Pirtobrutinib is under clinical development by Loxo Oncology and currently in the Phase II, Phase III and Pre-Registration 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 Pirtobrutinib’s likelihood of approval (LoA) and phase transition for B-Cell Chronic Lymphocytic Leukemia took place on 29 Sep 2022, 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 Pirtobrutinib Likelihood of Approval (LoA) and Phase Transition Success Rate (PTSR) Report.

Pirtobrutinib overview

LOXO-305 (RXC-005) is under development for the treatment of chronic lymphocytic leukemia (CLL), small lymphocytic leukemia (SLL), non-Hodgkin lymphoma including mantle cell lymphoma, marginal zone lymphoma, Waldenstrom macroglobulinemia, B-cell cancers including R/R chronic lymphocytic leukemia (CLL) in patients resistant to ibrutinib, follicular lymphoma and diffuse large B-cell lymphoma. It is administered through oral and intravenous route. The drug candidate is a next generation reversible BTK inhibitor.It acts by targeting tyrosine protein kinase BTK. It is a new molecular entity (NME).

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.

Quick View Pirtobrutinib LOA Data

Report Segments
  • Innovator
Drug Name
  • Pirtobrutinib
Administration Pathway
  • Intravenous
  • Oral
Therapeutic Areas
  • Oncology
Key Developers
  • Sponsor Company: Loxo Oncology
  • Originator: Redx Pharma
Highest Development Stage
  • Pre-Registration


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.