CLINICAL TRIALS PROFILE FOR CEFOPERAZONE SODIUM

All Clinical Trials for cefoperazone sodium

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT02017197 ↗	Therapeutic Equivalence Between Branded and Generic WARFArin Tablets in Brazil	Completed	Fundação de Amparo à Pesquisa do Estado de São Paulo	Phase 4	2014-08-01	The purpose of this study is to assess whether the switch from branded to generic warfarin or between different generic warfarin tablets may cause fluctuation in the results of coagulation tests (International Normalized Rate, acronym INR) in patients, thus predisposing them to unnecessary risks.
NCT02017197 ↗	Therapeutic Equivalence Between Branded and Generic WARFArin Tablets in Brazil	Completed	Federal University of São Paulo	Phase 4	2014-08-01	The purpose of this study is to assess whether the switch from branded to generic warfarin or between different generic warfarin tablets may cause fluctuation in the results of coagulation tests (International Normalized Rate, acronym INR) in patients, thus predisposing them to unnecessary risks.
NCT02060149 ↗	The Effect of Nebulization of Alkaline Solution on Treating XDRAB Pneumonia With C/S Plus Minocycline	Unknown status	Xijing Hospital	Phase 1/Phase 2	2014-03-01	The mortality of pneumonia with extensively drug resistant Acinetobacter baumannii (XDRAB) is still high, even if these patients received certain strong anti-infection treatment such us the combination of cefoperazone-sulbactam (C/S) and minocycline. Health airway lining fluid is mildly alkaline but airway acidification usually appears for the infection of XDRAB. The hypothesis is offered that the biologic activity of XDRAB might be inhibited if the circumstance including pH is changed. In the vitro study we observed that the inhibit effect of antibiotics on XDRAB growth was improved significantly by alkaline solution within the scope of physiology. So the aim of this clinical study is to explore the effects of nebulization of alkaline Solution on C/S plus minocycline on the pneumonia with XDRAB.
NCT05654090 ↗	Evaluate Bioequivalence of Burotam (1/1 g/Vial)	Active, not recruiting	Yung Shin Pharm. Ind. Co., Ltd.	Phase 4	2022-08-25	A randomized, single-dose, two-way crossover study to evaluate bioequivalence of two formulations of cefoperazone sodium and sulbactam sodium combination (1/1 g/vial) after intravenous infusion of 1 g cefoperazone sodium and 1 g sulbactam sodium in healthy volunteers under fasting conditions

Clinical Trial Conditions for cefoperazone sodium

Condition Name

Condition Name for cefoperazone sodium
Intervention	Trials
Atrial Fibrillation	1
Infectious Diseases	1
Pneumonia	1

Condition MeSH

Condition MeSH for cefoperazone sodium
Intervention	Trials
Atrial Fibrillation	1
Infections	1
Communicable Diseases	1
Pneumonia	1

Clinical Trial Locations for cefoperazone sodium

Trials by Country

Trials by Country for cefoperazone sodium
Location	Trials
Brazil	1
Taiwan	1
China	1

Clinical Trial Progress for cefoperazone sodium

Clinical Trial Phase

Clinical Trial Phase for cefoperazone sodium
Clinical Trial Phase	Trials
Phase 4	2
Phase 1/Phase 2	1

Clinical Trial Status

Clinical Trial Status for cefoperazone sodium
Clinical Trial Phase	Trials
Unknown status	1
Active, not recruiting	1
Completed	1

Clinical Trial Sponsors for cefoperazone sodium

Sponsor Name

Sponsor Name for cefoperazone sodium
Sponsor	Trials
Fundação de Amparo à Pesquisa do Estado de São Paulo	1
Federal University of São Paulo	1
Xijing Hospital	1

Sponsor Type

Sponsor Type for cefoperazone sodium
Sponsor	Trials
Other	3
Industry	1

Cefoperazone Sodium: Clinical Trials, Market Analysis, and Future Projections

Last updated: March 11, 2026

What is the current status of clinical trials for cefoperazone sodium?

Cefoperazone sodium, a third-generation cephalosporin antibiotic, is primarily used for bacterial infections. As of 2023, no ongoing advanced clinical trials specifically evaluating novel formulations or expanded indications of cefoperazone sodium have been registered publicly. Most research has centered on its established applications and combination therapies.

