Finafloxacin

Summary

Finafloxacin (CHEMBL1908370) is an approved small-molecule antimicrobial agent; indicated across 3 conditions including urinary tract infection and otitis media.

At a glance

• Status: Approved (max clinical phase 4)
• Modality: Small molecule
• Indications: 3 conditions
• Clinical trials: 7
• Chemistry: 398.4 Da · C20H19FN4O4

Identifiers

Drug identity and classification

Field	Value
ChEMBL ID	CHEMBL1908370
Name	Finafloxacin
Type	Small molecule
Max phase	4
FDA approved	no
PubChem CID	11567473
ChEBI	CHEBI:85176
Molecular formula	C20H19FN4O4
Molecular weight	398.4
InChIKey	FYMHQCNFKNMJAV-HOTGVXAUSA-N

SMILES: C1CC1N2C=C(C(=O)C3=CC(=C(C(=C32)C#N)N4C[C@H]5[C@H](C4)OCCN5)F)C(=O)O

IUPAC name: 7-[(4aS,7aS)-3,4,4a,5,7,7a-hexahydro-2H-pyrrolo[3,4-b][1,4]oxazin-6-yl]-8-cyano-1-cyclopropyl-6-fluoro-4-oxoquinoline-3-carboxylic acid

ChEBI definition: A quinolone that is 4-oxo-1,4-dihydroquinoline-3-carboxylic acid which is substituted at positions 1, 6, 7 and 8 by cyclopropyl, fluoro, hexahydropyrrolo[3,4-b][1,4]oxazin-6-yl and cyano groups respectively; an antibiotic used for treatment of acute otitis externa (swimmer’s ear) caused by the bacteria Pseudomonas aeruginosa and Staphylococcus aureus.

Pharmacological roles (ChEBI): antimicrobial agent, antibacterial drug.

Also known as: AL-60371, Finafloxacin, Finafloxacine, Finafloxacino, Xtoro, FINAFLOXACIN, finafloxacin

Patent coverage: 86 distinct patent families (206 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

2 diseases in clinical trials (phase 1–3, investigational — not approved indications). Highest ChEMBL trial phase per disease; a non-cancer approved use is occasionally logged at phase 3 here.

Disease (in trials)	Phase	MONDO	EFO
urinary tract infection	2	MONDO:0100338	EFO:0003103
otitis media	2	MONDO:0005441	EFO:0004992

1 further indication record had no mapped disease name (EFO/MeSH-only) or were duplicates, and are omitted.

Clinical trials

Total trials: 7.

Phase distribution

Phase	Trials
PHASE2	3
PHASE3	2
PHASE1	2

Top trials by phase / activity

NCT	Phase	Status	Title
NCT01535560	PHASE3	COMPLETED	Safety and Efficacy Evaluation of Topical AL-60371 Otic Suspension, 0.3% in the Treatment of Acute Otitis Externa
NCT01535599	PHASE3	COMPLETED	Safety and Efficacy Evaluation of Topical AL-60371 Otic Suspension, 0.3% in the Treatment of Acute Otitis Externa
NCT00722735	PHASE2	COMPLETED	Finafloxacin 300 mg Twice a Day (b.i.d.) Versus Ciprofloxacin 250 mg Twice a Day (b.i.d) in Patients With Lower Uncomplicated UTI (uUTI)
NCT00723502	PHASE2	COMPLETED	Efficacy and Safety Study of Finafloxacin Used in Helicobacter Pylori Infected Patients
NCT01908803	PHASE2	TERMINATED	Proof-of-Concept Study of a Single Application of an Investigational Otic Suspension in Treatment of Acute Otitis Media With Tympanostomy Tubes
NCT00483158	PHASE1	COMPLETED	First Time in Man Study of Finafloxacin Hydrochloride
NCT01904162	PHASE1	COMPLETED	Effect of Age and Gender on the PK and Tolerability of Finafloxacin

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).