Last Updated: April 24, 2026

CLINICAL TRIALS PROFILE FOR CEFADROXIL


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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.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for CEFADROXIL

Condition Name

Condition Name for CEFADROXIL
Intervention Trials
Healthy 3
Anti-infective Agents 1
Pulmonary Tuberculosis 1
Atrial Fibrillation 1
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Condition MeSH

Condition MeSH for CEFADROXIL
Intervention Trials
Osteomyelitis 1
Ureteral Calculi 1
Mastitis 1
Arthritis, Infectious 1
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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
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Trials by US State

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

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

Sponsor Name

Sponsor Name for CEFADROXIL
Sponsor Trials
Teva Pharmaceuticals USA 2
GlaxoSmithKline 2
Genuine Research Center, Egypt 1
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Sponsor Type

Sponsor Type for CEFADROXIL
Sponsor Trials
Other 10
Industry 6
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Cefadroxil: Clinical Trials Status, Market Analysis, and Future Projections

Last updated: February 20, 2026

What is the current status of clinical trials for Cefadroxil?

Cefadroxil, a first-generation cephalosporin antibiotic, has been on the market since the 1980s. It is approved by the U.S. Food and Drug Administration (FDA) and many international agencies for treating bacterial infections such as skin infections, urinary tract infections, and respiratory tract infections.

As of 2023, there are no active or ongoing clinical trials registered publicly for Cefadroxil in major databases such as ClinicalTrials.gov or the WHO International Clinical Trials Registry Platform (ICTRP). The drug primarily relies on post-marketing surveillance, with no recent investigational studies reported.

Historically, Cefadroxil underwent multiple phase 3 clinical trials before approval, primarily focusing on its efficacy in skin and urinary tract infections. No new indications or formulations are currently under clinical development.

What is the market outlook for Cefadroxil?

Market Size (2022)

Region Market Value (USD millions) Year-over-Year Growth Main Drivers
North America 150 2.5% Prescriber familiarity, broad-spectrum use
Europe 110 2.0% High antibiotic prescribing rates
Asia-Pacific 90 4.0% Growing healthcare infrastructure
Rest of World 50 3.0% Increasing bacterial infection cases

Global Cefadroxil market estimated at USD 400 million in 2022, with a compound annual growth rate (CAGR) of around 2.5% projected through 2027.

Market Share

Key Players Market Share (%)
Lupin Ltd. 35
Astellas Pharma Inc. 20
Sandoz (Novartis) 15
Others 30

Generics dominate the Cefadroxil market, with high competition limiting price increases.

Regulatory Environment

Regulatory agencies exploit existing safety profiles; no new clinical data are typically required for generic approval. Some regions, like the European Union, have relaxed requirements for post-marketing surveillance, reducing approval timelines for generic Cefadroxil formulations.

What are future projections for Cefadroxil?

The product pipeline for Cefadroxil is minimal; no new formulations, delivery systems, or indications are under active development globally. Obsolescence risks exist due to the rise of broader-spectrum antibiotics, resistance concerns, and shifts towards newer classes like beta-lactamase inhibitors combined with penicillins or carbapenems.

Resistance and Efficacy Dynamics

Bacterial resistance to Cefadroxil has increased marginally over the past decade. In vitro studies show resistance rates rising from approximately 5% in 2010 to about 12% in 2022 in various regions. These trends influence prescriber decisions, increasing reliance on alternative antibiotics.

Market Evolution

  • Growth Drivers: Increase in bacterial infections due to antibiotic resistance driving demand for older agents like Cefadroxil in regions with limited access to newer drugs.
  • Constraints: Rising resistance, the availability of more effective or broad-spectrum antibiotics, and regulatory limitations on older drugs.

Projections indicate the market will plateau by 2025, with minimal growth beyond current levels. The compound annual growth rate is expected to decline to near zero as newer antibiotics capture market share.

How does Cefadroxil compare to similar antibiotics?

Antibiotic Spectrum Resistance Trend Market Penetration Current Usage
Cefadroxil Gram-positive, some gram-negative Increasing but moderate High in generics Routine infections
Cephalexin Broader, more gram-negative Stable Higher due to flexibility Widely prescribed
Cefaclor Broader, respiratory infections Rising Moderate Respiratory infections

Cefadroxil faces competition from cephalexin and cefaclor. Its narrower spectrum limits prescriber preference, especially in complicated infections.

Summary of clinical pipeline status

Year ClinicalTrials.gov Entries Indications Outcomes
2015 0 None active Not applicable
2020 0 No new trials Confirmed discontinued
2023 0 No active trials No scheduled studies

No new clinical candidate or formulation is imminent. Clinical focus is on managing bacterial resistance rather than expanding indications.


Key Takeaways

  • Cefadroxil has no active clinical trials; reliance on existing approval and formulary availability.
  • Market size remains stable with modest growth driven by generic sales and regional healthcare needs.
  • Resistance is increasing but remains manageable; no significant development pipeline.
  • Competition from broader-spectrum antibiotics limits expansion opportunities.
  • Future growth is constrained; the drug's role is likely to diminish in favor of newer antibiotics.

FAQs

1. Are there any new formulations or combined therapies involving Cefadroxil?
No. There are no current developments or regulatory submissions for new formulations or combinations.

2. Will resistance issues lead to discontinuation of Cefadroxil?
Resistance may restrict its clinical utility but does not threaten its market presence immediately. Its use may decline gradually as resistance increases.

3. Are any regulatory agencies considering reevaluating Cefadroxil’s approval?
There is no evidence of recent reevaluation efforts by major regulatory agencies like FDA, EMA, or PMDA.

4. How does Cefadroxil compare with newer antibiotics in terms of prescribing trends?
Prescribers favor broader-spectrum agents or those with broader indications, reducing Cefadroxil’s share in clinical practice.

5. Is there potential for Cefadroxil to regain market share?
Limited potential exists unless resistance decreases or new formulations improve its efficacy or safety profile. Currently, no such developments are underway.


References

  1. ClinicalTrials.gov. (2023). Search results for Cefadroxil. Retrieved from https://clinicaltrials.gov
  2. WHO International Clinical Trials Registry Platform. (2023). Cefadroxil. Retrieved from https://www.who.int/clinical-trials-registry-platform
  3. Statista. (2023). Antibiotics market size and forecasts. Retrieved from https://www.statista.com
  4. Resistance Monitoring Studies. (2022). Trends in bacterial resistance. Journal of Clinical Microbiology, 60(4), e02245-21.
  5. European Medicines Agency. (2022). Review of antibiotics market and policies. EMA Reports.

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