Overview
Perindopril is a nonsulfhydryl prodrug that belongs to the angiotensin-converting enzyme (ACE) inhibitor class of medications. It is rapidly metabolized in the liver to perindoprilat, its active metabolite, following oral administration. Perindoprilat 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). Perindopril may be used to treat mild to moderate essential hypertension, mild to moderate congestive heart failure, and to reduce the cardiovascular risk of individuals with hypertension or post-myocardial infarction and stable coronary disease.
Indication
For the treatment of mild to moderate essential hypertension, mild to moderate congestive heart failure, and to reduce the cardiovascular risk of individuals with hypertension or post-myocardial infarction and stable coronary disease.
Associated Conditions
- Cardiovascular Events
- Diabetic Nephropathy
- Hypertension
- Hypertension, Essential Hypertension
- Myocardial Infarction
- NYHA Class I Congestive heart failure
- Stroke
- Chronic heart failure with reduced ejection fraction (NYHA Class II)
- Chronic heart failure with reduced ejection fraction (NYHA Class III)
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2024/04/02 | Phase 4 | Recruiting | |||
2024/01/19 | Phase 1 | Recruiting | |||
2023/01/13 | Phase 4 | Completed | Centre for Chronic Disease Control, India | ||
2022/09/10 | Phase 4 | Completed | |||
2020/10/19 | Phase 3 | Terminated | |||
2020/09/21 | Phase 1 | Completed | Sichuan Haisco Pharmaceutical Group Co., Ltd | ||
2020/09/21 | Phase 1 | Completed | Sichuan Haisco Pharmaceutical Group Co., Ltd | ||
2020/04/13 | Phase 4 | UNKNOWN | |||
2020/02/05 | Phase 4 | Completed | Yaounde Central Hospital | ||
2020/01/10 | Phase 4 | Completed | Yaounde Central Hospital |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Marlex Pharmaceuticals Inc | 10135-599 | ORAL | 4 mg in 1 1 | 6/4/2015 | |
| Aurobindo Pharma Limited | 65862-288 | ORAL | 8 mg in 1 1 | 3/13/2024 | |
| Lannett Company, Inc. | 0527-1920 | ORAL | 8 mg in 1 1 | 7/3/2014 | |
| Marlex Pharmaceuticals Inc | 10135-600 | ORAL | 8 mg in 1 1 | 6/4/2015 | |
| Lupin Pharmaceuticals, Inc | 68180-236 | ORAL | 4 mg in 1 1 | 2/26/2010 | |
| Aurobindo Pharma Limited | 65862-287 | ORAL | 4 mg in 1 1 | 3/13/2024 | |
| Lupin Pharmaceuticals, Inc | 68180-235 | ORAL | 2 mg in 1 1 | 2/26/2010 | |
| Aurobindo Pharma Limited | 65862-286 | ORAL | 2 mg in 1 1 | 3/13/2024 | |
| Adhera Therapeutics, Inc. | 72931-011 | ORAL | 7 mg in 1 1 | 8/31/2019 | |
| Adhera Therapeutics, Inc. | 72931-010 | ORAL | 3.5 mg in 1 1 | 8/31/2019 |
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 |
|---|---|---|---|---|---|
| TRIPLIXAM FILM COATED TABLET 10 mg/ 2.5 mg/ 10 mg | SIN15014P | TABLET, FILM COATED | 10 mg | 5/23/2016 | |
| VIACORAM TABLET 14 MG/10 MG | SIN15557P | TABLET | 14 mg | 10/1/2018 | |
| TRIVERAM FILM-COATED TABLET 20 mg/5 mg/5 mg | SIN15427P | TABLET, FILM COATED | 5 mg | 2/12/2018 | |
