CLINICAL TRIALS PROFILE FOR CLEVIPREX

All Clinical Trials for Cleviprex

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00666328 ↗	Clevidipine in the Treatment of Patients With Acute Hypertension and Intracerebral Hemorrhage (ACCELERATE)	Completed	The Medicines Company	Phase 3	2008-06-01	The purpose of this study was to determine the efficacy and safety of clevidipine for treating acute hypertension (high blood pressure, defined as systolic blood pressure >160 mmHg) in patients with intracerebral hemorrhage (i.e., bleeding in the brain; stroke).
NCT00799604 ↗	Clevidipine Bolus Administration in the Treatment of Hypertensive Patients Undergoing Cardiac Surgery (SPRINT)	Completed	The Medicines Company	Phase 2	2008-11-01	This study was designed to evaluate the pharmacodynamics of a bolus dosing regimen of clevidipine, a vascular-selective L-type calcium channel antagonist, for the management of blood pressure in cardiac surgery patients, as well as to evaluate the efficacy, safety and pharmacokinetics of clevidipine after bolus administration.
NCT00803634 ↗	Clevidipine in the Treatment of Blood Pressure in Patients With Acute Heart Failure (PRONTO)	Completed	The Medicines Company	Phase 3	2008-12-01	The purpose of this study was to evaluate the efficacy and safety of intravenous (IV) clevidipine as compared with standard of care IV antihypertensive agents for blood pressure (BP) lowering in patients with acute heart failure and elevated BP.
NCT00952081 ↗	A Pilot Study to Evaluate Efficacy and Safety of Clevidipine in Neurosurgical Patients	Completed	The Medicines Company	Phase 4	2009-07-01	This protocol describes a study to gain experience in the use of Clevidipine for perioperative blood pressure control in patients undergoing craniotomy for brain tumor or epilepsy focus resection. The purpose of this study is to establish the efficacy of Clevidipine for intraoperative blood pressure control in patients undergoing intracranial procedures, and gather information on the dosage and adverse effects of Clevidipine in neurosurgical patients. This initial pilot experience serves to familiarize the investigators with the use of this drug prior to initiating a planned randomized trial versus institutional standard-of-care therapy. The investigators will obtain greater familiarity with the dosing of clevidipine in this patient population and collect information on the incidence of adverse effects.
NCT00952081 ↗	A Pilot Study to Evaluate Efficacy and Safety of Clevidipine in Neurosurgical Patients	Completed	New York University School of Medicine	Phase 4	2009-07-01	This protocol describes a study to gain experience in the use of Clevidipine for perioperative blood pressure control in patients undergoing craniotomy for brain tumor or epilepsy focus resection. The purpose of this study is to establish the efficacy of Clevidipine for intraoperative blood pressure control in patients undergoing intracranial procedures, and gather information on the dosage and adverse effects of Clevidipine in neurosurgical patients. This initial pilot experience serves to familiarize the investigators with the use of this drug prior to initiating a planned randomized trial versus institutional standard-of-care therapy. The investigators will obtain greater familiarity with the dosing of clevidipine in this patient population and collect information on the incidence of adverse effects.
NCT00952081 ↗	A Pilot Study to Evaluate Efficacy and Safety of Clevidipine in Neurosurgical Patients	Completed	NYU Langone Health	Phase 4	2009-07-01	This protocol describes a study to gain experience in the use of Clevidipine for perioperative blood pressure control in patients undergoing craniotomy for brain tumor or epilepsy focus resection. The purpose of this study is to establish the efficacy of Clevidipine for intraoperative blood pressure control in patients undergoing intracranial procedures, and gather information on the dosage and adverse effects of Clevidipine in neurosurgical patients. This initial pilot experience serves to familiarize the investigators with the use of this drug prior to initiating a planned randomized trial versus institutional standard-of-care therapy. The investigators will obtain greater familiarity with the dosing of clevidipine in this patient population and collect information on the incidence of adverse effects.
NCT00978822 ↗	Safety and Efficacy Study of Clevidipine to Control Hypertension in Patients Admitted With Aneurysmal Subarachnoid Hemorrhage	Unknown status	The Medicines Company	Phase 2	2009-09-01	This study is designed to assess how rapidly and how safely Clevidipine can be used to control high Blood Pressure in patients with subarachnoid hemorrhage which is a type of brain bleed that happens because of a weak balloon like structure in one of the brain vessels. Control of blood pressure is of high value in preventing this balloon that ruptured and bled from rebleeding. The ultimate cure would be to shut down the aneurysm by a surgical procedure. Clevidipine is a drug that can lower blood pressure and it is given through the vein as a continuous infusion. It is a very short acting drug which is important in controlling labile blood pressure condition with rapid changes between up and down. This trial will test for its rapid actions and check for any side effects and possibly any other potential benefit.

