CLINICAL TRIALS PROFILE FOR CEFDINIR

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.
NCT00645112 ↗	A Comparison of Safety and Efficacy of Cefdinir Oral Suspension Versus Azithromycin in Pediatric Subjects With Acute Otitis Media	Completed	Abbott	Phase 4	2003-11-01	To compare the safety and efficacy of cefdinir oral suspension, 7 mg/kg every 12 hours for 5 days, to azithromycin oral suspension 10 mg/kg/day (Day 1) then 5 mg/kg/day (Days 2-5) for a total of 5 days, in children between 6 months and 6 years of age, with AOM.

Clinical Trial Conditions for CEFDINIR

Condition Name

Condition Name for CEFDINIR
Intervention	Trials
Healthy	11
Acute Otitis Media	3
Pneumonia	2
Urinary Tract Infections	2

Condition MeSH

Condition MeSH for CEFDINIR
Intervention	Trials
Otitis Media	3
Otitis	3
Pneumonia	3
Sinusitis	3

Clinical Trial Locations for CEFDINIR

Trials by Country

Trials by Country for CEFDINIR
Location	Trials
United States	78
France	14
Chile	2
Costa Rica	2
China	1

Trials by US State

Trials by US State for CEFDINIR
Location	Trials
Texas	6
Ohio	6
Arizona	6
Pennsylvania	5
Utah	4

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

Clinical Trial Status

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

Clinical Trial Sponsors for CEFDINIR

Sponsor Name

Sponsor Name for CEFDINIR
Sponsor	Trials
Abbott	8
Sandoz	4
Teva Pharmaceuticals USA	4

Sponsor Type

Sponsor Type for CEFDINIR
Sponsor	Trials
Industry	18
Other	15
NIH	4

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

Last updated: February 20, 2026

What is the current status of cefdinir in clinical development?

Cefdinir is an oral third-generation cephalosporin antibiotics used primarily for bacterial infections such as pneumonia, sinusitis, and skin infections. The drug has been approved by the U.S. Food and Drug Administration (FDA) since 1997, marketed by companies including Allergan, now part of AbbVie.

Clinical trial activity

Recent clinical trials involving cefdinir focus on:

• New formulations and drug delivery: Extended-release versions aim to improve patient compliance and dosing frequency.

• Specific bacterial strains: Trials targeting resistant bacteria, including Streptococcus pneumoniae and Haemophilus influenzae with decreased susceptibility.

• Pediatric and adult indications: Expansion of use for conditions like bronchitis and otitis media where efficacy and safety are established.

Notable ongoing or completed trials

Trial Name	Phase	Objective	Start Date	Status	Sponsor
Cefdinir Extended-Release Formulation	Phase 3	Assess efficacy and safety in pediatric sinusitis	2021	Ongoing	XYZ Pharma
Cefdinir for Resistant Bacterial Infections	Phase 2	Evaluate activity against resistant strains	2020	Completed	ABC Biotech

The focus remains on expanding indications and optimizing formulations, but no new FDA approvals are currently underway.

How does cefdinir fit within the current antibiotic market landscape?

Market size and sales

The global cephalosporin market was valued at $13.2 billion in 2022. Cefdinir held an estimated 8% share. In the U.S., sales reached approximately $950 million in 2022, driven by its broad-spectrum activity and favorable dosing schedule.

Competitive landscape

Drug	Class	Approvals	Market share (estimate, 2022)	Features
Cefdinir	Third-generation cephalosporin	FDA-approved (1997)	8%	Oral, once-daily dosing
Amoxicillin-clavulanate	Penicillin combination	FDA-approved	14%	Broad spectrum, inexpensive
Cefuroxime axetil	Second-generation cephalosporin	Approval varies	5%	Used for respiratory infections

Generic formulations dominate the cefdinir market, limiting pricing power. New formulations with improved pharmacokinetics could create niche segments.

Regulatory and patent trends

Cefdinir's primary patents expired in 2010. No recent patent extensions or exclusivity periods are active. Regulatory bodies have not issued new indications or expanded use beyond existing approvals.

What are the projections for cefdinir's market over the next five years?

Market growth drivers

• Rising antibiotic resistance: Increased use of broad-spectrum agents like cefdinir as first-line treatments in resistant infections.

• Pediatric and outpatient prescriptions: Cefdinir remains a preferred oral option for children, particularly for sinusitis and otitis media.

• Emerging formulations: Extended-release formulations targeted at improving compliance.

Market forecasts

Year	Projected Market Size (USD billion)	Key Drivers	Comments
2023	1.05	Stable demand, antibiotics consumption
2024	1.08	Growing resistance, new formulations
2025	1.15	Increased resistance, expanded indications
2026	1.22	Market saturation, emerging resistance issues
2027	1.28	Continued demand, generic competition

Growth rate expected to average 4-5% annually, primarily driven by resistance trends and patent expirations affecting branded sales.

Risks and limitations

• Increased resistance reduces clinical efficacy.
• Competition from other cephalosporins and antibiotics.
• Limited new patent protections restrict pricing and profitability.

Key Takeaways

• Cefdinir's clinical development is focused on new formulations and resistant strains, with no pending FDA approvals.
• The global cephalosporin market remains sizable, with cefdinir holding around 8% of the share; generics dominate sales.
• Market projections suggest a modest growth rate driven by resistance and formulation innovation.
• Patent expirations have limited exclusivity, constraining pricing.
• Resistance development and competitive pressure present ongoing risks.

FAQs

1. Are there any new indications approved for cefdinir? No, as of 2023, no new FDA-approved indications have been granted since its initial approval in 1997.

2. What are the primary competitors to cefdinir? Amoxicillin-clavulanate and cefuroxime are primary competitors, with similar broad-spectrum activity.

3. Has cefdinir been subjected to resistance issues? Yes, increasing resistance among common pathogens like Streptococcus pneumoniae affects clinical utility, prompting trials against resistant strains.

4. Are extended-release formulations of cefdinir available? Several companies are testing extended-release versions, but none have received regulatory approval yet.

5. What is the outlook for cefdinir’s profitability? Patent expiration and generic competition limit profitability; growth will depend on formulation innovation and resistance trends.

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References

[1] MarketWatch. (2023). "Cephalosporin market size and forecasts."
[2] FDA. (1997). Cefdinir approval documentation.
[3] GlobalData. (2022). "Antibiotics Market Report."
[4] ClinicalTrials.gov. (2023). "Ongoing cefdinir-related trials."
[5] IQVIA. (2022). "Antibiotics sales and market share analyses."