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Regorafenib - Bayer Healthcare

Drug Profile

Regorafenib - Bayer Healthcare

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

Latest Information Update: 01 Nov 2019

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At a glance

  • Originator Bayer HealthCare
  • Developer Bayer HealthCare; Bayer Zydus Pharma; British Columbia Cancer Agency; Global Coalition for Adaptive Research; 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; Bcr-Abl tyrosine kinase modulators; EphA2 receptor antagonists; Platelet-derived growth factor receptor antagonists; Proto oncogene protein b raf inhibitors; Proto oncogene protein c ret inhibitors; Proto oncogene protein c-kit 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 II/III Glioblastoma
  • Phase II Adenoid cystic carcinoma; Biliary cancer; Cholangiocarcinoma; Pancreatic cancer; Renal cell carcinoma; Solid tumours
  • Phase I Acute myeloid leukaemia
  • Preclinical Rhabdomyosarcoma
  • Discontinued Non-small cell lung cancer; Wet age-related macular degeneration

Most Recent Events

  • 18 Oct 2019 Bayer and Bristol-Myers Squibb plans a phase II trial for Colorectal Cancer (Combination therapy, Late stage disease, Metastatic disease) in USA, in October 2019 (NCT04126733)
  • 14 Oct 2019 Bayer and Bristol-Myers Squibb initiates a phase II trial for Colorectal cancer (Combination therapy, Late-stage disease; Metastatic disease, Second-line therapy or greater) in USA (PO) (NCT04126733)
  • 19 Jul 2019 Bayer enters into a clinical trial collaboration agreement with Bristol-Myers Squibb and Ono Pharmaceutical to evaluate regorafenib in combination with nivolumab for Colorectal cancer
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