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Serdexmethylphenidate/dexmethylphenidate
Serdexmethylphenidate is a prodrug that is metabolized to dexmethylphenidate, which inhibits the reuptake of dopamine and norepinephrine in the central nervous system.
Serdexmethylphenidate is a prodrug that is metabolized to dexmethylphenidate, which inhibits the reuptake of dopamine and norepinephrine in the central nervous system. Used for Attention-deficit/hyperactivity disorder (ADHD).
At a glance
| Generic name | Serdexmethylphenidate/dexmethylphenidate |
|---|---|
| Also known as | Azstarys |
| Sponsor | NYU Langone Health |
| Drug class | Sympathomimetic amine; CNS stimulant |
| Target | Dopamine transporter (DAT); Norepinephrine transporter (NET) |
| Modality | Small molecule |
| Therapeutic area | Neurology/Psychiatry |
| Phase | FDA-approved |
Mechanism of action
Serdexmethylphenidate itself is inactive and serves as a prodrug formulation designed to improve the pharmacokinetic profile of dexmethylphenidate. Once absorbed, it is converted to dexmethylphenidate, the active d-enantiomer of methylphenidate, which blocks dopamine and norepinephrine transporters (DAT and NET) in the brain, increasing synaptic concentrations of these neurotransmitters. This mechanism enhances attention, focus, and impulse control in patients with attention-deficit/hyperactivity disorder (ADHD).
Approved indications
- Attention-deficit/hyperactivity disorder (ADHD)
Common side effects
- Insomnia
- Decreased appetite
- Headache
- Nervousness/anxiety
- Tachycardia
- Elevated blood pressure
Key clinical trials
- A Safety/Tolerability and PK Study With Azstarys® in Children With ADHD (PHASE4)
- Duration and Efficacy of Azstarys on Adult ADHD Symptoms and Executive Function in Early Evening (PHASE4)
- An Efficacy and Safety Study w/ Azstarys® in Children 4-12 Years of Age With ADHD (PHASE4)
- Placebo-Controlled, Double-Blind, Study to Determine the Safety and Efficacy of SDX in Patients With IH (PHASE2)
- A Study to Evaluate the Efficacy, Safety and Tolerability of Oral AK0901 in Children With ADHD (PHASE3)
- KP415 Open-Label Safety Study in Children (6-12 Years of Age) With ADHD (PHASE3)
- KP415 Classroom Study in Children (6-12 Years of Age) With ADHD (PHASE3)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Serdexmethylphenidate/dexmethylphenidate CI brief — competitive landscape report
- Serdexmethylphenidate/dexmethylphenidate updates RSS · CI watch RSS
- NYU Langone Health portfolio CI