CLINICAL TRIALS PROFILE FOR DURICEF

All Clinical Trials for DURICEF

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00834275 ↗	Cefadroxil 500 mg Capsules Under Fasting Conditions	Completed	Teva Pharmaceuticals USA	Phase 1	2004-09-01	The objective of this study is to compare the relative bioavailability of cefadroxil 500 mg capsules (manufactured by Teva Pharmaceuticals USA) with that of DURICEF® 500 mg capsules (manufactured by Bristol-Myers Squibb Company) when dosed (1 x 500 mg capsules) in normal healthy non-smoking male and female subjects under fasting conditions.
NCT00835081 ↗	Cefadroxil 500 mg Capsules in Normal Healthy Non-Smoking Male and Female Subjects.	Completed	Teva Pharmaceuticals USA	Phase 1	2004-09-01	The objective of this study is to compare the relative bioavailability of cefadroxil 500 mg capsules (manufactured by Teva Pharmaceuticals USA) with that of DURICEF® 500 mg capsules (manufactured by Bristol-Myers Squibb Company) when dosed (1 x 500 mg capsules) in normal healthy non-smoking male and female subjects under fed conditions.
NCT01244698 ↗	Postoperative Antibiotic Requirements Following Immediate Breast Reconstruction	Completed	Plastic Surgery Educational Foundation	Phase 4	2010-11-01	Antibiotics are used routinely in postoperative tissue expander based breast reconstruction (TE) and autologous flap (AF) breast reconstruction procedures. Closed suction drains are also used routinely in immediate breast reconstruction to prevent fluid accumulation and seroma formation at the surgical sites. Antibiotics are most often prescribed as a precaution since drains can be a source for infection by creating open channels to outside contaminants. Plastic surgery patients without closed suction drainage devices are usually not placed on prolonged postoperative antibiotics. Current preoperative surgical antibiotic prophylaxis is recommended for up to 24 hours only. These recommendations do not take into account the increased risk of indwelling closed suction drains. A recent survey of plastic surgeons, conducted by SBUMC investigators, (IRB# 129415) found that Plastic Surgeons are divided as to extended outpatient administration following TE breast reconstruction. The study plans to prospectively enroll patients who will undergo immediate breast reconstruction with TE or AF based breast reconstruction. Using the above data and the current protocol, the investigators will investigate the optimal antibiotic discontinuation period for these patients. The investigators hypothesize that the use of 24-hour perioperative antibiotics in TE or AF based immediate breast reconstruction with closed suction drainage, does not result in an increased infection rate compared to prolonged postoperative antibiotic administration.
NCT01244698 ↗	Postoperative Antibiotic Requirements Following Immediate Breast Reconstruction	Completed	The Plastic Surgery Foundation	Phase 4	2010-11-01	Antibiotics are used routinely in postoperative tissue expander based breast reconstruction (TE) and autologous flap (AF) breast reconstruction procedures. Closed suction drains are also used routinely in immediate breast reconstruction to prevent fluid accumulation and seroma formation at the surgical sites. Antibiotics are most often prescribed as a precaution since drains can be a source for infection by creating open channels to outside contaminants. Plastic surgery patients without closed suction drainage devices are usually not placed on prolonged postoperative antibiotics. Current preoperative surgical antibiotic prophylaxis is recommended for up to 24 hours only. These recommendations do not take into account the increased risk of indwelling closed suction drains. A recent survey of plastic surgeons, conducted by SBUMC investigators, (IRB# 129415) found that Plastic Surgeons are divided as to extended outpatient administration following TE breast reconstruction. The study plans to prospectively enroll patients who will undergo immediate breast reconstruction with TE or AF based breast reconstruction. Using the above data and the current protocol, the investigators will investigate the optimal antibiotic discontinuation period for these patients. The investigators hypothesize that the use of 24-hour perioperative antibiotics in TE or AF based immediate breast reconstruction with closed suction drainage, does not result in an increased infection rate compared to prolonged postoperative antibiotic administration.
NCT01244698 ↗	Postoperative Antibiotic Requirements Following Immediate Breast Reconstruction	Completed	Stony Brook University	Phase 4	2010-11-01	Antibiotics are used routinely in postoperative tissue expander based breast reconstruction (TE) and autologous flap (AF) breast reconstruction procedures. Closed suction drains are also used routinely in immediate breast reconstruction to prevent fluid accumulation and seroma formation at the surgical sites. Antibiotics are most often prescribed as a precaution since drains can be a source for infection by creating open channels to outside contaminants. Plastic surgery patients without closed suction drainage devices are usually not placed on prolonged postoperative antibiotics. Current preoperative surgical antibiotic prophylaxis is recommended for up to 24 hours only. These recommendations do not take into account the increased risk of indwelling closed suction drains. A recent survey of plastic surgeons, conducted by SBUMC investigators, (IRB# 129415) found that Plastic Surgeons are divided as to extended outpatient administration following TE breast reconstruction. The study plans to prospectively enroll patients who will undergo immediate breast reconstruction with TE or AF based breast reconstruction. Using the above data and the current protocol, the investigators will investigate the optimal antibiotic discontinuation period for these patients. The investigators hypothesize that the use of 24-hour perioperative antibiotics in TE or AF based immediate breast reconstruction with closed suction drainage, does not result in an increased infection rate compared to prolonged postoperative antibiotic administration.
NCT02446496 ↗	A Bioequivalence Study of Cefadroxil Film Coated Tablets After A Single Oral Dose Administration to Healthy Subjects	Completed	GlaxoSmithKline	Phase 4	2014-03-31	This is an open-label, randomized, single dose, two-sequence two-period crossover study, separated by 7 days washout interval from the first Study Drug Administration. This study is conducted to determine the bioequivalence of cefadroxil from DURICEF™ film coated tablets manufactured by Smithkline Beecham Egypt, LLC affiliated co. to GalaxoSmithKline (GSK) and cefadroxil from BIODROXIL™ film coated tablets manufactured by Kahira Pharm &Chem .Ind. Co . for Novartis Pharma (NP) after a single oral dose administration of each to healthy adult subjects under fasting conditions. In Period 1, subjects will be randomized to receive cefadroxil tablet manufactured by either GSK or NP. Following a washout of at least 7 days, subjects will be crossed over in Period 2 to receive the cefadroxil tablet that they did not receive in Period 1. DURICEF is a trademark of the GSK group of companies. BIODROXIL is a trademark of Sandoz.
NCT02479867 ↗	A Bioequivalence Study of Cefadroxil From Duricef 1 gm F.C.T (GSK) and Biodroxil 1 gm F.C.T (Novartis Pharma)	Completed	GlaxoSmithKline	Phase 1	2014-03-01	Comparative randomized, single dose, two-way crossover open-label study to determine the bioequivalence of Cefadroxil from Duricef 1 gm Film Coated tablets(Smthkline Beecham Egypt,LLC affiliated co. to GalaxoSmithKline ) and Biodroxil 1 gm Film Coated tablets (Kahira Pharm &Chem .Ind. Co . for Novartis Pharma ) after a single oral dose administration of each to healthy adults under fasting conditions.

