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Ramipril

Generic Name
Ramipril
Brand Names
Altace, Altace HCT
Drug Type
Small Molecule
Chemical Formula
C23H32N2O5
CAS Number
87333-19-5
Unique Ingredient Identifier
L35JN3I7SJ

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

Published: Jul 25, 2025

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:

Continue reading the full research report

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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No EMA approvals found for this drug.

HSA Drug Approvals

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NMPA Drug Approvals

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No NMPA approvals found for this drug.

PPB Drug Approvals

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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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No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

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Approval Date
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Malaysia NPRA Drug Approvals

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No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

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MA Number
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