CLINICAL TRIALS PROFILE FOR CEFOXITIN

All Clinical Trials for CEFOXITIN

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00186082 ↗	Antibiotics for Postpartum Third and Fourth Degree Perineal Tear Repairs	Completed	Santa Clara Valley Health & Hospital System	N/A	2003-09-01	This study is undertaken to find out whether prophylactic antibiotics can decrease the infection rate in third and fourth degree perineal tear repairs done in the immediate postpartum period.
NCT00186082 ↗	Antibiotics for Postpartum Third and Fourth Degree Perineal Tear Repairs	Completed	Stanford University	N/A	2003-09-01	This study is undertaken to find out whether prophylactic antibiotics can decrease the infection rate in third and fourth degree perineal tear repairs done in the immediate postpartum period.
NCT00343317 ↗	Prophylactic Intrapartum Antibiotics and Immunological Markers for Postpartum Morbidity in HIV Positive Women	Completed	Bristol-Myers Squibb	N/A	2003-02-01	Postpartum infections are among the leading causes of maternal mortality world-wide, particularly in under-resourced countries. Available data suggests that HIV infected women are at greater risk of postpartum complications than uninfected women. In South Africa, HIV/AIDS and related infections are now cumulatively the leading causes of maternal deaths (though indirectly), with puerperal sepsis among the 5 most common causes. This was a prospective longitudinal cohort of HIV infected (n = 675) and uninfected (n = 648) women. These were women in whom vaginal delivery was anticipated, and were recruited at > 36 weeks of gestation during the antenatal period. Hypothesis - HIV infected women are at increased risk of postpartum infectious morbidity and this morbidity can be reduced by use of prophylactic intrapartum antibiotics.
NCT00343317 ↗	Prophylactic Intrapartum Antibiotics and Immunological Markers for Postpartum Morbidity in HIV Positive Women	Completed	University of KwaZulu	N/A	2003-02-01	Postpartum infections are among the leading causes of maternal mortality world-wide, particularly in under-resourced countries. Available data suggests that HIV infected women are at greater risk of postpartum complications than uninfected women. In South Africa, HIV/AIDS and related infections are now cumulatively the leading causes of maternal deaths (though indirectly), with puerperal sepsis among the 5 most common causes. This was a prospective longitudinal cohort of HIV infected (n = 675) and uninfected (n = 648) women. These were women in whom vaginal delivery was anticipated, and were recruited at > 36 weeks of gestation during the antenatal period. Hypothesis - HIV infected women are at increased risk of postpartum infectious morbidity and this morbidity can be reduced by use of prophylactic intrapartum antibiotics.
NCT00856089 ↗	Efficacy Study of Altabax to Clear Methicillin-resistant Staphylococcus Aureus (MRSA) Nasal Colonization	Withdrawn	GlaxoSmithKline	Phase 4	2009-05-01	The purpose of the study is to determine whether Altabax (retapamulin ointment, 1%) is effective in the treatment of methicillin-resistant Staphylococcus aureus (MRSA) nasal colonization. The hypothesis is that the prevalence of MRSA increases as a function of increasing clinical exposure and that the topical antibiotic Altabax is efficacious in clearing MRSA nasal colonization. The prevalence of MRSA nasal colonization among Tulane University medical students and residents and physicians of Tulane Medical Center and Ochsner Medical Center will be investigated. A total of 300 subjects will be recruited for the study. After giving informed consent, subjects will be swabbed to obtain specimens for culture and asked to complete a short survey to assess risk factors. Swabs will be used to directly inoculate three types of plates: CHROMagar MRSA plates, Spectra MRSA plates, and TSA with sheep blood plates. After appropriate incubation, Staph latex slide tests will be done and then results confirmed with cefoxitin disk susceptibility testing. MRSA positive subjects will be offered a treatment protocol with the topical antibiotic Altabax (retapamulin ointment, 1%) to be applied as a thin layer to the anterior nares twice daily for 5 days. After the 5-day treatment is complete, subjects will be retested for the presence of MRSA at day 7, day 12, day 30, and day 90. For this portion of the study, all cultures will additionally undergo disk susceptibility testing for retapamulin, erythromycin, clindamycin (including D-test), trimethoprim sulfa, and mupirocin (5 mcg and 20 mcg disks). In addition, Etests for retapamulin and mupirocin will be done. Genetic isolates will be characterized by rep-PCR pre-treatment and post-treatment. Data will be analyzed for MRSA prevalence and risk factor associations with MRSA colonization. Of those subjects found to be MRSA positive, data from the follow-up cultures will be used to assess the efficacy of Altabax in clearing MRSA nasal colonization.
NCT00856089 ↗	Efficacy Study of Altabax to Clear Methicillin-resistant Staphylococcus Aureus (MRSA) Nasal Colonization	Withdrawn	Tulane University School of Medicine	Phase 4	2009-05-01	The purpose of the study is to determine whether Altabax (retapamulin ointment, 1%) is effective in the treatment of methicillin-resistant Staphylococcus aureus (MRSA) nasal colonization. The hypothesis is that the prevalence of MRSA increases as a function of increasing clinical exposure and that the topical antibiotic Altabax is efficacious in clearing MRSA nasal colonization. The prevalence of MRSA nasal colonization among Tulane University medical students and residents and physicians of Tulane Medical Center and Ochsner Medical Center will be investigated. A total of 300 subjects will be recruited for the study. After giving informed consent, subjects will be swabbed to obtain specimens for culture and asked to complete a short survey to assess risk factors. Swabs will be used to directly inoculate three types of plates: CHROMagar MRSA plates, Spectra MRSA plates, and TSA with sheep blood plates. After appropriate incubation, Staph latex slide tests will be done and then results confirmed with cefoxitin disk susceptibility testing. MRSA positive subjects will be offered a treatment protocol with the topical antibiotic Altabax (retapamulin ointment, 1%) to be applied as a thin layer to the anterior nares twice daily for 5 days. After the 5-day treatment is complete, subjects will be retested for the presence of MRSA at day 7, day 12, day 30, and day 90. For this portion of the study, all cultures will additionally undergo disk susceptibility testing for retapamulin, erythromycin, clindamycin (including D-test), trimethoprim sulfa, and mupirocin (5 mcg and 20 mcg disks). In addition, Etests for retapamulin and mupirocin will be done. Genetic isolates will be characterized by rep-PCR pre-treatment and post-treatment. Data will be analyzed for MRSA prevalence and risk factor associations with MRSA colonization. Of those subjects found to be MRSA positive, data from the follow-up cultures will be used to assess the efficacy of Altabax in clearing MRSA nasal colonization.

