Sorafenib tosylate is under clinical development by Bayer and currently in the Phase II and Phase III in clinical pathway. The characteristics of the clinical trial as well as other attributes related to the drug, regulations, and company play a fundamental role in ensuring the likelihood of transition that the drug moves from its current development stage to next.

According to GlobalData, the latest event to affect Sorafenib tosylate’s likelihood of approval (LoA) and phase transition for Benign Tumor took place on 27 Jul 2022, which increased the likelihood that the drug progresses to the next phase in its clinical pathway and increased the likelihood of final approval for this indication.

GlobalData uses proprietary data and analytics to provide a complete picture of this assessment in their Sorafenib tosylate Likelihood of Approval (LoA) and Phase Transition Success Rate (PTSR) Report.

Sorafenib tosylate overview

Sorafenib tosylate (Nexavar) is an antiproliferative and angiogenesis inhibitor. Nexavar is formulated as film coated tablet for oral route of administration. Nexavar is indicated for hepatocellular carcinoma, metastatic renal cell carcinoma and for the treatment of patients with locally recurrent or metastatic, progressive, differentiated thyroid carcinoma (papillary, follicular, Hurthle cell) that is refractory to radioactive iodine treatment.

Sorafenib tosylate is under development for the treatment of desmoid tumors (benign tumor), metastatic or recurrent head and neck squamous cell cancer (first line therapy), transitional cell carcinoma of the urothelial tract, metastatic hepatocellular carcinoma (as a first line therapy), recurrent high-grade glioma, glioblastoma, gliosarcoma, anaplastic astrocytoma, anaplastic oligodendroglioma, anaplastic mixed oligoastrocytoma, or malignant astrocytoma, acute myeloid leukemia and myelodysplastic syndrome. It was under development for the treatment of metastatic colorectal carcinoma, non squamous non-small cell lung cancer,primary peritoneal tumor, epithelial ovarian cancer, renal cell carcinoma, von Hippel Lindau syndrome, hepatocellular carcinoma (as an adjuvant therapy), chronic myelocytic leukemia, CLL, metastatic renal cell cancer, metastatic melanoma, advanced or metastatic HER-2-negative breast cancer and as an adjuvant therapy for the treatment of gastric cancer and soft-tissue sarcoma.

Bayer overview

Bayer is engaged in the discovery, development, manufacturing, and commercialization of products for human health, and agriculture. It provides medicines for cardiovascular diseases, women’s health, cancer, hematology, ophthalmology and other indications. It also strives to develop new molecules and technologies for use in the fields of medicine and modern agriculture. The company’s product portfolio includes prescription products, specialty pharmaceuticals, diagnostic imaging equipment, non-prescription (over the counter or OTC) products, seeds, crop protection solutions and non-agricultural pest control solutions. Bayer markets its healthcare and crop protection products essentially through wholesalers, pharmacies, hospitals and retailers. It operates through a network of subsidiaries in Asia-Pacific, Europe, North America, Latin America, Africa and the Middle East. Bayer is headquartered in Leverkusen, North Rhine-Westphalia, Germany.

Quick View Sorafenib tosylate LOA Data

Report Segments
  • Innovator (NME)
Drug Name
  • Sorafenib tosylate
Administration Pathway
  • Oral
Therapeutic Areas
  • Genetic Disorders
  • Non Malignant Disorders
  • Oncology
Key Developers
  • Sponsor Company: Bayer
  • Originator: Onyx Pharmaceuticals and Bayer
Highest Development Stage
  • Marketed


GlobalData, the leading provider of industry intelligence, provided the underlying data, research, and analysis used to produce this article.

GlobalData’s Likelihood of Approval analytics tool dynamically assesses and predicts how likely a drug will move to the next stage in its clinical pathway (PTSR), as well as how likely the drug will be approved (LoA). This is based on a proprietary algorithm built from the drugs’ sales forecast, regulatory milestones, cost forecasts, WACC rate and other proprietary data sources found on GlobalData’s Pharmaceutical Intelligence Center.