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irbesartan and irbesartan-hydrochlorothiazide
irbesartan and irbesartan-hydrochlorothiazide is a Angiotensin II receptor blocker (ARB) / Thiazide diuretic combination Small molecule drug developed by Sanofi. It is currently FDA-approved for Hypertension (irbesartan monotherapy and combination), Diabetic nephropathy in patients with type 2 diabetes and hypertension (irbesartan monotherapy).
Irbesartan blocks angiotensin II type 1 receptors to relax blood vessels and lower blood pressure; the combination formulation adds hydrochlorothiazide, a thiazide diuretic that reduces fluid volume.
Irbesartan blocks angiotensin II type 1 receptors to relax blood vessels and lower blood pressure; the combination formulation adds hydrochlorothiazide, a thiazide diuretic that reduces fluid volume. Used for Hypertension (irbesartan monotherapy and combination), Diabetic nephropathy in patients with type 2 diabetes and hypertension (irbesartan monotherapy).
At a glance
| Generic name | irbesartan and irbesartan-hydrochlorothiazide |
|---|---|
| Sponsor | Sanofi |
| Drug class | Angiotensin II receptor blocker (ARB) / Thiazide diuretic combination |
| Target | AT1 receptor (angiotensin II type 1 receptor); sodium-chloride cotransporter (thiazide target) |
| Modality | Small molecule |
| Therapeutic area | Cardiovascular |
| Phase | FDA-approved |
Mechanism of action
Irbesartan is an angiotensin II receptor blocker (ARB) that selectively antagonizes AT1 receptors, preventing angiotensin II-mediated vasoconstriction and aldosterone release. Hydrochlorothiazide enhances this effect by inhibiting sodium reabsorption in the distal convoluted tubule, reducing blood volume and further lowering blood pressure. The combination provides complementary mechanisms for improved antihypertensive efficacy.
Approved indications
- Hypertension (irbesartan monotherapy and combination)
- Diabetic nephropathy in patients with type 2 diabetes and hypertension (irbesartan monotherapy)
Common side effects
- Dizziness
- Fatigue
- Musculoskeletal pain
- Hyperkalemia
- Hypotension
- Hypokalemia (with combination formulation)
- Hyperuricemia (with thiazide component)
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 and irbesartan-hydrochlorothiazide CI brief — competitive landscape report
- irbesartan and irbesartan-hydrochlorothiazide updates RSS · CI watch RSS
- Sanofi portfolio CI
Frequently asked questions about irbesartan and irbesartan-hydrochlorothiazide
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Related
- Drug class: All Angiotensin II receptor blocker (ARB) / Thiazide diuretic combination drugs
- Target: All drugs targeting AT1 receptor (angiotensin II type 1 receptor); sodium-chloride cotransporter (thiazide target)
- Manufacturer: Sanofi — full pipeline
- Therapeutic area: All drugs in Cardiovascular
- Indication: Drugs for Hypertension (irbesartan monotherapy and combination)
- Indication: Drugs for Diabetic nephropathy in patients with type 2 diabetes and hypertension (irbesartan monotherapy)
- Compare: irbesartan and irbesartan-hydrochlorothiazide vs similar drugs
- Pricing: irbesartan and irbesartan-hydrochlorothiazide cost, discount & access