Synonyms: Azstarys® (serdexmethylphenidate + dexmethylphenidate) | KP-484 | KP484
serdexmethylphenidate is an approved drug (FDA (2021))
Compound class:
Synthetic organic
Comment: Serdexmethylphenidate (KP484) is a prodrug that is a slow-release derivative of dexmethylphenidate (d-MPH).
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No information available. |
Summary of Clinical Use |
Serdexmethylphenidate in combination with dexmethylphenidate was approved by the FDA in March 2021 as a treatment for ADHD in children ≥6 years old. The orally administered fixed dose combination was known as KP415 during the development process. Serdexmethylphenidate has a delayed onset and prolonged duration of effects, so acts as a long-acting psychostimulant, whilst dexmethylphenidate provides a more rapid onset of action. |
Clinical Trials | |||||
Clinical Trial ID | Title | Type | Source | Comment | References |
NCT03460652 | KP415 Open-Label Safety Study in Children (6-12 Years of Age) With ADHD | Phase 3 Interventional | KemPharm, Inc. |