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Pirtobrutinib - Loxo Oncology

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Drug Profile

Pirtobrutinib - Loxo Oncology

Alternative Names: Jaypirca; LOXO-305; LY 3527727; RXC-005

Latest Information Update: 25 Sep 2025

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At a glance

  • Originator Redx Pharma
  • Developer Eli Lilly and Company; Loxo Oncology
  • Class Amides; Amines; Antineoplastics; Fluorobenzenes; Pyrazoles; Small molecules
  • Mechanism of Action Agammaglobulinaemia tyrosine kinase inhibitors
  • Orphan Drug Status

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

    No
  • New Molecular Entity Yes

Highest Development Phases

  • Marketed Chronic lymphocytic leukaemia; Mantle-cell lymphoma
  • Phase II Non-Hodgkin's lymphoma
  • Phase I/II Marginal zone B-cell lymphoma; Waldenstrom's macroglobulinaemia
  • No development reported Haematological malignancies

Most Recent Events

  • 19 Sep 2025 Registered for Chronic lymphocytic leukaemia (Second-line therapy or greater) in Japan (PO)
  • 08 Sep 2025 Findings from BRUIN CLL-313 and BRUIN CLL-314 trials will support label expansion efforts in earlier lines of therapy, with global regulatory submissions expected to begin later this year
  • 08 Sep 2025 Efficacy data from a phase III BRUIN CLL-313 trial in Chronic lymphocytic leukemia released by Eli Lilly and Company

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