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Tagraxofusp - Stemline Therapeutics

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Drug Profile

Tagraxofusp - Stemline Therapeutics

Alternative Names: Diphtheria-toxin-interleukin-3-fusion-protein; DT(388)IL3; DT-388-IL-3; DT-IL-3; ELZONRIS; Elzonris; NS-401; SL-401; tagraxofusp-erzs

Latest Information Update: 16 Apr 2025

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At a glance

  • Originator Scott & White Healthcare; Texas A&M University
  • Developer Dana-Farber Cancer Institute; Nippon Shinyaku; Stemline Therapeutics
  • Class Antineoplastics; Bacterial toxins; Immunotoxins; Interleukins; Recombinant fusion proteins; Skin disorder therapies
  • Mechanism of Action Peptide elongation factor 2 inhibitors
  • Orphan Drug Status

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

    Yes - Acute myeloid leukaemia; Blastic plasmacytoid dendritic cell neoplasm
  • New Molecular Entity Yes

Highest Development Phases

  • Marketed Blastic plasmacytoid dendritic cell neoplasm
  • Phase II Acute myeloid leukaemia; Myeloproliferative disorders
  • Phase I/II Multiple myeloma; Myelodysplastic syndromes
  • No development reported Hairy cell leukaemia; Systemic scleroderma

Most Recent Events

  • 28 Mar 2025 Preregistration for Blastic plasmacytoid dendritic cell neoplasm in Japan (IV)
  • 24 Dec 2024 Phase-II clinical trials in Acute myeloid leukaemia (First-line therapy, Combination therapy) in USA (IV) (NCT06456463)
  • 25 Sep 2024 Pharmacodynamics and adverse events data from preclinical studies in myeloproliferative disorders were presented at 29th Congress of the European Haematology Association (EHA-2024)

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