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Finafloxacin - MerLion Pharmaceuticals

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Drug Profile

Finafloxacin - MerLion Pharmaceuticals

Alternative Names: AL-60371; BY-377; EXE 844; EXE 844b; Finafloxacin hydrochloride; Gastrochinolon; Gastroquinolone; Xtoro

Latest Information Update: 10 Jul 2026

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At a glance

  • Originator Bayer
  • Developer Alcon; MerLion Pharmaceuticals
  • Class Anti-inflammatories; Antibacterials; Eye disorder therapies; Fluoroquinolones; Small molecules; Urinary anti-infective agents
  • Mechanism of Action DNA gyrase inhibitors; DNA topoisomerase IV inhibitors
  • Orphan Drug Status

    Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

    No
  • New Molecular Entity Yes

Highest Development Phases

  • Marketed Otitis externa
  • Phase II Helicobacter infections; Pyelonephritis; Urinary tract infections
  • Preclinical Melioidosis
  • No development reported Bacterial infections
  • Discontinued Otitis media; Respiratory tract infections

Most Recent Events

  • 08 Jul 2026 Launched for Otitis externa (In infants, In children, In adolescents, In adults) in USA (Otic)
  • 11 Dec 2024 Fonseca Biosciences announces intention to launch Finafloxacin for Otitis externa in mid-2025
  • 11 Dec 2024 Finafloxacin licensed to Fonseca Biosciences in USA

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