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SL-401 in Patients With Acute Myeloid Leukemia (AML) and Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN)

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Trial Profile

SL-401 in Patients With Acute Myeloid Leukemia (AML) and Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN)

Status: Completed
Phase of Trial: Phase I/II

Latest Information Update: 08 Jan 2026

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At a glance

  • Drugs Tagraxofusp (Primary)
  • Indications Acute myeloid leukaemia; Blastic plasmacytoid dendritic cell neoplasm
  • Focus Adverse reactions; Registrational; Therapeutic Use
  • Sponsors Stemline Therapeutics

Most Recent Events

  • 22 Dec 2025 According to Nippon Shinyaku media release, company has announced that the Ministry of Health, Labour and Welfare (MHLW) has approved ELZONRIS I.V. Injection (Tagraxofusp (genetically recombinant)) for the treatment of Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN) in Japan.
  • 28 Mar 2025 According to a Nippon Shinyaku media release, based on the results of Phase I/II trials conducted overseas in untreated and relapsed/refractory BPDCN patients, tagraxofusp has been approved by European Medicines Agency for adult patients with newly diagnosed BPDCN in January 2021.
  • 28 Mar 2025 According to a Nippon Shinyaku media release, company submitted a New Drug Application (NDA) to the Ministry of Health, Labour & Welfare (MHLW) for the manufacturing and marketing approval of NS-401 (tagraxofusp) for the treatment of Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN) in Japan.

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