Clinical Trial Conditions for CEFOXITIN

Condition Name

Condition Name for CEFOXITIN
Intervention	Trials
Antibiotic Prophylaxis	2
Bariatric Surgery Candidate	1
Metastatic Cancer	1
PPPD	1

Condition MeSH

Condition MeSH for CEFOXITIN
Intervention	Trials
Infections	4
Infection	4
Communicable Diseases	4
Surgical Wound Infection	2

Clinical Trial Locations for CEFOXITIN

Trials by Country

Trials by Country for CEFOXITIN
Location	Trials
United States	24
France	6
Canada	2
Australia	2
Ireland	1

Trials by US State

Trials by US State for CEFOXITIN
Location	Trials
New Jersey	2
California	2
Tennessee	1
Pennsylvania	1
Oregon	1

Clinical Trial Progress for CEFOXITIN

Clinical Trial Phase

Clinical Trial Phase for CEFOXITIN
Clinical Trial Phase	Trials
PHASE1	1
Phase 4	4
Phase 3	3

Clinical Trial Status

Clinical Trial Status for CEFOXITIN
Clinical Trial Phase	Trials
Completed	5
Terminated	4
Not yet recruiting	3

Clinical Trial Sponsors for CEFOXITIN

Sponsor Name

Sponsor Name for CEFOXITIN
Sponsor	Trials
Assistance Publique - Hôpitaux de Paris	2
The University of Queensland	2
Central Hospital, Nancy, France	2

Sponsor Type

Sponsor Type for CEFOXITIN
Sponsor	Trials
Other	77
Industry	2
FED	1

CEFOXITIN Market Analysis and Financial Projection

Last updated: May 4, 2026

CEFOXITIN: Clinical Trials Update, Market Analysis, and Projection

What is cefoxitin and what’s the current clinical-trials reality?

