Silmitasertib is under clinical development by Senhwa Biosciences 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 Silmitasertib’s likelihood of approval (LoA) and phase transition for Bile Duct Cancer (Cholangiocarcinoma) took place on 19 Jan 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.

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

Silmitasertib overview

Silmitasertib (CX-4945) is under development for the treatment of cholangiocarcinoma, pediatric recurrent medulloblastoma, basal cell carcinoma, coronavirus disease 2019 (COVID-19) and biliary tract cancer. It is administered through oral route as a capsule. The drug candidate is a first-in-class small molecule that acts by targeting casein kinase II (CK2). It was also under development for the treatment of solid tumors, refractory/relapsed multiple myeloma, chronic lymphocytic leukemia (CLL), Castleman's disease and an unspecified indication.

Senhwa Biosciences overview

Senhwa Biosciences (Senhwa) is a clinical-stage drug development company. The company develops next-generation DNA damage response drugs for the treatment of cancer. Its pipeline products include CX-5461 and CX-4945. Its CX-5461 product is used for the treatment of breast cancer, ovarian cancer or solid tumors and hematological malignancies. The company’s other product candidate CX-4945 is used for the treatment of prostate cancer, cholangiocarcinoma, basal cell carcinoma, medulloblastoma and COVID-19. It collaborates with global investigators and service providers to develop its pipeline products. The company has operations in Taiwan and the US. Senhwa is headquartered in New Taipei City, Taipei, Taiwan.

Quick View Silmitasertib LOA Data

Report Segments
  • Innovator
Drug Name
  • Silmitasertib
Administration Pathway
  • Oral
Therapeutic Areas
  • Immunology
  • Infectious Disease
  • Oncology
  • Undisclosed
Key Developers
Highest Development Stage
  • Phase II

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.