AMLODIPINE BESYLATE AND VALSARTAN (amlodipine besylate)
AMLODIPINE BESYLATE AND VALSARTAN is indicated for the treatment of Hypertension; Coronary Artery Disease; Angina.
How AMLODIPINE BESYLATE AND VALSARTAN Works
Amlodipine is a dihydropyridine calcium antagonist that inhibits the transmembrane influx of calcium ions into vascular smooth muscle and cardiac muscle. It exhibits greater selectivity for vascular smooth muscle cells than cardiac muscle cells. By acting directly on vascular smooth muscle, it functions as a peripheral arterial vasodilator, reducing peripheral vascular resistance and lowering blood pressure. Its antianginal effects are attributed to a reduction in the heart's total peripheral resistance (afterload) and the prevention of coronary artery constriction. Due to its unique receptor binding kinetics, amlodipine is characterized by a gradual onset of action and a prolonged effect.
Details
- Status
- Prescription
- First Approved
- 2013-03-28
- Routes
- ORAL
- Dosage Forms
- TABLET
Companies
AMLODIPINE BESYLATE AND VALSARTAN Approval History
What AMLODIPINE BESYLATE AND VALSARTAN Treats
3 indicationsAMLODIPINE BESYLATE AND VALSARTAN is approved for 3 conditions since its original approval in 2013. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Hypertension
- Coronary Artery Disease
- Angina
AMLODIPINE BESYLATE AND VALSARTAN 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.
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 AMLODIPINE BESYLATE AND VALSARTAN's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications AMLODIPINE BESYLATE AND VALSARTAN treats. First-in-class if their pivotal trials read out positive.
Drugs Similar to AMLODIPINE BESYLATE AND VALSARTAN
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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.
AMLODIPINE BESYLATE AND VALSARTAN FDA Label Details
Indications & Usage
AMLODIPINE BESYLATE AND VALSARTAN is indicated for the treatment of Hypertension; Coronary Artery Disease; Angina.
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.