Last reviewed · How we verify
Cleviprex (CLEVIDIPINE)
Cleviprex works by blocking calcium channels in blood vessel walls, causing them to relax and lower blood pressure.
Cleviprex (clevidipine) is a dihydropyridine calcium channel blocker developed by Medicines Co and currently owned by Chiesi. It targets the voltage-dependent L-type calcium channel subunit alpha-1C to treat hypertensive disorders. Cleviprex is a small molecule modality that was FDA-approved in 2008 and remains a branded product. Key safety considerations include its short half-life of 0.3 hours, which may require frequent dosing. As a patented product, Cleviprex is not yet available as a generic.
At a glance
| Generic name | CLEVIDIPINE |
|---|---|
| Sponsor | Chiesi |
| Drug class | Dihydropyridine Calcium Channel Blocker [EPC] |
| Target | Voltage-dependent L-type calcium channel subunit alpha-1C |
| Modality | Small molecule |
| Therapeutic area | Cardiovascular |
| Phase | FDA-approved |
| First approval | 2008 |
Mechanism of action
Clevidipine is dihydropyridine L-type calcium channel blocker. L-type calcium channels mediate the influx of calcium during depolarization in arterial smooth muscle. Experiments in anesthetized rats and dogs show that clevidipine reduces mean arterial blood pressure by decreasing systemic vascular resistance. Clevidipine does not reduce cardiac filling pressure (pre-load), confirming lack of effects on the venous capacitance vessels.
Approved indications
- Hypertensive disorder
Common side effects
- Acute renal failure
- Atrial fibrillation
- Nausea
- Vomiting
- Headache
- Hypotension
- Increased blood triglycerides
- Ileus
- Hypersensitivity
- Decreased oxygen saturation
- Reflex tachycardia
- Myocardial infarction
Key clinical trials
- Clevidipine for the Antihypertensive Treatment of Acute Intracerebral Hemorrhage
- Association of Angiotensin-Converting Enzyme Inhibitors and Angiotensin Receptor Blockers With Post-Stroke Pneumonia: A Real-World Retrospective Cohort Study
- Assessment of Efficacy, Safety and Dosing of Clevidipine in Pediatric Participants Undergoing Surgery (PIONEER) (PHASE4)
- Clevidipine Infusion for Blood Pressure Management After Successful Revascularization in Acute Ischemic Stroke (PHASE3)
- Effect of Treatment of Pre-induction Hypertension on Hemodynamic Stability During Induction of General Anesthesia (PHASE4)
- a Study Evaluating the Safety and Efficacy of Clevidipine for Patients Who With Hypertensive Emergency and Sub-emergency (PHASE3)
- A Study of Clevidipine Butyrate Injectable Emulsion in the Treatment of Hypertensive Emergency and Sub-emergency (PHASE3)
- Safety and Efficacy Study of Clevidipine to Control Hypertension in Patients Admitted With Aneurysmal Subarachnoid Hemorrhage (PHASE2)
Patents
| Patent | Expiry | Type |
|---|---|---|
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
| FDA Orange Book | Patents + exclusivity |