CLINICAL TRIALS PROFILE FOR CEFUROXIME AXETIL

All Clinical Trials for cefuroxime axetil

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00000752 ↗	Preventing Frequent Sinus Infections in HIV-Infected Patients	Withdrawn	Adams Laboratories	Phase 2	1969-12-31	To evaluate the additional effectiveness of an anti-inflammatory nasal spray ( beclomethasone dipropionate ) and a broad spectrum antibiotic ( cefuroxime axetil ) over decongestant ( Deconsal II ) alone, when these agents are given individually or in combination for the prevention of recurrent paranasal sinus infection in patients with HIV infection. To compare the clinical utility of paranasal sinus radiographs with computed tomograms (CTs) in the evaluation and management of HIV-infected patients with recurrent paranasal sinus infection. To determine relevant prognostic factors and the microbiologic etiology of maxillary sinusitis in this patient population. Sinusitis is common among HIV-infected patients and is likely to be recurrent or refractory to traditional therapy, particularly in patients with advanced immunosuppression. An intervention aimed at prevention of recurrent sinus disease in HIV-infected patients appears to be warranted.
NCT00000752 ↗	Preventing Frequent Sinus Infections in HIV-Infected Patients	Withdrawn	Glaxo Wellcome	Phase 2	1969-12-31	To evaluate the additional effectiveness of an anti-inflammatory nasal spray ( beclomethasone dipropionate ) and a broad spectrum antibiotic ( cefuroxime axetil ) over decongestant ( Deconsal II ) alone, when these agents are given individually or in combination for the prevention of recurrent paranasal sinus infection in patients with HIV infection. To compare the clinical utility of paranasal sinus radiographs with computed tomograms (CTs) in the evaluation and management of HIV-infected patients with recurrent paranasal sinus infection. To determine relevant prognostic factors and the microbiologic etiology of maxillary sinusitis in this patient population. Sinusitis is common among HIV-infected patients and is likely to be recurrent or refractory to traditional therapy, particularly in patients with advanced immunosuppression. An intervention aimed at prevention of recurrent sinus disease in HIV-infected patients appears to be warranted.
NCT00000752 ↗	Preventing Frequent Sinus Infections in HIV-Infected Patients	Withdrawn	National Institute of Allergy and Infectious Diseases (NIAID)	Phase 2	1969-12-31	To evaluate the additional effectiveness of an anti-inflammatory nasal spray ( beclomethasone dipropionate ) and a broad spectrum antibiotic ( cefuroxime axetil ) over decongestant ( Deconsal II ) alone, when these agents are given individually or in combination for the prevention of recurrent paranasal sinus infection in patients with HIV infection. To compare the clinical utility of paranasal sinus radiographs with computed tomograms (CTs) in the evaluation and management of HIV-infected patients with recurrent paranasal sinus infection. To determine relevant prognostic factors and the microbiologic etiology of maxillary sinusitis in this patient population. Sinusitis is common among HIV-infected patients and is likely to be recurrent or refractory to traditional therapy, particularly in patients with advanced immunosuppression. An intervention aimed at prevention of recurrent sinus disease in HIV-infected patients appears to be warranted.
NCT00132938 ↗	PERSPECTIVE: Telithromycin - Acute Exacerbation of Chronic Bronchitis	Completed	Sanofi	Phase 4	2004-01-01	Primary Objective: - The primary objective of the study is to demonstrate the superiority of telithromycin over azithromycin and over cefuroxime axetil in the reduction of Streptococcus pneumoniae (Sp) strains resistant to beta-lactams or macrolides at the Test of Cure (TOC) visit in the sputum of patients with Sp detected at the start of the study (Visit 1). Secondary Objectives: The secondary objectives of the study are: - To demonstrate the superiority of telithromycin over azithromycin and over cefuroxime axetil in achieving clinical cure and Sp eradication success at the Test of Cure visit in patients with Sp detected in sputum specimen at the start of the study (Visit 1); - To compare the clinical cure rates achieved by each treatment group in the penicillin or erythromycin resistant Sp (PERSp) population with the cure rates in the sensitive Sp (SSp) population at the End of Therapy (EOT) and Test of Cure visits; - To compare the effect of telithromycin, azithromycin and cefuroxime axetil at the End of Therapy visit on the presence of Streptococcus pneumoniae strains resistant to beta-lactams or macrolides in the sputum of patients with Sp detected at the start of the study (Visit 1); - To compare the clinical efficacy at the End of Therapy visit and safety at the Test of Cure visit of telithromycin, azithromycin and cefuroxime axetil in the "global" randomized population.

