Pexidartinib hydrochloride is under clinical development by Plexxikon and currently in the Phase I and Phase II 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 Pexidartinib hydrochloride’s likelihood of approval (LoA) and phase transition for Anaplastic Thyroid Cancer took place on 09 Apr 2021, 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.

In addition, the same event on 09 Apr 2021 increased Pexidartinib hydrochloride’s LoA and PTSR for Salivary Gland Cancer.

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

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 newly diagnosed glioblastoma, pigmented villonodular synovitis, tenosynovial giant cell tumour (TGCT), metastatic melanoma, recurrent mucoepidermal carcinoma (MEC) of salivary glands, KIT-Mutant melanoma, metastatic breast cancer, anaplastic thyroid cancer, malignant peripheral nerve sheath tumors,  gastrointestinal stromal tumors (GIST), metastatic adenocarcinoma of the pancreas, colorectal cancer, epithelial ovarian cancer, primary peritoneal cancer and fallopian tube cancer. The drug candidate is administered through the oral route. PLX-3397 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 and relapsed or refractory acute myelocytic leukemia (AML).

Plexxikon overview

Plexxikon, a subsidiary of Daiichi Sankyo Co Ltd, carries out the discovery and development of novel small molecule therapeutics to treat cancers. Its pipeline products portfolio includes pexidartinib indicated for the treatment of adjuvant glioblastoma, neoadjuvant breast, melanoma, and solid tumors; PLX7486 to treat pancreatic and solid tumors; PLX 9486 to treat the gastrointestinal stromal tumor and KIT-Mutant tumors; and PLX8394 to treat BRAF-Mutant tumors; PLX51107 against solid tumors, hematologic malignancies; PLX73086 addressing solid tumors. It conducts clinical trials to evaluate a novel drug or combination of drugs or the new use of a marketed drug. The company conducts research in collaboration with academic and clinical researchers to develop new drug therapies. Plexxikon is headquartered in South San Francisco, California, the US.

Quick View Pexidartinib hydrochloride LOA Data

Report Segments
  • Innovator (NME)
Drug Name
  • Pexidartinib hydrochloride
Administration Pathway
  • Oral
Therapeutic Areas
  • Central Nervous System
  • Genetic Disorders
  • Immunology
  • Oncology
Key Developers
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.