Pexidartinib hydrochloride is under clinical development by Daiichi Sankyo and currently in Phase II for Sarcomas. According to GlobalData, Phase II drugs for Sarcomas have a 27% phase transition success rate (PTSR) indication benchmark for progressing into Phase III. GlobalData’s report assesses how Pexidartinib hydrochloride’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.

Pexidartinib hydrochloride overview

Pexidartinib hydrochloride (Turalio) is an anti-neoplastic agent. It is formulated as hard gelatin capsules for oral route of administration. Pexidartinib hydrochloride is indicated for the treatment of or the treatment of adult patients with symptomatic tenosynovial giant cell tumor (TGCT) associated with severe morbidity or functional limitations and not amenable to improvement with surgery.

Pexidartinib hydrochloride (PLX-3397) is under development for the treatment of tenosynovial giant cell tumour (TGCT), malignant peripheral nerve sheath tumors and sarcoma. The drug candidate is administered through the oral route. It targets macrophage colony stimulating factor (CSF-1), mast/stem cell growth factor receptor kit and receptor-type tyrosine-protein kinase FLT3. This small molecule is developed using scaffold-based drug discovery platform.

It was also under development for the treatment of rheumatoid arthritis, Alzheimer's disease, Hodgkin lymphoma, prostate cancer, recurrent glioblastoma, solid tumors including head and neck cancer squamous cell carcinoma, pediatric neurofibromatoses type I (Von Recklinghausen’s Disease) bladder cancer, gastric cancer, non-small cell lung carcinoma, relapsed or refractory acute myelocytic leukemia (AML), newly diagnosed glioblastoma, pigmented villonodular synovitis, metastatic melanoma, recurrent mucoepidermal carcinoma (MEC) of salivary glands, KIT-Mutant melanoma, metastatic breast cancer, anaplastic thyroid cancer, gastrointestinal stromal tumors (GIST), metastatic adenocarcinoma of the pancreas, colorectal cancer, epithelial ovarian cancer, primary peritoneal cancer and fallopian tube cancer. 

Daiichi Sankyo overview

Daiichi Sankyo is a holding company, which carries out the research, development, manufacture, and marketing of pharmaceutical products. The company offers a wide range of prescription drugs, over the counter (OTC) drugs, vaccines, and others. Its portfolio encompasses medicines for cardiovascular, neurological, nephrological, diabetic, metabolic, and infectious diseases, and various types of cancers. Besides cancer, the company’s other research areas include rare diseases and immune disorders. Daiichi Sankyo sells its products through its group companies and an extensive network of medical representatives. It has operations in North America, South and Central America, Europe, and Asia. Daiichi Sankyo is headquartered in Tokyo, Japan.

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

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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.