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Substance

Serdexmethylphenidate/dexmethylphenidate

Original Wikipedia articleen.wikipedia.org/wiki/Serdexmethylphenidate/dexmethylphenidate revision used (24 October 2026)

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Overview

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] WP

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] WP

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

Uses, dosage and effects

Medical uses

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

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 Tₘₐₓ of approximately 2 hours and an mean terminal elimination half-life of 11.7 hours.[6] WP

History

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). The four-week trial was conducted at five sites in the United States. 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). The 12-month trial was conducted at 18 sites in the United States.[4] WP

Chemistry

Awaiting sourceFormula, structure and identifiers from PubChem.

Harm reduction information

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Pop culture

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Sources

  1. Journal / agency Azstarys- serdexmethylphenidate and dexmethylphenidate capsule
  2. Other KemPharm Announces FDA Approval of Azstarys (serdexmethylphenidate and dexmethylphenidate capsules, for oral use, CII), A New Once-Daily Treatment for ADHD. 3 March 2021
  3. Other McCuistion LE, Yeager JJ, Winton MB, DiMaggio K. Pharmacology E-Book: A Patient-Centered Nursing Process Approach. 2021
  4. Journal / agency Drug Trials Snapshots Azstarys. 8 March 2023
  5. Journal / agency Drug Approval Package: Azstarys. 1 April 2021
  6. Journal / agency 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

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