Omnicef

(Cefdinir)

ApprovedSmall molecule

AbbVie

Omnicef is one of 98 small molecule programs targeting Malnutrition. It is currently in Approved.

Indications

Total Trials

Active Trials

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[3][1]

Indication

MalnutritionActive, not recruiting

SinusitisActive, not recruiting

Skin InfectionActive, not recruiting

PneumoniaActive, not recruiting

MalnutritionPreclinical

Active, not recruiting

SinusitisApproved

Active, not recruiting

Skin InfectionApproved

Active, not recruiting

PneumoniaApproved

Active, not recruiting

Competition

Competitive Landscape

152 competitors in Pneumonia

#DrugCompanyPhaseTrials

Omnicef

AbbVie

Approved

1 2

Jakafi

Incyte

Preclinical

1 3

Primaquine

Sanofi

Preclinical

1 4

Prevacid

Takeda

Preclinical

1 5

Plaquenil

Jazz Pharmaceuticals

Preclinical

1 6

Innohep

Jazz Pharmaceuticals

Preclinical

1 7

Advil

KKenvue Brands

Preclinical

2 8

Zantac 150

CChattem

Preclinical

2 9

Aciphex

Akero Therapeutics

Preclinical

1 10

Protonix

WWyeth-Lederle Vaccines

Preclinical

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Clinical

Trials by Indication[1]

Acute otitis media3 trials

A Comparison of the Safety and Efficacy of Cefdinir Oral Suspension Versus Amoxicillin/Clavulanate in Pediatric Subjects With Acute Otitis Media

Completed·AAbbott·Phase 4·NCT00644943·425 enrolled

Safety and Efficacy Study of Cefdinir Oral Suspension, in Pediatric Subjects to Treat Acute Otitis Media

Completed·AAbbott·Phase 2/3·NCT00645203·447 enrolled

A Comparison of Safety and Efficacy of Cefdinir Oral Suspension Versus Azithromycin in Pediatric Subjects With Acute Otitis Media

Completed·AAbbott·Phase 4·NCT00645112·357 enrolled

Antibiotic3 trials

A Comparative, Single-Center, Pediatric Taste Test Study of Omnicef Versus Amoxicillin Antibiotic Suspension Medications

Completed·AAbbott·Phase 4·NCT00645125·154 enrolled

Pediatric Taste Test Study of Cefdinir (Omnicef) Versus Amoxicillin Antibiotic Suspension Medications

Completed·AAbbott·Phase 4·NCT00644891·158 enrolled

A Pediatric Taste Test Study of Omnicef Versus Zithromax Antibiotic Suspension Medications

Completed·AAbbott·Phase 4·NCT00644774·157 enrolled

Fasting Conditions2 trials

To Demonstrate the Relative Bioequivalence of Cefdinir and Omnicel 250mg/5 ml Oral Suspension Fasting Conditions

Completed· Novartis logo

Novartis·Phase 1·NCT00882570·40 enrolled

To Demonstrate the Relative Bioequivalence of Cefdinir and Omnicef 300 mg Capsule Fasting Conditions

Completed· Novartis logo

Novartis·Phase 1·NCT00882700·28 enrolled

Sinusitis2 trials

Comparison Study Between Cefdinir & Amoxicilline/Clavulanate in Acute Sinusitis and Assessment of Quality of Life

Completed·UUniversity of Chicago·Phase 4·NCT00147914·100 enrolled

Study of the Safety and Efficacy of Cefdinir and Levofloxacin for the Treatment of Subjects With Acute Bacterial Sinusitis

Completed·AAbbott·Phase 4·NCT00645073·271 enrolled

Pneumonia1 trial

Trial to Evaluate Beta-Lactam Antimicrobial Therapy of Community Acquired Pneumonia in Children

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 4·NCT02891915·385 enrolled

6 more indications

Skin Infection1 trial

A Study to Compare Cefdinir and Cephalexin for the Treatment of Mild to Moderate Uncomplicated Skin Infections

Completed·AAbbott·Phase 4·NCT00234949·380 enrolled

Fed1 trial

To Demonstrate the Relative Bioequivalence of Cefdinir and Omnicel 300 mg Capsule Fed Conditions

Completed· Novartis logo

Novartis·Phase 1·NCT00882154·28 enrolled

Oral1 trial

To Demonstrate the Relative Bioequivalence of Cefdinir and Omnicel 250 mg/5 ml Oral Suspension Fed Conditions

Completed· Novartis logo

Novartis·Phase 1·NCT00883883·40 enrolled

Adult1 trial

Comparison of Cefdinir and Cefdinir/Clavulanic Acid Combination in Adults

Unknown status·NNeutec Ar-Ge San ve Tic A.Ş·Phase 4·NCT03400735·50 enrolled

Kwashiorkor1 trial

Randomized, Double-blind, Placebo-controlled Trial to Evaluate the Effectiveness of Oral Antibiotics in the Community-based Treatment of Severe Acute Malnutrition in Malawian Children

Completed·WWashington University School of Medicine·Preclinical·NCT01000298·2,767 enrolled

Unspecified2 trials

Cefdinir Capsules 300 mg, Fasting

Completed· Teva logo

Teva·Phase 1·NCT00835484·32 enrolled

Cefdinir Capsules 300 mg, Non-fasting

Completed· Teva logo

Teva·Phase 1·NCT00834535·32 enrolled

Regulatory

FDA Approval Timeline[4]

Dec 4, 1997

OMNICEF

NDA NDA050739

Dec 4, 1997

OMNICEF

NDA NDA050749

Sources

References

[1]
ClinicalTrials.gov — 18 trial records for Cefdinir. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Cefdinir compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Cefdinir. EMBL-EBI & Wellcome Sanger Institute.
[4]
OpenFDA — FDA approval records (NDA NDA050739). U.S. Food & Drug Administration.
[5]
SEC EDGAR — AbbVie company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Highest Phase: Approved[1]
Company: AbbVie

Omnicef

Status by Indication[3][1]

Competitive Landscape

Trials by Indication[1]

Acute otitis media3 trials

Antibiotic3 trials

Fasting Conditions2 trials

Sinusitis2 trials

Pneumonia1 trial

Skin Infection1 trial

Fed1 trial

Oral1 trial

Adult1 trial

Kwashiorkor1 trial

Unspecified2 trials

FDA Approval Timeline[4]

References

Drug Info

Quick Facts

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