COZAAR (losartan potassium)
Cozaar helps adults and children over six years old manage high blood pressure, which reduces the risk of serious cardiovascular events like strokes and heart attacks. It is also used to lower the risk of stroke in hypertensive patients who have left ventricular hypertrophy, though this specific benefit may not apply to Black patients. Additionally, the medication treats kidney disease in patients with type 2 diabetes and high blood pressure who show signs of protein in their urine or elevated creatinine levels.
How COZAAR Works
This medication works by blocking the binding of angiotensin II, a hormone that causes blood vessels to narrow and triggers the release of salt-retaining hormones. By selectively targeting the AT1 receptor, the drug and its active metabolite prevent vasoconstriction and reduce aldosterone secretion. This process helps relax blood vessels and lower blood pressure without affecting the enzymes that regulate other cardiovascular proteins.
Details
- Status
- Prescription
- First Approved
- 1995-04-14
- Revenue
- $315M (Q4-2012)
- Routes
- ORAL
- Dosage Forms
- TABLET
COZAAR Approval History
What COZAAR Treats
6 indicationsCOZAAR is approved for 6 conditions since its original approval in 1995. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Hypertension
- Stroke
- Left Ventricular Hypertrophy
- Diabetic Nephropathy
- Type 2 Diabetes
- Proteinuria
COZAAR Boxed Warning
FETAL TOXICITY When pregnancy is detected, discontinue COZAAR as soon as possible. Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus [see Warnings and Precautions (5.1) ] . WARNING: FETAL TOXICITY See full prescribing information for complete boxed warning. When pregnancy is detected, discontinue COZAAR as soon as possible. Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus. ( 5.1 )...
WARNING: FETAL TOXICITY When pregnancy is detected, discontinue COZAAR as soon as possible. Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus [see Warnings and Precautions (5.1) ] . WARNING: FETAL TOXICITY See full prescribing information for complete boxed warning. When pregnancy is detected, discontinue COZAAR as soon as possible. Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus. ( 5.1 )
COZAAR Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Direct competitors
Same target(s) AND same indication — head-to-head.
MoA expansion candidates
Same target(s), different indications — where else is this mechanism being explored?
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
What's emerging in COZAAR's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications COZAAR treats. First-in-class if their pivotal trials read out positive.
Drugs Similar to COZAAR
3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
13 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) |
| NCT07547878 RAPID-CKD | 026-271 | Ph 4 | not yet recruiting | Rapid and Simultaneous Initiation of Four Guideline-Directed CKD Therapies (RAPID-CKD) |
| 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 |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
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.
COZAAR FDA Label Details
Indications & Usage
FDA Label (PDF)COZAAR is indicated for the treatment of Hypertension; Stroke; Left Ventricular Hypertrophy; Diabetic Nephropathy; Type 2 Diabetes; Proteinuria.
WARNING: FETAL TOXICITY When pregnancy is detected, discontinue COZAAR as soon as possible. Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus [see Warnings and Precautions (5.1) ] . WARNING: FETAL TOXICITY See full prescribing information for ...
Pro Intelligence Preview
Deep insights for COZAAR
Revenue Insights
- • Q4-2012: $315M
- • Historical trend analysis
Patent Timeline
- • Patent expiration dates
- • Generic/biosimilar risk
Trial Analysis
- • Clinical trial tracking
- • Development stage analysis
Competitive Landscape
- • 20 similar drugs
- • Same target/indication analysis
Full approval history • All patents • Revenue trends • Competitor analysis
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.