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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: 16 Oct 2024

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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

Highest Development Phases

  • Phase III Attention-deficit hyperactivity disorder

Most Recent Events

  • 12 Sep 2024 Cingulate Therapeutics commenced its final FDA-required study (Food effect study) for CTx 1301 in attention deficit hyperactivity disorder (ADHD)
  • 16 Aug 2024 Cingulate Therapeutics terminates a phase III trial for Attention-deficit hyperactivity disorder (In children) in USA (PO), due to continuation of the study is not required for NDA submission via the 505(b) pathway (NCT0594594)
  • 15 Aug 2024 Cingulate Therapeutics has patent protection for dexmethylphenidate controlled release in European union and United Kingdom

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