Regorafenib - Bayer Healthcare

Drug Profile

Regorafenib - Bayer Healthcare

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

Latest Information Update: 26 Jun 2018

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At a glance

  • Originator Bayer HealthCare
  • Developer Bayer HealthCare; Bayer Zydus Pharma; British Columbia Cancer Agency; Memorial Sloan-Kettering Cancer Center; Ono Pharmaceutical; Spanish Cooperative Group for Digestive Tumour Therapy
  • Class Amides; Antineoplastics; Eye disorder therapies; Fluorobenzenes; Phenylurea compounds; Pyridines; Small molecules
  • Mechanism of Action Bcr-abl tyrosine kinase inhibitors; 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 - Hepatocellular carcinoma; Gastrointestinal stromal tumours
  • New Molecular Entity Yes

Highest Development Phases

  • Marketed Colorectal cancer; Gastrointestinal stromal tumours; Hepatocellular carcinoma
  • Phase II Adenoid-cystic-carcinoma; Biliary cancer; Glioblastoma; Pancreatic cancer; Renal cell carcinoma; Solid tumours
  • Discontinued Non-small cell lung cancer; Wet age-related macular degeneration

Most Recent Events

  • 01 Jun 2018 Efficacy and adverse events data from a phase II trial Biliary cancer (Refactory metastatic disease, Late-stage disease) presented at the 54th Annual Meeting of the American Society of Clinical Oncology (ASCO- 2018)
  • 03 Apr 2018 Bayer completes a phase I trial in Solid tumours (Late stage disease, Combination therapy) in USA (PO) (NCT01973868)
  • 25 Jan 2018 Phase-I/II clinical trials in Solid tumours (Late-stage disease, Metastatic disease, Combination therapy) in Japan (PO) (NCT03406871)
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