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Last Updated: May 14, 2025

CLINICAL TRIALS PROFILE FOR CEFDINIR


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All Clinical Trials for Cefdinir

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00147914 ↗ Comparison Study Between Cefdinir & Amoxicilline/Clavulanate in Acute Sinusitis and Assessment of Quality of Life Completed University of Chicago Phase 4 2005-02-01 This study is a comparison between two commonly used antibiotics (Cefdinir vs. Amoxicillin/Clavulanate) in patients with acute sinus infection, surveying quality of life. The hypothesis is that the two treatments would be at the least equivalent based on clinical outcome measures of improvement in quality of life.
NCT00234949 ↗ A Study to Compare Cefdinir and Cephalexin for the Treatment of Mild to Moderate Uncomplicated Skin Infections Completed Abbott Phase 4 2005-03-01 The purpose of this study is to compare the efficacy and tolerability of cefdinir to that of cephalexin in patients with mild to moderate uncomplicated skin/skin structure infections.
NCT00644774 ↗ A Pediatric Taste Test Study of Omnicef Versus Zithromax Antibiotic Suspension Medications Completed Abbott Phase 4 2003-01-01 To compare the taste and smell acceptability of cefdinir (Omnicef) antibiotic suspension and azithromycin (Zithromax) antibiotic suspension following a single dose of each medication.
NCT00644891 ↗ Pediatric Taste Test Study of Cefdinir (Omnicef) Versus Amoxicillin Antibiotic Suspension Medications Completed Abbott Phase 4 2003-01-01 To compare the taste and smell acceptability scores of cefdinir (Omnicef) versus amoxicillin oral antibiotic suspension medications in pediatric subjects. It was designed to determine if Omnicef or amoxicillin is preferred to the other with regard to taste or smell.
NCT00644943 ↗ A Comparison of the Safety and Efficacy of Cefdinir Oral Suspension Versus Amoxicillin/Clavulanate in Pediatric Subjects With Acute Otitis Media Completed Abbott Phase 4 2003-02-01 The primary objective is to compare the safety and efficacy of cefdinir oral suspension, 7 mg/kg/day ql2hrs for 5 days, to amoxicillin/clavulanate oral suspension 45 mg/kg/day (based on amoxicillin component), in divided doses, q12h for 10 days, in children between 6 months and 6 years of age, with AOM.
NCT00645073 ↗ Study of the Safety and Efficacy of Cefdinir and Levofloxacin for the Treatment of Subjects With Acute Bacterial Sinusitis Completed Abbott Phase 4 2003-11-01 To compare the safety and efficacy of a ten-day course of therapy of cefdinir, 600 mg QD, to a ten-day course of therapy of levofloxacin, 500 mg QD, in the treatment of acute bacterial sinusitis.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Cefdinir

Condition Name

Condition Name for Cefdinir
Intervention Trials
Healthy 11
Acute Otitis Media 3
Urinary Tract Infections 2
Acute Bacterial Sinusitis 2
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Condition MeSH

Condition MeSH for Cefdinir
Intervention Trials
Pneumonia 3
Sinusitis 3
Otitis Media 3
Otitis 3
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Clinical Trial Locations for Cefdinir

Trials by Country

Trials by Country for Cefdinir
Location Trials
United States 78
France 14
Costa Rica 2
Chile 2
Malawi 1
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Trials by US State

Trials by US State for Cefdinir
Location Trials
Ohio 6
Arizona 6
Texas 6
Pennsylvania 5
Kentucky 4
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Clinical Trial Progress for Cefdinir

Clinical Trial Phase

Clinical Trial Phase for Cefdinir
Clinical Trial Phase Trials
Phase 4 14
Phase 2/Phase 3 2
Phase 2 2
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Clinical Trial Status

Clinical Trial Status for Cefdinir
Clinical Trial Phase Trials
Completed 22
Recruiting 2
Terminated 1
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Clinical Trial Sponsors for Cefdinir

Sponsor Name

Sponsor Name for Cefdinir
Sponsor Trials
Abbott 8
Teva Pharmaceuticals USA 4
Sandoz 4
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Sponsor Type

Sponsor Type for Cefdinir
Sponsor Trials
Industry 18
Other 15
NIH 4
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Cefdinir: Clinical Trials, Market Analysis, and Projections

Introduction to Cefdinir

Cefdinir, marketed under the brand name Omnicef, is a third-generation cephalosporin antibiotic used to treat various bacterial infections, including streptococcal pharyngitis, urinary tract infections, and other respiratory tract infections.

Clinical Trials and Efficacy

Streptococcal Pharyngitis

A significant clinical trial compared the efficacy of a 5-day regimen of cefdinir with a 10-day regimen of penicillin V in treating streptococcal pharyngitis in children. The study found that cefdinir eradicated a higher proportion of Streptococcus pyogenes (90% vs 72%) compared to penicillin V. However, there was no significant difference in clinical cure rates or adverse event rates between the two treatments[1].

Urinary Tract Infections

A retrospective comparative study evaluated the efficacy of cefdinir versus cephalexin in treating lower urinary tract infections (UTIs). The results indicated that both antibiotics had comparable efficacy, despite cefdinir having lower urine penetration. There were no significant differences in treatment failure rates at 7 and 14 days between the two groups[4].

