Ceftibuten

Generic Name: Ceftibuten

Brand Names: Cedax

Drug Type: Small Molecule

Chemical Formula: C_₁₅H_₁₄N_₄O_₆S_₂

CAS Number: 97519-39-6

Unique Ingredient Identifier: IW71N46B4Y

Background: Ceftibuten is a third-generation cephalosporin antibiotic that is orally-administered. It is typically used to treat acute bacterial exacerbations of chronic bronchitis (ABECB), acute bacterial otitis media, pharyngitis, and tonsilitis.

Indication: Indicated for the treatment of acute bacterial exacerbations of chronic bronchitis (ABECB), acute bacterial otitis media, pharyngitis, and tonsilitis.

Associated Conditions: Acute Bacterial Exacerbation of Chronic Bronchitis (ABECB), Acute Otitis Media (AOM), Acute Sinusitis, Acute Tracheobronchitis, Bacterial Infections, Bacterial Pneumonia, Lower Respiratory Tract Infection (LRTI), Lower Respiratory Tract Infection (LRTI) caused by susceptible bacteria, Pharyngitis, Skin and Soft Tissue Infections (SSTIs), Streptococcal Pharyngitis, Superinfection bacterial, Tonsillitis, Tonsillitis streptococcal, Upper Respiratory Tract Infection, Upper Respiratory Tract Infection caused by susceptible bacteria, Urinary Tract Infection caused by susceptible bacteria, Bacterial otitis media, Uncomplicated Lower Respiratory Tract Infection (LRTI), Uncomplicated Upper Respiratory Tract Infection, Uncomplicated Urethritis gonococcal

Clinical Trials

Safety and PK of Ceftibuten-ledaborbactam Etzadroxil Fixed-dose Combination

Phase 1

Active, not recruiting

Conditions: Healthy Volunteer
Pharmacokinetics
Safety
Drug-Drug Interaction (DDI)
FDC

Interventions: Drug: Ceftibuten-ledaborbactam etzadroxil

First Posted Date: 2024-12-13

Last Posted Date: 2025-03-28

Lead Sponsor: Venatorx Pharmaceuticals, Inc.

Target Recruit Count: 46

Registration Number: NCT06733675

Locations: 🇺🇸
ICON, Clinical Research Phase I Unit, Lenexa, Kansas, United States

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

Phase 1

Completed

Conditions: Pharmacokinetics
Healthy Volunteers

Interventions: Drug: ledaborbactam etzadroxil
Drug: ceftibuten

First Posted Date: 2024-10-30

Last Posted Date: 2025-03-25

Lead Sponsor: Venatorx Pharmaceuticals, Inc.

Target Recruit Count: 34

Registration Number: NCT06665555

Locations: 🇺🇸
Pulmonary Associates, Phoenix, Arizona, United States

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

Phase 1

Completed

Conditions: Healthy

Interventions: Drug: Ceftibuten
Drug: CTB-AVP in Tablet
Drug: Avibactam prodrug

First Posted Date: 2024-09-19

Last Posted Date: 2025-05-21

Lead Sponsor: Pfizer

Target Recruit Count: 13

Registration Number: NCT06593054

Locations: 🇧🇪
Pfizer Clinical Research Unit - Brussels, Brussels, Bruxelles-capitale, Région DE, Belgium

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

Phase 1

Completed

Conditions: Bacterial Infections

Interventions: Drug: Xeruborbactam Oral Prodrug
Drug: Ceftibuten

First Posted Date: 2023-12-05

Last Posted Date: 2025-05-14

Lead Sponsor: Qpex Biopharma, Inc.

Target Recruit Count: 32

Registration Number: NCT06157242

Locations: 🇺🇸
University of Miami Clinical Pharmacology, Miami, Florida, United States
🇺🇸
Orlando Clinical Research Center, Orlando, Florida, United States

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

Phase 1

Recruiting

Conditions: Bacterial Infections

Interventions: Drug: Xeruborbactam Oral Prodrug
Drug: Xeruborbactam Oral Prodrug Placebo
Drug: Ceftibuten
Drug: Ceftibuten Placebo

First Posted Date: 2023-10-12

Last Posted Date: 2025-02-26

Lead Sponsor: Qpex Biopharma, Inc.

Target Recruit Count: 71

Registration Number: NCT06079775

Locations: 🇦🇺
CMAX, Adelaide, South Australia, Australia

A Study to Learn About the Study Medicine Called CTB+AVP in Healthy Adult People.

Phase 1

Completed

Conditions: Healthy

Interventions: Drug: PF-07612577
Drug: Placebo
Drug: PF-06264006

First Posted Date: 2022-09-26

Last Posted Date: 2024-10-10

Lead Sponsor: Pfizer

Target Recruit Count: 42

Registration Number: NCT05554237

Locations: 🇧🇪
Pfizer Clinical Research Unit - Brussels, Brussels, Bruxelles-capitale, Région DE, Belgium

Food Effect on Ceftibuten/VNRX-7145 in Healthy Participants

Phase 1

Completed

Conditions: Pharmacokinetics

Interventions: Drug: VNRX-7145
Drug: Ceftibuten

First Posted Date: 2022-09-06

Last Posted Date: 2023-07-18

Lead Sponsor: Venatorx Pharmaceuticals, Inc.

Target Recruit Count: 24

Registration Number: NCT05527834

Locations: 🇺🇸
ICON Plc., Lenexa, Kansas, United States

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

Phase 1

Completed

Conditions: Pharmacokinetics

Interventions: Drug: VNRX-7145
Drug: Ceftibuten

First Posted Date: 2022-08-04

Last Posted Date: 2023-12-22

Lead Sponsor: Venatorx Pharmaceuticals, Inc.

Target Recruit Count: 32

Registration Number: NCT05488678

Locations: 🇺🇸
Nucleus Network, Saint Paul, Minnesota, United States
🇺🇸
Orlando Clinical Research Center, Orlando, Florida, United States
🇺🇸
Advanced Pharma, Miami, Florida, United States

Short-term Antibiotic Therapy for Pyelonephritis in Childhood

Phase 3

Terminated

Conditions: Pyelonephritis

Interventions: Drug: ceftibuten

First Posted Date: 2008-07-29

Last Posted Date: 2012-02-17

Lead Sponsor: IRCCS Burlo Garofolo

Target Recruit Count: 36

Registration Number: NCT00724256

Locations: 🇮🇹
Institute for Child Health Burlo Garofolo, Triest, Italy

Drug Development Updates

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