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Cozaar (losartan)
Losartan blocks the vasoconstrictor and aldosterone-secreting effects of angiotensin II by selectively binding to the AT1 receptor.
Losartan (Cozaar) was the first ARB, developed by Merck/DuPont and approved in 1995. It offers blood pressure control without the cough associated with ACE inhibitors. Available generically.
At a glance
| Generic name | losartan |
|---|---|
| Also known as | Cozaar |
| Sponsor | Merck & Co. |
| Drug class | ARB (Angiotensin II receptor blocker) |
| Target | AT1 receptor |
| Modality | Small molecule |
| Therapeutic area | Metabolic |
| Phase | FDA-approved |
| First approval | 1995-04-14 (United States) |
Mechanism of action
Losartan and its active metabolite work by blocking the effects of angiotensin II, a hormone that causes blood vessels to narrow and increases blood pressure. By binding to the AT1 receptor, they prevent these effects, helping to lower blood pressure and reduce the workload on the heart.
Approved indications
- Diabetic renal disease
- Hypertension with Left Ventricular Hypertrophy
- Hypertensive disorder
- Hypertensive urgency
Boxed warnings
- WARNING: FETAL TOXICITY When pregnancy is detected, discontinue losartan potassium 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 losartan potassium as soon as possible. Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus. (5.1)
Common side effects
- dizziness
- upper respiratory infection
- nasal congestion
- back pain
Key clinical trials
- A Randomized, Double-Blind, Efficacy and Safety Study of AR 14 (AZILSARTAN MEDOXOMIL) Treatment and Withdrawal, Followed by an Open-Label Extension, in Children 6 to Less Than 18 Years of Age With Hyp (Phase 3)
- A Randomized, Open-label, Single-dose, Two-treatment, Two-sequence, Two-period, Crossover Bioequivalence Study of Test Losartan Potassium Tablets (Containing Losartan Potassium 100 mg) of Pharmtechnol (Phase 1)
- Is There an Adverse Drug Reaction Between Renin-Angiotensin System Blockade and Inhaled Anesthetics? - A Pilot Study. Optional Deoxyribo-Nucleic Acid Donation for the Study of Hypertension. (Phase 4)
- An Open Label, Single Arm Prospective Study to Evaluate Efficacy and Safety of Losartan Based Therapy Reslio® (Losartan) and Resilo-h® (Losartan+Hydrochlorthiazide) in Diabetic and Uncontrolled Hypert (Phase 4)
- The Effects of Losartan and Spironolactone on Residual Renal Function Preservation in Peritoneal Dialysis Patients (NA)
- A 12-week Multicenter, Randomized, Double-blind, Parallel-group, Active-control Study to Evaluate the Antihypertensive Efficacy and Safety of Valsartan/Amlodipine-based Regimen Versus a Losartan-based (Phase 4)
- A Phase III, Randomized, Active-Comparator Controlled Clinical Trial to Study the Efficacy and Safety of MK-0954E in Japanese Patients With Essential Hypertension Uncontrolled With Losartan and Amlodi (Phase 3)
- Development of Cocktail for Measuring the Activity of Important Cytochrome P450 Enzymes (NA)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Cozaar CI brief — competitive landscape report
- Cozaar updates RSS · CI watch RSS
- Merck & Co. portfolio CI