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Dexmethylphenidate controlled release - Cingulate Therapeutics

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Drug Profile

Dexmethylphenidate controlled release - Cingulate Therapeutics

Alternative Names: CTX-1301; Dexmethylphenidate HCl

Latest Information Update: 21 Oct 2025

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At a glance

  • Originator Cingulate Therapeutics
  • Developer Bio-Images Drug Delivery; Cingulate Therapeutics
  • Class Behavioural disorder therapies; Phenylacetates; Piperidines; Small molecules
  • Mechanism of Action Adrenergic receptor agonists; Central nervous system stimulants; Dopamine uptake inhibitors; Neurokinin 1 antagonists; Substance P inhibitors
  • Orphan Drug Status

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

    No
  • New Molecular Entity No
  • Available For Licensing Yes

Highest Development Phases

  • Preregistration Attention-deficit hyperactivity disorder

Most Recent Events

  • 14 Oct 2025 FDA assigns PDUFA action date of (31/05/2026) for dexmethylphenidate controlled release for Attention-deficit hyperactivity disorder
  • 19 Aug 2025 Cingulate Therapeutics anticipates the US FDA decision regarding NDA acceptance in the fourth quarter 2025, with potential PDUFA date in mid-2026
  • 19 Aug 2025 Cingulate Therapeutics anticipates the launch of CTX 1301 in mid-2026

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