Gemcitabine hydrochloride is under clinical development by Innopharmax and currently in the Phase I 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 Gemcitabine hydrochloride’s likelihood of approval (LoA) and phase transition for Solid Tumor took place on 19 Aug 2021, which decreased the likelihood that the drug progresses to the next phase in its clinical pathway.

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

Gemcitabine hydrochloride overview

Gemcitabine hydrochloride (D07001-F4) is under development for the treatment of solid tumours such as colon cancer, cholangiocarcinoma, gallbladder 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 ribonucleotide reductase, thymidylate synthase (TS) and DNA synthesis. It is developed based on OralPAS technique.

Innopharmax overview

Innopharmax, a subsidiary of Synmosa Biopharma Corp, is a pharmaceutical company that develops and commercializes products for the treatment of 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 agents 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 headquarterd in Taipei, Taiwan

Quick View Gemcitabine hydrochloride LOA Data

Report Segments
  • Innovator
Drug Name
  • Gemcitabine hydrochloride
Administration Pathway
  • Oral
Therapeutic Areas
  • Oncology
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.