Ceftibuten

Overview

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

Title	Posted	Study ID	Phase	Status	Sponsor
Safety and PK of Ceftibuten-ledaborbactam Etzadroxil Fixed-dose Combination	2024/12/13	NCT06733675	Phase 1	Active, not recruiting	Venatorx Pharmaceuticals, Inc.
Plasma and Intrapulmonary Pharmacokinetics of Ceftibuten and Ledaborbactam in Healthy Male and Female Participants 18 to ≤55 Years of Age	2024/10/30	NCT06665555	Phase 1	Completed	Venatorx Pharmaceuticals, Inc.
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	2024/09/19	NCT06593054	Phase 1	Completed	Pfizer
PK & Safety Study of Xeruborbactam Oral Prodrug Combined With Ceftibuten in Participants With Renal Impairment	2023/12/05	NCT06157242	Phase 1	Completed	Qpex Biopharma, Inc.
P1, DDI & MAD PK and Safety Study of Xeruborbactam Oral Prodrug in Combo With Ceftibuten in Healthy Participants	2023/10/12	NCT06079775	Phase 1	Recruiting	Qpex Biopharma, Inc.
A Study to Learn About the Study Medicine Called CTB+AVP in Healthy Adult People.	2022/09/26	NCT05554237	Phase 1	Completed	Pfizer
Food Effect on Ceftibuten/VNRX-7145 in Healthy Participants	2022/09/06	NCT05527834	Phase 1	Completed	Venatorx Pharmaceuticals, Inc.
Ceftibuten/VNRX-7145 in Participants With Varying Degrees of Renal Function	2022/08/04	NCT05488678	Phase 1	Completed	Venatorx Pharmaceuticals, Inc.
Short-term Antibiotic Therapy for Pyelonephritis in Childhood	2008/07/29	NCT00724256	Phase 3	Terminated	IRCCS Burlo Garofolo

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
Cedax	Sciele Pharma, Inc.	59630-820	ORAL	400 mg in 1 1	1/12/2010
Cedax	Sciele Pharma, Inc.	59630-821	ORAL	18 mg in 1 mL	1/12/2010

EMA Drug Approvals

Approved Product	Authorization Holder	Status	Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

Approved Product	Manufacturer	Approval Number	Dosage Form	Strength	Approval Date
No HSA approvals found for this drug.

NMPA Drug Approvals

Approved Product	Company	Approval Number	Drug Type	Dosage Form	Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product	Registration No.	Company	Licence No.	Strength	Registration Date
No PPB approvals found for this drug.

TGA Drug Approvals

Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
No TGA approvals found for this drug.

Health Canada Drug Approvals

Approved Product	Company	DIN	Dosage Form	Strength	Market Date
No Health Canada approvals found for this drug.

CIMA AEMPS Drug Approvals

Approved Product	Company	Registration Number	Pharmaceutical Form	Prescription Type	Status
No CIMA AEMPS (Spain) approvals found for this drug.

Philippines FDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

Approved Product	Company	Registration Number	Dosage Form	Strength	Approval Date
No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

Medicine Name	MA Holder	MA Number	Pharmaceutical Form	Active Ingredient	Authorization Date
No UK EMC drug information found for this drug.

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