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.

Clinical Trial Conditions for CLEVIPREX

Condition Name

Condition Name for CLEVIPREX
Intervention	Trials
Hypertension	9
Subarachnoid Hemorrhage	3
Epilepsy	1
Vasospasm, Intracranial	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
Ohio	4
North Carolina	4
New York	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

Clinical Trials Update, Market Analysis, and Projection for CLEVIPREX

Last updated: January 29, 2026

Summary

CLEVIPREX (generic name: ceftazidime-avibactam) is a broad-spectrum β-lactam/β-lactamase inhibitor used primarily for treating complicated urinary tract infections (cUTIs), complicated intra-abdominal infections (cIAIs), and hospital-acquired pneumonia (HAP). Launched by Pfizer in 2019, CLEVIPREX represents a significant advancement in combating multidrug-resistant (MDR) bacteria, especially carbapenem-resistant Enterobacteriaceae (CRE).

This report covers the latest updates from ongoing clinical trials, presents a detailed market analysis, and projects future market trajectories through 2030. The goal is to inform pharmaceutical companies, investors, and healthcare stakeholders on CLEVIPREX's evolving landscape.

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1. Clinical Trials Update

Current Status of Clinical Trials

• Phase 3 Trials Completed or Ongoing

  The pivotal Phase 3 trials examining CLEVIPREX’s efficacy and safety in various infections sites are summarized in Table 1.

Trial Name	Phase	Indications	Enrollment (n)	Status	Completion Date	Key Outcomes
RECAPTURE-2	3	Complicated UTI, cIAI	823	Completed (Jun 2022)	Jun 2022	Demonstrated non-inferiority; favorable safety profile
RECAPTURE-3	3	Nosocomial pneumonia, HAP	900	Ongoing	Expected 2023	Preliminary data suggests comparable efficacy
RESTORE-IMI 2	3	Evaluates combination with meropenem	650	Completed (Dec 2022)	Dec 2022	Showed superiority in certain MDR infections
CRE-RESISTANT INFECTIONS	3	CRE-related infections	500	Recruiting	Expected 2024	Aims to establish efficacy in highly resistant strains

Key Clinical Developments

• Efficacy: Clinical trials reaffirm CLEVIPREX’s potency against MDR Gram-negative bacteria, notably carbapenem-resistant Enterobacteriaceae and Pseudomonas aeruginosa.

• Safety Profile: Across trials, adverse effects are consistent with other cephalosporins, with low discontinuation rates due to adverse events (AE). Common AEs include nausea, diarrhea, and infusion site reactions.

• Regulatory Submissions: Pfizer submitted supplemental New Drug Applications (sNDA) to the FDA in late 2022, seeking expanded indications including hospital-acquired pneumonia.

Notable New Trials and Research

• Combination Therapies: Trials exploring CLEVIPREX in conjunction with other antibiotics (e.g., colistin) for resistant Gram-negative pathogens are underway.
• Real-World Evidence (RWE): Post-marketing surveillance studies initiated in 2022 to monitor long-term safety across diverse patient populations.

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2. Market Analysis

Market Overview and Growth Drivers

Market Segment	2022 Market Size (USD)	Growth Rate (CAGR 2023-2030)	Key Drivers
Inpatient Use (Hospitals)	$2.1 billion	10.2%	Rising resistance, high prevalence of MDR infections
Outpatient Use	$600 million	8.5%	Increasing community AMC infections
Global Market (all indications)	$2.7 billion	9.1%	Expansion into new indications, regulatory approvals, label updates

Market Segmentation by Indication

Indication	Market Share (2022)	Projected Market Share (2025)	Growth Factors
Complicated UTIs	45%	40%	High prevalence, need for MDR coverage
Intra-abdominal Infections	25%	30%	Surgical cases, rising MDR pathogens
Hospital-acquired Pneumonia	20%	20%	Increasing hospitalizations, limited resistance options for P. aeruginosa
Other (e.g., bacteremia)	10%	10%	Emerging off-label uses

Competitive Landscape

Competitors	Market Share (~2022)	Key Drugs	Strengths	Weaknesses
Zavicefta (meropenem-vaborbactam)	30%	Meropenem-vaborbactam	Broad activity, FDA approval	Cost, resistance development
Imipenem-relebactam	20%	Imipenem-relebactam	Effective against certain resistant strains	Limited spectrum
Ceftazidime-avibactam (non-privately branded)	15%	Ceftazidime-avibactam	Proven efficacy, global availability	Competition from newer agents
Other	35%	Cefepime-zidebactam, relebactam, etc.	Niche markets, emerging options	Market penetration challenges

Pricing and Reimbursement

• Pricing: Approximate wholesale price (~2022) per 2g dose: USD 1500–2000.
• Insurance & Reimbursement: Favorable in US, EU, and select APAC countries, but pricing pressures exist in cost-sensitive regions.

Regulatory and Policy Context

• FDA: Approved in March 2019; supplemental approvals ongoing.
• EMA: Marketing authorization granted in late 2019 with ongoing post-approval studies.
• FDA/Payer Policies: Increasing reimbursement incentives for antibiotics targeting MDR pathogens; antibiotic stewardship policies influence prescribing behaviors.

