Overview
Lisinopril is an angiotensin converting enzyme inhibitor (ACEI) used to treat hypertension, heart failure, and myocardial infarction. Lisinopril and captopril are the only ACEIs that are not prodrugs. It functions by inhibition of angiotensin converting enzyme as well as the renin angiotensin aldosterone system. ACEIs are commonly used as a first line therapy in the treatment of hypertension, along with thiazide diuretics or beta blockers. Lisinopril was granted FDA approval on 29 December 1987.
Indication
Lisinopril is indicated for the treatment of acute myocardial infarction, hypertension in patients ≥6 years, and as an adjunct therapy for heart failure. A combination product with hydrochlorothiazide is indicated for the treatment of hypertension.
Associated Conditions
- Acute Myocardial Infarction (AMI)
- Cardiovascular Events
- Congestive Heart Failure (CHF)
- Diabetic Nephropathy
- Hypertension
- Migraine
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2025/01/14 | Phase 1 | Completed | |||
2024/12/20 | N/A | Not yet recruiting | Closed Loop Medicine | ||
2022/09/07 | Early Phase 1 | Recruiting | |||
2021/09/30 | Phase 1 | Completed | |||
2021/09/24 | Phase 3 | Terminated | |||
2021/08/23 | Not Applicable | Withdrawn | |||
2021/05/13 | Phase 1 | Completed | |||
2020/09/16 | Phase 2 | Recruiting | |||
2020/07/24 | Phase 2 | Active, not recruiting | |||
2019/12/09 | Phase 2 | Withdrawn |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Physicians Total Care, Inc. | 54868-4785 | ORAL | 20 mg in 1 1 | 11/4/2009 | |
| MedVantx, Inc. | 66116-300 | ORAL | 10 mg in 1 1 | 12/7/2012 | |
| Denton Pharma, Inc. DBA Northwind Pharmaceuticals | 70934-229 | ORAL | 40 mg in 1 1 | 1/1/2023 | |
| PD-Rx Pharmaceuticals, Inc. | 43063-482 | ORAL | 10 mg in 1 1 | 5/10/2023 | |
| Preferred Pharmaceuticals Inc. | 68788-6407 | ORAL | 10 mg in 1 1 | 7/24/2023 | |
| Upsher-Smith Laboratories, LLC | 24979-240 | ORAL | 10 mg in 1 1 | 1/2/2025 | |
| ST. MARY'S MEDICAL PARK PHARMACY | 60760-586 | ORAL | 10 mg in 1 1 | 6/29/2023 | |
| Aurobindo Pharma Limited | 65862-037 | ORAL | 2.5 mg in 1 1 | 11/19/2022 | |
| NuCare Pharmaceuticals, Inc. | 68071-3178 | ORAL | 20 mg in 1 1 | 2/11/2021 | |
| Physicians Total Care, Inc. | 54868-4977 | ORAL | 10 mg in 1 1 | 11/4/2009 |
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 |
|---|---|---|---|---|---|
| ZESTRIL TABLET 10 mg | SIN02372P | TABLET, FILM COATED | 10 mg | 11/3/1988 | |
| LISINOPRIL STADA TABLET 10 mg | SIN11596P | TABLET | 10 mg | 7/26/2001 | |
| Lisdene Tablet 10mg | SIN13846P | TABLET | 10 mg | 8/6/2010 | |
| DAPRIL 5 TABLET 5 mg | SIN11994P | TABLET | 5 mg | 6/24/2002 | |
| ZESTRIL TABLET 5 mg | SIN02369P | TABLET, FILM COATED | 5 mg | 11/3/1988 | |
| LISORIL 10 TABLET 10 mg | SIN07870P | TABLET | 10 mg | 10/6/1994 | |
| LISINOPRIL STADA TABLET 5 mg | SIN11594P | TABLET | 5 mg | 7/26/2001 | |
| DAPRIL 20 TABLET 20 mg | SIN11996P | TABLET | 20 mg | 6/24/2002 | |
| ZESTRIL TABLET 20 mg | SIN02370P | TABLET, FILM COATED | 20 mg | 11/3/1988 | |
| LISORIL 5 TABLET 5 mg | SIN07868P | TABLET | 5 mg | 10/6/1994 |
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 |
|---|---|---|---|---|---|
| PMS-LISINOPRIL TABLETS 5MG | N/A | N/A | N/A | 2/28/2013 | |
| LISORIL-5 TABLETS 5MG | N/A | N/A | N/A | 8/16/2013 | |
| LISORIL-10 TABLETS 10MG | N/A | N/A | N/A | 8/16/2013 |
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| ZESTRIL 20mg tablet blister pack | 70839 | Medicine | A | 11/16/1999 | |
| ZESTRIL 5mg tablet blister pack | 70837 | Medicine | A | 11/16/1999 | |
