(Tipiracil hydrochloride + trifluridine) is under clinical development by Taiho Oncology and currently in Phase I for Pancreatic Endocrine Tumor. According to GlobalData, Phase I drugs for Pancreatic Endocrine Tumor have an 80% phase transition success rate (PTSR) indication benchmark for progressing into Phase II. GlobalData’s report assesses how (Tipiracil hydrochloride + trifluridine)’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.

(Tipiracil hydrochloride + trifluridine) overview

Tipiracil hydrochloride and Trifluridine (Orcantas, Lonsurf) is a fixed dose combination that acts as an anti-neoplastic agent, where tipiracil is an inhibitor of the FTD-degrading enzyme thymidine phosphorylase and trifluridine is an antineoplastic nucleoside analog. It is formulated as film coated tablets, coated tablets for oral route of administration. It is indicated for the treatment of unresectable advanced or recurrent colorectal cancer, gallbladder cancer, biliary tract cancer, high grade, extrapulmonary neuroendocrine carcinoma, esophageal cancer, including squamous cell carcinoma, adenoid squamous cell carcinoma (Pseudoglandular squamous cell carcinoma), basaloid squamous cell carcinoma. Lonsurf is indicated for the treatment of patients with metastatic colorectal cancer who have been previously treated with fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy, an anti-VEGF biological therapy, and if RAS wild-type, an anti-EGFR therapy, for the treatment of adult patients with metastatic gastric cancer or adenocarcinoma of the gastroesophageal junction, who have been previously treated with at least two prior lines of chemotherapy including a fluoropyrimidine, a platinum, and either a taxane or irinotecan and if appropriate with HER2/neu-targeted therapy.

TAS-102 is under development for the treatment of colorectal cancer, rectal cancer, metastatic pancreatic neuroendocrine tumors (second line therapy), metastatic urothelial cacner, refractory metastatic colorectal cancer, gastrointestinal tumors, metastatic and locally advanced unresectable pancreatic adenocarcinoma, adenocarcinoma of the gastroesophageal junction and squamous cell non-small cell lung cancer. It was also under development for small cell lung cancer.

For a complete picture of (Tipiracil hydrochloride + trifluridine)’s drug-specific PTSR and LoA scores, buy the report here.

This content was updated on 2 September 2023

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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.