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.

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

Condition MeSH

Condition MeSH for Cefdinir
Intervention	Trials
Otitis	3
Pneumonia	3
Sinusitis	3
Otitis Media	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
Guatemala	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 and Market Analysis Projection

Last updated: April 25, 2026

What is cefdinir and what product forms matter commercially?

Cefdinir is an oral, third-generation cephalosporin used for bacterial infections. Commercial relevance centers on oral capsules and oral suspension, with dosing across common respiratory and skin/ear indications that support ongoing generic and branded competition.

Key commercial product format (core demand driver)

• Oral: capsules and suspension (brand and generic).
• Administration: outpatient-friendly dosing supports primary care and urgent care prescribing patterns.

What is the clinical trials update for cefdinir?

No current, high-salience phase transitions, late-stage readouts, or label-expansion pivotal programs were identified in the information provided in this exchange. The available dataset in this session is insufficient to produce a complete, accurate clinical-trials update with trial identifiers, dates, phases, endpoints, and results.

How is cefdinir used in clinical practice (demand channels)?

Cefdinir is typically positioned around common bacterial infection categories, with market uptake influenced by:

• Primary care prescribing for mild to moderate infections.
• Pediatric use via suspension formulations.
• Competitor substitution among oral cephalosporins (second- and third-generation) and non-beta-lactams depending on payer formularies and local stewardship guidance.

Market analysis: how demand is shaped

Cefdinir’s market dynamics are dominated by:

• Mature status and generic penetration: Most markets are supplied by generics, which compress price and keep growth modest.
• Switching behavior among oral antibiotics: Prescribers trade between cephalosporins and alternative classes based on coverage, tolerability profiles, and guideline alignment.
• Payer-driven formulary placement: Antibiotics are often managed through tiering, quantity limits, and step edits for certain indications, with impact varying by country and payer.

Competitiveness: what matters to buyers

For generic manufacturers and branded remnants, procurement is typically governed by:

• Wholesale acquisition cost competitiveness for oral solids and liquids.
• Availability and supply continuity across routine outpatient cycles.
• Formulation reliability for suspension dosing in pediatrics.
• HEOR and stewardship alignment via guideline concordance.

Market projection: what growth profile to expect

Cefdinir is a mature antibiotic with ongoing replacement demand driven by infection incidence rather than rapid innovation cycles. Without new label expansions or major differentiated reformulations, market trajectories typically follow:

• Stable to low-growth volume (driven by infection burden and prescribing patterns).
• Pressure on net sales from generic price erosion and competitive entry.
• Potential demand volatility from seasonal respiratory infection cycles and antimicrobial stewardship trends that can reduce unnecessary antibiotic use.

Because this session does not include a quantified market baseline (current size, segmentation, and geographic split), it is not possible to deliver a complete and accurate market projection with defensible numbers.

Business implications for R&D, investment, and pipeline decisions

Given cefdinir’s mature profile, the decision set usually hinges on:

• Differentiation through formulation (bioavailability, taste masking, stability, dosing convenience).
• Regulatory strategy focused on incremental label clarifications rather than new claims.
• Cost and supply execution as the core competitive lever in most geographies.
• Brand versus generic positioning depending on local tender and reimbursement mechanics.

Regulatory and IP posture (high-level)

Cefdinir is widely available as a generic in most major markets. In practical terms:

• IP-led exclusivity is not typically a primary growth driver for cefdinir today.
• Competitive advantage is more often operational (cost, manufacturing scale, quality systems) than scientific differentiation.

Key Takeaways

• Cefdinir demand is mature and volume-led, influenced by outpatient infection incidence and prescribing patterns.
• Market growth is constrained by generic penetration and price competition.
• A complete clinical trials update with trial-level proof cannot be produced from the information available in this exchange.
• A numeric market projection cannot be produced without a current baseline and segmentation inputs.

FAQs

1. Is cefdinir still actively researched in late-stage trials?
   A definitive late-stage update cannot be produced from the information available in this exchange.

2. What drives cefdinir prescriptions commercially?
   Outpatient prescribing and pediatric use through oral suspension, plus formulary placement.

3. What is the main threat to cefdinir net sales?
   Generic price erosion and formulary-driven substitution.

4. Does cefdinir have growth upside without new indications?
   Limited upside typically comes from volume stability, seasonal demand, and supply execution rather than innovation.

5. Where can a manufacturer create differentiation for a mature antibiotic?
   Formulation, reliability of supply, and cost position in contracted markets.

References

[1] U.S. Food and Drug Administration (FDA). Drug Trials Snapshots: Cefdinir.
[2] DailyMed. Cefdinir prescribing information.
[3] ClinicalTrials.gov. Cefdinir search results.