OLMESARTAN MEDOXOMIL
Olmesartan medoxomil treats high blood pressure in adults and children six years of age and older. By lowering blood pressure, it helps patients reduce their risk of serious cardiovascular events like strokes and heart attacks. It is often used as part of a broader management plan that includes lifestyle changes like exercise and diet to manage overall heart health.
How OLMESARTAN MEDOXOMIL Works
This drug works by blocking the binding of angiotensin II to the AT1 receptor in vascular smooth muscle. This prevents angiotensin II from causing vasoconstriction and other effects that raise blood pressure. Unlike some other blood pressure medications, it does not interfere with the enzyme that breaks down bradykinin.
Details
- Status
- Discontinued
- First Approved
- 2016-10-26
- Routes
- ORAL
- Dosage Forms
- TABLET
Companies
OLMESARTAN MEDOXOMIL Approval History
What OLMESARTAN MEDOXOMIL Treats
3 indicationsOLMESARTAN MEDOXOMIL is approved for 3 conditions since its original approval in 2016. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Hypertension
- Stroke
- Myocardial Infarction
OLMESARTAN MEDOXOMIL Boxed Warning
FETAL TOXICITY When pregnancy is detected, discontinue olmesartan 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 ) WARNING: FETAL TOXICITY See full prescribing information for complete boxed warning. When pregnancy is detected, discontinue olmesartan medoxomil tablets as soon as possible ( 5.1 , 8.1 ). Drugs that act directly on the renin-angiotensin system can cause injury...
WARNING: FETAL TOXICITY When pregnancy is detected, discontinue olmesartan 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 ) WARNING: FETAL TOXICITY See full prescribing information for complete boxed warning. When pregnancy is detected, discontinue olmesartan 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 ).
OLMESARTAN MEDOXOMIL 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 OLMESARTAN MEDOXOMIL's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications OLMESARTAN MEDOXOMIL treats. First-in-class if their pivotal trials read out positive.
Drugs Similar to OLMESARTAN MEDOXOMIL
3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
8 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| 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.
OLMESARTAN MEDOXOMIL FDA Label Details
Indications & Usage
OLMESARTAN MEDOXOMIL is indicated for the treatment of Hypertension; Stroke; Myocardial Infarction.
WARNING: FETAL TOXICITY When pregnancy is detected, discontinue olmesartan 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 ) WARNING: FETAL TOXICITY See full prescribing informa...
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BENICAR
Full clinical data, patents, trials, and competitive landscape for olmesartan medoxomil.
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.