CADUET (amlodipine besylate)
Caduet is a fixed-dose combination of amlodipine besylate, a dihydropyridine calcium channel blocker, and atorvastatin calcium, an HMG-CoA reductase inhibitor. It is indicated for patients who require treatment for both hypertension (or coronary artery disease) and dyslipidemia. By addressing multiple cardiovascular risk factors simultaneously, Caduet is used to reduce the risk of myocardial infarction, stroke, revascularization procedures, and angina. It is also indicated as an adjunct to diet for the reduction of elevated LDL-C, total cholesterol, and triglycerides in patients with primary hyperlipidemia or various forms of familial hypercholesterolemia.
How CADUET Works
Caduet utilizes two distinct mechanisms of action to manage cardiovascular risk: 1. **Amlodipine:** A dihydropyridine calcium channel blocker (CCB) that inhibits the transmembrane influx of calcium ions into vascular smooth muscle and cardiac muscle. This results in peripheral arterial vasodilation, which reduces peripheral vascular resistance and lowers blood pressure. In patients with angina, it improves oxygen delivery and reduces afterload. 2. **Atorvastatin:** A selective, competitive inhibitor of HMG-CoA reductase, the rate-limiting enzyme that converts 3-hydroxy-3-methylglutaryl-coenzyme A to mevalonate, a precursor of sterols including cholesterol. By inhibiting this enzyme, it reduces hepatic cholesterol synthesis and increases the number of LDL receptors on the surface of hepatocytes, leading to enhanced uptake and catabolism of LDL-C.
Development Insights
Details
- Status
- Prescription
- First Approved
- 2004-01-30
- Routes
- ORAL
- Dosage Forms
- TABLET
CADUET Approval History
What CADUET Treats
9 indicationsCADUET is approved for 9 conditions since its original approval in 2004. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Hypertension
- Coronary Artery Disease
- Myocardial Infarction
- Stroke
- Angina
- Type 2 Diabetes
- Congestive Heart Failure
- Hyperlipidemia
CADUET 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 CADUET's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications CADUET treats. First-in-class if their pivotal trials read out positive.
Drugs Similar to CADUET
3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
10 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT03860220 | STAROS | Ph 4 | completed | The Efficacy and Safety of Triple Therapy of Telmisartan/Amlodipine/Rosuvastatin |
| 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 |
| NCT01190007 results posted | A3841064 | Ph 4 | completed | Open Label Study To Evaluate The Long-Term Safety Profiles Of Caduet In Japanese Patients |
| 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.
CADUET FDA Label Details
Indications & Usage
FDA Label (PDF)CADUET is indicated for the treatment of Hypertension; Coronary Artery Disease; Myocardial Infarction; Stroke; Angina; Type 2 Diabetes; Congestive Heart Failure; Hyperlipidemia; Heterozygous Familial Hypercholesterolemia.
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment