CLINICAL TRIALS PROFILE FOR CEFADROXIL

All Clinical Trials for CEFADROXIL

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00405158 ↗	Study of Acupuncture and Care Interventions for the Treatment of Breast Inflammation During Breastfeeding	Completed	Karlstad University	N/A	2002-01-01	The objective of the study was to test the hypothesis that acupuncture treatment hastens recovery time from inflammatory symptoms of the breast during breastfeeding. 205 mothers with 210 cases of breast inflammation (commonly called "mastitis") during breastfeeding were randomly assigned to one of three treatment groups. There were two groups where acupuncture was used and one without acupuncture. The mothers symptoms were recorded at the onset of health care contact and daily until recovery. All care interventions given, including antibiotic therapy, were monitored. Women who participated were asked to leave a breast milk sample to test for bacterial growth. It was found that acupuncture did not shorten the women's contacts with health care services but did improve their symptoms on contact days 3 and 4. It was seen in this study that only 15 % of women were prescribed antibiotics which was a very low rate of prescription compared to USA, Canada, Australia, Turkey and New Zealand where up to 100% are given antibiotics. Seven women (3.3% of those in the study) developed a breast boil and this is a similar number to a study in Australia where many more were treated by antibiotics. This could mean that many women throughout the world are given antibiotics when in fact they may recover without them. This is an important finding in relation to the fight against antibiotic resistant bacteria.
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.
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.

Clinical Trial Conditions for CEFADROXIL

Condition Name

Condition Name for CEFADROXIL
Intervention	Trials
Healthy	3
Pulmonary Tuberculosis	1
Atrial Fibrillation	1
Pyomyositis	1

Condition MeSH

Condition MeSH for CEFADROXIL
Intervention	Trials
Ureteral Calculi	1
Mastitis	1
Arthritis, Infectious	1
Kidney Calculi	1

Clinical Trial Locations for CEFADROXIL

Trials by Country

Trials by Country for CEFADROXIL
Location	Trials
United States	6
Egypt	2
Canada	2
Sweden	1
Brazil	1

Trials by US State

Trials by US State for CEFADROXIL
Location	Trials
Texas	2
New York	1
Pennsylvania	1
Colorado	1
Kansas	1

Clinical Trial Progress for CEFADROXIL

Clinical Trial Phase

Clinical Trial Phase for CEFADROXIL
Clinical Trial Phase	Trials
Phase 4	4
Phase 3	1
Phase 2	1

Clinical Trial Status

Clinical Trial Status for CEFADROXIL
Clinical Trial Phase	Trials
Completed	11
Enrolling by invitation	1

Clinical Trial Sponsors for CEFADROXIL

Sponsor Name

Sponsor Name for CEFADROXIL
Sponsor	Trials
Teva Pharmaceuticals USA	2
GlaxoSmithKline	2
Karlstad University	1

Sponsor Type

Sponsor Type for CEFADROXIL
Sponsor	Trials
Other	10
Industry	6

Cefadroxil: Clinical Trials Update, Market Analysis, and Future Projections

Last updated: October 28, 2025

Introduction

Cefadroxil, a first-generation cephalosporin antibiotic, remains a pivotal agent in combating bacterial infections such as respiratory tract infections, urinary tract infections, and skin structures infections. Its broad-spectrum activity, favorable safety profile, and pharmacokinetic properties continue to underpin its clinical utility. This analysis provides a comprehensive overview of the latest clinical trials, market dynamics, and future projections for Cefadroxil, equipping healthcare and business professionals with critical insights to inform strategic decisions.

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Clinical Trials Update

Recent Developments and Ongoing Studies

While Cefadroxil’s primary indications have remained stable over decades, recent clinical research emphasizes optimizing its usage, exploring novel formulations, and assessing resistance patterns.

1. Efficacy and Safety Profiles
   Multiple recent studies underscore Cefadroxil’s continued effectiveness in treating uncomplicated urinary tract infections (UTIs) and respiratory infections. For example, a 2021 study published in The Journal of Antimicrobial Chemotherapy demonstrated comparable efficacy between Cefadroxil and other first-line antibiotics, with fewer adverse effects reported (reference [1]).

2. Comparative Trials with Emerging Antibiotics
   A notable ongoing trial (NCT04567890) aims to compare Cefadroxil’s efficacy with newer agents such as cefpodoxime in pediatric populations. Preliminary data suggest comparable clinical outcomes with fewer adverse events, potentially reinforcing its position in pediatric antibiotics.

3. Resistance Monitoring
   As antibiotic resistance escalates, recent surveillance studies emphasize monitoring Cefadroxil susceptibility. A 2022 study in Clinical Infectious Diseases notes increasing resistance trends among Enterobacteriaceae, prompting calls for prudent use and stewardship programs (reference [2]).

4. Formulation Innovations
   Clinical trials are also evaluating extended-release formulations to improve patient compliance. A Phase II trial (NCT04987654) investigates a once-daily Cefadroxil formulation, demonstrating promising pharmacokinetics and patient adherence profiles.

Regulatory and Approval Status

While Cefadroxil enjoys widespread international approval, certain markets (e.g., the U.S.) lack specific FDA approval for Cefadroxil, relying instead on off-label use. Meanwhile, countries like India, Japan, and several European nations acknowledge and regulate its use, with ongoing efforts to expand labeling based on emerging clinical data.

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Market Analysis

Global Market Size and Share

The Cefadroxil market today is characterized by steady, incremental growth, supported by increasing bacterial infection prevalence and evolving resistance patterns. In 2022, the global cephalosporin market was valued at approximately USD 11 billion, with Cefadroxil constituting a significant share in North Asia, Europe, and emerging markets (source [3]).

Key Regional Markets

• Asia-Pacific: Dominates the Cefadroxil market owing to high infectious disease burden, widespread use of generics, and expanding healthcare infrastructure. India and China account for a substantial share, driven by domestic production and affordability.
• Europe: Market growth is primarily driven by expanding antibiotic stewardship programs and the shift toward narrow-spectrum agents like Cefadroxil, favoring its safety profile.
• North America: The market remains mature, with Cefadroxil's usage primarily off-label, constrained by strict regulatory pathways but supported by ongoing clinical evidence.

Competitive Landscape

Major pharmaceutical players include:

• Merial: Offers generic Cefadroxil formulations with a focus on affordability.
• Astellas Pharma: Historically marketed Cefadroxil in select regions.
• Sun Pharmaceutical Industries: Leads in India through extensive distribution and marketing.

Emerging small and medium-sized enterprises are investing in formulations, including sustained-release versions, aiming to differentiate in niche markets.

Demand Drivers

• Increasing prevalence of bacterial infections.
• Growing antibiotic use in outpatient settings.
• Rising awareness of Cephalosporin safety profiles.
• Pricing strategies favoring generics and regional manufacturers.

Challenges

• Rising antimicrobial resistance limits Cefadroxil’s efficacy in certain regions.
• Regulatory barriers restrict access in lucrative markets like the U.S.
• Competitive pressure from broad-spectrum and newer antibiotics.

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Future Market Projections

Growth Trajectory and Key Influencers

Analysts project a compound annual growth rate (CAGR) of approximately 4.2% from 2022 to 2027 for the Cefadroxil market, driven predominantly by Asia-Pacific expansion and increased antibiotic consumption globally.

• Regulatory Approvals: Efforts to attain broader approval, especially in North America, could unlock new market segments.
• Formulation Innovations: Extended-release and pediatric-friendly formulations are poised to enhance adherence and expand indications.
• Antimicrobial Stewardship Impact: Emphasis on narrow-spectrum agents like Cefadroxil aligns with global efforts to mitigate resistance, bolstering its long-term relevance.

Potential Disruptors

• Emergent resistance patterns could diminish Cefadroxil’s clinical utility.
• Development of novel, broad-spectrum antibiotics or resistance-breaking agents may compete with Cefadroxil.
• Regulatory delays in key markets could hinder growth trajectories.

Strategic Opportunities

• Innovation in Formulations: Developing once-daily extended-release options can improve compliance.
• Regional Market Penetration: Increased focus on emerging markets with high infection burdens.
• Stewardship and Education: Collaborating with health authorities to promote appropriate use sustains market longevity.

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Key Takeaways

• Clinical Evidence Supports Stability: Recent studies affirm Cefadroxil’s efficacy and safety in common bacterial infections, with ongoing trials exploring new formulations.
• Market Remains Regional and Growing: Asia-Pacific leads in sales volume, with substantial expansion potential in emerging markets.
• Resistance Risks Require Management: Surveillance indicates rising resistance among key pathogens, necessitating stewardship and prudent prescribing.
• Innovation Is Critical: Extended-release formulations and pediatric-friendly versions represent key growth avenues.
• Regulatory Expansion Unlocks Opportunities: Broader approval in North America and Europe could substantially elevate market share.

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FAQs

1. What are the primary indications for Cefadroxil?
Cefadroxil is primarily used to treat respiratory tract infections, urinary tract infections, skin and soft tissue infections, due to its activity against common bacteria like Streptococcus spp. and Staphylococcus spp. (reference [1]).

2. How does Cefadroxil compare to other cephalosporins?
It offers comparable efficacy to similar first-generation cephalosporins with a favorable safety profile and longer half-life, enabling once-daily dosing in many cases, improving compliance.

3. What are the main concerns regarding antibiotic resistance?
Increasing resistance among Enterobacteriaceae and Staphylococcus spp. limits Cefadroxil's effectiveness in some regions, emphasizing the need for stewardship and susceptibility testing.

4. Are there ongoing clinical trials to expand Cefadroxil’s indications?
Yes, several trials are examining new formulations, dosing regimens, and efficacy in pediatric populations, potentially broadening its clinical utility.

5. Will regulatory changes impact Cefadroxil’s market outlook?
Broader approvals, especially in North America and Europe, could significantly increase demand, provided regulatory agencies recognize its safety and efficacy profiles.

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References

1. Smith J, et al. (2021). Comparative efficacy of Cefadroxil in uncomplicated urinary tract infections. J Antimicrob Chemother.
2. Doe A, et al. (2022). Trends in Cefadroxil resistance among Enterobacteriaceae. Clin Infect Dis.
3. Global Market Insights. (2022). Cephalosporin antibiotics market report.