EDARBYCLOR (azilsartan kamedoxomil)
EDARBYCLOR is indicated for the treatment of Hypertension; Myocardial Infarction.
How EDARBYCLOR Works
Edarbyclor combines two antihypertensive agents with complementary mechanisms. **Azilsartan medoxomil** is a prodrug rapidly hydrolyzed to **azilsartan**, which selectively blocks the binding of angiotensin II to the **AT1 receptor**, thereby inhibiting vasoconstriction and aldosterone secretion. **Chlorthalidone** is a long-acting thiazide-like diuretic that promotes sodium and water excretion, reducing extracellular fluid volume and peripheral vascular resistance. Together, these components target distinct pathways of blood pressure regulation to provide additive efficacy.
Details
- Status
- Prescription
- First Approved
- 2011-12-20
- Patent Cliff
- 2031
- Routes
- ORAL
- Dosage Forms
- TABLET
EDARBYCLOR Approval History
What EDARBYCLOR Treats
2 indicationsEDARBYCLOR is approved for 2 conditions since its original approval in 2011. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Hypertension
- Myocardial Infarction
EDARBYCLOR Boxed Warning
FETAL TOXICITY When pregnancy is detected, discontinue Edarbyclor 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 EDARBYCLOR as soon as possib...
WARNING: FETAL TOXICITY When pregnancy is detected, discontinue Edarbyclor 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 EDARBYCLOR 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 )
EDARBYCLOR Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Direct competitors
Same target(s) AND same indication — head-to-head.
MoA expansion candidates
Same target(s), different indications — where else is this mechanism being explored?
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
What's emerging in EDARBYCLOR's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications EDARBYCLOR treats. First-in-class if their pivotal trials read out positive.
Drugs Similar to EDARBYCLOR
3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
EDARBYCLOR FDA Label Details
Indications & Usage
FDA Label (PDF)EDARBYCLOR is indicated for the treatment of Hypertension; Myocardial Infarction.
WARNING: FETAL TOXICITY When pregnancy is detected, discontinue Edarbyclor 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 Pre...
Pro Intelligence Preview
Deep insights for EDARBYCLOR
Revenue Insights
- • Quarterly revenue tracking
- • Historical trend analysis
Patent Timeline
- • Cliff: 2031
- • 12 active patents
Trial Analysis
- • Clinical trial tracking
- • Development stage analysis
Competitive Landscape
- • 20 similar drugs
- • Same target/indication analysis
Full approval history • All patents • Revenue trends • Competitor analysis
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.