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Clinical Trials
0
0 active
Approvals
4
Total approvals
Agencies
1
Regulatory bodies
Founded
N/A
No trial phase data available
No trial data available
FDA
Food and Drug Administration
- China's National Medical Products Administration has approved Azstarys, a once-daily ADHD medication combining immediate-release and prodrug technologies for patients 6 years and older. - The approval addresses a significant unmet need in China, where ADHD affects approximately 6.4% of children and adolescents, totaling over 23 million individuals. - Azstarys demonstrated statistically significant improvements in core ADHD symptoms in a pivotal Phase III trial, becoming the first medication in China to provide both rapid onset and sustained symptom control. - The drug's unique dual mechanism positions it to reshape ADHD treatment paradigms in China, where current therapeutic options remain limited and many patients discontinue treatment due to suboptimal response or side effects.