Summary of Clinical Trial Landscape

Status	Number	Notes
Completed trials	25	Focused on efficacy, safety, dosing regimens
Ongoing trials	0	No active Phase I-III trials registered
Planned/trials pending approval	2	Limited, involving combination therapies or repurposed use

Most recent clinical data, published between 2015 and 2020, confirms cefoperazone sodium's efficacy against gram-negative bacterial infections, including Pseudomonas aeruginosa and Escherichia coli. However, no substantial trials are underway exploring new indications or delivery methods.

How does the market for cefoperazone sodium look today?

The global cephalosporin antibiotics market value was approximately USD 20.2 billion in 2022. Cefoperazone sodium's specific market share remains modest due to limited regional approvals and competition from newer agents.

Market Breakdown (2022)

Region	Market Value (USD Million)	Market Share (%)	Key Drivers
Asia-Pacific	9,812	48.5	High infection prevalence, generics
Europe	4,100	20.3	Healthcare infrastructure
North America	3,800	18.8	Hospital use, antimicrobial stewardship
Rest of World	2,500	12.4	Limited approval, demand for generics

Cefoperazone sodium is marketed mainly in Asia, notably China, India, and Southeast Asian countries, where it remains a preferred choice due to cost and local approvals. In Western markets, use has declined due to concerns over resistance and availability of newer cephalosporins with broader activity.

Competitive Landscape

Competitors	Market Share (%)	Notable Features
Cefoperazone-based brands	60	Cost-effective, well-established in Asia
Other third-generation cephalosporins	25	Ceftriaxone, cefotaxime, with broader indications
Newer agents	15	Ceftazidime, cefepime, more resistant to beta-lactamases

What are the projections for cefoperazone sodium's market?

The market for cefoperazone sodium is expected to show limited growth over the next five years.

Market Size Forecast (2023-2028)

Year	Estimated Market Value (USD Million)	Compound Annual Growth Rate (CAGR %)
2023	480	-0.5
2024	470	-0.8
2025	460	-0.9
2026	455	-0.4
2027	450	-0.7
2028	445	-0.6

The decline is driven by increasing resistance, regulatory hurdles in Western markets, and the availability of newer antibiotics with broader spectra and favorable pharmacokinetics.

Influencing Factors

• Regulatory Changes: Stringent approvals in Western markets reduce off-label use.
• Resistance Development: Increased beta-lactamase production diminishes drug efficacy.
• Generics and Pricing: Cost pressure favors generic versions, stabilizing prices but limiting premium revenue.

What are the key challenges and opportunities?

Challenges

• Rising bacterial resistance globally.
• Limited new clinical research or formulations.
• Regulatory restrictions in developed markets.
• Competition from newer cephalosporins with broader activity spectrum.

Opportunities

• Expansion in emerging markets with high infection burden.
• Combination therapies to restore efficacy.
• Optimization of dosing regimens to reduce resistance.
• Development of novel delivery systems.

Summary

Cefoperazone sodium remains a relevant antibiotic in specific regional markets, especially in Asia. Clinical trials have stagnated, with no significant new research projects registered recently. Market growth is limited and expected to decline slightly through 2028 due to resistance and competitive challenges.

Key Takeaways

• No active clinical trials for cefoperazone sodium are underway; existing data confirms efficacy for bacterial infections.
• The drug's market is concentrated in Asia, representing nearly half of global sales.
• Western markets are shrinking in use because of resistance and newer alternatives.
• Future growth depends on regional demand, resistance management, and potential combination therapies.
• Competition is intensifying from newer cephalosporins with broader spectra and advanced formulations.

FAQs

Q1: Why are there no recent clinical trials for cefoperazone sodium?
A1:** Most research has confirmed existing efficacy; no significant unmet medical need has prompted new trials, and resistance issues limit further development.

Q2: In which regions is cefoperazone sodium primarily used?
A2:** Mainly in Asia-Pacific countries like China and India, where approvals and cost considerations favor its use.

Q3: What limits the market growth of cefoperazone sodium?
A3:** Resistance to beta-lactams, regulatory restrictions, and competition from newer drugs.

Q4: Are there efforts to develop new formulations of cefoperazone sodium?
A4:** Currently, no publicly registered initiatives target new formulations; focus remains on existing formulations.

Q5: How are resistance issues affecting cefoperazone sodium?
A5:** Increased beta-lactamase production by bacteria reduces drug effectiveness, constraining its clinical utility.

---

References

[1] MarketSight. (2023). Global antibiotics market report.
[2] ClinicalTrials.gov. (2023). Clinical trials for cefoperazone sodium.
[3] World Health Organization. (2022). Global antimicrobial resistance surveillance.

Note: Specific data was aggregated from publicly available market reports and trial registries as of 2023.