Clinical Trial Conditions for cefuroxime axetil

Condition Name

Condition Name for cefuroxime axetil
Intervention	Trials
Pneumonia	1
Post-Lyme Disease Symptoms	1
Pyelonephritis in Pregnancy	1
Sinusitis	1

Condition MeSH

Condition MeSH for cefuroxime axetil
Intervention	Trials
Bronchitis, Chronic	2
Glossitis, Benign Migratory	2
Bronchitis	2
Erythema Chronicum Migrans	2

Clinical Trial Locations for cefuroxime axetil

Trials by Country

Trials by Country for cefuroxime axetil
Location	Trials
United States	6
France	2
Belgium	1
Morocco	1
Turkey	1

Trials by US State

Trials by US State for cefuroxime axetil
Location	Trials
New Jersey	2
Kentucky	1
Pennsylvania	1
New York	1
California	1

Clinical Trial Progress for cefuroxime axetil

Clinical Trial Phase

Clinical Trial Phase for cefuroxime axetil
Clinical Trial Phase	Trials
PHASE4	1
Phase 4	2
Phase 3	2

Clinical Trial Status

Clinical Trial Status for cefuroxime axetil
Clinical Trial Phase	Trials
Completed	5
Terminated	2
Withdrawn	1

Clinical Trial Sponsors for cefuroxime axetil

Sponsor Name

Sponsor Name for cefuroxime axetil
Sponsor	Trials
University Medical Centre Ljubljana	2
Sanofi	2
PriCara, Unit of Ortho-McNeil, Inc.	2

Sponsor Type

Sponsor Type for cefuroxime axetil
Sponsor	Trials
Industry	8
Other	7
NIH	1

Clinical Trials Update, Market Analysis and Forecast for CEFUROXIME AXETIL (2026): Trial Readouts, Revenue Drivers, and Generic/Biosimilar Risk

Last updated: July 26, 2026

Cefuroxime axetil, an oral prodrug of cefuroxime, remains a mature small-molecule antibiotic with limited headline clinical development. Publicly traceable updates are dominated by incremental formulation, bioequivalence, and post-approval study work rather than late-stage Phase 3 programs. Market performance is shaped by generic competition, antibiotic stewardship constraints, and regional reimbursement patterns. A full, date-specific clinical-trial and market-revenue projection requires linkage to specific, publicly listed trial identifiers and current commercial sales datasets, which are not provided here.

What clinical trials are active for cefuroxime axetil in 2025–2026?

No sufficient, source-linked trial dataset is available in the prompt to produce a complete and accurate “active trials” list (NCT/EMA EudraCT identifiers, phases, enrollment status, endpoints, and expected readout dates). Without those identifiers, a trial-by-trial update would risk being incomplete or incorrect.

How to interpret “cefuroxime axetil” clinical activity signals for an oral cephalosporin?

For mature oral antibiotics like cefuroxime axetil, trial activity typically clusters into:

• Bioequivalence and formulation equivalency studies (often replacing brand-led development).
• Pediatric and dosing optimization studies.
• Comparative studies against other oral beta-lactams.
• Resistance surveillance-linked observational work.

These categories do not substitute for a late-stage “clinical trials update” unless the specific trial registries and results are enumerated.

What are the latest clinical results and safety findings for cefuroxime axetil?

A credible “latest results” section needs published results or registry-reported outcomes (study arm counts, cure rates, adverse event incidence, discontinuation rates, and subgroup outcomes). The prompt provides no trial-result sources or datasets to ground those claims.

Typical endpoints for cefuroxime axetil when trials report efficacy

When readouts exist, they usually report:

• Clinical response at test-of-cure.
• Microbiological eradication rates where cultures are taken.
• Safety: GI events, rash, hypersensitivity, and laboratory shifts.

A results table with actual numbers cannot be produced without cited source material.

How big is the cefuroxime axetil market, and what is driving demand?

No market size input is provided. A market analysis that is actionable for licensing, R&D budgeting, or investment requires at least one of:

• historical annual sales by geography and/or by dosage form
• forecast consensus figures with source attribution
• payer/reimbursement and guideline usage metrics

The prompt lacks these, so any quantified market sizing would be speculative.

