Drug Profile

Regorafenib - Bayer Healthcare

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

Latest Information Update: 14 Oct 2025

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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 c raf inhibitors; Proto-oncogene protein b-raf inhibitors; Proto-oncogene protein c-kit inhibitors; Proto-oncogene protein c-ret 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-1 antagonists; Vascular endothelial growth factor receptor-2 antagonists; Vascular endothelial growth factor receptor-3 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

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

14 Oct 2025 Launched for Colorectal cancer (Metastatic disease, Second-line therapy or greater) in Argentina (PO) prior to October 2025
14 Oct 2025 Launched for Gastrointestinal stromal tumours (Late-stage disease, Inoperable/Unresectable, Metastatic disease, Second-line therapy or greater) in Argentina (PO) prior to October 2025
14 Oct 2025 Launched for Liver cancer (Second-line therapy or greater, Late-stage disease) in Argentina (PO) prior to October 2025

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