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Regorafenib - Bayer Healthcare

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Drug Profile

Regorafenib - Bayer Healthcare

Alternative Names: BAY-734506; fluoro-sorafenib; Resihance; Stivarga

Latest Information Update: 13 Feb 2024

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At a glance

  • Originator Bayer HealthCare
  • Developer ARCAGY/GINECO Group; Bayer HealthCare; Bayer Zydus Pharma; Bristol-Myers Squibb; British Columbia Cancer Agency; Global Coalition for Adaptive Research; Jiangsu Hengrui Medicine Co.; Memorial Sloan-Kettering Cancer Center; Merck Sharp & Dohme; Ono Pharmaceutical; Spanish Cooperative Group for Digestive Tumour Therapy; University of Pittsburgh
  • Class Amides; Antineoplastics; Eye disorder therapies; Fluorobenzenes; Phenylurea compounds; Pyridines; Small molecules
  • Mechanism of Action Bcr-abl tyrosine kinase inhibitors; EphA2 receptor antagonists; Mitogen-activated-protein kinase 11-inhibitors; Platelet-derived growth factor receptor antagonists; Proto oncogene protein b raf inhibitors; Proto oncogene protein c ret inhibitors; Proto oncogene protein c-kit inhibitors; Proto oncogene proteins c raf inhibitors; Raf kinase inhibitors; Receptor protein-tyrosine kinase antagonists; TIE 2 receptor antagonists; TrkA receptor antagonists; Type 1 fibroblast growth factor receptor antagonists; Type-2 fibroblast growth factor receptor antagonists; Vascular endothelial growth factor receptor 3 antagonists; Vascular endothelial growth factor receptor-1 antagonists; Vascular endothelial growth factor receptor-2 antagonists
  • Orphan Drug Status

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

    Yes - Liver cancer; Gastrointestinal stromal tumours
  • New Molecular Entity Yes

Highest Development Phases

  • Marketed Colorectal cancer; Gastrointestinal stromal tumours; Liver cancer
  • Phase III Glioblastoma
  • Phase II Adenoid cystic carcinoma; Biliary cancer; Cholangiocarcinoma; Ovarian cancer; Pancreatic cancer; Renal cell carcinoma; Solid tumours
  • No development reported Acute myeloid leukaemia; Rhabdomyosarcoma
  • Discontinued Non-small cell lung cancer; Wet age-related macular degeneration

Most Recent Events

  • 24 Jan 2024 Phase-II clinical trials in Solid tumours in South Korea (PO) (NCT06246643)
  • 20 Oct 2023 Efficacy and adverse events data from phase I/II trial in Solid tumours presented at the 48th European Society for Medical Oncology Congress (ESMO-2023)
  • 30 Apr 2023 Translational Research in Oncology in collaboration with Bayer and Novartis withdrew a phase II REFIT-MSS trial due to sponsor decision not to proceed further (Combination therapy, Second line or greater, Late stage) in Solid tumours (PO) (NCT05582031)
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