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Temozolomide suspension - ORPHELIA Pharma

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Drug Profile

Temozolomide suspension - ORPHELIA Pharma

Alternative Names: Kimozo; KIZFIZO; ORP-005; Ped-TMZ

Latest Information Update: 29 Sep 2025

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At a glance

  • Originator ORPHELIA Pharma
  • Class 2 ring heterocyclic compounds; Amides; Antineoplastics; Imidazoles; Small molecules; Triazenes
  • Mechanism of Action DNA cross linking agents; DNA synthesis inhibitors
  • Orphan Drug Status

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

    Yes - Neuroblastoma
  • New Molecular Entity No

Highest Development Phases

  • Preregistration Neuroblastoma
  • No development reported Cancer; Glioblastoma; Glioma

Most Recent Events

  • 18 Aug 2025 The University Of Birmingham plans a phase I/II BEACON 2 trial for Neuroblastoma (In infants, In children, In adolescent, In adults, In elderly, Combination therapy, Refractory metastatic disease, Second-line therapy or greater) (PO) in Denmark, Belgium, Norway, Germany, France, Netherlands, Italy, Sweden, Austria, Spain, Switzerland, New Zealand, Israel, Australia, and UK in June 2026 (CTIS2024-516115-24-00)
  • 28 Jan 2025 No recent reports of development identified for clinical-Phase-Unknown development in Neuroblastoma(Combination therapy, In children, Second-line therapy or greater) in France (PO, Suspension)
  • 28 Jan 2025 No recent reports of development identified for clinical-Phase-Unknown development in Neuroblastoma(In children, Second-line therapy or greater) in France (PO, Suspension)

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