Besifloxacin

Summary

Besifloxacin (CHEMBL1201760) is an approved small molecule (ATC S01AE08); indicated across 3 conditions including eye infectious disorder and bacterial conjunctivitis.

At a glance

• Status: Approved (max clinical phase 4)
• Modality: Small molecule
• ATC class: S01AE08
• Indications: 3 conditions
• Clinical trials: 12
• Chemistry: 393.8 Da · C19H21ClFN3O3

Identifiers

Drug identity and classification

Field	Value
ChEMBL ID	CHEMBL1201760
Name	Besifloxacin
Type	Small molecule
Max phase	4
FDA approved	yes
PubChem CID	10178705
ATC	S01AE08
Molecular formula	C19H21ClFN3O3
Molecular weight	393.8
InChIKey	QFFGVLORLPOAEC-SNVBAGLBSA-N

SMILES: C1CCN(C[C@@H](C1)N)C2=C(C=C3C(=C2Cl)N(C=C(C3=O)C(=O)O)C4CC4)F

IUPAC name: 7-[(3R)-3-aminoazepan-1-yl]-8-chloro-1-cyclopropyl-6-fluoro-4-oxoquinoline-3-carboxylic acid

Also known as: Besifloxacin, Besifloxacine, Besifloxacino, ISV-403, BESIFLOXACIN, BESIFLOXACIN HYDROCHLORIDE, Besifloxacin HCl (Besivance)

Parent form; salt/anhydrous children: CHEMBL1201761

Patent coverage: 374 distinct patent families (917 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

No target linkage available.

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
eye infectious disorder	4	MONDO:0043885	EFO:1001888
bacterial conjunctivitis	3	MONDO:0006668	EFO:1000829
cataract	1	MONDO:0005129	MONDO:0005129

Clinical trials

Total trials: 12.

Phase distribution

Phase	Trials
PHASE4	3
PHASE3	3
PHASE1	3
PHASE2/PHASE3	1
PHASE2	1
Not specified	1

Top trials by phase / activity

NCT	Phase	Status	Title
NCT00924729	PHASE4	COMPLETED	Study of Ocular Penetration of Topically Administered Fluoroquinolones
NCT01296191	PHASE4	COMPLETED	Aqueous Absorption and Pharmacokinetics of Besivance Versus VIGAMOX in Patients Undergoing Phacoemulsification
NCT01296542	PHASE4	COMPLETED	A Comparison of Prophylactic Antibacterial Efficacy of Besivance vs. VIGAMOX Prior to Cataract Surgery
NCT00347932	PHASE3	COMPLETED	A Study to Determine if 0.6% ISV-403 is Safe and Effective in the Treatment of Bacterial Conjunctivitis.
NCT00348348	PHASE3	COMPLETED	A Study to Investigate the Safety and Efficacy of BOL-303224 in the Treatment of Bacterial Conjunctivitis
NCT00972777	PHASE2/PHASE3	COMPLETED	Efficacy of Besifloxacin Ophthalmic Suspension in the Treatment of Bacterial Conjunctivitis
NCT01740388	PHASE3	TERMINATED	Clinical and Microbial Efficacy of Besifloxacin Ophthalmic Suspension, 0.6% in the Treatment of Bacterial Conjunctivitis
NCT00622908	PHASE2	COMPLETED	Clinical and Microbial Efficacy of ISV403 in Bacterial Conjunctivitis
NCT00824070	PHASE1	COMPLETED	Assessment of the Concentrations of Besifloxacin, Moxifloxacin, or Gatifloxacin in the Aqueous Humor of Subjects
NCT00905762	PHASE1	COMPLETED	Concentration of Besifloxacin, Gatifloxacin, and Moxifloxacin in Human Conjunctiva After Topical Instillation
NCT04542759	PHASE1	COMPLETED	Effect of Topical Besifloxacin on Ocular Surface Bacterial Microbiota Prior to Cataract Surgery
NCT02497365	Not specified	COMPLETED	Besifloxacin in Bacterial Keratitis

Clinical evidence (CIViC)

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

Pharmacology

Pharmacogenomics

No PharmGKB pharmacogenomic data curated for this drug.

Related molecules

Related molecules

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