Shanghai Ark Biopharmaceutical Co., Ltd. („ArkBio“) today announced the successful completion of the Phase III clinical study of AK0901, a novel drug for the treatment of attention deficit hyperactivity disorder (ADHD). This milestone represents a substantial step forward for ArkBio in the research and development of drugs for pediatric psychiatric disorders, potentially offering new treatment options and improved therapeutic outcomes for children with ADHD in China.
ADHD is a chronic neurodevelopmental disorder characterized by age-inappropriate attention deficits and/or hyperactivity-impulsivity, often persisting into adulthood. Globally, approximately 7.2% of children are affected, with 60%–80% continuing to exhibit symptoms during adolescence and 50.9% into adulthood. About 65% of patients present with one or more comorbidities. ADHD impairs learning and causes multidimensional, lifelong functional challenges. In China, the prevalence of ADHD among children and adolescents is 6.4%, affecting over 23 million individuals. However, current treatment options remain limited, with existing drugs often falling short in terms of efficacy, safety, or convenience of drug administration, leading to poor patient compliance.
AK0901, a novel methylphenidate-based drug, is the first and only drug combining two active components of immediate-release dexmethylphenidate (d-MPH) and prodrug serdexmethylphenidate (SDX). It works by inhibiting the reuptake of dopamine and norepinephrine in the synaptic cleft, enhancing neurotransmitter efficiency to alleviate ADHD symptoms. AK0901 (Azstarys®) received U.S. FDA approval in March 2021 as the new-generation methylphenidate drug in nearly two decades, demonstrating superior safety and clinical efficacy, and a potential as best-in-class therapeutic drug for the treatment of pediatric ADHD.
