 1 | 6/6/2016 | |
Exelan Pharmaceuticals, Inc. | 76282-272 | ORAL | 2.5 mg in 1 1 | 8/27/2016 | |
Physicians Total Care, Inc. | 54868-5856 | ORAL | 2.5 mg in 1 1 | 1/31/2013 | |
A-S Medication Solutions | 50090-1120 | ORAL | 10 mg in 1 1 | 11/8/2022 | |
Proficient Rx LP | 63187-644 | ORAL | 2.5 mg in 1 1 | 12/1/2018 | |
DIRECT RX | 61919-833 | ORAL | 10 mg in 1 1 | 2/9/2016 | |
Medsource Pharmaceuticals | 45865-441 | ORAL | 10 mg in 1 1 | 12/27/2019 | |
Aurobindo Pharma Limited | 65862-475 | ORAL | 2.5 mg in 1 1 | 11/8/2022 | |
A-S Medication Solutions | 50090-4597 | ORAL | 5 mg in 1 1 | 3/1/2021 | |
Zydus Pharmaceuticals USA Inc. | 68382-147 | ORAL | 10 mg in 1 1 | 11/7/2023 |
EMA Drug Approvals
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Approved Product | Authorization Holder | Status | Issued Date |
---|---|---|---|
No EMA approvals found for this drug. |
HSA Drug Approvals
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Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
---|---|---|---|---|---|
No HSA approvals found for this drug. |
NMPA Drug Approvals
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Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
---|---|---|---|---|---|
No NMPA approvals found for this drug. |
PPB Drug Approvals
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Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
---|---|---|---|---|---|
No PPB approvals found for this drug. |
TGA Drug Approvals
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Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
---|---|---|---|---|---|
VASCALACE CAPS 1.25 ramipril 1.25 mg capsule bottle | 203718 | Medicine | A | 8/14/2013 | |
RAMIPRIL AN ramipril 1.25 mg capsule blister pack | 203705 | Medicine | A | 8/14/2013 | |
APO-RAMIPRIL ramipril 2.5 mg tablets blister pack | 231161 | Medicine | A | 12/22/2014 | |
NOUMED RAMIPRIL ramipril 10 mg tablet blister pack | 308524 | Medicine | A | 11/14/2018 | |
PRILACE ramipril 10mg capsule bottle | 133098 | Medicine | A | 3/6/2007 | |
APO-RAMIPRIL ramipril 10 mg tablets blister pack | 231162 | Medicine | A | 12/22/2014 | |
RAMIPRIL AN ramipril 5 mg capsule bottle | 203724 | Medicine | A | 8/14/2013 | |
AURO-RAMIPRIL TABLETS 2.5 ramipril 2.5mg tablet bottle | 175229 | Medicine | A | 10/6/2011 | |
RAMIPRIL AN 5mg ramipril 5mg tablet bottle | 175236 | Medicine | A | 10/6/2011 | |
VASCALACE 1.25 ramipril 1.25mg tablet bottle | 175218 | Medicine | A | 10/6/2011 |
Health Canada Drug Approvals
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Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
---|---|---|---|---|---|
RAMIPRIL CAPSULES | ranbaxy pharmaceuticals canada inc. | 02332299 | Capsule - Oral | 1.25 MG | N/A |
RAMIPRIL-HCTZ | sanis health inc | 02412640 | Tablet - Oral | 5.0 MG | 10/10/2013 |
RAMIPRIL-HCTZ | PRO DOC LIMITEE | 02415887 | Tablet - Oral | 5.0 MG | 11/28/2013 |
SANDOZ RAMIPRIL | 02291428 | Tablet - Oral | 5 MG | 7/5/2007 | |
PRIVA-RAMIPRIL | pharmapar inc | 02449722 | Capsule - Oral | 10 MG | N/A |
PMS-RAMIPRIL | 02343932 | Capsule - Oral | 15 MG | 5/11/2010 | |
IPG-RAMIPRIL | marcan pharmaceuticals inc | 02418878 | Capsule - Oral | 5 MG | N/A |
AURO-RAMIPRIL | auro pharma inc | 02387417 | Capsule - Oral | 10 MG | 9/13/2012 |
BIO-RAMIPRIL | biomed pharma | 02449757 | Capsule - Oral | 10 MG | N/A |
ALTACE | bausch health, canada inc. | 02221853 | Capsule - Oral | 10 MG | 3/24/1997 |
CIMA AEMPS Drug Approvals
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Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
---|---|---|---|---|---|
RAMIPRIL TECNIGEN 10 mg COMPRIMIDOS EFG | Tecnimede España Industria Farmaceutica S.A. | 73548 | COMPRIMIDO | Medicamento Sujeto A Prescripción Médica. Tratamiento De Larga Duración | Commercialized |
RAMIPRIL STADA 5 MG COMPRIMIDOS EFG | Laboratorio Stada S.L. | 78417 | COMPRIMIDO | Medicamento Sujeto A Prescripción Médica. Tratamiento De Larga Duración | Commercialized |
TARLODIX 10MG/5 MG CAPSULAS DURAS | Adamed Laboratorios S.L.U. | 86560 | CÁPSULA DURA | Medicamento Sujeto A Prescripción Médica | Commercialized |
RAMIPRIL COMBIX 2.5 mg COMPRIMIDOS EFG | Laboratorios Combix S.L.U. | 73781 | COMPRIMIDO | Medicamento Sujeto A Prescripción Médica. Tratamiento De Larga Duración | Not Commercialized |
RAMIPRIL KRKA 10 MG COMPRIMIDOS EFG | Krka D.D. Novo Mesto | 80776 | COMPRIMIDO | Medicamento Sujeto A Prescripción Médica. Tratamiento De Larga Duración | Commercialized |
RAMIPRIL TEVAGEN 10 MG COMPRIMIDOS EFG | Teva Pharma S.L.U. | 78053 | COMPRIMIDO | Medicamento Sujeto A Prescripción Médica. Tratamiento De Larga Duración | Commercialized |
RAMIPRIL BEXAL 5 mg COMPRIMIDOS EFG | Bexal Farmaceutica S.A. | 65914 | COMPRIMIDO | Medicamento Sujeto A Prescripción Médica. Tratamiento De Larga Duración | Not Commercialized |
RAMIPRIL ALTER 5 MG COMPRIMIDOS EFG | Laboratorios Alter S.A. | 76965 | COMPRIMIDO | Medicamento Sujeto A Prescripción Médica. Tratamiento De Larga Duración | Not Commercialized |
RAMIPRIL RATIOPHARM 5 mg COMPRIMIDOS | Teva Pharma S.L.U. | 66449 | COMPRIMIDO | Medicamento Sujeto A Prescripción Médica. Tratamiento De Larga Duración | Commercialized |
ACOVIL 10 MG COMPRIMIDOS | Sanofi-Aventis Ireland Limited | PA0540-084-008IP | COMPRIMIDO | Medicamento Sujeto A Prescripción Médica. Tratamiento De Larga Duración | Commercialized |
Philippines FDA Drug Approvals
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Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
---|---|---|---|---|---|
No Philippines FDA approvals found for this drug. |
Saudi SFDA Drug Approvals
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Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
---|---|---|---|---|---|
No Saudi SFDA approvals found for this drug. |
Malaysia NPRA Drug Approvals
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Approved Product | Company | Registration Number | Dosage Form | Strength | Approval Date |
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UK EMC Drug Information
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Medicine Name | MA Holder | MA Number | Pharmaceutical Form | Active Ingredient | Authorization Date |
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No UK EMC drug information found for this drug. |
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