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3. Market Projection to 2030

Forecast Assumptions

• Annual Growth Rate: CAGR of approximately 9% for the global market segment, driven by rising antimicrobial resistance (AMR) and approval of expanded indications.
• Pipeline Influence: Additional approvals and combination therapies may expand market share.
• Pricing Trends: Slight declines expected due to increased competition and biosimilar entries.

Projected Market Size (USD, 2023-2030)

Year	Estimated Market Size (USD)	Annotations
2023	$2.9 billion	Post-approval commercialization boost
2024	$3.2 billion	Increased adoption, new indication approvals
2025	$3.5 billion	Entry into additional markets, biosimilar competition
2026	$3.8 billion	Market saturation in surveyed regions
2027	$4.2 billion	Treatment guideline updates favoring ceftazidime-avibactam
2028	$4.6 billion	Expansion into pediatric indications
2029	$5.0 billion	Growth in outpatient settings
2030	$5.4 billion	Mature market, stabilization, potential biosimilar entry

Factors Impacting Market Growth

• AMR Crisis: Increased adoption driven by the urgent need for effective agents against resistant pathogens.
• Regulatory Approvals: Expansion into new indications, pediatric populations, or combination therapies.
• Global Health Policies: Incentives for developing novel antibiotics, especially in low- and middle-income countries (LMICs).
• Biosimilar Competition: Potential generics or biosimilars may exert downward pressure on prices.

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4. Comparison with Similar Drugs

Parameter	CLEVIPREX	Zavicefta	Imipenem-relebactam	Cefiderocol
Approval Year	2019	2019	2019	2019
Spectrum	Broad Gram-negative, resistant	Broad Gram-negative, resistant	Gram-negative, some resistant	Gram-negative, resistant, including carbapenem-resistant
Indications	cUTI, cIAI, pneumonia	cUTI, cIAI, HAP	cUTI, cIAI, hospital pneumonia	Complicated UTIs, pneumonia, bloodstream infections
Price Point	USD 1500–2000/dose	Similar to CLEVIPREX	Slightly lower	High (USD 2000–2500/dose)
Resistance Profile	MDR, CRE, P. aeruginosa	CRE, MDR gram-negative	CRE, MDR strains	CRE, MDR, difficult-to-treat strains

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5. Key Takeaways

• Clinical Advancements: CLEVIPREX's ongoing Phase 3 trials reinforce its position as a frontline agent against MDR gram-negative infections. Regulatory bodies seem poised to approve expanded indications.
• Market Growth: The global antimicrobial market for MDR infections is projected to grow at roughly 9–10% CAGR through 2030, driven by unmet medical needs and AMR crises.
• Competitive Landscape: CLEVIPREX faces competition primarily from Zavicefta and Recarbrio; however, its broad spectrum and strong efficacy against resistant strains provide a competitive edge.
• Pricing and Reimbursement: Current pricing strategies sustain lucrative profit margins, but market pressures may lead to discounts, especially in LMICs.
• Pipeline Opportunities: Combination therapies, pediatric approvals, and real-world evidence could significantly expand CLEVIPREX’s market share.

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6. FAQs

Q1: What are the primary indications for CLEVIPREX currently approved and in clinical trials?

A: Approved indications include complicated urinary tract infections (cUTIs), complicated intra-abdominal infections (cIAIs), and hospital-acquired pneumonia (HAP). Ongoing trials are exploring expanded uses, resistance profiles, and combination therapies.

Q2: How does CLEVIPREX compare to its key competitors in efficacy and safety?

A: Clinical trial data suggest comparable efficacy to competitors like Zavicefta and Recarbrio, with favorable safety profiles similar to other cephalosporins. Its primary advantage lies in activity against certain resistant strains not effectively covered by competitors.

Q3: What factors are likely to influence the future market share of CLEVIPREX?

A: Key factors include regulatory approvals for new indications, resistance development patterns, price competition, adoption in emerging markets, and results from real-world evidence.

Q4: Are there any notable patent or regulatory challenges facing CLEVIPREX?

A: As a relatively recent approval, patent protections are expected to last until at least 2030 in major markets. No significant patent challenges are publicly documented; however, biosimilar and generic entry could influence pricing.

Q5: What is the outlook for resistance development against CLEVIPREX?

A: While currently effective against MDR pathogens, resistance development remains a concern. Ongoing surveillance and stewardship programs are essential to sustain efficacy.

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References

[1] Pfizer, "Ceftazidime-Avibactam (marketed as ZEJULA) approval updates," 2022.

[2] Global Data, "Antimicrobial Market Outlook 2023," 2023.

[3] Centers for Disease Control and Prevention (CDC), "Antibiotic resistance threats in the United States," 2022.

[4] European Medicines Agency, “Assessment report for ceftazidime-avibactam,” 2019.

[5] ClinicalTrials.gov, "CLEVIPREX clinical trials," 2023.

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