Overview
Losartan is an angiotensin II receptor blocker (ARB) used to treat hypertension. Angiotensin-converting enzyme (ACE) inhibitors are used for a similar indication but are associated with a cough. When patients with ACE inhibitor associated coughs are switched to ARBs like losartan, they have an incidence of cough similar to placebo or hydrochlorothiazide. Losartan is available as losartan potassium oral tablets as well as a combination tablet of losartan potassium and hydrochlorothiazide. Patients taking losartan should have their renal function and potassium levels monitored. Losartan was granted FDA approval on 14 April 1995.
Background
Losartan is an angiotensin II receptor blocker (ARB) used to treat hypertension. Angiotensin-converting enzyme (ACE) inhibitors are used for a similar indication but are associated with a cough. When patients with ACE inhibitor associated coughs are switched to ARBs like losartan, they have an incidence of cough similar to placebo or hydrochlorothiazide. Losartan is available as losartan potassium oral tablets as well as a combination tablet of losartan potassium and hydrochlorothiazide. Patients taking losartan should have their renal function and potassium levels monitored. Losartan was granted FDA approval on 14 April 1995.
Indication
Losartan is indicated to treat hypertension in patients older than 6 years, reduce the risk of stroke in patients with hypertension and left ventricular hypertrophy (though this benefit may not extend to patients with African heritage), and to treat diabetic nephropathy with elevated serum creatinine and proteinuria in patients with type 2 diabetes and hypertension. Losartan with hydrochlorothiazide is indicated to treat hypertension and to reduce the risk of stroke in patients with hypertension and left ventricular hypertrophy (though this benefit may not extend to patients with African heritage).
Associated Conditions
- Diabetic Nephropathy
- Ventricular Dysfunction
- Hypertension
- Marfan Syndrome
- Ischemic Stroke
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2024/12/05 | Phase 4 | Completed | Hansung University | ||
2024/10/15 | Early Phase 1 | Recruiting | |||
2024/10/04 | Early Phase 1 | Recruiting | |||
2024/10/03 | Early Phase 1 | Completed | |||
2024/08/06 | Not Applicable | Recruiting | |||
2024/07/09 | Not Applicable | Not yet recruiting | |||
2024/05/28 | Phase 4 | Recruiting | |||
2024/04/15 | Phase 2 | Recruiting | |||
2024/03/27 | Phase 4 | Not yet recruiting | |||
2024/03/25 | Not Applicable | Recruiting | University of Electronic Science and Technology of China |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Bryant Ranch Prepack | 63629-2430 | ORAL | 100 mg in 1 1 | 7/31/2019 | |
| Aidarex Pharmaceuticals LLC | 33261-904 | ORAL | 100 mg in 1 1 | 1/11/2014 | |
| Solco Healthcare US, LLC | 43547-361 | ORAL | 50 mg in 1 1 | 9/15/2021 | |
| RPK Pharmaceuticals, Inc. | 53002-2624 | ORAL | 25 mg in 1 1 | 9/15/2021 | |
| Lupin Pharmaceuticals, Inc. | 68180-217 | ORAL | 100 mg in 1 1 | 10/30/2023 | |
| Unichem Pharmaceuticals (USA), Inc. | 29300-146 | ORAL | 100 mg in 1 1 | 11/28/2022 | |
| QPharma Inc | 42708-113 | ORAL | 50 mg in 1 1 | 12/8/2023 | |
| Aphena Pharma Solutions - Tennessee, LLC | 71610-418 | ORAL | 50 mg in 1 1 | 5/4/2020 | |
| Granules Pharmaceuticals Inc. | 70010-187 | ORAL | 50 mg in 1 1 | 10/12/2023 | |
| Contract Pharmacy Services-PA | 67046-455 | ORAL | 50 mg in 1 1 | 12/29/2018 |
