Cefzil

(cefprozil)

ApprovedSmall molecule

CCordenpharma

Cefzil is one of 41 small molecule programs targeting Fasting Conditions. 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

Fasting ConditionsCompleted

AntibioticRecruiting

Fasting ConditionsPreclinical

Completed

AntibioticApproved

Recruiting

Competition

Competitive Landscape

35 competitors in Fasting Conditions

#DrugCompanyPhaseTrials

Dynastat

Pfizer

Phase 3

1 2

Cefzil

CCordenpharma

Approved

4 3

Flomax

Sanofi

Phase 1

2 4

Jardiance

Boehringer Ingelheim

Phase 1

4 5

Lamisil

Novartis

Preclinical

1 6

Monopril

Bristol-Myers Squibb

Preclinical

1 7

Ambien

PPurdue Pharma LP

Preclinical

4 8

Jardiance

Boehringer Ingelheim

Phase 1

1 9

Anjeso

Boehringer Ingelheim

Preclinical

3 10

Isopto Carpine

AAdvanz Pharma

Preclinical

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

Timeline

Expected Milestones

Q2 2028

Post-ApprovalRecruiting

Antibiotic

NCT06494072

Clinical

Trials by Indication[1]

Fasting Conditions4 trials

To Demonstrate the Relative Bioavailability of Cefzil 250 mg/5 ml Cefprozil Oral Suspension Following a 10 ml Dose Fasting Conditions.

Completed· Novartis logo

Novartis·Phase 1·NCT00881153·20 enrolled

Cefprozil 500 mg Tablets Under Fasting Conditions

Completed· Teva logo

Teva·Phase 1·NCT00840281·38 enrolled

To Demonstrate the Relative Bioavailability of Cefzil 500 mg Cefprozil Tablets Under Fasting Conditions

Completed· Novartis logo

Novartis·Phase 1·NCT00881426·26 enrolled

Show 1 more trial

Bioequivalence Study of Cefprozil Tablets, USP 500 mg Under Fasting Conditions

Completed·RRanbaxy Laboratories Limited·N/A·NCT00778778·27 enrolled

Fed3 trials

Cefprozil 500 mg Tablets Under Fed Conditions

Completed· Teva logo

Teva·Phase 1·NCT00840866·39 enrolled

To Demonstrate the Relative Bioavailability of Cefzil 500 mg Cefprozil Tablets Under Fed Conditions

Completed· Novartis logo

Novartis·Phase 1·NCT00881855·35 enrolled

Bioequivalence Study of Cefprozil Tablets, USP 500 mg Undef Fed Conditions

Completed·RRanbaxy Laboratories Limited·N/A·NCT00778245·26 enrolled

Oral3 trials

To Demonstrate the Relative Bioavailability of Cefzil 250 mg/5 ml Cefprozil Oral Suspension Fed Conditions

Completed· Novartis logo

Novartis·Phase 1·NCT00881400·24 enrolled

Cefprozil for Oral Suspension 250 mg/5 mL, Non-fasting

Completed· Teva logo

Teva·Phase 1·NCT00835354·26 enrolled

Cefprozil for Oral Suspension 250 mg/5 mL, Fasting

Completed· Teva logo

Teva·Phase 1·NCT00835614·26 enrolled

Antibiotic1 trial

Short Versus Standard of Care Antibiotic Duration for Children Hospitalized for CAP

Recruiting·MMedical College of Wisconsin·Phase 4·NCT06494072·236 enrolled

Regulatory

FDA Approval Timeline[4]

Dec 23, 1991

CEFZIL

NDA NDA050665

Dec 23, 1991

CEFZIL

NDA NDA050664

Sources

References

[1]
ClinicalTrials.gov — 11 trial records for cefprozil. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — cefprozil compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for cefprozil. EMBL-EBI & Wellcome Sanger Institute.
[4]
OpenFDA — FDA approval records (NDA NDA050665). U.S. Food & Drug Administration.
[5]
SEC EDGAR — Cordenpharma company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

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

Cefzil

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q2 2028

Trials by Indication[1]

Fasting Conditions4 trials

Fed3 trials

Oral3 trials

Antibiotic1 trial

FDA Approval Timeline[4]

References

Drug Info

Quick Facts

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