Product Description
Finafloxacin is a fluoroquinolone antibiotic indicated in the treatment of acute otitis externa (swimmer's ear) caused by the bacteria Pseudomonas aeruginosa and Staphylococcus aureus. (Sourced from: https://pubchem.ncbi.nlm.nih.gov/compound/Finafloxacin)
Mechanisms of Action: TOP2 Inhibitor
Novel Mechanism: No
Modality: Small Molecule
Route of Administration: Oral, Auricular
FDA Designation: *
Approval Status: Approved
Approved Countries: Canada | Egypt
Approved Indications: None
Known Adverse Events: None
Company: MerLion
Company Location:
Company CEO:
Additional Commercial Interests: None
Clinical Description
Countries in Clinic:
Active Clinical Trial Count:
Recent & Upcoming Milestones
Highest Development Phases
Phase 3: Otitis Externa
Phase 2: Helicobacter Infections|Gram-Negative Bacterial Infections|Dyspepsia|Urinary Tract Infections|Otitis Media|Nephritis|Pyelonephritis
Phase 1: Otitis Media|Healthy Volunteers|Helicobacter Infections|Pneumonia, Bacterial|Communicable Diseases|Urinary Tract Infections
Trial ID |
Trial |
Phase |
Trial Status |
Disease |
Primary Completion Date |
Probability of Success |
Latest Trial Update Date |
Data Updated |
|---|---|---|---|---|---|---|---|---|
NCT01908764 |
C-13-023 | P1 |
Withdrawn |
Otitis Media |
2015-01-01 |
2019-03-19 |
Treatments |
|
NCT01910883 |
FINA-006 | P1 |
Completed |
Healthy Volunteers |
2012-03-01 |
2024-11-27 |
Primary Endpoints|Treatments |
|
NCT01907867 |
FINA-008 | P1 |
Completed |
Pneumonia, Bacterial |
2012-02-01 |
2024-11-27 |
Primary Endpoints|Treatments |
|
NCT01904162 |
FINA-005 | P1 |
Completed |
Healthy Volunteers |
2010-02-01 |
2024-11-27 |
Primary Endpoints|Treatments |
|
NCT00483158 |
FINA-001 | P1 |
Completed |
Helicobacter Infections|Urinary Tract Infections|Communicable Diseases |
2008-05-01 |
2024-11-27 |
Primary Endpoints|Treatments |
|
2017-002689-30 |
2017-002689-30 | P2 |
Completed |
Otitis Media |
2018-09-06 |
2025-06-28 |
Primary Completion Date|Start Date|Study Completion Date|Treatments|Trial Status |
|
NCT01908803 |
BID for 7 Days | P2 |
Terminated |
Otitis Media |
2014-08-01 |
2024-11-27 |
Primary Endpoints|Treatments |
|
2011-006041-14 |
2011-006041-14 | P2 |
Completed |
Nephritis|Urinary Tract Infections |
2014-06-15 |
2022-03-13 |
Treatments |
|
NCT01928433 |
FINA-007 | P2 |
Completed |
Pyelonephritis|Urinary Tract Infections |
2014-06-01 |
2024-11-27 |
Primary Endpoints |
|
2009-011865-10 |
FLASH 2 Study | P2 |
Completed |
Helicobacter Infections |
2009-10-12 |
2022-03-13 |
Treatments |
|
2007-007742-35 |
FLUT | P2 |
Terminated |
Urinary Tract Infections |
2009-05-14 |
2022-03-12 |
Treatments |
|
NCT00723502 |
FLASH | P2 |
Completed |
Gram-Negative Bacterial Infections|Dyspepsia|Helicobacter Infections |
2009-04-01 |
2025-08-27 |
Primary Endpoints|Treatments |
|
NCT00722735 |
FLUT | P2 |
Completed |
Urinary Tract Infections |
2009-04-01 |
2024-11-27 |
Primary Endpoints|Treatments |
|
2007-007749-11 |
FLASH | P2 |
Completed |
Helicobacter Infections |
2008-12-19 |
2022-03-12 |
Treatments |
|
NCT01535599 |
C-10-018 | P3 |
Completed |
Otitis Externa |
2013-05-01 |
2019-03-19 |
Treatments |
|
NCT01535560 |
C-10-019 | P3 |
Completed |
Otitis Externa |
2012-10-01 |
2019-03-19 |
Treatments |
Recent News Events
Date |
Type |
Title |
|---|---|---|
|
04/21/2023 |
News Article |
GL CHEMTEC Announces Formation of Scientific Advisory Board |
|
05/18/2021 |
News Article |
MerLion Pharmaceuticals Completes Growth Financing Round |