TheraRadar
Data updated: May 26, 2026

LOSARTAN POTASSIUM

Cardiovascular Approved 2010-04-06
Jump to: Indications Approvals Trials Competitors Safety Patents
14
Indications
--
Phase 3 Trials
16
Years on Market

Details

Status
Discontinued
First Approved
2010-04-06
Routes
ORAL
Dosage Forms
TABLET

Companies

Teva TORRENT PHARMS PRINSTON INC MSN Apotex WATSON LABS GRAVITI PHARMS AIPING PHARM INC HETERO LABS LTD V Hikma ZYDUS PHARMS USA INC IPCA LABS LTD GRANULES ALEMBIC PHARMS LTD UNICHEM Viatris Lupin Aurobindo Pharma MICRO LABS JUBILANT CADISTA CHARTWELL RX STRIDES PHARMA MACLEODS PHARMS LTD HISUN PHARM HANGZHOU
Active Ingredient: LOSARTAN POTASSIUM

LOSARTAN POTASSIUM Approval History

2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
552 FDA actions from 2010 to 2026
May 2026 SUPPL
Label · Labeling
Apr 2026 SUPPL
Label · Labeling
Jan 2026 SUPPL
Label · Labeling

What LOSARTAN POTASSIUM Treats

14 FDA approvals

Originally approved for its first indication in 2010 . Covers 14 distinct patient populations.

  • Other (14)
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Clinical Trial Registry

12 trials
Trial Sponsor ID Phase Status Title
NCT04106856 SHAPER HCI121104 NCI-2019-05882, HCI121104 Ph 1 active not recruiting Losartan and Hypofractionated Rx After Chemo for Tx of Borderline Resectable or Locally Advanced Pancreatic Cancer (SHAPER)
NCT04539808 results posted STUDY00021614 NCI-2020-06277, STUDY00021614 Ph 2 active not recruiting NeoOPTIMIZE: Early Switching of mFOLFIRINOX or Gemcitabine/Nab-Paclitaxel Before Surgery for the Treatment of Resectable, Borderline Resectable, or Locally-Advanced Unresectable Pancreatic Cancer
NCT05402397 HGNPE 7122 Ph 4 completed Losartan and Uric Acid Metabolism in Children With Proteinuric Nephropathies
NCT00756938 results posted 0954-337 2008_545, CTRI/2009/091/000045 Ph 3 completed Study of Losartan in Pediatric Patients With Hypertension (MK-0954-337)
NCT00496834 results posted 0954-330 2007_015 Ph 4 completed LAAS (Losartan Anti-Atherosclerosis Study)(0954-330)(COMPLETED)
NCT03467217 STOP-NAFLD results posted 9 STOP-NAFLD U01DK061730 Ph 2 terminated Losartan for the Treatment of Pediatric NAFLD
NCT01808196 results posted 2012-0106 Ph 2 completed Testing Effectiveness of Losartan in Patients With EoE With or Without a CTD
NCT03029091 results posted 2015-9021 U54AI117804 Ph 2 completed An Open-Label Trial of Losartan Potassium in Participants With Eosinophilic Esophagitis (EoE)
NCT04222686 CARE-PLP CARE-PLP Ph 4 completed Evaluation of Losartan and Perindopril in Blacks Type 2 Diabetics Patients
NCT01302691 results posted 0954E-357 Ph 3 completed MK-0954E Study in Participants With Hypertension (MK-0954E-357)
NCT01234922 results posted IRB00014933 NCI-2010-02043, IRB00014933 Ph 2 terminated Benazepril Hydrochloride, Lisinopril, Ramipril, or Losartan Potassium in Treating Hypertension in Patients With Solid Tumors
NCT00949884 results posted CS0866-A-U452 Ph 4 completed Olmesartan Comparison to Losartan in Hypertensive Subjects
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Active Pipeline

Pro

Ongoing clinical trials by development phase

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Key Completed Trials

Pro

Completed studies with published results, ranked by significance

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Trial Timeline

ClinicalTrials.gov ↗ Pro

Full development history with FDA approval milestones

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Understanding FDA Approval Types
Count Type What it means
- ORIG Original approval - drug first enters market
- SUPPL - Efficacy New indication (new disease/condition approved)
- SUPPL - Labeling Label text changes (warnings, dosing updates)
- SUPPL - Manufacturing Production changes (new facility)
- SUPPL - Chemistry Formulation changes (new dosage strength)

Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.

LOSARTAN POTASSIUM FDA Label Details

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Full clinical data, patents, trials, and competitive landscape for losartan potassium.

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Data Sources

FDA Approval: ANDA076958 → Trials: ClinicalTrials.gov →

Data sourced from official FDA and NIH databases. Click links to verify on original sources.