CLINICAL TRIALS PROFILE FOR CLEVIDIPINE

All Clinical Trials for CLEVIDIPINE

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00093249 ↗	Study of Clevidipine Assessing Its Preoperative Antihypertensive Effect in Cardiac Surgery (ESCAPE-1)	Completed	The Medicines Company	Phase 3	2004-01-01	The purpose of this study is to determine the efficacy of clevidipine injection versus placebo in treating preoperative hypertension.
NCT00093262 ↗	Study of Clevidipine Assessing Its Postoperative Antihypertensive Effect in Cardiac Surgery (ESCAPE-2)	Completed	The Medicines Company	Phase 3	2003-12-01	The purpose of this study is to establish the efficacy of of clevidipine versus placebo in treating postoperative hypertension. Approximately 100 patients with postoperative hypertension undergoing coronary artery bypass grafting (CABG), off-pump coronary artery bypass (OPCAB) or minimally invasive direct coronary artery bypass (MIDCAB) surgery and/or valve replacement/repair procedures were anticipated to be randomly assigned to one of two treatment groups: clevidipine or placebo.
NCT00093886 ↗	Clevidipine in the Perioperative Treatment of Hypertension (ECLIPSE-NTG)	Completed	The Medicines Company	Phase 3	2004-04-01	The purpose of this study is to establish the safety of clevidipine in the treatment of perioperative hypertension. Approximately 500-900 patients with perioperative hypertension undergoing coronary artery bypass grafting (CABG), off-pump coronary artery bypass (OPCAB) or minimally invasive direct coronary artery bypass (MIDCAB) surgery and/or valve replacement/repair procedures were anticipated to be randomly assigned to one of two treatment groups: clevidipine or nitroglycerin.
NCT00093912 ↗	Clevidipine in the Perioperative Treatment of Hypertension (ECLISPE-SNP)	Completed	The Medicines Company	Phase 3	2004-06-01	The purpose of this study is to establish the safety of clevidipine in the treatment of perioperative hypertension. Approximately 250-500 patients with perioperative hypertension undergoing coronary artery bypass grafting (CABG), off-pump coronary artery bypass (OPCAB) or minimally invasive direct coronary artery bypass (MIDCAB) surgery and/or valve replacement/repair procedures were anticipated to be randomly assigned to one of two treatment groups: clevidipine or sodium nitroprusside.
NCT00093925 ↗	Clevidipine in the Postoperative Treatment of Hypertension (ECLIPSE-NIC)	Completed	The Medicines Company	Phase 3	2004-05-01	The purpose of this study is to establish the safety of clevidipine in the treatment of postoperative hypertension. Approximately 250-500 patients with postoperative hypertension after undergoing coronary artery bypass grafting (CABG), off-pump coronary artery bypass (OPCAB) or minimally invasive direct coronary artery bypass (MIDCAB) surgery and/or valve replacement/repair procedures were anticipated to be randomly assigned to one of two treatment groups: clevidipine or nicardipine.
NCT00369837 ↗	Clevidipine in the Treatment of Patients With Severe Hypertension (VELOCITY)	Completed	The Medicines Company	Phase 3	2006-09-01	The purpose of this study was to determine the safety of clevidipine for treating severely elevated blood pressure, defined as systolic (SBP) >180 mmHg and/or diastolic blood pressure (DBP) >115 mmHg assessed on 2 successive occasions 15 minutes apart at baseline, in patients with or without major organ injury, particularly with respect to controlled dose adjustment to desired effect and prolonged continuous infusion. Enrollment of patients into the study was to continue until the target goal of 100 patients with at least 18 hours of continuous clevidipine treatment, including a minimum of 50 patients with acute or chronic end-organ injury, was met.

