MedPath

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)
Associated Therapies
-
pharmavoice.com
·

A drug for fewer than 1,000 patients? Awareness and diagnosis are key.

Zevra Therapeutics launched Miplyffa, the first treatment for Niemann-Pick disease type C, available since November at over $100,000 per month. The drug, used with miglustat, has seen early adoption success and aims to increase disease diagnosis. Zevra plans to expand Miplyffa to Europe in 2025 and continues to develop other treatments for rare conditions.
globenewswire.com
·

Aquestive Therapeutics Reports Third Quarter 2024 Financial Results and Provides Business Update

Aquestive Therapeutics reports Q3 2024 financials, $78M cash, and updates on Anaphylm (epinephrine) Sublingual Film and AQST-108 (epinephrine) Topical Gel development, with pre-NDA and pre-IND meetings scheduled for Q4 2024. Libervant (diazepam) Buccal Film for ages 2-5 is available through retail channels. The company reaffirms cash runway into 2026 and will host an investment community call on November 5, 2024.
finance.yahoo.com
·

KemPharm Won FDA Approval, But This Analyst Isn’t Happy

KemPharm's Azstarys, a new ADHD treatment, received FDA approval, potentially bringing significant financial benefits. However, analyst Oren Livnat downgraded KemPharm to Neutral due to concerns over the drug's label and economic uncertainties, despite its promising efficacy and market potential.
© Copyright 2025. All Rights Reserved by MedPath