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Melatonin controlled-release - Neurim Pharmaceuticals

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Drug Profile

Melatonin controlled-release - Neurim Pharmaceuticals

Alternative Names: Circadin; KI 1001 - Kuhnil; KI1001; Melatonin extended-release; Melatonin prolonged-release; Melatonin sustained-release; Orlogin; Paediatric Prolonged-Release Melatonin; PedPRM; Rx PedPRM; Slenyto

Latest Information Update: 08 Apr 2025

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At a glance

  • Originator Neurim Pharmaceuticals
  • Developer Kuhnil Pharmaceutical Company; Neurim Pharmaceuticals; Sigma Pharmaceuticals
  • Class Anti-inflammatories; Chemoprotectants; Hormones; Radioprotectives; Sleep disorder therapies; Tryptamines
  • Mechanism of Action Antioxidants; Melatonin receptor agonists
  • Orphan Drug Status

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

    Yes - Sleep disorders
  • New Molecular Entity No
  • Available For Licensing Yes

Highest Development Phases

  • Marketed Insomnia
  • Phase III Sleep disorders
  • Discontinued Tardive dyskinesia

Most Recent Events

  • 26 Mar 2025 European Commission approves melatonin controlled release for treatment of Insomnia (In Children, In adolescents) in European Union, Iceland, Liechtenstein, Norway
  • 31 Jan 2025 Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopts a positive opinion, recommending an extension to the existing indication to include the treatment of Insomnia in children with attention deficit hyperactivity disorder (ADHD) in January 2025
  • 31 Dec 2024 European Commission approves melatonin controlled release for treatment of Insomnia in children with neurogenetic disorders (NGDs) (In Children, In adolescents) in European Union, Iceland, Liechtenstein, Norway before December 2024

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