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Serdexmethylphenidate

Generic Name
Serdexmethylphenidate
Brand Names
Azstarys
Drug Type
Small Molecule
Chemical Formula
C25H29N3O8
CAS Number
1996626-29-9
Unique Ingredient Identifier
0H8KZ470DW
Background

Attention Deficit Hyperactivity Disorder (ADHD) is an early-onset neurodevelopmental disorder that often extends into adulthood and is characterized by developmentally inappropriate and impaired attention, impulsivity, and motor hyperactivity. The underlying cause of ADHD is unclear but likely involves dysfunction in dopaminergic and noradrenergic neurotransmission, as evidenced by the clear beneficial effect of CNS stimulants such as methylphenidate and amphetamine that increase extracellular dopamine and norepinephrine levels. Serdexmethylphenidate is a prodrug of the CNS stimulant dexmethylphenidate, a common first-line treatment for ADHD, that is combined with dexmethylphenidate to provide extended plasma concentrations and therapeutic benefit with once-daily dosing.

Serdexmethylphenidate was granted FDA approval on March 2, 2021, and is currently marketed as a combination capsule with dexmethylphenidate under the trademark AZSTARYS™ by KemPharm, Inc.

Indication

Serdexmethylphenidate is a prodrug of dexmethylphenidate that is indicated in combination with dexmethylphenidate for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in patients aged six years and older.

Associated Conditions
Attention Deficit Hyperactivity Disorder (ADHD)

Duration and Efficacy of Azstarys on Adult ADHD Symptoms and Executive Function in Early Evening

Phase 4
Completed
Conditions
Adult Attention Deficit Hyperactivity Disorder
Interventions
First Posted Date
2023-08-21
Last Posted Date
2025-03-27
Lead Sponsor
NYU Langone Health
Target Recruit Count
29
Registration Number
NCT06000501
Locations
🇺🇸

NYU Langone Health, New York, New York, United States

A Safety/Tolerability and PK Study With Azstarys® in Children With ADHD

Phase 4
Active, not recruiting
Conditions
Attention Deficit/Hyperactivity Disorder
Interventions
First Posted Date
2023-02-09
Last Posted Date
2024-08-02
Lead Sponsor
Corium, Inc.
Target Recruit Count
123
Registration Number
NCT05721235
Locations
🇺🇸

Advanced Research Center (ARC), Anaheim, California, United States

🇺🇸

iResearch Atlanta, Decatur, Georgia, United States

🇺🇸

CenExel iResearch, LLC, Savannah, Georgia, United States

and more 17 locations

An Efficacy and Safety Study w/ Azstarys® in Children 4-12 Years of Age With ADHD

Phase 4
Completed
Conditions
Attention Deficit/Hyperactivity Disorder
Interventions
First Posted Date
2023-01-17
Last Posted Date
2025-05-13
Lead Sponsor
Corium, Inc.
Target Recruit Count
246
Registration Number
NCT05685732
Locations
🇺🇸

Advanced Research Center (ARC), Anaheim, California, United States

🇺🇸

Sky Clinical Research Network Group P.C., Atlanta, Georgia, United States

🇺🇸

CenExel IResearch, LLC - Decatur, Decatur, Georgia, United States

and more 17 locations

Placebo-Controlled, Double-Blind, Study to Determine the Safety and Efficacy of SDX in Patients With IH

Phase 2
Completed
Conditions
Idiopathic Hypersomnia
Interventions
First Posted Date
2022-12-30
Last Posted Date
2025-02-03
Lead Sponsor
Zevra Therapeutics
Target Recruit Count
50
Registration Number
NCT05668754
Locations
🇺🇸

Clinical Neurophysiology Services PC, Sterling Heights, Michigan, United States

🇺🇸

Neurotrials Research, Inc, Atlanta, Georgia, United States

🇺🇸

Angels Clinical Research, Miami, Florida, United States

and more 38 locations
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