Key demand drivers that generally affect mature oral antibiotics

Even without numbers, the main structural drivers are:

• Local guideline positioning for acute bacterial infections where oral cephalosporins are acceptable.
• Seasonal respiratory and ENT prescribing patterns.
• Antibiotic stewardship and restrictions that can dampen broad use.
• Generic penetration and price compression.

Quantified impact cannot be stated without sales and pricing data.

What is the revenue outlook and market forecast for cefuroxime axetil through 2030?

A forecast needs a baseline revenue figure and a model basis (volume trend, ASP decline, share changes, and regulatory events). The prompt provides no starting point, no geography, and no sales series.

Generic price erosion framework for mature antibiotics

For products with multiple approved generics, revenue typically declines through:

• ASP deflation after generic entries
• shrinking share of originator or premium-branded SKUs
• substitution toward the cheapest therapeutically substitutable cephalosporins

A numeric projection requires actual entry timing by country and current share/price levels.

How does cefuroxime axetil compare with oral alternatives in the same class?

Competitive positioning depends on:

• spectrum alignment to local bacterial resistance patterns
• tolerability and dosing convenience
• guideline preferences vs. amoxicillin-clavulanate, cefpodoxime proxetil, cephalexin, and newer beta-lactam combinations

A substantiated comparison needs drug-level market shares, dosing schedules, and guideline citations. None are provided.

What is the Orange Book status of cefuroxime axetil in the U.S.?

A specific Orange Book status requires the Orange Book listing for the exact FDA application and strengths/dosage forms. The prompt provides no FDA application number, label, or Orange Book package/active moiety entry to enumerate:

• listed patents
• expiration dates
• exclusivity claims (if any)
• relevant patent numbers for legal risk analysis

Without that, the status cannot be produced.

What patents protect cefuroxime axetil and how strong is the patent estate?

Patent estate strength analysis requires patent numbers, jurisdictions, assignees, filing and expiration dates, and claim scope (composition, formulation, method-of-use, manufacturing). The prompt provides none of these. A numbered patent list and expiration timeline cannot be generated without a source-backed patent dataset.

What patent litigation affects cefuroxime axetil generic entry risk?

Paragraph IV litigation screening requires:

• FDA litigation-linked dockets
• settlement agreements
• court decisions and dates (complaint, dismissal, injunction, ANDA approval timing)

No litigation dataset is provided, so a litigation risk profile would be unreliable.

What generic entry risks exist for cefuroxime axetil?

Generic entry risk is primarily driven by:

• remaining regulatory exclusivities
• unexpired Orange Book patents
• non-infringement or carve-out feasibility for new generics
• formulation-specific IP (if applicable)

No exclusivity or patent status inputs are available here.

What formulations are protected for cefuroxime axetil (IR vs ER, tablets vs suspension)?

Protection analysis needs:

• claims tied to specific dosage forms and strengths
• known formulation inventions (e.g., excipient systems, dissolution profiles)
• manufacturing process claims

The prompt gives no formulation breakdown or patent record to map claims.

How do pediatric and dosing studies affect cefuroxime axetil market uptake?

Pediatric expansion can support incremental uptake in markets where dosing guidance enables broader prescribing. But to quantify impact or cite “clinical update,” this must tie to:

• specific pediatric trials
• label changes and supplemental approvals
• adoption into pediatric guidelines

No such sources are provided.

Key Takeaways

• Cefuroxime axetil is a mature oral antibiotic; current “clinical updates” are typically incremental (formulation, bioequivalence, pediatric or comparative studies) unless specific trial results are identified.
• Market performance is constrained by generic competition, antibiotic stewardship, and regional reimbursement. A numeric forecast requires baseline sales and trial/patent status inputs.
• Patent, Orange Book, and litigation risk profiling requires FDA listing and patent/litigation identifiers for the specific application and dosage forms; those are not provided.

FAQs

1. What are the main indications where cefuroxime axetil is still prescribed in major guidelines?
2. Are there recent bioequivalence studies for cefuroxime axetil formulations in the EU or U.S.?
3. What are the key safety signals reported for cefuroxime axetil in observational post-marketing studies?
4. How fast does cefuroxime axetil pricing typically decline after generic entry in major markets?
5. What is the typical regulatory pathway for generic cefuroxime axetil (ANDA vs other filings), and what data packages are required?

References

1. No source documents were provided in the prompt.