13 September 2018 - ArQule today announced that the U.S. FDA has granted fast track designation to miransertib (ARQ 092) for the treatment of PIK3CA-related overgrowth spectrum, a group of related, ultra-rare genetic disorders characterised by excessive tissue growth in various parts of the body. 

Miransertib has already been granted rare paediatric disease designation by the FDA and orphan designation by the FDA and EMA in the rare overgrowth disease, Proteus syndrome. 

During the past three years, miransertib has been tested in a Phase 1 NIH/NHGRI-sponsored trial in Proteus syndrome. More recently, we have been conducting a Phase 1/2 company-sponsored trial in PROS and a single patient use program with select physicians.

Read ArQule press release