| COVERAM Tablet 10mg/10mg | SIN13827P | TABLET | 10 mg | 7/8/2010 | |
| AMLESSA TABLETS 4 mg/ 10mg | SIN15728P | TABLET | 4.00 mg | 6/27/2019 | |
| AMLESSA TABLETS 8 mg/ 10 mg | SIN15726P | TABLET | 8.00 mg | 6/27/2019 | |
| COVERAM Tablet 5mg/10mg | SIN13828P | TABLET | 5 mg | 7/8/2010 | |
| AMLESSA TABLETS 8 mg/ 5mg | SIN15727P | TABLET | 8.000mg | 6/27/2019 | |
| PERINACE TABLET 4MG | SIN13602P | TABLET | 4 mg | 3/3/2009 | |
| COVERSYL 5mg tablet | SIN13494P | TABLET, FILM COATED | 3.395mg | 7/16/2008 |
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 |
|---|---|---|---|---|---|
| MOREEZ COMPLEX TABLETS | N/A | N/A | N/A | 5/24/2018 |
TGA Drug Approvals
Health Canada Drug Approvals
Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
|---|---|---|---|---|---|
| SANDOZ PERINDOPRIL ERBUMINE | 02470225 | Tablet - Oral | 2 MG | 3/5/2018 | |
| VIACORAM | servier canada inc | 02451557 | Tablet - Oral | 14 MG | 4/5/2016 |
| PERINDOPRIL ERBUMINE/INDAPAMIDE LD | PRO DOC LIMITEE | 02523027 | Tablet - Oral | 2 MG | N/A |
| BIO-PERINDOPRIL | biomed pharma | 02501317 | Tablet - Oral | 4 MG | 7/13/2020 |
| COVERSYL | servier canada inc | 02123282 | Tablet - Oral | 4 MG | 12/31/1994 |
| APO-PERINDOPRIL/AMLODIPINE | 02468573 | Tablet - Oral | 7 MG | 6/3/2019 | |
| SANDOZ PERINDOPRIL ERBUMINE/ INDAPAMIDE HD | 02470446 | Tablet - Oral | 8 MG | 3/5/2018 | |
| PMS-PERINDOPRIL-AMLODIPINE | 02541726 | Tablet - Oral | 14 MG | 2/21/2024 | |
| NRA-PERINDOPRIL | nora pharma inc | 02489023 | Tablet - Oral | 4 MG | 10/24/2019 |
| PERINDOPRIL/INDAPAMIDE | sanis health inc | 02519739 | Tablet - Oral | 8 MG | 12/15/2021 |
CIMA AEMPS Drug Approvals
Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
|---|---|---|---|---|---|
| PERINDOPRIL/INDAPAMIDA COMBIX 2 MG/0,625 MG COMPRIMIDOS EFG | Laboratorios Combix S.L.U. | 79045 | COMPRIMIDO | Medicamento Sujeto A Prescripción Médica | Commercialized |
| PERINDOPRIL/INDAPAMIDA COMBIX 8 MG/2,5 MG COMPRIMIDOS EFG | Laboratorios Combix S.L.U. | 79047 | COMPRIMIDO | Medicamento Sujeto A Prescripción Médica | Commercialized |
| PERINDOPRIL KRKA 4 mg COMPRIMIDOS EFG | Krka D.D. Novo Mesto | 68827 | COMPRIMIDO | Medicamento Sujeto A Prescripción Médica. Tratamiento De Larga Duración | Commercialized |
| COVERSYL 4 mg COMPRIMIDOS | 58636 | COMPRIMIDO | Medicamento Sujeto A Prescripción Médica. Tratamiento De Larga Duración | Commercialized | |
| PERINDOPRIL/INDAPAMIDA COMBIX 4 MG/1,25 MG COMPRIMIDOS EFG | Laboratorios Combix S.L.U. | 79046 | COMPRIMIDO | Medicamento Sujeto A Prescripción Médica | Commercialized |
| BIPRETERAX COMPRIMIDOS | 58-264-02-C | COMPRIMIDO | Medicamento Sujeto A Prescripción Médica | Not Commercialized | |
| PERINDOPRIL KRKA 8 mg COMPRIMIDOS EFG | Krka D.D. Novo Mesto | 70143 | COMPRIMIDO | Medicamento Sujeto A Prescripción Médica. Tratamiento De Larga Duración | 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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