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Melatonin controlled-release - Neurim Pharmaceuticals

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: 12 Nov 2018

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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 Drug-induced dyskinesia

Most Recent Events

  • 05 Nov 2018 Registered for Insomnia (In adolescents, In children) in Iceland, Liechtenstein, Norway, European Union (PO)
  • 27 Jul 2018 Preregistration for Insomnia (In adolescents, In children) in European Union (PO) before July 2018 (Neurim Pharmaceuticals website, July 2018)
  • 27 Jul 2018 The Committee for Medicinal Products for Human Use of EMA grants a positive opinion for marketing authorization of melatonin controlled-release for the treatment of insomnia
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