AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM (amlodipine besylate)
This combination product is indicated for patients requiring concurrent
How AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM Works
The amlodipine component works by blocking calcium ions from entering vascular and cardiac muscle cells, which relaxes blood vessels and reduces peripheral resistance to lower blood pressure. Meanwhile, atorvastatin targets the HMG-CoA reductase enzyme to inhibit the production of mevalonate, a necessary precursor for the body to create cholesterol.
Details
- Status
- Prescription
- First Approved
- 2013-11-29
- Routes
- ORAL
- Dosage Forms
- TABLET
Companies
AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM Approval History
What AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM Treats
4 indicationsAMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM is approved for 4 conditions since its original approval in 2013. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Hypertension
- Coronary Artery Disease
- Cardiovascular Disease
- Hyperlipidemia
AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM 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 AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM treats. First-in-class if their pivotal trials read out positive.
Drugs Similar to AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM
3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
20 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT03753555 INSIST-HRMRI | k（2018）44 | Ph 4 | recruiting | The Effect of InTensive Statin in Ischemic Stroke With inTracranial Atherosclerotic Plaques |
| NCT04434664 BLOCK HFpEF results posted | 833517 | Ph 4 | completed | BLOCKade of Calcium Channels and Beta Adrenergic Receptors for the Treatment of Hypertension in HFpEF |
| NCT04767984 | NCI 20-02-02 P30CA060553, UG1CA242643 | Ph 2 | active not recruiting | Testing Atorvastatin to Lower Colon Cancer Risk in Longstanding Ulcerative Colitis |
| NCT05826912 APT-TBI-01 | APT-TBI-01 | Ph 2 | enrolling by invitation | Multi-Arm Multi-Stage Adaptive Platform Trial (APT) for the Acute Treatment of Traumatic Brain Injury |
| NCT06081166 | TA-8995-11 | Ph 1 | completed | A Drug-drug Interaction Study Evaluating the PK Effects of Obicetrapib on Atorvastatin and Rosuvastatin |
| 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) |
| NCT01665677 results posted | PRO00021090 WVU 011012, 116837-IRG-09-061-01 | Ph 2 | completed | Atorvastatin as GVHD Prophylaxis for Allogeneic Hematopoietic Cell Transplantation |
| NCT05583643 | FWA00025577 | Ph 1 | completed | Clinical & Biochemical Effect of Atorvastatin in Nano Particles Gel in Periodontitis Treatment |
| NCT02940548 NARRAS | 2016PHB013-02 | Ph 4 | terminated | Nifedipine GITS and Amlodipine Besylate on Recovery of Blood Pressure Rhythm and Arterial Stiffness |
| NCT01527045 results posted | 2546.00 NCI-2011-03828, 2546.00 | Ph 2 | completed | Donor Atorvastatin Treatment in Preventing Severe Acute GVHD After Nonmyeloablative Peripheral Blood Stem Cell Transplant in Patients With Hematological Malignancies |
| 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 |
| NCT00687271 results posted | 6213-006 2007_514, 2007-003684-41 | Ph 2 | completed | A Study of MK-6213 Co-Administered With Atorvastatin in Participants With Hypercholesterolemia (MK-6213-006) |
| NCT01050348 IMPRES | 09-004 / WPCI 2009-08 | Ph 4 | completed | To Investigate the Role of Upstream High Dose Statin in STEMI |
| NCT01220973 results posted | 0220090006, 080811 0220090006, NCI-2012-00540 | Ph 2 | completed | Atorvastatin Calcium and Celecoxib in Treating Patients With Rising PSA Levels After Local Therapy for Prostate Cancer |
| NCT01525407 results posted | 2545.00 NCI-2011-03827, 2545.00 | Ph 2 | completed | Donor Atorvastatin Treatment for Preventing Severe Acute Graft-Versus-Host Disease in Patients Undergoing Myeloablative Peripheral Blood Stem Cell Transplantation |
| NCT00637481 | NCI-2009-00859 NCI-2009-00859, CDR0000653466 | Ph 1 | completed | A Phase I Prevention Study of Atorvastatin in Women at Increased Risk for Breast Cancer |
| 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 ATORVASTATIN CALCIUM FDA Label Details
Indications & Usage
AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM is indicated for the treatment of Hypertension; Coronary Artery Disease; Cardiovascular Disease; Hyperlipidemia.
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.