Melatonin oral gel - Spherium Biomed

Drug Profile

Melatonin oral gel - Spherium Biomed

Alternative Names: JAN-13004; SP-13004

Latest Information Update: 29 Jun 2018

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At a glance

  • Originator Spherium Biomed
  • Class Hormones; Sleep disorder therapies; Tryptamines
  • Mechanism of Action Undefined mechanism
  • Orphan Drug Status

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

  • New Molecular Entity No

Highest Development Phases

  • Phase I/II Stomatitis

Most Recent Events

  • 01 Jun 2018 Efficacy and adverse events data from the phase I/II MUCOMEL trial in stomatitis (Chemoradiation therapy induced oral mucositis) presented at the 54th Annual Meeting of the American Society of Clinical Oncology (ASCO-2018)
  • 22 Dec 2017 Spherium Biomed completes a phase I/II trial in Stomatitis (Chemotherapy-induced) in Spain (PO) (EudraCT2015-001534-13) (NCT02630004)
  • 15 Mar 2016 Biomarkers information updated
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