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IXALTIS expands development of Litoxetine to the USA




Toulouse (31) / Archamps (74), October 16th, 2017 - Following the launch of the phase II clinical study of its leading compound Litoxetine IXA-001 in Europe and Canada, Ixaltis announces the acceptance by the Food and Drug Administration of their Investigational New Drug (IND) application.



The open IND will allow Ixaltis to conduct a clinical study in the US with the objective of assessing the safety, tolerability and efficacy of Litoxetine as treatment for men and women suffering from urinary incontinence.



While Ixaltis has already initiated a phase II clinical study in women affected by Mixed Urinary Incontinence disorders in Europe (25 centres in 6 countries: Canada, France, Georgia, Poland, Ukraine and United Kingdom), the start of clinical development in USA represents a major step in the program investigating the role of litoxetine to address unmet medical need in patients facing urinary incontinence.


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