Sorafenib tosylate is under clinical development by Bayer and currently in Phase II for Acute Myelocytic Leukemia (AML, Acute Myeloblastic Leukemia). According to GlobalData, Phase II drugs for Acute Myelocytic Leukemia (AML, Acute Myeloblastic Leukemia) have a 30% phase transition success rate (PTSR) indication benchmark for progressing into Phase III. GlobalData’s report assesses how Sorafenib tosylate’s drug-specific PTSR and Likelihood of Approval (LoA) scores compare to the indication benchmarks. Buy the report here.

GlobalData tracks drug-specific phase transition and likelihood of approval scores, in addition to indication benchmarks based off 18 years of historical drug development data. Attributes of the drug, company and its clinical trials play a fundamental role in drug-specific PTSR and likelihood of approval.

Sorafenib tosylate overview

Sorafenib tosylate (Nexavar) is an antiproliferative and angiogenesis inhibitor. Nexavar is formulated as film coated tablets 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.

For a complete picture of Sorafenib tosylate’s drug-specific PTSR and LoA scores, buy the report here.

This content was updated on 2 September 2023

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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 clinical development (PTSR), as well as how likely the drug will be approved (LoA). This is based on a combination of machine learning and a proprietary algorithm to process data points from various databases found on GlobalData’s Pharmaceutical Intelligence Center.