Adverse Events and Tolerability

Clinical trials involving both adult and pediatric patients have shown that cefdinir is generally well-tolerated. The most common adverse events were mild and self-limiting, primarily involving gastrointestinal disturbances such as diarrhea and nausea. Discontinuation rates due to adverse events were low, around 3% in adults and 2% in pediatric patients[3].

Market Analysis

Global Market Size and Growth

The global cefdinir market is expected to witness significant growth from 2024 to 2031. In 2023, the global market size was substantial, and the compound annual growth rate (CAGR) is projected to be notable over the forecast period. The market has been segmented by product type (tablets, capsules, liquid, and injection), sales channels (hospitals, retail OTC, third-party terminals, and online), and geographical regions (North America, Europe, Asia-Pacific, Middle East & Africa, and Latin America)[2].

Regional Analysis

  • North America: This region is expected to contribute significantly to the global market due to high demand and advanced healthcare infrastructure.
  • Europe: Europe also holds a substantial share, driven by the presence of major pharmaceutical companies and a well-established healthcare system.
  • Asia-Pacific: This region is anticipated to experience rapid growth due to increasing healthcare expenditure and a large patient population.
  • Middle East & Africa and Latin America: These regions are also expected to grow, albeit at a slower pace, due to improving healthcare facilities and increasing awareness of antibiotic treatments[2].

Key Players and Market Dynamics

Major players in the cefdinir market include TEVA, LUPIN, YONGNING PHARMA, and others. These companies are focusing on expanding their product portfolios and strengthening their market presence through strategic initiatives. The market is driven by factors such as increasing bacterial infections, advancements in pharmaceutical technology, and growing healthcare expenditure. However, it is also restrained by factors like antibiotic resistance and regulatory challenges[2].

Market Projections

Forecasted Growth

The global cefdinir market is projected to grow significantly from 2025 to 2031. The tablet segment is expected to account for a noticeable share of the market and is projected to experience significant growth. The hospital segment is anticipated to expand at a significant CAGR, retaining its position throughout the forecast period[2].

Segment Analysis

  • Product Type: Tablets are expected to dominate the market, followed by capsules and liquid formulations.
  • Sales Channels: Hospitals are expected to be the primary sales channel, with retail OTC and online channels also contributing significantly.
  • Geographical Split: North America, Europe, and Asia-Pacific are expected to be the major contributors to the global market[2].

Pharmaceutical Grade Cefdinir Market

The global pharmaceutical grade cefdinir market is also expected to grow from 2023 to 2030. This growth is driven by the increasing demand for high-quality antibiotics and the expansion of pharmaceutical manufacturing capabilities. The U.S. and European markets are expected to be significant contributors, with China also showing promising growth due to its large manufacturing base and growing healthcare needs[5].

Key Takeaways

  • Efficacy: Cefdinir has shown high efficacy in treating streptococcal pharyngitis and comparable efficacy to cephalexin in treating UTIs.
  • Tolerability: Cefdinir is generally well-tolerated with mild and self-limiting adverse events.
  • Market Growth: The global cefdinir market is projected to grow significantly from 2025 to 2031, driven by increasing demand and advancements in pharmaceutical technology.
  • Regional Analysis: North America, Europe, and Asia-Pacific are expected to be major contributors to the global market.
  • Key Players: Major pharmaceutical companies like TEVA and LUPIN are focusing on expanding their product portfolios and market presence.

FAQs

What is cefdinir used for?

Cefdinir is a cephalosporin antibiotic used to treat various bacterial infections, including streptococcal pharyngitis, urinary tract infections, and other respiratory tract infections.

How effective is cefdinir in treating streptococcal pharyngitis?

Cefdinir has been shown to eradicate a higher proportion of Streptococcus pyogenes compared to a 10-day regimen of penicillin V in treating streptococcal pharyngitis in children[1].

What are the common adverse events associated with cefdinir?

The most common adverse events associated with cefdinir are mild and self-limiting, primarily involving gastrointestinal disturbances such as diarrhea and nausea[3].

Which regions are expected to drive the growth of the global cefdinir market?

North America, Europe, and Asia-Pacific are expected to be the major contributors to the global cefdinir market due to high demand and advanced healthcare infrastructure[2].

What is the projected growth rate of the global cefdinir market from 2025 to 2031?

The global cefdinir market is projected to grow at a significant compound annual growth rate (CAGR) from 2025 to 2031, driven by increasing demand and advancements in pharmaceutical technology[2].

Sources

  1. A study of 5-day cefdinir treatment for streptococcal pharyngitis in children. PubMed.
  2. Cefdinir Market Report 2024 (Global Edition). Cognitive Market Research.
  3. Omnicef (Cefdinir): Side Effects, Uses, Dosage, Interactions, Warnings. RxList.
  4. Cefdinir vs cephalexin for the treatment of urinary tract infections. American Journal of Health-System Pharmacy.
  5. 2024-2030 Global Pharmaceutical Grade Cefdinir Industry. YH Research.
Last updated: 2025-01-07

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