BENICAR (olmesartan medoxomil)
Benicar treats high blood pressure in adults and children aged six and older. By lowering blood pressure, it helps patients reduce their risk of suffering from cardiovascular events such as strokes and heart attacks. It is often used as one component of a comprehensive health plan that includes lifestyle changes like exercise and diet.
How BENICAR Works
This medication works by blocking angiotensin II from binding to AT1 receptors in the vascular smooth muscle. By preventing this binding, the drug stops the vasoconstriction and sodium reabsorption typically triggered by the renin-angiotensin system. This allows blood vessels to relax, which results in lower blood pressure.
Development Insights
Details
- Status
- Prescription
- First Approved
- 2002-04-25
- Routes
- ORAL
- Dosage Forms
- TABLET
BENICAR Approval History
What BENICAR Treats
1 indicationsBENICAR is approved for 1 conditions since its original approval in 2002. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Hypertension
BENICAR Boxed Warning
FETAL TOXICITY When pregnancy is detected, discontinue Benicar 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). WARNING: FETAL TOXICITY See full prescribing information for complete boxed warning. When pregnancy is detected, discontinue Benicar 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...
WARNING: FETAL TOXICITY When pregnancy is detected, discontinue Benicar 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). WARNING: FETAL TOXICITY See full prescribing information for complete boxed warning. When pregnancy is detected, discontinue Benicar 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 ).
BENICAR 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 BENICAR's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications BENICAR treats. First-in-class if their pivotal trials read out positive.
Drugs Similar to BENICAR
3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
9 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT07547878 RAPID-CKD | 026-271 | Ph 4 | not yet recruiting | Rapid and Simultaneous Initiation of Four Guideline-Directed CKD Therapies (RAPID-CKD) |
| NCT00649389 results posted | CS8635-A-U301 | Ph 3 | completed | Safety and Efficacy Study of a Triple Combination Therapy in Subjects With Hypertension |
| NCT01132768 CONFIRM | DSE-OLM-01-09 | Ph 4 | terminated | The Confirmatory Olmesartan Plaque Regression Study |
| NCT00676845 ArtStiff | DSE-866/47 2007-003131-23 EudraCT number | Ph 3 | completed | Study to Determine if Olmesartan Medoxomil Has the Potential to Benefit the Cardiovascular System in Terms of Arterial Protection |
| NCT01684748 ARB results posted | arbfat | Ph 4 | completed | Angiotensin II Blockade and Inflammation in Obesity |
| NCT02495324 FAST | BR-FVO-CT-401 | Ph 4 | completed | Fimasartan Achieving SBP Target (FAST) Study |
| NCT01611077 Sevicontrol-2 | Sevicontrol-2 | Ph 4 | completed | Efficacy and Safety of a Therapy Change From Candesartan 32 mg to Fixed Combination of Olmesartan 40 mg/Amlodipine 10 mg |
| NCT01907373 | 200704 | Ph 4 | completed | Drug Interaction Study of Olmesartan in Healthy Chinese Volunteers |
| NCT00949884 results posted | CS0866-A-U452 | Ph 4 | completed | Olmesartan Comparison to Losartan in Hypertensive Subjects |
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.
BENICAR FDA Label Details
Indications & Usage
FDA Label (PDF)BENICAR is indicated for the treatment of Hypertension.
WARNING: FETAL TOXICITY When pregnancy is detected, discontinue Benicar 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). WARNING: FETAL TOXICITY See full prescribing information for complete boxed w...
Track BENICAR with TheraRadar Pro
Watchlist alerts, full database access, CSV exports across 14,000+ drugs.
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