Gemcitabine hydrochloride is under clinical development by Innopharmax and currently in Phase II for Metastatic Biliary Tract Cancer. According to GlobalData, Phase II drugs for Metastatic Biliary Tract Cancer have a 27% phase transition success rate (PTSR) indication benchmark for progressing into Phase III. GlobalData’s report assesses how Gemcitabine hydrochloride’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.
Gemcitabine hydrochloride overview
Gemcitabine hydrochloride (D07001-F4) is under development for the treatment of solid tumours such as cholangiocarcinoma, gallbladder cancer, lung cancer, pancreatic cancer and also malignant lymphomas. It is administered through the oral route. Gemcitabine is a fluorine-substituted deoxycytidine analogue with a broad spectrum of antitumor activity. It acts by targeting ribonucleoside diphosphate reductase subunit M1. It is developed based on OralPAS technique.
It was under development for colon cancer.
Innopharmax overview
Innopharmax, a subsidiary of Synmosa Biopharma Corp, is a pharmaceutical company that develops and commercializes products for treating oncology and specialty. The company provides anti-infection agents, oncology agents, contrast agents, immunological agents and drugs for rare diseases, among others. It offers pipeline products such as agents for metabolic diseases, CNS and urology agents, among others. Innopharmax develops and acquires drug candidates for further clinical development and commercialization. The company also undertakes contract formulation development of pharmaceuticals including immediate-release formulations to alternative dosage designs and controlled-release formulations. It markets its products through its distributors. InnoPharmax is headquartered in Taipei, Taiwan.
For a complete picture of Gemcitabine hydrochloride’s drug-specific PTSR and LoA scores, buy the report here.
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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.
