LOXO-435 is under clinical development by Loxo Oncology and currently in Phase I for Metastatic Transitional (Urothelial) Tract Cancer. According to GlobalData, Phase I drugs for Metastatic Transitional (Urothelial) Tract Cancer have a 90% phase transition success rate (PTSR) indication benchmark for progressing into Phase II. GlobalData’s report assesses how LOXO-435’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.

LOXO-435 overview

LOXO-435 is under development for the treatment of solid tumor and metastatic urothelial cell cancer. The therapeutic candidate acts by targeting fibroblast growth factor receptor 3 (FGFR3). It is administered through oral route.

Loxo Oncology overview

Loxo Oncology is a bio pharmaceutical company that carries out the development of targeted small molecule therapeutics for the treatment of cancer. The company’s lead product candidate includes LOXO-195, an inhibitor of tropomyosin receptor kinase (TRK), used for the treatment of solid tumor types such as neuroblastoma and lung, thyroid and breast cancers; LOXO-292, an inhibitor of Rearranged during Transfection (RET) tyrosine kinase used for the treatment of lung, thyroid, breast and colon cancers; and LOXO-305, a reversible BTK inhibitor. It is also developing a pipeline of additional product candidates targeting cancers driven by genetic alterations. Loxo Oncology is headquartered in Stamford, Connecticut, the US.

For a complete picture of LOXO-435’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.