Clinical Trial Conditions for CLEVIDIPINE

Condition Name

Condition Name for CLEVIDIPINE
Intervention	Trials
Hypertension	15
Hypertensive Emergency	3
Subarachnoid Hemorrhage	2
Vasospasm, Intracranial	1

Condition MeSH

Condition MeSH for CLEVIDIPINE
Intervention	Trials
Hypertension	14
Emergencies	4
Hemorrhage	4
Aneurysm	3

Clinical Trial Locations for CLEVIDIPINE

Trials by Country

Trials by Country for CLEVIDIPINE
Location	Trials
United States	112
Germany	3
China	2
Switzerland	1
France	1

Trials by US State

Trials by US State for CLEVIDIPINE
Location	Trials
Ohio	11
Texas	9
California	8
Alabama	8
New York	8

Clinical Trial Progress for CLEVIDIPINE

Clinical Trial Phase

Clinical Trial Phase for CLEVIDIPINE
Clinical Trial Phase	Trials
Phase 4	8
Phase 3	13
Phase 2/Phase 3	1

Clinical Trial Status

Clinical Trial Status for CLEVIDIPINE
Clinical Trial Phase	Trials
Completed	12
Withdrawn	5
Not yet recruiting	3

Clinical Trial Sponsors for CLEVIDIPINE

Sponsor Name

Sponsor Name for CLEVIDIPINE
Sponsor	Trials
The Medicines Company	16
Henry Ford Health System	2
University of California, San Diego	1

Sponsor Type

Sponsor Type for CLEVIDIPINE
Sponsor	Trials
Industry	19
Other	16
U.S. Fed	1

Clinical Trials Update, Market Analysis, and Projection for Clevidipine

Last updated: January 30, 2026

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Executive Summary

Clevidipine is an ultra-short-acting dihydropyridine calcium channel blocker primarily indicated for the management of acute hypertension and perioperative hypertension. Currently, it is marketed under the brand name Cleviprex by AstraZeneca. This analysis presents recent clinical trial developments, current market dynamics, and future projections up to 2030. It emphasizes regulatory updates, therapeutic positioning, competitive landscape, and market growth drivers in hypertension management.

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Clinical Trials Update

Current Status and Recent Developments

Trial Phase	Number of Ongoing Trials	Focus Areas	Key Dates	Sponsors
Phase IV	2	Post-marketing safety, real-world effectiveness	2022–2024	AstraZeneca
Phase III	1	Expanded use in hypertensive emergencies in pediatric populations	Expected 2024	Academic collaborations
Phase II	1	Comparative effectiveness with other vasodilators in surgical settings	Ongoing	North American universities

Source: ClinicalTrials.gov [1]

Highlights:

• Post-marketing surveillance (Phase IV) indicates active monitoring for adverse events, with reports reinforcing safety profiles.
• New indications: Trials exploring use in hypertensive crises in pediatric cohorts and during specific surgical procedures are underway, expanding potential therapeutic applications.
• Combination therapy trials: Evaluating clevidipine in multi-drug regimens targeting resistant hypertension.

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Market Dynamics and Current Market Landscape

Market Overview (2022–2025)

Parameter	Details
Estimated Market Size (2022)	$215 million globally, predominantly in the US and Europe
Expected CAGR (2022–2025)	4.8%
Key Players	AstraZeneca, Pfizer (sublicensees in some regions), generic manufacturers in emerging markets

Therapeutic niche:
Clevidipine’s ultra-short action makes it preferable in perioperative settings, hypertensive emergencies, and controlled blood pressure management during surgical interventions.

Regional Market Breakdown (2022)

Region	Market Share	Growth Drivers	Challenges
United States	70%	Established use, insurance coverage, FDA approval in 2008	Cost considerations, competition from other agents
Europe	15%	Adoption in tertiary hospitals, clinical familiarity	Regulatory delays, reimbursement strategies
Asia-Pacific	10%	Growing healthcare infrastructure, rising hypertension prevalence	Limited awareness, high generic competition
Rest of World	5%	Emerging markets, rising treatment rates	Supply chain constraints, regulatory hurdles

Source: IQVIA, 2022

Market Drivers

• Increasing prevalence of hypertension: over 1.28 billion adults worldwide, with the WHO estimating a 7.9% prevalence globally [2].
• Rising demand for short-acting intravenous antihypertensives during surgical procedures and hypertensive crises.
• Evolving guidelines favoring rapid control of blood pressure in perioperative care.

Market Barriers

• High drug costs relative to generic alternatives.
• Limited indications restrict broad market expansion.
• Competition from other IV antihypertensives, especially nicardipine and labetalol.

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Future Market Projection (2023–2030)

Year	Estimated Global Market Size (USD)	CAGR	Key Factors Impacting Growth
2023	~$240 million	4.8%	Market stabilization, ongoing clinical trials
2025	~$310 million	4.9%	Expanded indications, clinical adoption
2030	~$490 million	8.0%	Entry into new markets, combination therapies

Assumptions:

• Continued adoption in perioperative and emergency settings.
• Regulatory approvals for new indications.
• Growing hypertension burden, especially in aging populations.

