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Treosulfan - Medac

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Drug Profile

Treosulfan - Medac

Alternative Names: CB-2562; CB-40067; CCRIS 2781; Dihydroxybusulphan; HSDB-6963; NSC 39069; Ovastat; Trecondyv

Latest Information Update: 14 Nov 2023

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At a glance

  • Originator Medac
  • Developer Center for International Blood and Marrow Transplant Research; Fondazione San Raffaele; Medac; Medexus Pharmaceuticals
  • Class Antineoplastics; Butylene glycols; Mesylates; Small molecules
  • Mechanism of Action Alkylating agents; 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 - Transplant rejection
  • New Molecular Entity Yes

Highest Development Phases

  • Marketed Acute myeloid leukaemia; Myelodysplastic syndromes; Ovarian cancer
  • Phase II Haematological malignancies; Haemoglobinopathies; Immunodeficiency disorders; Inborn error metabolic disorders; Myeloid leukaemia; Precursor cell lymphoblastic leukaemia-lymphoma
  • No development reported Renal cell carcinoma; Small cell lung cancer; Solid tumours
  • Discontinued Malignant melanoma

Most Recent Events

  • 12 Jan 2023 Medexus pharmaceuticals announces intention to resubmit NDA to US FDA for Acute myeloid leukaemia and Myelodysplastic syndromes (in combination with fludarabine as a preparative regimen for allogeneic hematopoietic stem cell transplantation) in USA
  • 19 Sep 2022 Medac receives second notice of incomplete response from US FDA for treosulfan NDA resubmission
  • 09 Sep 2022 Medac plans a phase I pharmacokinetics trial (Combination therapy, In adults, In elderly) (IV) in October 2022 (NCT05534620)

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