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Avapro (IRBESARTAN HYDROCHLORIDE)
Avapro works by blocking the action of angiotensin II, a hormone that constricts blood vessels and increases blood pressure.
At a glance
| Generic name | IRBESARTAN HYDROCHLORIDE |
|---|---|
| Sponsor | Sanofi |
| Drug class | Angiotensin 2 Receptor Blocker [EPC] |
| Target | Type-1 angiotensin II receptor |
| Modality | Small molecule |
| Therapeutic area | Metabolic |
| Phase | FDA-approved |
| First approval | 1997 |
Mechanism of action
Mechanism of Action. Angiotensin II is potent vasoconstrictor formed from angiotensinI in reaction catalyzed by angiotensin-converting enzyme (ACE, kininaseII). Angiotensin II is the principal pressor agent of the renin-angiotensinsystem (RAS) and also stimulates aldosterone synthesis and secretion by adrenalcortex, cardiac contraction, renal resorption of sodium, activity of the sympatheticnervous system, and smooth muscle cell growth. Irbesartan blocks the vasoconstrictorand aldosterone-secreting effects of angiotensin II by selectively bindingto the AT1 angiotensin II receptor. There is also anAT2 receptor in many tissues, but it is not involvedin cardiovascular homeostasis.Irbesartan is specific competitive antagonist of AT1 receptorswith much greater affinity (more than 8500-fold) for the AT1 receptorthan for the AT2 receptor and no agonist activity.Blockade of the AT1 receptor removes thenegative feedback of angiotensin II on renin secretion, but the resultingincreased plasma ren
Approved indications
- Diabetic renal disease
- Hypertensive disorder
Boxed warnings
- WARNING: FETAL TOXICITY When pregnancy is detected, discontinue AVAPRO 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 AVAPRO 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
- Hyperkalemia
- Dizziness
- Orthostatic hypotension
- Fatigue
- Diarrhea
- Cough
- Dyspepsia/heartburn
- Urticaria
- Angioedema
- Anaphylactic reaction
- Anaphylactic shock
- Jaundice
Drug interactions
- lithium
- spironolactone
- triamterene
Key clinical trials
- Randomized, Embedded, Multifactorial Adaptive Platform Trial for Community- Acquired Pneumonia (PHASE3)
- Multiple Treatments for Ebola Virus Disease (EVD) (PHASE1,PHASE2)
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:
- Avapro CI brief — competitive landscape report
- Avapro updates RSS · CI watch RSS
- Sanofi portfolio CI