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Dexmethylphenidate controlled release - Cingulate Therapeutics

Drug Profile

Dexmethylphenidate controlled release - Cingulate Therapeutics

Alternative Names: CTX-1301; Dexmethylphenidate HCl

Latest Information Update: 12 Sep 2023

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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

  • 11 Sep 2023 Efficacy and adverse event data from a phase III CTx-1301-022 trial in Attention deficit hyperactivity disorder released by Cingulate Therapeutics
  • 14 Aug 2023 Cingulate Therapeutics plans to file an NDA to the US FDA for Attention deficit hyperactivity disorder under the Section 505(b) pathway, in second half of 04 (939646
  • 14 Aug 2023 Updated efficacy and adverse event data from a phase III trial in Attention-deficit hyperactivity disorder (ADHD) released by Cingulate Therapeutics
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