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Serdexmethylphenidate/dexmethylphenidate - Zevra Therapeutics

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Drug Profile

Serdexmethylphenidate/dexmethylphenidate - Zevra Therapeutics

Alternative Names: AK-0901; AZSTARYS; D-methylphenidate prodrug - Zevra Therapeutics; D-threo-methylphenidate prodrug - Zevra Therapeutics; KP 415; Methylphenidate-prodrug- Zevra Therapeutics; SDX - Zevra Therapeutics; SDX/d-MPH - Zevra Therapeutics; Serdexmethylphenidate chloride - Zevra Therapeutics; Serdexmethylphenidate/d-MPH - Zevra Therapeutics

Latest Information Update: 16 Apr 2024

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At a glance

  • Originator KemPharm
  • Developer Ark Biosciences; Zevra Therapeutics
  • Class Amines; Behavioural disorder therapies; Drug withdrawal therapies; Ethers; Phenylacetates; Piperidines; Pyridines; Sleep disorder therapies; Small molecules
  • Mechanism of Action Adrenergic receptor modulators; Central nervous system stimulants; Dopamine release stimulants
  • Orphan Drug Status

    Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

    No
  • New Molecular Entity Yes

Highest Development Phases

  • Marketed Attention-deficit hyperactivity disorder

Most Recent Events

  • 11 Apr 2024 Ark Biosciences plans a phase-III trial for Attention-deficit hyperactivity disorder (In children) in China (PO) (NCT06359899)
  • 26 Jun 2023 The US label for serdexmethylphenidate/dexmethylphenidate carries a blackbox warning for the high potential for abuse and dependence associated with CNS stimulants, including AZSTARYS, other methylphenidate-containing products, and amphetamines. Additional warning about serious cardiovascular disorders, psychotic or manic symptoms, prolonged penile erections and priapism, Raynaud's phenomenon, and growth suppression in pediatric patients
  • 22 May 2023 Updated adverse events data from a phase III trial in Attention-deficit hyperactivity disorder (In children) released by Corium

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