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Cirtuvivint - Biosplice Therapeutics

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Drug Profile

Cirtuvivint - Biosplice Therapeutics

Alternative Names: NSC-835563; SM-08502

Latest Information Update: 12 May 2025

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At a glance

  • Originator Samumed
  • Developer Biosplice Therapeutics
  • Class Amides; Antineoplastics; Isoquinolines; Piperazines; Pyrazoles; Pyridines; Small molecules
  • Mechanism of Action DYRK kinase inhibitors
  • Orphan Drug Status

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

    Yes - Pancreatic cancer
  • New Molecular Entity Yes

Highest Development Phases

  • Phase II Soft tissue sarcoma
  • Phase I Acute myeloid leukaemia; Colorectal cancer; Myelodysplastic syndromes; Non-small cell lung cancer; Prostate cancer; Solid tumours
  • Preclinical Haematological malignancies

Most Recent Events

  • 01 May 2025 Phase-II clinical trials in Soft tissue sarcoma (Late-stage disease, Second-line therapy or greater) in Spain (PO) (EudraCT2024-511987-10-00)
  • 20 Feb 2025 Biosplice Therapeutics suspends phase I trial as per CTEP PIO in Myelodysplastic syndromes (Second-line therapy or greater, Combination therapy, Monotherapy) in USA (PO) (NCT06484062)
  • 17 Sep 2024 Biosplice Therapeutics establishes CRADA with National Cancer Institute (NCI) for the development of Cirtuvivint in Myeloid Leukemia (AML) and Myelodysplastic Syndromes (MDS)

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