NDAORALTABLET
Approved
Sep 1997
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
21
Data completeness
6/8 — Strong
AVAPRO (irbesartan) by Sanofi is angiotensin 2 receptor antagonists [moa]. Approved for angiotensin 2 receptor blocker [epc]. First approved in 1997.
Drug data last refreshed 8h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
AVAPRO (irbesartan) is an oral angiotensin II receptor blocker approved in 1997 for hypertension management. It works by blocking angiotensin II receptors to reduce blood pressure and protect target organs. This small-molecule antihypertensive is a foundational therapy in cardiovascular disease prevention.
$3MPart D
LOE ApproachingDeclining
Product is in managed-decline phase; commercial teams are focused on generic transition and cost-containment strategies rather than growth initiatives.
Mechanism of Action
Angiotensin 2 Receptor Antagonists
Pharmacologic Class:
Angiotensin 2 Receptor Blocker
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (21)
Pharmacokinetics of Irbesartan High/Amlodipine FDC and Co-administration of Irbesartan High and Amlodipine in Healthy Volunteers
Started Oct 2022
44 enrolled
Healthy Volunteers
Pharmacokinetics of Irbesartan/Amlodipine High FDC and Co-administration of Irbesartan and Amlodipine High in Healthy Volunteers
Started Sep 2022
44 enrolled
Healthy Volunteers
Pharmacokinetics of Irbesartan/Amlodipine FDC and Co-administration of Irbesartan and Amlodipine in Healthy Volunteers
Started Sep 2022
46 enrolled
Healthy Volunteers
Clinical Efficacy and Safety Evaluation of Irbesartan High and Amlodipine Combined Therapy in Essential Hypertension Patients
Started Jul 2022
157 enrolled
Essential Hypertension
Clinical Efficacy and Safety Evaluation of Irbesartan and Amlodipine Combined Therapy in Essential Hypertension Patients
Started Jul 2022
271 enrolled
Essential Hypertension
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.