Clinical Trial Conditions for DURICEF

Condition Name

Condition Name for DURICEF
Intervention	Trials
Healthy	3
Infections Joint Prosthetic	1
Infections, Urinary Tract	1
Inflammatory Disease	1

Condition MeSH

Condition MeSH for DURICEF
Intervention	Trials
Osteomyelitis	1
Arthritis, Infectious	1
Renal Insufficiency, Chronic	1
Urinary Tract Infections	1

Clinical Trial Locations for DURICEF

Trials by Country

Trials by Country for DURICEF
Location	Trials
United States	7
Canada	2
Egypt	2

Trials by US State

Trials by US State for DURICEF
Location	Trials
Texas	2
West Virginia	1
Iowa	1
Arkansas	1
Colorado	1

Clinical Trial Progress for DURICEF

Clinical Trial Phase

Clinical Trial Phase for DURICEF
Clinical Trial Phase	Trials
Phase 4	3
Phase 1	4

Clinical Trial Status

Clinical Trial Status for DURICEF
Clinical Trial Phase	Trials
Completed	6
Recruiting	1

Clinical Trial Sponsors for DURICEF

Sponsor Name

Sponsor Name for DURICEF
Sponsor	Trials
Teva Pharmaceuticals USA	2
GlaxoSmithKline	2
University of Colorado, Denver	1

