In December 2018, the Menarini Group signed with Helsinn an exclusive licensing agreement to commercialize Pracinostat worldwide (excluding US, Canada, Japan and South America).
Pracinostat is an inhibitor of class I, II, and IV histone deacetylase in clinical development.
The compound is currently in development with a multiregional phase III trial in combination with Azacitidine for the treatment of adult patients with newly diagnosed acute myeloid leukemia (AML) who are unfit for intensive induction chemotherapy.
Pracinostat is also being tested in an open label phase II study in combination with Azacitidine for the treatment of naïve patients with high risk myelodysplastic syndrome (MDS).
The U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy Designation for Pracinostat in combination with Azacitidine for the treatment of patients with newly diagnosed AML who are ≥75 years of age or unfit for intensive chemotherapy.
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