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 TherapeuticsLatest Information Update: 27 Jun 2025
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
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Orphan Drug Status
Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.
- New Molecular Entity Yes
Highest Development Phases
- Marketed Attention-deficit hyperactivity disorder
Most Recent Events
- 16 Jun 2025 Preregistration for Attention-deficit hyperactivity disorder (In children, In adolescents, In adults, In the elderly) in China (PO)
- 16 Jun 2025 Ark Biopharmaceutical receives Priority review from NMPA for the treatment of Attention deficit hyperactivity disorder (In adolescents, In adults, In children, In the elderly) (PO)
- 16 Jun 2025 National Medical Products Administration (NMPA) accepts New Drug Application (NDA) for Attention deficit hyperactivity disorder (In adolescents, In adults, In children, In the elderly)