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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: 22 Jun 2026

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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

  • 16 Jun 2026 Cingulate Therapeutics has patent protection for use of Dexmethylphenidate controlled release for treatment of Attention-deficit hyperactivity disorder in USA
  • 02 Jun 2026 Cingulate plans to submit requested information in CRL to US FDA
  • 02 Jun 2026 US FDA issues CRL for NDA application of CTx 1301 in Attention-deficit hyperactivity disorder

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