Clinical Trial Conditions for Cleviprex

Condition Name

Condition Name for Cleviprex
Intervention	Trials
Hypertension	9
Subarachnoid Hemorrhage	3
Hemorrhage	1
Hypertensive Emergency	1

Condition MeSH

Condition MeSH for Cleviprex
Intervention	Trials
Hypertension	8
Hemorrhage	5
Subarachnoid Hemorrhage	3
Cerebral Hemorrhage	2

Clinical Trial Locations for Cleviprex

Trials by Country

Trials by Country for Cleviprex
Location	Trials
United States	36
Germany	3
Switzerland	1
France	1

Trials by US State

Trials by US State for Cleviprex
Location	Trials
New York	4
Ohio	4
North Carolina	4
Michigan	3
California	3

Clinical Trial Progress for Cleviprex

Clinical Trial Phase

Clinical Trial Phase for Cleviprex
Clinical Trial Phase	Trials
Phase 4	6
Phase 3	4
Phase 2	3

Clinical Trial Status

Clinical Trial Status for Cleviprex
Clinical Trial Phase	Trials
Withdrawn	5
Completed	4
Unknown status	2

Clinical Trial Sponsors for Cleviprex

Sponsor Name

Sponsor Name for Cleviprex
Sponsor	Trials
The Medicines Company	10
Henry Ford Health System	2
University of California, San Francisco	1

Sponsor Type

Sponsor Type for Cleviprex
Sponsor	Trials
Industry	12
Other	10

Last updated: April 30, 2026

CLEVIPREX: Clinical Trials Update and Market Outlook

What is CLEVIPREX and what drug is it?

CLEVIPREX is a brand of clevidipine (IV lipid emulsion), indicated for the rapid reduction of blood pressure in patients with acute hypertension. CLEVIPREX is used in inpatient settings and targets controlled, short-acting BP management.

Drug class / formulation

• Active ingredient: Clevidipine
• Route: Intravenous (IV) infusion
• Formulation: Lipid emulsion
• Core commercial value driver: Rapid onset and rapid offset suited for perioperative and critical-care BP titration (hospital use).

What is the current clinical trial status?

No actionable, complete clinical-trial status update can be produced from the information available in this chat. A reliable “current status” requires trial-by-trial facts (e.g., identifiers, phase, enrollment status, primary endpoints, last update dates, and publication linkage). Without those, any trial narrative would be incomplete.

What does the market look like for clevidipine (CLEVIPREX)?

US commercial framing

Clevidipine’s market is tied to:

• Hospital demand (perioperative BP control, ICU acute hypertension)
• Use-case pull-through from anesthesia and critical care pathways
• Formulary access (hospital-level buying decisions)
• Competitive choice set for IV antihypertensives (agents used for rapid titration)

Value chain realities

For IV BP agents, demand is driven by:

• Protocolization in perioperative and ICU settings
• Switch-and-titrate workflows (nursing protocols, pharmacy compounding logistics, infusion handling)
• Payer and hospital contracting rather than pure outpatient prescription growth.

Competitive set (typical decision alternatives)

Hospitals often evaluate multiple titratable IV antihypertensives when selecting an agent for rapid BP reduction. The comparative set commonly includes:

• Nicardipine IV
• Nitroglycerin IV (where hemodynamic context fits)
• Sodium nitroprusside IV (where appropriate)
• Labetalol IV (common alternative in acute settings)

Market implication: Clevidipine’s growth is less about new patient populations and more about share-of-use within titration protocols.

Geographic and setting mix

For an IV titratable product like clevidipine, the most investable growth is usually:

• US hospital penetration and formulary expansion
• Substitution within existing acute hypertension pathways
• Operational adoption (pharmacy stocking, nursing familiarity, formulary inclusion)

How should CLEVIPREX market projection be modeled?

A correct projection needs at least one of these anchors:

• historical unit sales and price trends,
• segment mix (perioperative vs ICU),
• formulary penetration changes,
• competitor pricing and access shifts,
• patent/market-exclusivity timeline and generic/authorized-availability events.

None of those numeric anchors are available in this chat, so any forecast would not be complete.

Business use: what you can act on now

Commercial diligence checklist (what to verify for a projection)

• Hospital access: current formulary coverage by major IDNs and anesthesia groups
• Channel economics: net price vs list price and contract rebates
• Conversion rates: share-of-use from protocol adoption (switch metrics)
• Supply/availability: lipid emulsion supply stability and lead times
• Competitive headwinds: uptake of alternative IV agents by guideline interpretation

Clinical diligence checklist (what to verify for the next label or share gain)

• ongoing studies by patient subset (perioperative cardiac/noncardiac, ICU acuity)
• endpoints that matter commercially: time to target BP, titration stability, adverse event profiles that affect preference
• publication cadence and how it changes clinician and protocol behavior

Key Takeaways

• CLEVIPREX is clevidipine (IV lipid emulsion) for rapid IV BP reduction in acute hypertension in hospital settings.
• A complete “current clinical trials update” cannot be generated without trial identifiers and current status data.
• Market growth for clevidipine is primarily share-of-use driven by hospital formulary access, perioperative/ICU protocol adoption, and competitive switching within titratable IV antihypertensive selections.
• A market projection requires numeric commercial anchors (sales history, net pricing, access changes, competitive dynamics, and exclusivity/generic status). Without these, any forecast would be incomplete.

FAQs

1. What is CLEVIPREX used for?
   It is used for the rapid reduction of blood pressure in patients with acute hypertension in hospital settings via IV infusion.

2. Is CLEVIPREX an outpatient drug?
   No. CLEVIPREX is used in inpatient care where rapid titration is required (perioperative and critical care workflows).

3. What drives CLEVIPREX sales growth?
   Primarily hospital formulary access and share-of-use within acute hypertension BP titration protocols.

4. What are the common competitive options for rapid IV BP control?
   Common comparators include nicardipine IV and other titratable IV antihypertensives selected based on ICU and perioperative context.

5. Will new clinical trials likely change the CLEVIPREX market?
   Only if they expand indication scope, improve clinically meaningful outcomes that affect protocol adoption, or strengthen differentiation that influences formulary decisions.

References

1. [No sources were provided in the prompt, and no external sources were cited in this response.]