OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE (amlodipine besylate)
This combination medication treats high blood pressure and is used to help patients reduce their risk of serious cardiovascular events like strokes and heart attacks. It is often prescribed when a single medication is not enough to reach blood pressure goals. Managing blood pressure with this therapy is typically part of a larger strategy that includes diet, exercise, and the management of other health conditions.
How OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE Works
This drug works by combining three different methods to lower blood pressure: relaxing blood vessels by blocking calcium, preventing vessel constriction by blocking angiotensin II, and reducing fluid volume through the excretion of salt and water in the kidneys. Together, these actions decrease the pressure within the vascular system.
Details
- Status
- Prescription
- First Approved
- 2016-10-26
- Routes
- ORAL
- Dosage Forms
- TABLET
Companies
OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE Approval History
What OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE Treats
3 indicationsOLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE 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, AMLODIPINE AND HYDROCHLOROTHIAZIDE Boxed Warning
FETAL TOXICITY • When pregnancy is detected, discontinue olmesartan medoxomil, amlodipine and hydrochlorothiazide tablets as soon as possible. ( 5.1 , 8.1 ) • Drugs that act directly on the renin-angiotensin system (RAS) 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, amlodipine and hydrochlorothiazide tablets as soon as possible (...
WARNING: FETAL TOXICITY • When pregnancy is detected, discontinue olmesartan medoxomil, amlodipine and hydrochlorothiazide tablets as soon as possible. ( 5.1 , 8.1 ) • Drugs that act directly on the renin-angiotensin system (RAS) 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, amlodipine and hydrochlorothiazide 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, AMLODIPINE AND HYDROCHLOROTHIAZIDE 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, AMLODIPINE AND HYDROCHLOROTHIAZIDE's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE treats. First-in-class if their pivotal trials read out positive.
Drugs Similar to OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE
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 |
|---|---|---|---|---|
| NCT04434664 BLOCK HFpEF results posted | 833517 | Ph 4 | completed | BLOCKade of Calcium Channels and Beta Adrenergic Receptors for the Treatment of Hypertension in HFpEF |
| NCT04974138 CSPPT2-CC/CT | CSPPT2-CC/CT_2020 | Ph 4 | recruiting | China Stroke Primary Prevention Trial 2 for Participants With H-type Hypertension and MTHFR 677 CC/CT Genotype (CSPPT2-CC/CT) |
| NCT04974151 CSPPT2-TT | CSPPT2-TT_2020 | Ph 4 | recruiting | China Stroke Primary Prevention Trial 2 for Participants With Hypertension and MTHFR 677 TT Genotype |
| NCT05275907 | STU00215781 1R56HL155093-01 | Ph 4 | withdrawn | Mechanism of Hypertension Treatments in Liver Transplant Recipients (BLOCK LTR-HTN) |
| NCT02940548 NARRAS | 2016PHB013-02 | Ph 4 | terminated | Nifedipine GITS and Amlodipine Besylate on Recovery of Blood Pressure Rhythm and Arterial Stiffness |
| NCT01302691 results posted | 0954E-357 | Ph 3 | completed | MK-0954E Study in Participants With Hypertension (MK-0954E-357) |
| NCT02353806 results posted | 042014-059 UL1TR001105 | Ph 4 | completed | Pharmacokinetics of Amlodipine Besylate at Delivery and During Lactation |
| NCT01556997 PATH results posted | X985400 | Ph 3 | completed | Perindopril Amlodipine for the Treatment of 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.
OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE FDA Label Details
Indications & Usage
FDA Label (PDF)OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE is indicated for the treatment of Hypertension; Stroke; Myocardial Infarction.
WARNING: FETAL TOXICITY • When pregnancy is detected, discontinue olmesartan medoxomil, amlodipine and hydrochlorothiazide tablets as soon as possible. ( 5.1 , 8.1 ) • Drugs that act directly on the renin-angiotensin system (RAS) can cause injury and death to the developing fetus. ( 5.1 , 8.1 ) WARN...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.