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Edarbi (AZILSARTAN MEDOXOMIL)
Azilsartan blocks angiotensin II's vasoconstrictor and aldosterone-secreting effects by selectively binding to the AT1 receptor.
At a glance
| Generic name | AZILSARTAN MEDOXOMIL |
|---|---|
| Sponsor | Arbor Pharms Ireland |
| Drug class | Angiotensin 2 Receptor Blocker |
| Target | AT1 receptor |
| Modality | Small molecule |
| Therapeutic area | Cardiovascular |
| Phase | FDA-approved |
| First approval | 2011 |
Mechanism of action
Azilsartan works by blocking the effects of angiotensin II, a hormone that causes blood vessels to narrow and increases blood pressure. By binding to the AT1 receptor, azilsartan prevents these effects, leading to lower blood pressure.
Approved indications
- Hypertensive disorder
Boxed warnings
- WARNING: FETAL TOXICITY When pregnancy is detected, discontinue Edarbi 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 Edarbi 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
- diarrhea
Key clinical trials
- Association of Angiotensin-Converting Enzyme Inhibitors and Angiotensin Receptor Blockers With Post-Stroke Pneumonia: A Real-World Retrospective Cohort Study
- A Study of Azilsartan in Children From 6 to Less Than 16 Years Old With High Blood Pressure
- Bioequivalence Study of Azilsartan Medoxomil 80 mg Tablets (Gedeon Richter Plc., Hungary) and Edarbi® 80 mg Tablets (JSC Nizhpharm, Russia) (PHASE1)
- An Efficacy and Safety Study in Children 6 to Less Than 18 Years of Age With Hypertension (PHASE3)
- Effect of Sacubitril/Valsartan on Cardiac Function in Hypertensive Patients Stratified by BMI: A Real World Study
- A Study of TAK-536 in Children From 2 to Less Than 6 Years Old With High Blood Pressure (PHASE3)
- Drug-Drug Interaction Study Between HUC2-565-A and HUC2-565-B (PHASE1)
- Efficacy and Safety of Mexartan Potassium Tablets (AZL-M) and Calcium Channel Blockers (CCB) in the Treatment of Adults With Essential Hypertension in Chinese Population: a National Multicenter, Prospective, Observational Study
Patents
| Patent | Expiry | Type |
|---|---|---|
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 |
| FDA Orange Book | Patents + exclusivity |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Edarbi CI brief — competitive landscape report
- Edarbi updates RSS · CI watch RSS
- Arbor Pharms Ireland portfolio CI