CLEVIPREX (clevidipine)
Cleviprex (clevidipine) is a dihydropyridine calcium channel blocker indicated for the rapid reduction of blood pressure when oral therapy is not feasible or desirable. It is designed for intravenous administration to provide controlled, titratable blood pressure management in acute settings.
How CLEVIPREX Works
Clevidipine is an L-type calcium channel blocker that inhibits the influx of extracellular calcium into arterial smooth muscle cells during depolarization. This action induces vasodilation, which reduces mean arterial blood pressure by decreasing systemic vascular resistance. Clevidipine is selective for arterial resistance vessels and does not affect venous capacitance vessels, thereby having no significant effect on cardiac filling pressure (pre-load).
Development Insights
Details
- Status
- Prescription
- First Approved
- 2008-08-01
- Patent Cliff
- 2031
- Routes
- INTRAVENOUS
- Dosage Forms
- EMULSION
CLEVIPREX Approval History
What CLEVIPREX Treats
1 FDA approvalsOriginally approved for its first indication in 2008 .
- Other (1)
Other
(1 approval)- • Approved indication (Aug 2008)Letter
CLEVIPREX Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
MoA expansion candidates
Same target(s), different indications — where else is this mechanism being explored?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
Clinical Trial Registry
13 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT01938547 PIONEER results posted | MDCO-CLV-12-01 | Ph 4 | terminated | Assessment of Efficacy, Safety and Dosing of Clevidipine in Pediatric Participants Undergoing Surgery (PIONEER) |
| NCT05175547 CLEVER | CLEVER | Ph 3 | completed | Clevidipine Infusion for Blood Pressure Management After Successful Revascularization in Acute Ischemic Stroke |
| NCT06063772 INGRESS | 807353 | Ph 4 | not yet recruiting | Effect of Treatment of Pre-induction Hypertension on Hemodynamic Stability During Induction of General Anesthesia |
| NCT02011321 CLEVAS | HFHS-CLEVIDIPINE-PV | Ph 2 | withdrawn | Clevidipine for Vasospasm After Subarachnoid Hemorrhage (SAH) |
| NCT01369147 results posted | IRB00049495 1R21DK089369 | Ph 2 | terminated | The Energy Dose Study |
| NCT03300479 Clevidipine | 2017-00379 | Ph 4 | withdrawn | Clevidipine (Cleviprex®) Compared With Urapidil (Ebrantil®) |
| NCT01645111 results posted | IRB12-00261 | Ph 2, Ph 3 | completed | An Open-label Trial of Clevidipine for Controlled Hypotension During Spinal Fusion |
| NCT00952081 results posted | 08-745 | Ph 4 | completed | A Pilot Study to Evaluate Efficacy and Safety of Clevidipine in Neurosurgical Patients |
| NCT00666328 ACCELERATE results posted | TMC-CLV-07-02 | Ph 3 | completed | Clevidipine in the Treatment of Patients With Acute Hypertension and Intracerebral Hemorrhage (ACCELERATE) |
| NCT00803634 PRONTO results posted | TMC-CLV-08-01 TMC-CLV-08-01 | Ph 3 | completed | Clevidipine in the Treatment of Blood Pressure in Patients With Acute Heart Failure (PRONTO) |
| NCT00799604 SPRINT results posted | TMC-CLV-08-02 | Ph 2 | completed | Clevidipine Bolus Administration in the Treatment of Hypertensive Patients Undergoing Cardiac Surgery (SPRINT) |
| NCT01910532 | 2009H0336 | Ph 4 | withdrawn | The Evaluation of Clevidipine in Patients Requiring ICP Monitoring and IV Antihypertensive Therapy |
| NCT01121458 CARVE | Dallas VA #09-041 | Ph 4 | completed | Clevidipine for Vasoreactivity Evaluation of the Pulmonary Arterial Bed |
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.
CLEVIPREX FDA Label Details
Indications & Usage
FDA Label (PDF)Cleviprex is indicated for the reduction of blood pressure when oral therapy is not feasible or not desirable. Cleviprex is a dihydropyridine calcium channel blocker indicated for the reduction of blood pressure when oral therapy is not feasible or not desirable.
Pro Intelligence Preview
Deep insights for CLEVIPREX
Revenue Insights
- • Quarterly revenue tracking
- • Historical trend analysis
Patent Timeline
- • Cliff: 2031
- • 27 active patents
Trial Analysis
- • 14 total trials
- • Stage: Mature
Competitive Landscape
- • Competitor tracking
- • Same target/indication analysis
Full approval history • All patents • Revenue trends • Competitor analysis
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