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.
Background
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
View More Clinical Trials
Sign in to access the complete clinical trial database with detailed study information.
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2018/01/08 | Phase 4 | Withdrawn | |||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 | UNKNOWN | |||
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
View More FDA Approvals
Sign in to access additional FDA-approved drug information with detailed regulatory data.
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
View More EMA Approvals
Sign in to access additional EMA-approved drug information with detailed regulatory data.
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
| No EMA approvals found for this drug. | |||
HSA Drug Approvals
View More HSA Approvals
Sign in to access additional HSA-approved drug information with detailed regulatory data.
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
View More NMPA Approvals
Sign in to access additional NMPA-approved drug information with detailed regulatory data.
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| Lisinopril Tablets | 国药准字H20065769 | 化学药品 | 片剂 | 6/18/2020 | |
| Lisinopril Tablets | 国药准字H20103384 | 化学药品 | 片剂 | 6/22/2020 | |
| Lisinopril Tablets | 国药准字H20065767 | 化学药品 | 片剂 | 6/18/2020 | |
| Lisinopril Tablets | 国药准字H20093521 | 化学药品 | 片剂 | 6/18/2024 | |
| Lisinopril Tablets | 国药准字H10960265 | 化学药品 | 片剂 | 7/30/2024 | |
| Lisinopril Tablets | 国药准字H20066146 | 化学药品 | 片剂 | 3/5/2021 | |
| Lisinopril Tablets | 国药准字H20065768 | 化学药品 | 片剂 | 6/18/2020 | |
| Lisinopril Tablets | 国药准字H20065066 | 化学药品 | 片剂 | 11/9/2020 | |
| Lisinopril Tablets | 国药准字H20094032 | 化学药品 | 片剂 | 2/7/2024 | |
| Lisinopril Tablets | 国药准字H20094033 | 化学药品 | 片剂 | 2/7/2024 |
PPB Drug Approvals
View More PPB Approvals
Sign in to access additional PPB-approved drug information with detailed regulatory data.
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
View More TGA Approvals
Sign in to access additional TGA-approved drug information with detailed regulatory data.
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 |