AZILSARTAN MEDOXOMIL AND CHLORTHALIDONE (azilsartan kamedoxomil)
Edarbyclor treats high blood pressure to help lower the risk of serious cardiovascular events like strokes and heart attacks. It is used for patients who haven't reached their blood pressure goals with a single medication or as a starting option for those likely to need multiple drugs. Managing blood pressure with this combination is part of a broader approach to cardiovascular health that may include diet
Development Insights
Details
- Status
- Prescription
- First Approved
- 2025-01-21
- Routes
- ORAL
- Dosage Forms
- TABLET
AZILSARTAN MEDOXOMIL AND CHLORTHALIDONE Approval History
What AZILSARTAN MEDOXOMIL AND CHLORTHALIDONE Treats
2 indicationsAZILSARTAN MEDOXOMIL AND CHLORTHALIDONE is approved for 2 conditions since its original approval in 2025. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Hypertension
- Myocardial Infarction
AZILSARTAN MEDOXOMIL AND CHLORTHALIDONE 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 )
AZILSARTAN MEDOXOMIL AND CHLORTHALIDONE 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 AZILSARTAN MEDOXOMIL AND CHLORTHALIDONE's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications AZILSARTAN MEDOXOMIL AND CHLORTHALIDONE treats. First-in-class if their pivotal trials read out positive.
Drugs Similar to AZILSARTAN MEDOXOMIL AND CHLORTHALIDONE
3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
6 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT01309828 results posted | TAK-491CLD_309 2010-023098-21, U1111-1119-5131 | Ph 3 | completed | Long-Term Safety of Azilsartan Medoxomil and Chlorthalidone Compared to Olmesartan Medoxomil and Hydrochlorothiazide in Participants With Hypertension and Kidney Disease |
| NCT00996281 results posted | TAK-491CLD_308 2008-008260-28, U1111-1111-7891 | Ph 3 | completed | Safety and Tolerability of Azilsartan Medoxomil Plus Chlorthalidone Compared to Olmesartan Medoxomil Plus Hydrochlorothiazide in Participants With Essential Hypertension |
| NCT00846365 results posted | TAK-491CLD_301 U1111-1112-4287 | Ph 3 | completed | Efficacy and Safety of Azilsartan Medoxomil Plus Chlorthalidone in Participants With Moderate to Severe Hypertension |
| NCT00847626 results posted | TAK-491CLD_302 2008-004218-28, U1111-1113-8735 | Ph 3 | completed | Efficacy and Safety of Azilsartan Medoxomil Combined With Chlorthalidone in Participants With Moderate to Severe Hypertension |
| NCT00818883 results posted | TAK-491CLD_306 U1111-1112-7119 | Ph 3 | completed | Efficacy and Safety of Azilsartan Medoxomil and Chlorthalidone in Participants With Moderate to Severe Hypertension |
| NCT01033071 results posted | TAK-491CLD_303 U1111-1112-4298 | Ph 3 | completed | Efficacy and Safety of Azilsartan Medoxomil and Chlorthalidone Compared to Olmesartan Medoxomil and Hydrochlorothiazide in Participants With Moderate to Severe Hypertension. |
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.
AZILSARTAN MEDOXOMIL AND CHLORTHALIDONE FDA Label Details
Indications & Usage
AZILSARTAN MEDOXOMIL AND CHLORTHALIDONE 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...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment