Ark Biosciences has filed its dexmethylphenidate + serdexmethylphenidate capsule for paediatric ADHD treatment with China's CDE, marking the first global combination of immediate-release dexmethylphenidate (d-MPH) and the prodrug serdexmethylphenidate (SDX).
Licensed from Commave in 2021 in a USD 105.5 million deal, the drug met all primary and secondary endpoints in its China Phase III trial (6 to 12-year-olds). It was approved in the US in 2021 as the first new methylphenidate-class ADHD treatment in two decades.