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
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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 |