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.
Background
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
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 |
|---|---|---|---|---|---|
| Ramipril Tablets | 国药准字H20030723 | 化学药品 | 片剂 | 8/17/2020 | |
| Ramipril Tablets | 国药准字HJ20140440 | 化学药品 | 片剂 | 12/31/2020 | |
| Ramipril Tablets | 国药准字HJ20140441 | 化学药品 | 片剂 | 12/31/2020 | |
| Ramipril Tablets | 国药准字H20030724 | 化学药品 | 片剂 | 8/17/2020 | |
| Ramipril Tablets | 国药准字H20030725 | 化学药品 | 片剂 | 8/17/2020 | |
| Ramipril Tablets | 国药准字H20060766 | 化学药品 | 片剂 | 12/4/2020 |
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 |