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Azstarys (SERDEXMETHYLPHENIDATE)
Azstarys increases levels of dopamine and norepinephrine in the brain to help regulate attention and impulse control.
At a glance
| Generic name | SERDEXMETHYLPHENIDATE |
|---|---|
| Sponsor | Commcave Therapeutics Sa |
| Modality | Small molecule |
| Therapeutic area | Metabolic |
| Phase | FDA-approved |
| First approval | 2021 |
Mechanism of action
Serdexmethylphenidate is prodrug of dexmethylphenidate. Dexmethylphenidate HCl is central nervous system (CNS) stimulant. The mode of therapeutic action in ADHD is not known.
Approved indications
- Attention deficit hyperactivity disorder
Boxed warnings
- WARNING: ABUSE, MISUSE, AND ADDICTION AZSTARYS has a high potential for abuse and misuse, which can lead to the development of a substance use disorder, including addiction. Misuse and abuse of CNS stimulants, including AZSTARYS, can result in overdose and death [see Overdosage ( 10 )], and this risk is increased with higher doses or unapproved methods of administration, such as snorting or injection. Before prescribing AZSTARYS, assess each patient’s risk for abuse, misuse, and addiction. Educate patients and their families about these risks, proper storage of the drug, and proper disposal of any unused drug. Throughout AZSTARYS treatment, reassess each patient’s risk of abuse, misuse, and addiction and frequently monitor for signs and symptoms of abuse, misuse, and addiction [see Warnings and Precautions ( 5.1 ) and Drug Abuse and Dependence ( 9.2 )]. WARNING: ABUSE, MISUSE, AND ADDICTION See full prescribing information for complete boxed warning. AZSTARYS has a high potential for abuse and misuse, which can lead to the development of a substance use disorder, including addiction. Misuse and abuse of CNS stimulants, including AZSTARYS, can result in overdose and death ( 5.1 , 9.2 , 10 ): Before prescribing AZSTARYS, assess each patient’s risk for abuse, misuse, and addiction. Educate patients and their families about these risks, proper storage of the drug, and proper disposal of any unused drug. Throughout treatment, reassess each patient’s risk and frequently monitor for signs and symptoms of abuse, misuse, and addiction.
Common side effects
- decreased appetite
- decreased weight
- nausea
- abdominal pain
- dyspepsia
- vomiting
- insomnia
- anxiety
- dizziness
- irritability
- affect lability
- tachycardia
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)
Patents
| Patent | Expiry | Type |
|---|---|---|
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 |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
| FDA Orange Book | Patents + exclusivity |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Azstarys CI brief — competitive landscape report
- Azstarys updates RSS · CI watch RSS
- Commcave Therapeutics Sa portfolio CI