31.08.2022 - New Press Release

MerLion Pharmaceuticals Announces Successful FDA Type C Meeting for the Systemic Application of the Antibiotic Finafloxacin Against Infections caused by Burkholderia pseudomallei (Melioidosis)

All Press Releases

MerLion Pharmaceuticals

We are focused on the development of novel antibiotics to combat the evolving threat of bacterial infections in humans and animals.

Who we are

Xtoro™

Xtoro™ is the US FDA- and Health Canada-approved drug containing finafloxacin for the treatment of ear infections.

Learn more

Biodefense

Finafloxacin is developed as a medical countermeasure against biothread agents.

Learn more

cUTI

Finafloxacin is an important candidate for treatment of cUTI and other hospital indications.

Learn more

Fighting life-threatening infections

MerLion Pharmaceuticals is addressing one of the most pressing problems in today's medicine: the need for novel and efficient anti-infectives to combat bacterial infections and amongst those in particular infectious diseases caused by antibiotic-resistant bacteria.

MerLion is working for this purpose primarily on developing finafloxacin for the human health sector.

Finafloxacin

Finafloxacin is a next-generation fluoroquinolone antibiotic with unique properties and is one of the safest and fastest acting fluoroquinolones.

Finafloxacin has demonstrated outstanding safety and efficacy in several clinical trials and is currently being developed by MerLion as novel treatment in several indications.

Following successful clinical phase III trials, Xtoro™ (a suspension formulation of finafloxacin) has been granted market approval for the treatment of acute otitis externa (AOE) from the US Food and Drug Administration (FDA) and Health Canada so far.

MerLion is working with the UK Defence Science and Technology Laboratory (Dstl) on a program funded by the US Defense Threat Reduction Agency (DTRA) for the use of finafloxacin against a number of pathogens that are considered to be  bioweapon threats.

Finafloxacin has successfully completed a phase II trial for complicated urinary tract infections (cUTIs) including pyelonephritis, using both oral and intravenous routes of administration (tablets and solution for infusion).