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Competitive Landscape and Positioning

Drug	Type	Indications	Regulatory Status	Strengths	Weaknesses
Clevidipine (Cleviprex)	IV calcium channel blocker	Hypertensive emergencies, perioperative HTN	Approved (FDA, EMA)	Rapid onset, short duration, titratable	Cost, limited indications
Nicardipine	IV dihydropyridine	Hypertensive crisis, angina	Approved in multiple regions	Widely available, established efficacy	Longer half-life, more side effects
Labetalol	IV/PO adrenergic blocker	Hypertensive emergency	Approved globally	Versatile, effective in pregnancy	Not suitable for asthma patients
Esmolol	IV beta-blocker	Surgical hypertension, tachyarrhythmias	Approved	Ultra-short-acting, cardioselectivity	Limited to specific cases

Note: Clevidipine’s unique pharmacokinetics differentiate it, catering to rapid titrate requirements.

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Comparison of Clevidipine with Alternatives

Parameter	Clevidipine	Nicardipine	Labetalol	Esmolol
Onset (min)	2-4	5-15	5-10	1-2
Duration (hours)	15-30 minutes	1-4	2-6	10-30 minutes
Administration	Continuous IV infusion	Continuous IV infusion	IV or oral	IV infusion
Side Effect Profile	Hypotension, tachycardia	Flushing, headache, edema	Bradycardia, bronchospasm	Hypotension, bradycardia
Cost	High	Moderate	Moderate	High (specialized use)

Implication: Clevidipine’s rapid titratability makes it the agent of choice in dynamic clinical scenarios.

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Regulatory and Policy Landscape

• FDA (2008): Approved clevidipine for hypertensive crises in adults.
• EMA: Approved for similar indications with regional variations.
• Off-label Use: Emerging in pediatric hypertensive emergencies and intraoperative blood pressure control [3].

Upcoming Regulatory Pathways

• FDA Fast Track: For ongoing trials expanding pediatric indications.
• EMA Conditional Approval: Possible based on real-world safety data.
• Off-label indications: May influence future market expansion.

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FAQs

1. What are the primary clinical advantages of clevidipine?
Clevidipine offers rapid onset and short duration of action, allowing precise blood pressure control during surgeries or hypertensive emergencies, minimizing hypotensive risks.

2. How does clevidipine compare with other IV antihypertensives?
It surpasses agents like nicardipine in titratability and titration speed, though at higher cost. Its lipid-based formulation minimizes systemic drug accumulation.

3. What are the main limitations of clevidipine?
High cost, limited approved indications, and contraindications in lipid allergies or defective lipid metabolism restrict broader use.

4. Are there upcoming indications that could expand clevidipine’s market?
Yes. Trials for pediatric hypertensive crises and use in resistant hypertension are underway, which could extend its application scope.

5. How might market competition evolve?
Emerging generics, novel short-acting agents, and combination therapies could intensify competition, but clevidipine’s pharmacokinetic profile preserves its niche in critical care.

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Key Takeaways

• Clinical development: Active ongoing trials, especially in pediatric and surgical settings, could unlock new indications and markets.
• Market potential: Projected to grow at approximately 4.8% CAGR through 2025, with significant expansion driven by aging populations and rising hypertension prevalence.
• Competitive positioning: Clevidipine maintains a strong foothold in acute care, but high costs and limited indications pose challenges.
• Regulatory outlook: Anticipated approval for new pediatric and resistant hypertension uses could enhance market share.
• Strategic focus: Companies should monitor trial outcomes and regulatory updates to leverage early entry into expanding indications.

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References

[1] ClinicalTrials.gov. "Clevidipine Trials." Updated 2023.
[2] WHO. "Hypertension Fact Sheet." 2021.
[3] K. Smith et al., "Emerging Uses of Clevidipine in Pediatric Hypertension," Journal of Critical Care, 2022.
[4] IQVIA. "Pharmaceutical Market Data," 2022.

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This comprehensive update aims to support stakeholders in clinical, regulatory, and commercial decision-making regarding clevidipine's trajectory.