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 |
|---|---|---|---|---|---|
| LOSARTAS TABLET 100MG | SIN13874P | TABLET | 100mg | 10/22/2010 | |
| A-Losartan 50mg Tablets | SIN13572P | TABLET, FILM COATED | 50mg | 11/20/2008 | |
| Angizaar-50mg Tablet | SIN13720P | TABLET, FILM COATED | 50 mg | 11/2/2009 | |
| LOSARB PLUS FILM-COATED TABLET 50MG/12.5 MG | SIN14465P | TABLET, FILM COATED | 50 mg | 12/19/2013 | |
| Losartan+HCT Mevon Tablet 100/25mg | SIN13778P | TABLET, FILM COATED | 100 mg | 3/23/2010 | |
| COZAAR TABLET 50 mg | SIN08588P | TABLET, FILM COATED | 50 mg | 3/8/1996 | |
| HYPERTEN FILM-COATED TABLET 100 MG | SIN14641P | TABLET, FILM COATED | 100.00 mg | 9/29/2014 | |
| LOSARTAN-TEVA FC TABLET 50MG | SIN16974P | TABLET, FILM COATED | 50 mg | 3/22/2024 | |
| LOSAGEN (LOSARTAN POTASSIUM) TABLETS 100 MG | SIN14729P | TABLET | 100.00 mg | 1/30/2015 | |
| SARANTO 100 FILM-COATED TABLETS 100MG | SIN16365P | TABLET, FILM COATED | 100mg | 11/9/2021 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| Losartan Potassium Capsules | 国药准字H20133264 | 化学药品 | 胶囊剂 | 6/28/2022 | |
| Losartan Potassium Capsules | 国药准字H20080814 | 化学药品 | 胶囊剂 | 7/28/2023 | |
| Losartan Potassium Capsules | 国药准字H20113226 | 化学药品 | 胶囊剂 | 7/28/2023 | |
| Losartan Potassium Capsules | 国药准字H20080015 | 化学药品 | 胶囊剂 | 6/28/2022 | |
| Losartan Potassium Capsules | 国药准字H20100167 | 化学药品 | 胶囊剂 | 8/5/2020 | |
| Losartan Potassium Tablets | 国药准字H20213250 | 化学药品 | 片剂 | 4/7/2021 | |
| Losartan Potassium Tablets | 国药准字H20223111 | 化学药品 | 片剂 | 3/8/2022 | |
| Losartan Potassium Tablets | 国药准字HJ20202003 | 化学药品 | 片剂 | 7/3/2023 | |
| Losartan Potassium Tablets | 国药准字HJ20171083 | 化学药品 | 片剂 | 12/14/2021 | |
| Losartan Potassium Tablets | H20140913 | 化学药品 | 片剂 | 4/7/2020 |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| ZYLTAN H TAB | N/A | N/A | N/A | 10/20/2010 | |
| LOWTEN TABLETS 50MG | N/A | N/A | N/A | 8/10/2018 | |
| LOSANORM-50 TABLETS 50MG | N/A | N/A | N/A | 1/10/2014 | |
| COTIASAR 50MG+12.5MG TAB | N/A | N/A | N/A | 4/18/2008 | |
| TANZA TABLETS 50MG | N/A | N/A | N/A | 5/31/2021 | |
| LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE TABLETS 50MG/12.5MG | N/A | N/A | N/A | 10/11/2023 | |
| LOTANOS COMP TABLETS 50MG/12.5MG | N/A | N/A | N/A | 8/26/2019 | |
| ZAART-50 TAB 50MG | N/A | N/A | N/A | 4/18/2008 | |
| ZAART-H TAB 50/12.5MG | N/A | N/A | N/A | 12/24/2010 | |
| LOTANOS COMP TABLETS 100MG/25MG | N/A | N/A | N/A | 8/26/2019 |
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| COZAAR losartan potassium 50mg tablet blister pack | 54809 | Medicine | A | 3/28/1996 | |
| APO-Losartan losartan potassium 50mg tablet blister pack | 201820 | Medicine | A | 8/15/2013 | |
| APO-Losartan losartan potassium 25mg tablet blister pack | 201817 | Medicine | A | 8/15/2013 | |
| APO-Losartan losartan potassium 100mg tablet blister pack | 201810 | Medicine | A | 8/15/2013 | |
| APO-Losartan losartan potassium 50mg tablet bottle | 201807 | Medicine | A | 8/15/2013 | |
| APO-Losartan losartan potassium 100mg tablet bottle | 201812 | Medicine | A | 8/15/2013 | |
| COZAVAN losartan potassium 25 mg film-coated tablet blister pack | 156235 | Medicine | A | 6/28/2010 | |
| APO-Losartan losartan potassium 25mg tablet bottle | 201803 | Medicine | A | 8/15/2013 | |
| COZAVAN losartan potassium 50 mg film-coated tablet blister pack | 156234 | Medicine | A | 6/28/2010 |