Serdexmethylphenidate/dexmethylphenidate

Not to be confused with serdexmethylphenidate.

Serdexmethylphenidate/dexmethylphenidate

Combination of
Serdexmethylphenidate	Prodrug of dexmethylphenidate
Dexmethylphenidate	Catecholamine reuptake inhibitor
Clinical data
Trade names	Azstarys
Other names	KP415
AHFS/Drugs.com	Micromedex Detailed Consumer Information
License data	US  DailyMed:  Azstarys
Routes of administration	By mouth
ATC code	N06BA15 ( WHO )
Legal status
Legal status	US: Schedule II [1]
Identifiers
KEGG	D11989

Serdexmethylphenidate/dexmethylphenidate, sold under the brand name Azstarys, is a fixed-dose combination medication containing serdexmethylphenidate, a prodrug of dexmethylphenidate, and dexmethylphenidate, a d-threo enantiomer of racemic methylphenidate, which is used to treat attention deficit hyperactivity disorder (ADHD) in people aged six years and older. ^{[1] [2] [3]}

Side effects include decreased appetite, nausea, indigestion, weight loss, dizziness, mood swings, increased blood pressure, trouble sleeping, vomiting, stomach pain, anxiety, irritability, and increased heart rate. ^[4]

It was approved for medical use in the United States in March 2021. ^{[4] [5] [2]}

Medical uses

52.3 mg/10.4 mg Azstarys capsules

Serdexmethylphenidate/dexmethylphenidate is indicated for the treatment of attention deficit hyperactivity disorder in people six years of age and older. ^[4]

Pharmacology

Pharmacokinetics

When administered orally in a 70:30 molar ratio, serdexmethylphenidate/dexmethylphenidate produces a dexmethylphenidate plasma concentration profile with a time to maximum concentration T_max of approximately 2 hours and an mean terminal elimination half-life of 11.7 hours. ^[6]

History

The US Food and Drug Administration (FDA) approved serdexmethylphenidate/dexmethylphenidate based on evidence from one clinical trial of 150 participants with attention deficit hyperactivity disorder 6 to 12 years of age (Study 1). ^[4] The four-week trial was conducted at five sites in the United States. ^[4] The safety and tolerability of serdexmethylphenidate/dexmethylphenidate was examined in an open-label trial of 238 participants with attention deficit hyperactivity disorder 6 to 12 years of age (Study 2). ^[4] The 12-month trial was conducted at 18 sites in the United States. ^[4]

References

1. "Azstarys- serdexmethylphenidate and dexmethylphenidate capsule". DailyMed. Archived from the original on 13 July 2021. Retrieved 13 July 2021.
2. "KemPharm Announces FDA Approval of Azstarys (serdexmethylphenidate and dexmethylphenidate capsules, for oral use, CII), A New Once-Daily Treatment for ADHD" (Press release). KemPharm. 3 March 2021. Archived from the original on 3 March 2021. Retrieved 3 March 2021– via GlobeNewswire.
3. McCuistion LE, Yeager JJ, Winton MB, DiMaggio K (2021). "Chapter 18: Stimulants". Pharmacology E-Book: A Patient-Centered Nursing Process Approach. St. Louis, MO: Elsevier Health Sciences. p. 203. ISBN   978-0-323-79316-2. Archived from the original on 9 January 2022. Retrieved 9 January 2022.
4. "Drug Trials Snapshots Azstarys". U.S. Food and Drug Administration (FDA). 8 March 2023. Retrieved 8 March 2023. This article incorporates text from this source, which is in the public domain .
5. "Drug Approval Package: Azstarys". U.S. Food and Drug Administration (FDA). 1 April 2021. Archived from the original on 3 May 2021. Retrieved 8 March 2023.
6. "These highlights do not include all the information needed to use AZSTARYS safely and effectively. See full prescribing information for AZSTARYS. AZSTARYS (serdexmethylphenidate and dexmethylphenidate) capsules, for oral use, CII Initial U.S. Approval: 2021". dailymed.nlm.nih.gov. Retrieved 7 September 2025.