| APOTEX LISINOPRIL lisinopril 5 mg tablets blister pack | 143911 | Medicine | A | 8/27/2008 | |
| ZESTRIL 10mg tablet blister pack | 70838 | Medicine | A | 11/16/1999 | |
| LISINOPRIL SANDOZ lisinopril dihydrate 20mg tablet blister pack | 158108 | Medicine | A | 3/31/2010 | |
| LISORIL lisinopril 2.5mg (as dihydrate) tablet blister pack | 106491 | Medicine | A | 7/27/2006 | |
| ZINOPRIL 10 lisinopril 10mg (as dihydrate) tablet blister pack | 152717 | Medicine | A | 1/30/2009 | |
| APO- LISINOPRIL lisinopril 20 mg tablets bottle pack | 144029 | Medicine | A | 8/27/2008 | |
| OZTEN lisinopril 20 mg tablet blister pack | 153188 | Medicine | A | 3/4/2009 | |
| LISINOPRIL SANDOZ lisinopril dihydrate 10mg tablet blister pack | 158101 | Medicine | A | 3/31/2010 |
Health Canada Drug Approvals
Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
|---|---|---|---|---|---|
| APO-LISINOPRIL | 02217511 | Tablet - Oral | 20 MG | 10/30/1996 | |
| IPG-LISINOPRIL | marcan pharmaceuticals inc | 02420759 | Tablet - Oral | 5 MG | N/A |
| TEVA-LISINOPRIL (TYPE P) | teva canada limited | 02285088 | Tablet - Oral | 10 MG | 10/17/2007 |
| NU-LISINOPRIL | nu-pharm inc | 02242712 | Tablet - Oral | 40 MG | N/A |
| NU-LISINOPRIL/HCTZ | nu-pharm inc | 02336782 | Tablet - Oral | 20 MG | N/A |
| NU-LISINOPRIL | nu-pharm inc | 02242711 | Tablet - Oral | 20 MG | N/A |
| ZESTORETIC | searchlight pharma inc | 02103729 | Tablet - Oral | 10 MG | 12/31/1994 |
| TEVA-LISINOPRIL (TYPE P) | teva canada limited | 02285096 | Tablet - Oral | 20 MG | 10/17/2007 |
| LISINOPRIL | meliapharm inc | 02294605 | Tablet - Oral | 20 MG | 3/12/2008 |
| LISINOPRIL TABLETS USP | 02389142 | Tablet - Oral | 10 MG | N/A |
CIMA AEMPS Drug Approvals
Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
|---|---|---|---|---|---|
| ZESTORETIC 20 mg/12,5 mg COMPRIMIDOS | Atnahs Pharma Netherlands Bv. | 59582 | COMPRIMIDO | Medicamento Sujeto A Prescripción Médica | Commercialized |
| ZESTRIL 20 mg COMPRIMIDOS | Atnahs Pharma Netherlands Bv. | 59127 | COMPRIMIDO | Medicamento Sujeto A Prescripción Médica. Tratamiento De Larga Duración | Commercialized |
| PRINIVIL 5 mg COMPRIMIDOS | Pan Quimica Farmaceutica S.A. | 59128 | COMPRIMIDO | Medicamento Sujeto A Prescripción Médica. Tratamiento De Larga Duración | Commercialized |
| LISINOPRIL ARISTO 20 mg COMPRIMIDOS EFG | Aristo Pharma Iberia S.L. | 64564 | COMPRIMIDO | Medicamento Sujeto A Prescripción Médica. Tratamiento De Larga Duración | Not Commercialized |
| LISINOPRIL CINFA 5 mg COMPRIMIDOS EFG | Laboratorios Cinfa S.A. | 64563 | COMPRIMIDO | Medicamento Sujeto A Prescripción Médica. Tratamiento De Larga Duración | Commercialized |
| LISINOPRIL-HIDROCLOROTIAZIDA TEVA 20 mg/12.5 mg COMPRIMIDOS EFG | Teva Pharma S.L.U. | 66333 | COMPRIMIDO | Medicamento Sujeto A Prescripción Médica | Commercialized |
| LISINOPRIL ARISTO 5 mg COMPRIMIDOS EFG | Aristo Pharma Iberia S.L. | 64565 | COMPRIMIDO | Medicamento Sujeto A Prescripción Médica. Tratamiento De Larga Duración | Not Commercialized |
| LISINOPRIL CINFA 20 mg COMPRIMIDOS EFG | Laboratorios Cinfa S.A. | 64562 | COMPRIMIDO | Medicamento Sujeto A Prescripción Médica. Tratamiento De Larga Duración | Commercialized |
| PRINIVIL PLUS 20 mg/12,5 mg COMPRIMIDOS | Pan Quimica Farmaceutica S.A. | 59583 | COMPRIMIDO | Medicamento Sujeto A Prescripción Médica | Commercialized |
| TENSIKEY COMPLEX 20 mg/12.5 mg COMPRIMIDOS | Pharminicio S.L. | 64089 | COMPRIMIDO | Medicamento Sujeto A Prescripción Médica | 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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