Galunisertib monohydrate is under clinical development by Eli Lilly and Co and currently in the Phase I and Phase II 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 Galunisertib monohydrate’s likelihood of approval (LoA) and phase transition for Peritoneal Cancer took place on 17 Nov 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 Galunisertib monohydrate Likelihood of Approval (LoA) and Phase Transition Success Rate (PTSR) Report.

Galunisertib monohydrate overview

Galunisertib monohydrate (LY-2157299) is under development for the treatment of hepatocellular carcinoma, recurrent glioblastoma, non-small cell lung cancer,  non-small cell lung cancer, primary, recurrent or progressive uterine, ovarian, fallopian tube or peritoneal carcinosarcoma, castration resistant prostate cancer, metastatic colorectal cancer and metastatic unresectable pancreatic cancer. It is administered through oral route. The drug candidate is a new chemical entity (NCE). The drug candidate targets TGFbR1 (transforming growth factor beta receptor 1). It was also  under development for the treatment of malignant glioma, myelodysplastic syndromes, metastatic uveal melanoma and metastatic breast cancer.

Eli Lilly and Co overview

Eli Lilly and Co (Lilly) is a healthcare company that is engaged in the discovery, development, and marketing of human healthcare products. The company offers medicines for cardiovascular conditions, diabetes, endocrinology, cancer, neurological problems, immune disorders, men’s health and musculoskeletal problems. The company distributes its pharmaceutical health products through independent wholesale distributors. Lilly conducts research and development activities to discover and deliver innovative medicines. It also promotes products through sales representatives and marketing agreements with other pharmaceutical companies. The company also offers its products in North America, South America, Europe, South Asia, the Middle East, Africa and North Asia-Pacific. Lilly is headquartered in Indianapolis, Indiana, the US.

Quick View Galunisertib monohydrate LOA Data

Report Segments
  • Innovator
Drug Name
  • Galunisertib monohydrate
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.