CDEK
← All drugs Report issue

finafloxacin

Trade name: xtoro

Small moleculeapproved

Approved

Dec 17, 2014

Finafloxacin is a fluoroquinolone antimicrobial agent that exhibits optimum efficacy in slightly acidic environments and is a highly potent eradicator of Helicobacter pylori. Being developed to treat serious bacterial infections associated with an acidic environment, including urinary tract infections and Helicobacter pylori infections finafloxacin is approved for treatment of acute otitis externa (swimmer’s ear) caused by the bacteria Pseudomonas aeruginosa and Staphylococcus aureus. XTORO (finafloxacin otic suspension), 0.3% is supplied as a sterile, preserved, aqueous suspension. Finafloxacin is a drug with a favorable safety profile. — NCATS

Clinical trial activity

11 trials · 5 clinical orgs · 3 marketing orgs

Phase 1
5
Phase 2
6
Phase 3
2
Phase 4
0

Earliest trial started Aug 1, 2007 (NCT00483158)

Timeline

2000s

  1. Jan 1, 2007

    MerLion Pharmaceuticals GmbH — Earliest Phase 1 Sponsor(trial)

  2. Jan 1, 2008

    MerLion Pharmaceuticals GmbH — Earliest Phase 2 Sponsor(trial)

2010s

  1. Jan 1, 2012

    Alcon — Earliest Phase 3 Sponsor(trial)

  2. Dec 17, 2014

    Alcon — Earliest FDA Approval

  3. Dec 17, 2014

    MerLion Pharmaceuticals GmbH — NDA Secondary Org

  4. Dec 17, 2014

    Alcon — NDA Organization

  5. Dec 17, 2014

    FONSECA BIOSCIENCES — Marketing Organization

  6. Dec 17, 2014

    FONSECA BIOSCIENCES — NDA Secondary Org

Indications

Approved for

Studied for

Mechanism of action

Approval history

  • approvedPriority reviewDec 17, 2014

Chemistry & pharmacology

Loading structure…

SMILES

OC(=O)C1=CN(C2CC2)C3=C(C=C(F)C(N4C[C@@H]5NCCO[C@H]5C4)=C3C#N)C1=O
Mol. weight
398.3877 g/mol
Lipinski Ro5
Pass
Rule of 3
No
Chirality
Single Stereoisomer
Inorganic
No
Polymer
No
Delivery
Topical
Availability
Discontinued

Oral

No

Parenteral

No

Topical

Yes

Sources

Also known as

  • 8-cyano-1-cyclopropyl-6-fluoro-7-[(4as,7as)-hexahydropyrrolo[3,4-b][1,4]oxazin-6(2h)-yl]-4-oxo-1,4-dihydro-3-quinolinecarboxylic acid
  • 8-cyano-1-cyclopropyl-6-fluoro-7-[(4as,7as)-hexahydropyrrolo[3,4-b][1,4]oxazin-6(2h)-yl]-4-oxo-1,4-dihydro-3-quinolinecarboxylic acid
  • al-60371
  • bay35-3377
  • finafloxacin
  • finafloxacin
  • finafloxacin
  • finafloxacin
  • finafloxacin
  • finafloxacin
  • finafloxacin
  • finafloxacin
  • finafloxacin
  • finafloxacin
  • finafloxacin
  • finafloxacin hcl
  • finafloxacin hydrochloride
  • finafloxacin hydrochloride
  • gastrochinolon
  • gastrochinolon
  • gastroquinolone
  • gastroquinolone
  • xtoro
  • xtoro
  • xtoro
  • xtoro

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT01908764Phase 1Nov 1, 2014Alcon
NCT01908803Phase 2Dec 1, 2013Alcon
NCT01928433Phase 2Dec 1, 2012Medical University of Lodz, MerLion Pharmaceuticals GmbH, Philipps University of Marburg
NCT01535560Phase 3Apr 1, 2012Alcon
NCT01535599Phase 3Mar 1, 2012Alcon
NCT01907867Phase 1Jan 1, 2012MerLion Pharmaceuticals GmbH
NCT01910883Phase 1Sep 1, 2010MerLion Pharmaceuticals GmbH
NCT01904162Phase 1Feb 1, 2010MerLion Pharmaceuticals GmbH
NCT00722735Phase 2Oct 1, 2008MerLion Pharmaceuticals GmbH
NCT00723502Phase 2Sep 1, 2008MerLion Pharmaceuticals GmbH
NCT00483158Phase 1Aug 1, 2007MerLion Pharmaceuticals GmbH, Swiss Pharma
Showing 11 of 11 trials
Page 1 / 1

Organizations

Research & Development (5)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
MerLion Pharmaceuticals GmbHFor profit7722007
AlconFor profit4432012
Medical University of LodzAcademic/Hospital1012012
Philipps University of MarburgAcademic/Hospital1012012
Swiss PharmaAcademic/Hospital1012007
5 organizations
Page 1 / 1

Marketing (4)

OrganizationOrg typeRelationshipDate
AlconFor profitNDADec 17, 2014
FONSECA BIOSCIENCESFor profitMKTGDec 17, 2014
FONSECA BIOSCIENCESFor profitNDA2Dec 17, 2014
MerLion Pharmaceuticals GmbHFor profitNDA2Dec 17, 2014