Cefoxitin is an injectable, second-generation cephalosporin. Its clinical use is established, and the current global clinical-trials footprint is dominated by legacy-standard practice rather than late-stage registrational development. Public clinical-trials activity is generally sparse and does not show a sustained pipeline of phase-advancing programs that would drive near-term market expansion through new regulatory approvals.

Implication for business planning: market dynamics for cefoxitin are driven primarily by (1) hospital formulary position, (2) generic supply and pricing, and (3) antimicrobial stewardship constraints, not by a new-cycle clinical development engine.

Public clinical-trials data pattern

Across major trial registries, cefoxitin shows limited new-study volume compared with actively developed antibiotics, with most entries reflecting:

• pharmacokinetic or dosing practice studies,
• retrospective or observational use patterns,
• infection-control or microbiology-focused assessments,
• older protocol replications rather than new phase registrations.

No evidence in the public registry landscape indicates that cefoxitin is the subject of a broad, modern, late-phase (Phase 3) registration program that would materially reset its regulatory standing in major jurisdictions in the next 24 to 36 months.

Sources: Clinical trial registry searches (details below in citations).

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Where does cefoxitin sit in the market and who buys it?

Cefoxitin’s commercial base is hospital procurement across indications where broad-spectrum cephalosporin coverage is clinically acceptable, including:

• surgical prophylaxis,
• mixed aerobic-anaerobic infections (where local guidelines include cephalosporins),
• intra-abdominal and gynecologic infection settings where stewardship and local antibiograms support its use.

The customer is overwhelmingly:

• acute-care hospitals,
• regional hospital networks,
• government and large institutional buyers via tender and contracted pricing.

Competitive set

Cefoxitin competes most directly with other injectable β-lactams and peri-operative prophylaxis alternatives used on formularies, including:

• other cephalosporins (1st to 3rd generation where clinically interchangeable),
• β-lactam/β-lactamase inhibitor combinations used for similar infection syndromes,
• carbapenems in higher-severity pathways where escalation is needed (driven by resistance profiles rather than cost alone).

Because cefoxitin is mature and typically off-patent, competition is mostly generic-to-generic rather than brand-to-brand.

Regulatory and commercial structure

• Cefoxitin is widely generic.
• Competitive pricing pressure is structurally high.
• Procurement is typically tender-driven, which makes revenue sensitive to supply availability, bid pricing, and substitution.

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What drives price, volume, and margins for cefoxitin?

1) Antibiotic stewardship substitution

Stewardship programs increasingly narrow use of broad-spectrum agents. Cefoxitin retains use where it is still guideline-supported for prophylaxis or specific infection categories, but it can lose share when:

• local policy prefers different agents with better resistance coverage,
• stewardship mandates de-escalation pathways that favor narrower spectrum once microbiology returns.

2) Generic supply and tender pricing

For off-patent injectables, revenue typically tracks:

• global generic manufacturing capacity,
• raw material costs and scale utilization,
• tender cycles and contract lengths.

Margins compress when multiple suppliers chase the same institutional contracts.

3) Resistance and formulary guidelines

Cefoxitin’s position is shaped by:

• local antimicrobial resistance patterns (especially Gram-negative and anaerobic coverage considerations),
• formulary committees’ sensitivity to susceptibility data,
• compliance with surgical prophylaxis timing protocols.

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Market Analysis: size, growth, and risks

How big is the cefoxitin market and what is the likely demand trend?

Public market-sizing for cefoxitin varies by dataset and geography because it is often bundled into “injectable cephalosporins” or “antibiotics” categories. The consistent cross-source narrative is that mature antibiotics face:

• flat to low growth,
• declines in some countries due to stewardship substitution,
• continued demand in institutional settings for surgical prophylaxis and specific infection use where cephalosporins remain acceptable.

Projection base: mature demand with pricing erosion as the dominant economic factor.

What market risks matter most?

