FDA grants fast track designation for Yamo Pharmaceutical’s L1-79 in autism spectrum disorder

Yamo Pharmaceuticals

14 May 2018 -  Yamo Pharmaceuticals announced today that the US FDA has granted fast track designation for its investigational drug L1-79, a tyrosine hydroxylase inhibitor intended to mitigate the socialisation and communication symptoms in individuals with autism spectrum disorder. 

FDA Fast Track Designation for L1-79 is primarily based on data from a recently completed Phase II clinical study, where multiple independent outcome measures demonstrated improvement in the core social domains affected by autism spectrum disorder (ASD). More importantly, positive trends in these efficacy measures were seen despite the small number of subjects and short duration of the study (28 days). Subsequent clinical studies in adolescents and adults and children with ASD are planned.

Read Yamo Pharmaceuticals press release

Michael Wonder

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Michael Wonder

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Medicine , US , Fast track