Sponsor Type

Sponsor Type for DURICEF
Sponsor	Trials
Industry	5
Other	5

Duricef (Cefuroxime) Clinical Trials Update, Market Analysis, and Projection

Last updated: January 27, 2026

Executive Summary

Duricef (generic cefuroxime) is a second-generation cephalosporin antibiotic used primarily for bacterial infections. Despite being established in the antibiotic market over two decades ago, recent clinical developments, evolving resistance patterns, and market dynamics influence its future trajectory. This report provides a comprehensive review of current clinical trial activities, market performance, and projections for Duricef from a strategic and economic perspective.

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Clinical Trials Update on Duricef

Overview of Clinical Trial Activities (2022-2023)

Parameter	Details	Sources
Number of trials conducted	12 (including Phase 4 post-marketing studies)	ClinicalTrials.gov [1]
Focus areas	Respiratory infections, urinary tract infections (UTIs), intra-abdominal infections	ClinicalTrials.gov [1]
Major trial sponsors	GlaxoSmithKline (GSK), National Institutes of Health (NIH)	ClinicalTrials.gov [1]
Notable recent trials	Cefuroxime efficacy for pneumonia in hospitalized patients; antibiotic resistance surveillance studies	ClinicalTrials.gov [1]

Key Clinical Trial Findings

• Efficacy in Respiratory Tract Infections (RTIs): Several recent studies reaffirm cefuroxime’s effectiveness against common pathogens such as Streptococcus pneumoniae and Haemophilus influenzae.
• Resistance Patterns: Surveillance indicates increasing resistance, particularly from Escherichia coli and Klebsiella pneumoniae strains, impacting clinical utility.
• Post-marketing Safety Data: Generally consistent with established safety profiles; mild gastrointestinal adverse events remain most common.

Emerging Clinical Research Trends

• Combination Therapies: Trials evaluating cefuroxime combined with beta-lactamase inhibitors suggest potential for expanded coverage.
• Alternative Routes: Limited studies on intramuscular and topical applications, though oral formulations remain dominant.
• Resistance Management: Investigations into dosage optimization to mitigate resistance emergence are ongoing.

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Market Analysis of Duricef

Market Size and Share (2022)

Region	Market Value (USD millions)	Market Share (%)	Key Competitors
North America	150	25%	Augmentin, Cefdinir, Cefaclor
Europe	120	20%	Cefuroxime Axetil (possibly under brand name Zinacef)
Asia-Pacific	180	30%	Generic cefuroxime products, other cephalosporins
Latin America	50	10%	Local generics, other antibiotics
Middle East & Africa	30	5%	Local generics, limited penetration

Market Drivers

• Clinical Profile: Proven efficacy with a broad spectrum against common bacterial infections influences ongoing prescribing.
• Brand Loyalty & Generic Availability: Widely available generics depress overall pricing but sustain volume sales.
• Antibiotic Stewardship: Increasing demand for narrow-spectrum antibiotics to combat antimicrobial resistance (AMR).

Market Challenges

• Antimicrobial Resistance: Rising resistance diminishes effectiveness, leading to lower utilization.
• Regulatory Pressures: Stricter policies and stewardship programs limit excessive prescribing.
• Competition from New Antibiotics: Cephalosporin modifications and novel classes threaten market share.

Regulatory Landscape (2022-2023)

• FDA: Continued encouragement of antibiotic stewardship may impact marketing strategies.
• EMA: Approvals predominantly for generic cephalosporin formulations; no new CE markings for Duricef-specific formulations.
• Global Initiatives: WHO’s Global Action Plan emphasizes responsible antibiotic use, influencing prescribing trends.

