Ceftibuten

Summary

Ceftibuten (CHEMBL1605) is an approved small-molecule antibacterial drug (ATC J01DD14); indicated across 3 conditions including bacterial infectious disease and pyelonephritis.

At a glance

• Status: Approved (max clinical phase 4)
• Modality: Small molecule
• ATC class: J01DD14
• Indications: 3 conditions
• Clinical trials: 10
• Chemistry: 410.4 Da · C15H14N4O6S2

Identifiers

Drug identity and classification

Field	Value
ChEMBL ID	CHEMBL1605
Name	Ceftibuten
Type	Small molecule
Max phase	4
FDA approved	yes
PubChem CID	5282242
ChEBI	CHEBI:3510
ATC	J01DD14
Molecular formula	C15H14N4O6S2
Molecular weight	410.4
InChIKey	UNJFKXSSGBWRBZ-BJCIPQKHSA-N

SMILES: C1C=C(N2[C@H](S1)[C@@H](C2=O)NC(=O)/C(=C\CC(=O)O)/C3=CSC(=N3)N)C(=O)O

IUPAC name: (6R,7R)-7-[[(Z)-2-(2-amino-1,3-thiazol-4-yl)-4-carboxybut-2-enoyl]amino]-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid

ChEBI definition: A third-generation cephalosporin antibiotic with a [(2Z)-2-(2-amino-1,3-thiazol-4-yl)-4-carboxybut-2-enoyl]amino substituent at the 7 position of the cephem skeleton. An orally-administered agent, ceftibuten is used as the dihydrate to treat urinary-tract and respiratory-tract infections.

Pharmacological roles (ChEBI): antibacterial drug.

Also known as: ACHN-383, ACHN383, Ceftibuten, Ceftibutene, Ceftibuteno, Ceftibutin, NSC-758925, PF-06264006, SCH 39720, SCH-39720, Seftem, cephem

Parent form; salt/anhydrous children: CHEMBL1200985

Patent coverage: 4,450 distinct patent families (17,652 SureChEMBL compound mentions), from 1 matched compound structure(s). Mentions count patents naming the compound (not distinct inventions), so promiscuous / reference molecules inflate the mention figure — families are the dedup metric.

Targets

Targets

Broader ChEMBL bioactivity targets: 1 (assay-derived). Sample: Solute carrier family 15 member 2.

Bioactivity

No ChEMBL bioactivity rows at pChembl ≥ 5 (expected for biologics / antibodies).

Target pathways

No target-pathway data for this drug (no mapped target genes).

Indications & clinical

Indications

3 indications (1 at ChEMBL trial phase 4). Phase below is the highest clinical-trial phase recorded for this drug against each disease — not the molecule’s overall approval status (that is in the Summary).

Indication	Trial phase	MONDO	EFO
bacterial infectious disease	4	MONDO:0005113	EFO:0000771
pyelonephritis	3	MONDO:0006939	EFO:1001141
osteomyelitis	0	MONDO:0005246	EFO:0003102

Clinical trials

Total trials: 10.

Phase distribution

Phase	Trials
PHASE1	9
PHASE3	1

Top trials by phase / activity

NCT	Phase	Status	Title
NCT00724256	PHASE3	TERMINATED	Short-term Antibiotic Therapy for Pyelonephritis in Childhood
NCT06733675	PHASE1	RECRUITING	Safety and PK of Ceftibuten-ledaborbactam Etzadroxil Fixed-dose Combination
NCT03163550	PHASE1	COMPLETED	A Study to Assess the Safety, Tolerability, Pharmacokinetics, Food Effect, and Drug-Drug Interaction Potential of ACHN-383 and ACHN-789
NCT05488678	PHASE1	COMPLETED	Ceftibuten/VNRX-7145 in Participants With Varying Degrees of Renal Function
NCT05527834	PHASE1	COMPLETED	Food Effect on Ceftibuten/VNRX-7145 in Healthy Participants
NCT05554237	PHASE1	COMPLETED	A Study to Learn About the Study Medicine Called CTB+AVP in Healthy Adult People.
NCT06079775	PHASE1	COMPLETED	P1, DDI & MAD PK and Safety Study of Xeruborbactam Oral Prodrug in Combo With Ceftibuten in Healthy Participants
NCT06157242	PHASE1	COMPLETED	PK & Safety Study of Xeruborbactam Oral Prodrug Combined With Ceftibuten in Participants With Renal Impairment
NCT06593054	PHASE1	COMPLETED	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
NCT06665555	PHASE1	COMPLETED	Plasma and Intrapulmonary Pharmacokinetics of Ceftibuten and Ledaborbactam in Healthy Male and Female Participants 18 to ≤55 Years of Age

Clinical evidence (CIViC)

No CIViC predictive evidence (expected for non-precision-medicine drugs).

Pharmacology

Pharmacogenomics

No CPIC/DPWG dosing guideline or drug-level clinical/variant annotations in PharmGKB for this molecule.

Related molecules

Related molecules

No competitor molecules sharing a primary target (ChEMBL phase ≥2 or PubChem drug-class).