ArkBio’s Azstarys Granted Priority Review for ADHD Treatment
Monday, June 16, 2025
Ark Biopharmaceutical has announced that China’s National Medical Products Administration (NMPA) has accepted its New Drug Application (NDA) for Azstarys, an extended-release capsule therapy for Attention-Deficit/Hyperactivity Disorder (ADHD).
Azstarys includes an in-built abuse-deterrent feature due to its slow-converting SDX component, which helps to reduce peak plasma levels and potential misuse through non-oral methods an important consideration in ADHD treatment.
Azstarys (AK0901) is the first methylphenidate combination drug of its kind approved globally. It combines immediate-release dexmethylphenidate (d-MPH) with serdexmethylphenidate (SDX), a prodrug that provides sustained release. First approved by the U.S. FDA in 2021, the drug offers a dual-phase release system designed to deliver both rapid symptom relief and extended control throughout the day.
The application has also been granted Priority Review status.
The pharmacokinetic profile of Azstarys supports symptom management for up to 13 hours. Its fast-acting d-MPH component starts working within 30 minutes, while the SDX component gradually converts to d-MPH in the intestine, helping to reduce evening rebound symptoms and improve daily functioning for both children and adults. The formulation is also designed to minimise sleep disturbances.
In a Phase III clinical trial conducted across eight hospitals in China, the drug showed significant improvements over placebo across primary and secondary efficacy measures. No drug-related serious adverse events were reported, reinforcing its safety and tolerability, particularly in children.
Its introduction is expected to enhance treatment options by offering a single-dose solution with both immediate and long-lasting effects.
Azstarys is positioned as a third-generation methylphenidate treatment and, if approved, will be the first combination therapy for ADHD to enter the Chinese market.
Source: arkbiosciences.com