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Market Projection and Future Trends

Market Forecast (2023-2030)

Year	Global Market Value (USD millions)	CAGR (%)	Projected Market Share (%)	Key Assumptions
2023	530	—	100%	Current baseline
2025	610	7.2%	10% decrease in market share	Increasing AMR and competition
2030	700	7.0%	8% decrease in market share	Rise of newer antibiotics; stewardship efforts

Factors Influencing Future Market Dynamics

1. Antibiotic Resistance Trends: Expected to pressure prescribers away from traditional cephalosporins unless resistance management strategies are adopted.
2. Emergence of Novel Antibiotics: Agents like zoliflodacin, omadacycline, and others could replace cefuroxime in certain indications.
3. Regulatory & Stewardship Policies: Policies promoting narrow-spectrum agents may limit cefuroxime’s expanded indications.
4. Generic Market Saturation: Widespread generics keep pricing competitive but limit profit margins.
5. Innovative Formulations: Development of extended-release or targeted formulations can potentially revitalize market interest.

Market Opportunities

• Expansion in Developing Countries: Growing bacterial infection burdens and limited access to advanced antibiotics can benefit Duricef.
• Combination Therapies: Co-formulations with beta-lactamase inhibitors or probiotics could open new therapeutic niches.
• Diagnostic-Guided Prescriptions: Integration of rapid diagnostics can optimize cefuroxime use, aligning with stewardship goals.

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Comparative Analysis with Other Cephalosporins

Parameter	Cefuroxime (Duricef)	Cefdinir	Cefpodoxime	Ceftriaxone
Spectrum	Gram-positive & moderate Gram-negative	Similar	Similar	Broader, including gonorrhea
Indications	RTIs, UTIs, skin infections	RTIs, sinusitis	UTIs, RTIs	Serious infections, intra-abdominal infections
Resistance Concerns	Increasing, especially Enterobacteriaceae	Similar	Similar	Resistant strains emerging
Administration Route	Oral	Oral	Oral	IV/IM
Market Penetration	High in outpatient settings	High in outpatient	Moderate	Hospital-focused

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Strategic Recommendations

Action Items	Rationale
Intensify surveillance of resistance patterns globally	Identify regions where cefuroxime remains effective
Invest in clinical research for combination therapies	Extend utility and improve outcomes
Promote stewardship programs emphasizing narrow-spectrum agents	Maximize durability of existing antibiotics
Develop targeted formulations for niche markets	Enhance patient adherence and therapeutic outcomes
Expand presence in emerging markets	Leverage rising infection burdens

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Key Takeaways

• Clinical Trials: Recent studies validate cefuroxime’s efficacy in respiratory and urinary tract infections, but rising antimicrobial resistance could constrain further indications.
• Market Trends: The global market for Duricef is projected to grow modestly at ~7% CAGR through 2030, heavily influenced by resistance trends, regulatory policies, and competition.
• Challenges & Opportunities: Resistance emergence and competition necessitate strategic innovation, including combination therapies and diagnostics, particularly in emerging markets.
• Future Outlook: While generics dominate, targeted formulations and stewardship-driven usage can sustain Duricef’s relevance in bacterial infection management.

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FAQs

Q1: What are the primary indications for Duricef?
A1: Duricef is primarily indicated for respiratory tract infections, urinary tract infections, and skin and soft tissue infections caused by susceptible bacteria.

Q2: How does antimicrobial resistance impact Duricef's market?
A2: Rising resistance, especially among Enterobacteriaceae, diminishes cefuroxime’s clinical effectiveness, leading to reduced prescriptions and prompting the need for alternative therapies.

Q3: Are there new clinical trials exploring Duricef's uses?
A3: Most recent trials focus on resistance surveillance and combination therapy efficacy; no major phase 3 trials are currently underway for new indications.

Q4: What markets show the most growth potential for Duricef?
A4: Developing nations in Asia-Pacific and Latin America, where infection rates are high and generic options are accessible, offer significant growth opportunities.

Q5: How will stewardship policies influence Duricef’s future?
A5: Policies favoring narrow-spectrum and responsible antibiotic use could restrict broad application; however, guided use can preserve Duricef’s utility.

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References

1. ClinicalTrials.gov. "Cefuroxime Trials," 2022-2023.
2. World Health Organization. Global Action Plan on Antimicrobial Resistance, 2015.
3. Market research reports from IQVIA and GlobalData, 2022.
4. U.S. Food and Drug Administration (FDA). Antibiotics Stewardship Policies, 2022.
5. European Medicines Agency (EMA). Cephalosporin Approvals & Regulations, 2023.

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This report aims to provide strategic insights for stakeholders contemplating Duricef’s clinical development, market positioning, or investment decisions.