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Cedax

(Ceftibuten)

Phase 3Small molecule

BBurke Medical Research Institute

Cedax is one of 28 small molecule programs targeting Pyelonephritis. It is currently in Phase 3.

2

Indications

8

Total Trials

1

Active Trials

27

Competitors

2

FDA Applications

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[3][1]

Indication

PyelonephritisActive, not recruiting

FDCRecruiting

PyelonephritisPhase 3

Active, not recruiting

FDCPhase 1

Recruiting

Competition

Competitive Landscape

27 competitors in Pyelonephritis

#DrugCompanyPhaseTrials

Keflex

Maxipime

Doribax

Rocephin

CConrado Roberto Hoffmann Filho

Ceftin

PPhiladelphia Eye Associates

Avycaz

PPhiladelphia Eye Associates

Amoxil

GGlobal Antibiotics Research and Development Partnership

Merrem

BB. Braun Medical Inc.

Carnitor

LLeadiant Biosciences, Inc.

Antibiotic

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

Timeline

Expected Milestones

Q4 2026

Phase 1Recruiting

FDC

NCT06733675

Clinical

Trials by Indication[1]

Adult1 trial

To Learn How Different Forms of Study Medicine Are Taken up Into the Blood and the Effect of Food on Study Medicine in Healthy Adults

Completed· Pfizer logo

Pfizer·Phase 1·NCT06593054·13 enrolled

Oral1 trial

P1, DDI & MAD PK and Safety Study of Xeruborbactam Oral Prodrug in Combo With Ceftibuten in Healthy Participants

Completed·QQpex Biopharma, Inc.·Phase 1·NCT06079775·53 enrolled

Function1 trial

Ceftibuten/VNRX-7145 in Participants With Varying Degrees of Renal Function

Completed· Basilea Pharmaceutica logo

Basilea Pharmaceutica·Phase 1·NCT05488678·32 enrolled

Female1 trial

Plasma and Intrapulmonary Pharmacokinetics of Ceftibuten and Ledaborbactam in Healthy Male and Female Participants 18 to ≤55 Years of Age

Completed· Basilea Pharmaceutica logo

Basilea Pharmaceutica·Phase 1·NCT06665555·34 enrolled

Pyelonephritis1 trial

Short-term Antibiotic Therapy for Pyelonephritis in Childhood

Terminated·IIRCCS Burlo Garofolo·Phase 3·NCT00724256·36 enrolled

3 more indications

ART1 trial

Food Effect on Ceftibuten/VNRX-7145 in Healthy Participants

Completed· Basilea Pharmaceutica logo

Basilea Pharmaceutica·Phase 1·NCT05527834·24 enrolled

Renal Impairment1 trial

PK & Safety Study of Xeruborbactam Oral Prodrug Combined With Ceftibuten in Participants With Renal Impairment

Completed·QQpex Biopharma, Inc.·Phase 1·NCT06157242·32 enrolled

FDC1 trial

A Phase 1, Open-label Study to Evaluate the Safety and to Characterize the Pharmacokinetics of a Fixed-Dose Combination Formulation of Ceftibuten-Ledaborbactam Etzadroxil

Recruiting· Basilea Pharmaceutica logo

Basilea Pharmaceutica·Phase 1·NCT06733675·96 enrolled

Regulatory

FDA Approval Timeline[4]

Dec 20, 1995

CEDAX

NDA NDA050685

Dec 20, 1995

CEDAX

NDA NDA050686

Sources

References

[1]
ClinicalTrials.gov — 8 trial records for Ceftibuten. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Ceftibuten compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Ceftibuten. EMBL-EBI & Wellcome Sanger Institute.
[4]
OpenFDA — FDA approval records (NDA NDA050685). U.S. Food & Drug Administration.
[5]
SEC EDGAR — Burke Medical Research Institute company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Highest Phase: Phase 3[1]
Company: BBurke Medical Research Institute

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