1. Stewardship-driven volume pressure
   • Higher likelihood of volume declines in institutions that shift peri-operative prophylaxis to alternatives.
2. Supply concentration
   • If a limited number of manufacturers dominate certain tenders, disruptions can cause short-term availability issues and temporary price spikes, followed by corrective bid cycles.
3. Alternative regimen preference
   • β-lactam/β-lactamase inhibitor combinations can displace cefoxitin when clinical policy shifts toward broader practical coverage.

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Projection: revenue path under generic economics

What is the practical near-term forecast for cefoxitin?

Given:

• mature, largely off-patent status,
• limited evidence of major new clinical registrational development,
• procurement-driven economics for injectables,

the near-term projection is best modeled as volume-stable with net price erosion, producing low single-digit to flat revenue growth in many markets, with regional variance.

Scenario framework (directional)

| Driver | Downside case | Base case | Upside case | |---|---|---| | Institutional formulary | Share loss to alternative peri-op agents | Maintains current access | Maintains access plus incremental substitution wins | | Pricing | Tender-driven price compression accelerates | Gradual erosion | Price holds due to supply tightness or contracted pricing | | Supply reliability | Manufacturing disruptions cause lost contract fill | Stable supply | Supply outperforms demand enabling bid wins | | Stewardship | Higher restriction rates | Balanced use | Policy aligns with cefoxitin use cases |

This structure supports a projection where revenue is dominated by price changes, not by expansion in treated indications.

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What patent or regulatory events could change the trajectory?

Cefoxitin’s competitive landscape is primarily shaped by:

• generic entry and manufacturing capacity,
• any country-specific regulatory approvals for additional formulations,
• potential changes in hospital guidelines.

There is no basis in the public clinical-development pattern to treat cefoxitin as entering a new patent-driven growth cycle.

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Actionable implications for R&D and investment

Where is value most likely created or lost?

• Created: in controlled distribution, reliable supply, and contract execution for institutional tenders.
• Lost: where stewardship policies reduce broad-spectrum peri-op choices, or where competitors underbid reliably.

What diligence should be prioritized?

1. Tender and formulary data by region
   • Track quarterly contract awards and substitution patterns.
2. Supply chain resilience
   • Identify manufacturer coverage gaps and fill-rate history.
3. Guideline alignment by indication
   • Map cefoxitin use to current peri-operative prophylaxis protocols and local antibiograms.

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Key Takeaways

• Cefoxitin’s clinical-trials landscape shows limited evidence of new late-stage registrational development; public activity is sparse and mostly practice-oriented.
• The market is institutional and procurement-driven, with competitive dynamics dominated by generic supply and tender pricing.
• Near-term growth is expected to be flat to low single-digit at best, with revenue more sensitive to price erosion and contract fill than to new clinical adoption.
• The main swing factors are stewardship/formulary substitution and supply reliability rather than innovation-led demand expansion.

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FAQs

1) Is cefoxitin currently in a late-stage Phase 3 development cycle?

No evidence in public trial registries shows a sustained, late-stage registrational program that would materially alter cefoxitin’s near-term regulatory trajectory.

2) What are cefoxitin’s primary buyers?

Hospitals and health systems purchasing injectable antibiotics through tender and contracted procurement.

3) What most influences cefoxitin revenue in the next 12 to 24 months?

Tender pricing, institutional formulary access, and supply fill rates.

4) Does antimicrobial resistance increase or reduce cefoxitin use?

It can reduce use where susceptibility declines drive guideline changes, and it can preserve use where local antibiograms support cefoxitin’s role in prophylaxis or targeted syndromes.

5) What is the most likely market trend for cefoxitin pricing?

Downward pressure from generic competition, with periodic disruptions potentially creating short-term price spikes.

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References

[1] ClinicalTrials.gov. (n.d.). Search results for cefoxitin. https://clinicaltrials.gov/
[2] World Health Organization. (n.d.). WHO model list of essential medicines (relevant context for antibiotic use categories). https://www.who.int/
[3] US FDA. (n.d.). Drugs@FDA database (cefoxitin-related listings and labeling context). https://www.accessdata.fda.gov/scripts/cder/daf/
[4] Centers for Disease Control and Prevention (CDC). (n.d.). Surgical site infection prevention guidance (context for peri-operative prophylaxis antibiotic selection). https://www.cdc.gov/