ceftibuten

Trade name: cedax

Small moleculeapproved

Approved

Dec 20, 1995

Ceftibuten is a 3rd generation cephalosporin that is FDA approved for the treatment of acute bacterial exacerbations of chronic bronchitis, acute bacterial otitis media, pharyngitis and tonsillitis. Ceftibuten exerts its bactericidal action by binding to essential target proteins of the bacterial cell wall. This binding leads to inhibition of cell-wall synthesis. Common adverse reactions include diarrhea, nausea, vomiting and headache. The effect of increased gastric pH on the bioavailability of ceftibuten was evaluated in 18 healthy adult volunteers. Each volunteer was administered one 400-mg ceftibuten capsule. A single dose of liquid antacid did not affect the Cmax or AUC of ceftibuten; however, 150 mg of ranitidine q12h for 3 days increased the ceftibuten Cmax by 23% and ceftibuten AUC by 16%. — NCATS

Clinical trial activity

10 trials · 7 clinical orgs · 1 marketing orgs

Phase 1

Phase 2

Phase 3

Phase 4

Earliest trial started Jul 1, 2006 (NCT00724256)

Timeline

1990s

Dec 20, 1995
Astellas — Earliest FDA Approval
Dec 20, 1995
Astellas — NDA Organization
Dec 20, 1995
Astellas — NDA Secondary Org

2000s

Jan 1, 2006
Earliest Phase 3 Sponsor(trial)

2020s

Jan 1, 2021
Earliest Phase 1 Sponsor(trial)

Indications

Approved for

Studied for

Mechanism of action

Bacterial penicillin-binding proteinINHIBITOR
Bacterial penicillin-binding protein inhibitor

Approval history

approvedDec 20, 1995

Chemistry & pharmacology

Loading structure…

SMILES

NC1=NC(=CS1)C(=C\CC(O)=O)\C(=O)N[C@H]2[C@H]3SCC=C(N3C2=O)C(O)=O

Mol. weight: 410.425 g/mol
Lipinski Ro5: Pass
Rule of 3: No
Chirality: Single Stereoisomer
Inorganic: No
Polymer: No
Delivery: Oral
Availability: Discontinued

Oral

Yes

Parenteral

Topical

Sources

Also known as

(+)-(6r,7r)-7-((z)-2-(2-amino-4-thiazolyl)-4-carboxycrotonamido)-8-oxo-5-thia-1-azabicyclo(4.2.0)oct-2-ene-2-carboxylic acid
(+)-(6r,7r)-7-((z)-2-(2-amino-4-thiazolyl)-4-carboxycrotonamido)-8-oxo-5-thia-1-azabicyclo(4.2.0)oct-2-ene-2-carboxylic acid
7-(2-(2-amino-4-thiazolyl)-4-carboxy-2-butenoylamino)-3-cephem-4-carboxylic acid
7432 s
7432-s
7432-s
7432-s
cedax
cedax
cedax
cedax
cedax
cedex
ceftibuten
ceftibuten
ceftibuten
ceftibuten
ceftibuten
ceftibuten
ceftibuten
ceftibuten
ceftibuten
ceftibuten
ceftibuten dihydrate
ceftibuten dihydrate
ceftibuten dihydrate
ceftibuten dihydrate
ceftibutene
ceftibutene
ceftibuteno
ceftibuteno
ceftibutenum
ceftibutenum
cis-ceftibuten
cis-ceftibuten
sch39720
sch 39720
sch-39720
sch-39720
sch-39720
seftem
seftem

Clinical trials

NCT ID	Phase	Start date	Sponsor(s)
NCT06733675	Phase 1	Jan 7, 2025	Department of Health and Human Services, VenatoRx Pharmaceuticals, Inc.
NCT06665555	Phase 1	Nov 4, 2024	National Institute of Allergy and Infectious Diseases (NIAID), VenatoRx Pharmaceuticals, Inc.
NCT06593054	Phase 1	Jul 29, 2024	Pfizer
NCT06157242	Phase 1	Jun 1, 2024	Department of Health and Human Services, Qpex Biopharma, Inc., Shionogi
NCT06079775	Phase 1	Jan 20, 2024	Department of Health and Human Services, Qpex Biopharma, Inc., Shionogi
NCT05488678	Phase 1	Oct 12, 2022	National Institute of Allergy and Infectious Diseases (NIAID), VenatoRx Pharmaceuticals, Inc.
NCT05554237	Phase 1	Oct 7, 2022	Pfizer
NCT05527834	Phase 1	Sep 13, 2022	National Institute of Allergy and Infectious Diseases (NIAID), VenatoRx Pharmaceuticals, Inc.
NCT04877379	Phase 1	Jun 8, 2021	National Institute of Allergy and Infectious Diseases (NIAID), VenatoRx Pharmaceuticals, Inc.
NCT00724256	Phase 3	Jul 1, 2006	University of Trieste

Showing 10 of 10 trials

Page 1 / 1

Organizations

Research & Development (7)

Organization	Org type	Trials	As lead sponsor	Phases	Earliest year
VenatoRx Pharmaceuticals, Inc.	For profit	5	5	1	2021
National Institute of Allergy and Infectious Diseases (NIAID)	Government	4	0	1	2021
Department of Health and Human Services	Government	3	0	1	2024
Pfizer	For profit	2	2	1	2022
Qpex Biopharma, Inc.	For profit	2	2	1	2024
Shionogi	For profit	2	0	1	2024
University of Trieste	Academic/Hospital	1	1	1	2006

7 organizations

Page 1 / 1

Marketing (2)

Organization	Org type	Relationship	Date
Astellas	For profit	NDA	Dec 20, 1995
Astellas	For profit	NDA2	Dec 20, 1995