SD-101 is under clinical development by TriSalus Life Sciences and currently in Phase II for Bile Duct Cancer (Cholangiocarcinoma). According to GlobalData, Phase II drugs for Bile Duct Cancer (Cholangiocarcinoma) have a 33% phase transition success rate (PTSR) indication benchmark for progressing into Phase III. GlobalData’s report assesses how SD-101’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.

SD-101 overview

SD-101 is under development for the treatment of breast cancer, pancreatic ductal adenocarcinoma, metastatic uveal melanomat, hepatocellular Ccarcinoma (HCC) and Intrahepatic cholangiocarcinoma (ICC), liver and pancreatic tumor and metastatic colorectal cancer. The drug candidate is administered by intratumoral, intralesional, intramuscular and subcutaneous routes. SD-101 is toll-like receptor 9 (TLR9) agonist. It is an immunostimulatory CpG. The drug candidate is based on immunostimulatory sequences (ISS) technology. 

It was under development for the treatment of solid tumor, high grade lymphoma, low-grade B-cell lymphoma, mantle cell lymphoma, follicular lymphoma, small lymphocytic lymphoma, lymphoplasmacytic lymphoma, B-Cell chronic lymphocytic leukemia, lung cancer, liver cancer, metastatic melanoma, metastatic pancreatic adenocarcinoma and head and neck cancer squamous cell carcinoma, B-cell non-Hodgkin lymphoma, advanced or multiple malignancies. It was also under development for the treatment of non-Hodgkin lymphoma (NHL) or Hodgkin lymphoma (HL), and hepatitis C.

TriSalus Life Sciences overview

TriSalus Life Sciences, formerly Surefire Medical, is an immune-oncology company which is engaged in developing and commercializing drug delivery infusion systems and medicines to treat solid tumors. The company’s products include TriNav, pancreatic and SIS (saline infusion son hysterography) infusion systems. It is investigating drugs against uveal melanoma liver metastases, pancreatic ductal adenocarcinoma (PDAC), melanoma, head and neck squamous cell carcinoma (HNSCC), lymphoma and breast cancer. The company utilizes its proprietary smart valve technology which is based on pressure-enabled drug delivery (PEDD) approach to deliver therapeutics. TriSalus Life Sciences is headquartered in Westminster, Colorado, the US.

For a complete picture of SD-101’s drug-specific PTSR and LoA scores, buy the report here.


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.