Silmitasertib is under clinical development by Senhwa Biosciences and currently in Phase II for Bile Duct Cancer (Cholangiocarcinoma). According to GlobalData, Phase II drugs for Bile Duct Cancer (Cholangiocarcinoma) have a 30% phase transition success rate (PTSR) indication benchmark for progressing into Phase III. GlobalData’s report assesses how Silmitasertib’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.

Silmitasertib overview

Silmitasertib (CX-4945) is under development for the treatment of cholangiocarcinoma, pediatric recurrent medulloblastoma, basal cell carcinoma, coronavirus disease 2019 (COVID-19), community-acquired pneumonia (CAP) associated with viral infection 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. It develops next-generation deoxyribonucleic acid (DNA) damage response drugs for the treatment of cancer. Its pipeline products include CX-5461 and CX-4945. The company’s pidnarulex (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 silmitasertib 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.

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

This content was updated on 7 February 2024

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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.