MedPath

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

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.

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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