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
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Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2018/07/26 | Phase 1 | UNKNOWN | Bright Future Pharmaceuticals Factory O/B Bright Future Pharmaceutical Laboratories Limited | ||
2018/03/09 | Phase 4 | Completed | |||
2018/02/06 | Phase 2 | Not yet recruiting | |||
2018/01/08 | Phase 4 | Withdrawn | |||
2017/06/28 | Phase 2 | Terminated | |||
2017/06/22 | Phase 4 | UNKNOWN | Hospital General Universitario Gregorio Marañon | ||
2016/07/28 | Phase 4 | Completed | |||
2016/05/17 | Phase 4 | Completed | Uppsala University | ||
2016/02/15 | Phase 2 | UNKNOWN | Monia Lorini | ||
2015/12/30 | Phase 1 | Completed | Intarcia Therapeutics |
FDA Drug Approvals
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Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| BluePoint Laboratories | 68001-337 | ORAL | 40 mg in 1 1 | 6/30/2021 | |
| Aphena Pharma Solutions - Tennessee, LLC | 43353-866 | ORAL | 10 mg in 1 1 | 5/28/2014 | |
| Exelan Pharmaceuticals Inc. | 76282-420 | ORAL | 20 mg in 1 1 | 5/7/2020 | |
| Proficient Rx LP | 63187-098 | ORAL | 10 mg in 1 1 | 11/1/2018 | |
| A-S Medication Solutions | 50090-3175 | ORAL | 30 mg in 1 1 | 12/12/2022 | |
| Unit Dose Services | 50436-0376 | ORAL | 5 mg in 1 1 | 12/27/2016 | |
| Bryant Ranch Prepack | 71335-0176 | ORAL | 5 mg in 1 1 | 5/6/2020 | |
| Solco healthcare U.S., LLC | 43547-418 | ORAL | 30 mg in 1 1 | 9/20/2018 | |
| NuCare Pharmaceuticals,Inc. | 68071-3409 | ORAL | 20 mg in 1 1 | 9/18/2023 | |
| RPK Pharmaceuticals, Inc. | 53002-1674 | ORAL | 20 mg in 1 1 | 2/9/2021 |
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 |
|---|---|---|---|---|---|
| LISINOPRIL STADA TABLET 20 mg | SIN11597P | TABLET | 20 mg | 7/26/2001 | |
| LISORIL-20 TABLET 20 mg | SIN12220P | TABLET | 20 mg | 3/6/2003 | |
| NOPERTEN 5 TABLET 5 mg | SIN12005P | TABLET | 5 mg | 7/1/2002 | |
| NOPERTEN 10 TABLET 10 mg | SIN12006P | TABLET | 10 mg | 7/1/2002 | |
| DAPRIL 10 TABLET 10 mg | SIN11995P | TABLET | 10 mg | 6/24/2002 | |
| HIPRIL-5 TABLET 5 mg | SIN12037P | TABLET | 5 mg | 7/30/2002 |
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 |
|---|---|---|---|---|---|
| LISODRATE TABLETS 5 mg lisinopril (as dihydrate) 5mg tablet blister pack | 198016 | Medicine | A | 8/2/2013 | |
| LISINOPRIL-WGR lisinopril 2.5 mg (as dihydrate) tablet blister pack | 198020 | Medicine | A | 8/2/2013 | |
| APO-LISINOPRIL lisinopril 20mg (as dihydrate) tablet blister pack | 213395 | Medicine | A | 10/17/2013 | |
| NOUMED LISINOPRIL lisinopril (as dihydrate) 20mg tablet blister pack | 285672 | Medicine | A | 6/14/2017 | |
| APOTEX LISINOPRIL lisinopril 20 mg tablets blister pack | 143975 | Medicine | A | 8/27/2008 | |
| OZTEN lisinopril 10 mg tablet blister pack | 153187 | Medicine | A | 3/4/2009 | |
| APO-LISINOPRIL lisinopril 10mg (as dihydrate) tablet blister pack | 213394 | Medicine | A | 10/17/2013 | |
| APO-LISINOPRIL lisinopril 5mg (as dihydrate) tablet blister pack | 213393 | Medicine | A | 10/17/2013 | |
| LISINOPRIL-WGR lisinopril 5 mg (as dihydrate) tablet blister pack | 198021 | Medicine | A | 8/2/2013 | |
| FIBSOL 20 lisinopril 20mg (as dihydrate) tablet blister pack | 101318 | Medicine | A | 5/7/2004 |
Health Canada Drug Approvals
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Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
|---|---|---|---|---|---|
| LISINOPRIL | meliapharm inc | 02294591 | Tablet - Oral | 10 MG | 3/12/2008 |
| DOM-LISINOPRIL | dominion pharmacal | 02294648 | Tablet - Oral | 20 MG | 4/16/2008 |
| APO-LISINOPRIL/HCTZ | 02261979 | Tablet - Oral | 10 MG | 9/5/2007 | |
| TEVA-LISINOPRIL (TYPE P) | teva canada limited | 02285061 | Tablet - Oral | 5 MG | 10/17/2007 |
| PRO-LISINOPRIL - 5 | PRO DOC LIMITEE | 02310961 | Tablet - Oral | 5 MG | 7/3/2008 |
| RATIO-LISINOPRIL Z | ratiopharm inc division of teva canada limited | 02299887 | Tablet - Oral | 10 MG | 10/17/2007 |
| NU-LISINOPRIL/HCTZ | nu-pharm inc | 02336774 | Tablet - Oral | 20 MG | N/A |
| NU-LISINOPRIL | nu-pharm inc | 02335492 | Tablet - Oral | 40 MG | N/A |
| LISINOPRIL | sorres pharma inc | 02321610 | Tablet - Oral | 10 MG | 6/22/2009 |
| TEVA-LISINOPRIL (TYPE Z) | teva canada limited | 02285134 | Tablet - Oral | 20 MG | 10/17/2007 |
CIMA AEMPS Drug Approvals
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Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
|---|---|---|---|---|---|
| PRINIVIL 20 mg COMPRIMIDOS | Pan Quimica Farmaceutica S.A. | 59129 | COMPRIMIDO | Medicamento Sujeto A Prescripción Médica. Tratamiento De Larga Duración | Commercialized |
| LISINOPRIL TEVA-RATIOPHARM 20 mg COMPRIMIDOS EFG | Teva Pharma S.L.U. | 63962 | COMPRIMIDO | Medicamento Sujeto A Prescripción Médica. Tratamiento De Larga Duración | Commercialized |
Philippines FDA Drug Approvals
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Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Philippines FDA approvals found for this drug. | |||||
Saudi SFDA Drug Approvals
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Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Saudi SFDA approvals found for this drug. | |||||
Malaysia NPRA Drug Approvals
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Approved Product | Company | Registration Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Malaysia NPRA approvals found for this drug. | |||||
UK EMC Drug Information
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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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