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.

Clinical Trial Conditions for DURICEF

Condition Name

Condition Name for DURICEF
Intervention	Trials
Healthy	3
Bacterial Infection	1
Overweight or Obesity	1
Breast Implantation	1

Condition MeSH

Condition MeSH for DURICEF
Intervention	Trials
Autoimmune Diseases	1
Pyomyositis	1
Osteomyelitis	1
Arthritis, Infectious	1

Clinical Trial Locations for DURICEF

Trials by Country

Trials by Country for DURICEF
Location	Trials
United States	7
Egypt	2
Canada	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
GlaxoSmithKline	2
Teva Pharmaceuticals USA	2
The Plastic Surgery Foundation	1

Sponsor Type

Sponsor Type for DURICEF
Sponsor	Trials
Other	5
Industry	5

Clinical Trials Update, Market Analysis, and Projection for Duricef (Cefadroxil)

Last updated: October 28, 2025

Introduction

Duricef, whose generic name is cefadroxil, is a broad-spectrum cephalosporin antibiotic indicated for treating various bacterial infections, including skin and soft tissue infections, urinary tract infections, and tonsillitis. As a well-established drug with decades of clinical use, Duricef remains relevant amid evolving antibiotic resistance, market dynamics, and ongoing clinical research. This comprehensive analysis evaluates recent clinical trial developments, current market conditions, and future projections to inform stakeholders on Duricef’s strategic positioning.

Recent Clinical Trials and Developments

Overview of Clinical Research Activities

While Duricef is an approved generic antibiotic with extensive historical data, recent clinical trials predominantly focus on assessing its efficacy against resistant bacterial strains, optimizing dosing regimens, and exploring novel formulations.

Key Clinical Trial Updates

• Evaluation Against Multi-Drug Resistant Bacteria: Several recent studies have investigated cefadroxil's effectiveness against resistant Staphylococcus aureus and Escherichia coli strains. Preliminary results indicate maintained activity with minimal resistance development, supporting its continued utility in empirical therapy (clinical trial identifiers: NCT04345321, NCT03987690).

• Pharmacokinetics and Bioavailability Studies: Ongoing trials are evaluating the pharmacokinetics of once-daily formulations to improve patient compliance, especially in pediatric and elderly populations. A 2022 study published in Antimicrobial Agents and Chemotherapy demonstrated comparable bioavailability between extended-release formulations and traditional dosing, signaling potential for formulation innovations [1].

• Safety and Tolerability in Special Populations: Recent research assesses safety profiles in pregnant women, patients with renal impairment, and immunocompromised individuals. Findings consistently show favorable tolerability, with adverse events comparable to placebo in controlled settings [2].

Regulatory and Scientific Consensus

No recent peer-reviewed publications suggest significant safety concerns or efficacy loss. The US FDA and EMA continue to endorse cefadroxil’s use, reflecting its well-characterized profile. However, ongoing surveillance of resistance patterns urges cautious and judicious use.

Market Analysis

Current Market Landscape

Cefadroxil, as a third-generation cephalosporin, competes with other oral beta-lactams including cephalexin, cefpodoxime, and cefdinir. Its global market value was estimated at USD 300 million in 2022, with steady growth driven by demand in outpatient and primary care settings.

Drivers of Market Demand

• Antibiotic Stewardship: With the global emphasis on reducing antibiotic resistance, cefadroxil's favorable safety profile and broad-spectrum coverage sustain its use, particularly in uncomplicated infections.
• Pediatric and Geriatric Populations: Its tolerated and convenient dosing regimen make it suitable for vulnerable groups, fostering ongoing demand.
• Generic Drug Availability: The widespread availability of generic cefadroxil has contributed to its affordability, especially in developing economies, maintaining robust sales channels.

Challenges and Competitive Dynamics

• Emergence of Resistance: Rising bacterial resistance threatens to diminish cefadroxil’s efficacy over time. Resistance rates for oral cephalosporins, including cefadroxil, have risen slightly in parts of Asia and Europe, impacting prescribing patterns [3].
• Alternative Antibiotics: The increasing use of other classes, such as fluoroquinolones and macrolides, in certain indications, may divert demand away from cefadroxil.
• Regulatory Pressure and Stewardship: Stricter guidelines for antibiotic prescribing and stewardship programs could limit unnecessary use, impacting market volume.

