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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: 16 Sep 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

  • 10 Sep 2025 Registered for Insomnia (In children, In adolescents) in Canada (PO)
  • 10 Sep 2025 Neurim Pharmaceuticals plans to launch Melatonin controlled release in Canada for Insomnia
  • 26 Mar 2025 European Commission approves melatonin controlled release for treatment of Insomnia (In Children, In adolescents) in European Union, Iceland, Liechtenstein, Norway

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