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Irbesartan and Hydrochlorothiazide
Irbesartan blocks the vasoconstrictor and aldosterone-secreting effects of angiotensin II by binding to the AT1 receptor.
Irbesartan and Hydrochlorothiazide, marketed by Roxane Laboratories, is a combination therapy indicated for hypertension. The drug's mechanism of action, which involves blocking the vasoconstrictor and aldosterone-secreting effects of angiotensin II, provides a strong therapeutic profile for managing blood pressure. The key composition patent expires in 2028, posing a significant risk of increased generic competition.
At a glance
| Generic name | Irbesartan and Hydrochlorothiazide |
|---|---|
| Sponsor | Roxane Laboratories |
| Drug class | Thiazide Diuretic [EPC] |
| Target | AT1 angiotensin II receptor |
| Modality | Small molecule |
| Phase | FDA-approved |
Mechanism of action
Irbesartan works by blocking the effects of angiotensin II, a potent vasoconstrictor that increases blood pressure and stimulates aldosterone production. By binding to the AT1 receptor, irbesartan prevents these effects, leading to lower blood pressure.
Approved indications
- Hypertension
- Initial Therapy for Hypertension
Boxed warnings
- WARNING: FETAL TOXICITY When pregnancy is detected, discontinue AVALIDE as soon as possible [see Warnings and Precautions (5.1) and Use in Specific Populations (8.1) ] . Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus [see Warnings and Precautions (5.1) and Use in Specific Populations (8.1) ] . WARNING: FETAL TOXICITY See full prescribing information for complete boxed warning. When pregnancy is detected, discontinue AVALIDE as soon as possible. ( 5.1 , 8.1 ) Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus. ( 5.1 , 8.1 )
Common side effects
- Chest Pain
- Fatigue
- Influenza
- Edema
- Tachycardia
- Abdominal Pain
- Dyspepsia/heartburn
- Nausea/vomiting
- Allergy
- Musculoskeletal Pain
- Dizziness
- Dizziness Orthostatic
Drug interactions
- NSAIDs and selective COX-2 inhibitors
- Dual blockade of the renin-angiotensin system (RAS)
- Antidiabetic drugs
- Cholestyramine and colestipol
- Lithium
- Carbamazepine
- Agents increasing serum potassium
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 Hydrochlorothiazide CI brief — competitive landscape report
- Irbesartan and Hydrochlorothiazide updates RSS · CI watch RSS
- Roxane Laboratories portfolio CI