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Larotrectinib - Bayer/Loxo Oncology

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Drug Profile

Larotrectinib - Bayer/Loxo Oncology

Alternative Names: AR-470; ARRY-470; BAY 2757556; Larotrectinib sulfate - Bayer/Loxo Oncology; LOXO 101; VITRAKVI

Latest Information Update: 24 Nov 2025

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At a glance

  • Originator Array BioPharma
  • Developer Bayer; Loxo Oncology; National Cancer Institute (USA)
  • Class Amides; Antineoplastics; Fluorobenzenes; Pyrazoles; Pyrimidines; Pyrrolidines; Small molecules; Tumour-agnostic therapies
  • Mechanism of Action TrkA receptor antagonists; TrkB receptor antagonists; TrkC receptor antagonists
  • Orphan Drug Status

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

    Yes - Soft tissue sarcoma; Solid tumours
  • New Molecular Entity Yes

Highest Development Phases

  • Marketed Solid tumours
  • Phase II Histiocytosis; Non-Hodgkin's lymphoma
  • Phase I/II CNS cancer

Most Recent Events

  • 29 Sep 2025 Loxo Oncology in collaboration with Bayer completes a phase II NAVIGATE basket trial in Solid tumours in US, Denmark, France, Japan, Norway, China, Czech Republic, Slovakia, Hungary, Sweden, Belgium, South Korea, Singapore, Spain, Portugal, Ireland, Argentina, Australia, Brazil, Canada, Germany, India, Italy, Poland, Russia, Taiwan, Turkey (NCT02576431) (EudraCT2015-003582-28)
  • 10 Dec 2024 Efficacy and adverse events data from a phase II NAVIGATE trial and phase I/II SCOUT trail in Breast cancer were presented at the 47th Annual San Antonio Breast Cancer Symposium (SABCS-2024)
  • 31 May 2024 Updated pooled efficacy and adverse events data from a phase I trial, phase I/II SCOUT trial and the phase II NAVIGATE in Solid tumors presented at the 60th Annual Meeting of the American Society of Clinical Oncology, 2024 (ASCO-2024)

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