AZILSARTAN MEDOXOMIL (azilsartan kamedoxomil)
Azilsartan medoxomil tablets are indicated for the treatment of hypertension in adults, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes, including the class to which this drug principally belongs.
Development Insights
Details
- Status
- Prescription
- First Approved
- 2022-07-20
- Routes
- ORAL
- Dosage Forms
- TABLET
AZILSARTAN MEDOXOMIL Approval History
What AZILSARTAN MEDOXOMIL Treats
1 FDA approvalsOriginally approved for its first indication in 2022 .
- Other (1)
Other
(1 approval)- • Approved indication (Jul 2022)Letter
AZILSARTAN MEDOXOMIL Boxed Warning
FETAL TOXICITY When pregnancy is detected, discontinue azilsartan medoxomil tablets 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 az...
WARNING: FETAL TOXICITY When pregnancy is detected, discontinue azilsartan medoxomil tablets 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 azilsartan medoxomil tablets 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 )
Clinical Trial Registry
7 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT02480764 results posted | TAK-491_305 U1111-1159-5579 | Ph 3 | completed | Azilsartan Medoxomil (TAK-491) Compared to Valsartan in Chinese Participants With Hypertension |
| NCT02517866 results posted | AZI-P4-002 U1111-1156-8501 | Ph 4 | completed | Azilsartan Medoxomil in the Treatment of Essential Hypertension and Type 2 Diabetes in Asia |
| NCT02203916 results posted | TAK-491_307 U1111-1130-9186 | Ph 3 | completed | Azilsartan Medoxomil (TAK-491) Compared to Placebo in Korean Adults With Hypertension |
| NCT01496430 results posted | TAK-491_304 U1111-1125-1197 | Ph 3 | terminated | Efficacy and Safety of Azilsartan Medoxomil Used in Combination With Metformin in Participants With Hypertension and Diabetes |
| NCT00760214 results posted | 01-06-TL-491-020 2007-002583-10, U1111-1113-8982 | Ph 3 | completed | Efficacy and Safety Study of Azilsartan Medoxomil Compared to Ramipril for Treating Essential 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 |
| NCT00696436 results posted | 01-06-TL-491-019 U1111-1113-9161 | Ph 3 | completed | An Efficacy and Safety Study of Azilsartan Medoxomil Compared to Valsartan and Olmesartan in Participants With Essential 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 FDA Label Details
Indications & Usage
Azilsartan medoxomil tablets are indicated for the treatment of hypertension in adults, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes, including the class to which this drug principally belongs. There are no controlled trials demonstrating risk reduction with azilsartan medoxomil tablets. Control of high blood pressure should be part of comprehensive cardiovascular...
WARNING: FETAL TOXICITY When pregnancy is detected, discontinue azilsartan medoxomil tablets 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...
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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