AZOR (amlodipine besylate)
AZOR is indicated for the treatment of Hypertension; Stroke; Myocardial Infarction.
How AZOR Works
Azor utilizes two distinct mechanisms of action to reduce blood pressure. The amlodipine component is a dihydropyridine calcium antagonist that inhibits the transmembrane influx of calcium ions into vascular smooth muscle and cardiac muscle, resulting in peripheral arterial vasodilation. The olmesartan medoxomil component is an ARB that selectively blocks the binding of angiotensin II to the AT₁ receptor in vascular smooth muscle, inhibiting its potent vasoconstrictor effects. Together, these components reduce systemic vascular resistance and blood pressure more effectively than either component alone.
Details
- Status
- Prescription
- First Approved
- 2007-09-26
- Routes
- ORAL
- Dosage Forms
- TABLET
AZOR Approval History
What AZOR Treats
3 indicationsAZOR is approved for 3 conditions since its original approval in 2007. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Hypertension
- Stroke
- Myocardial Infarction
AZOR Boxed Warning
FETAL TOXICITY When pregnancy is detected, discontinue Azor 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 Azor 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...
WARNING: FETAL TOXICITY When pregnancy is detected, discontinue Azor 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 Azor 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 ).
AZOR Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
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 AZOR's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications AZOR treats. First-in-class if their pivotal trials read out positive.
Drugs Similar to AZOR
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.
AZOR FDA Label Details
Indications & Usage
FDA Label (PDF)AZOR is indicated for the treatment of Hypertension; Stroke; Myocardial Infarction.
WARNING: FETAL TOXICITY When pregnancy is detected, discontinue Azor 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 complet...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.