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Irbesartan - Hydrochlorothiazide
Irbesartan blocks angiotensin II receptors to lower blood pressure, while hydrochlorothiazide is a thiazide diuretic that reduces fluid volume.
Irbesartan blocks angiotensin II receptors to lower blood pressure, while hydrochlorothiazide is a thiazide diuretic that reduces fluid volume. Used for Hypertension, Hypertension in patients with type 2 diabetes mellitus.
At a glance
| Generic name | Irbesartan - Hydrochlorothiazide |
|---|---|
| Sponsor | Sanofi |
| Drug class | Angiotensin II receptor blocker / Thiazide diuretic combination |
| Target | AT1 receptor (angiotensin II type 1 receptor) / Sodium-chloride cotransporter |
| Modality | Small molecule |
| Therapeutic area | Cardiovascular |
| Phase | FDA-approved |
Mechanism of action
Irbesartan is an angiotensin II receptor blocker (ARB) that prevents angiotensin II from binding to AT1 receptors on blood vessels and the adrenal gland, causing vasodilation and reduced aldosterone secretion. Hydrochlorothiazide is a thiazide diuretic that inhibits sodium reabsorption in the distal convoluted tubule, increasing urinary sodium and water excretion. Together, these complementary mechanisms provide additive blood pressure reduction.
Approved indications
- Hypertension
- Hypertension in patients with type 2 diabetes mellitus
Common side effects
- Dizziness
- Fatigue
- Hyperkalemia (irbesartan component)
- Hypokalemia (hydrochlorothiazide component)
- Hyperglycemia
- Hyperuricemia
- Cough
Key clinical trials
- Standardized Antihypertensive Treatment Protocol (NA)
- ACEI or ARB and COVID-19 Severity and Mortality in US Veterans
- Observational Study of Azilsartan/Chlorthalidone and Irbesartan/Hydrochlorothiazide in Hypertension and Obesity.
- Nephropathy In Type 2 Diabetes and Cardio-renal Events (PHASE4)
- Coronavirus (COVID-19) ACEi/ARB Investigation (PHASE4)
- Crossover Bioequivalence Study of Irbesartan Hydrochlorothiazide 300/25 mg Tablets Under Fed Conditions (NA)
- Crossover Bioequivalence Study of Irbesartan HCTZ 300/25 mg Tablets Under Fasted Conditions (NA)
- A Clinical Study to Compare Combination of Aliskiren+ HCTZ to Irbesartan+ HCTZ or Amlodipine+ HCTZ or HCTZ Alone in Obese Hypertensive Not Responsive to HCTZ 25 mg (PHASE3)
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 |
|---|---|
| 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:
- Irbesartan - Hydrochlorothiazide CI brief — competitive landscape report
- Irbesartan - Hydrochlorothiazide updates RSS · CI watch RSS
- Sanofi portfolio CI