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

Latest Information Update: 12 Dec 2016

Price : $50

At a glance

  • Originator Neurim Pharmaceuticals
  • Developer Kuhnil Pharmaceutical Company; Neurim Pharmaceuticals; Sigma Pharmaceuticals
  • Class Hormones; 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
  • On Fast track

    Fast track status is assigned by the US FDA so therapies with the potential to address unmet needs can move faster through development.

    No
  • New Molecular Entity No
  • Available For Licensing Yes

Highest Development Phases

  • Marketed Insomnia
  • Phase III Sleep disorders
  • Discontinued Drug-induced dyskinesia

Most Recent Events

  • 06 Dec 2016 Melatonin controlled release (paediatric formulation, PedPRM) licensed to Kuhnil Pharmaceutical in South Korea for Sleep disorders
  • 06 Dec 2016 Neurim Pharmaceuticals completes a phase III trial in Sleep disorders (In adolescents, In children) in USA, United Kingdom, Finland, France and Netherlands (PO) (NCT01906866; 9208462)
  • 16 Nov 2016 Neurim Pharmaceuticals grants Aspen Australia marketing rights for paediatric prolonged-release melatonin in Australia and New Zealand for Sleep disorders
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