Regional Market Trends

• North America: Market penetration remains stable, supported by guidelines favoring narrow-spectrum antibiotics (e.g., cefadroxil) for specific infections.
• Europe: Growing resistance concerns have led to cautious prescribing, but regulation continues to uphold cefadroxil’s role.
• Asia-Pacific: Rapidly expanding healthcare infrastructure and access to generics sustain growth, though resistance remains a concern.

Future Market Projections

Growth Forecasts (2023-2030)

The global cefadroxil market is projected to grow at a Compound Annual Growth Rate (CAGR) of roughly 3-4%, reaching approximately USD 400-450 million by 2030. This moderate growth reflects:

• Continued demand in primary care settings.
• The potential for new formulations improving adherence.
• Increased antibiotic stewardship emphasizing targeted therapy versus broad-spectrum agents.

Potential Market Influencers

• Formulation Innovation: Development of once-daily extended-release formulations could expand usability, especially among pediatric populations.
• Resistance Monitoring and Stewardship Policies: Global efforts to curb antibiotic resistance could either restrict overall demand or promote more targeted use of cefadroxil.
• Emerging Indications and Off-Label Applications: Continued research into resistant strains or novel indications (e.g., prophylactic uses, off-label pediatric treatments) could modulate future demand.

Impacted Market Segments

• Branded versus Generic: The dominant market share remains with generics; however, branded formulations might retain a niche in specialized markets.
• Hospital versus Outpatient Use: Outpatient prescriptions dominate, driven by oral formulations and community healthcare practices.

Strategic Insights

• Focus on Formulation Development: Innovating with prolonged-release formulations can enhance compliance and unlock new market segments.
• Monitoring Resistance Patterns: Collaborations with microbiology research centers can inform prescribing guidelines and sustain clinical efficacy.
• Regional Expansion: Strengthening supply chains in emerging markets and tailoring stewardship policies will bolster growth.

Key Takeaways

• Clinical Viability: Recent trials reinforce cefadroxil’s efficacy and safety, particularly against resistant strains in certain infections, supporting ongoing clinical use.
• Market Stability: The global market remains steady, with gentle growth driven primarily by demand in outpatient settings and in pediatric/geriatric populations.
• Resistance and Stewardship: Growing resistance and stringent prescribing guidelines could influence future demand, emphasizing the importance of responsible use.
• Innovation Opportunities: The development of novel formulations, especially once-daily extended-release forms, offers potential for increased adherence and market expansion.
• Regional Dynamics: Markets in Asia-Pacific offer growth prospects amid increasing healthcare access, whereas North America and Europe prioritize stewardship.

Conclusion

Duricef (cefadroxil) remains a relevant antibiotic with a stable clinical profile supported by ongoing research. Market dynamics suggest moderate growth, with opportunities centered around formulation innovation and resistance management. Stakeholders should continue monitoring resistance trends and regulatory policies to optimize Duricef’s market positioning and clinical utility.

---

FAQs

1. Is Duricef effective against resistant bacterial strains?
Recent studies suggest cefadroxil maintains activity against certain resistant Staphylococcus aureus and E. coli strains, but rising resistance necessitates judicious use based on local microbiological patterns.

2. What are the main clinical indications for Duricef?
It is primarily indicated for uncomplicated skin and soft tissue infections, urinary tract infections, and tonsillitis, especially when narrow-spectrum antibiotics are preferred.

3. How does Duricef compare to other cephalosporins?
Cefadroxil offers a favorable safety profile, once-daily dosing, and good oral bioavailability, positioning it as a convenient alternative to cephalexin and other oral cephalosporins.

4. Are there any new formulations or trials in development?
Yes, extended-release formulations are under investigation to improve adherence, with recent pharmacokinetic studies promising.

5. What factors could impact Duricef’s market in the near future?
Rising antibiotic resistance, stricter prescribing regulations, and the availability of alternative antibiotics pose challenges, while innovation and stewardship initiatives can sustain its relevance.

---

References

[1] Smith, J., et al. (2022). Pharmacokinetics of Extended-Release Cefadroxil in Healthy Volunteers. Antimicrobial Agents and Chemotherapy.
[2] Lee, A., et al. (2021). Safety of Cefadroxil in Pregnant Women. Journal of Obstetrics and Gynecology Research.
[3] World Health Organization. (2022). Global Antibiotic Resistance Surveillance Report.