Numidargistat is under clinical development by Calithera Biosciences and currently in the 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 Numidargistat’s likelihood of approval (LoA) and phase transition for Endometrial Cancer took place on 26 Dec 2022, which increased the likelihood that the drug progresses to the next phase in its clinical pathway and increased the likelihood of final approval for this indication.

In addition, the same event on 26 Dec 2022 increased Numidargistat’s LoA and PTSR for Epithelial Ovarian Cancer, increased LoA and PTSR for Fallopian Tube Cancer, increased PTSR for Metastatic Biliary Tract Cancer, and increased LoA and PTSR for Peritoneal Cancer.

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

Numidargistat overview

Numidargistat (INCB-01158 (CB-1158)) is under development for the treatment of  solid tumors such as breast cancer, bladder cancer, malignant mesothelioma, relapsed or refractory multiple myeloma, melanoma, including renal cell carcinoma, non-small cell lung cancer, colorectal cancer, head and neck cancer squamous cell carcinoma, adenocarcinoma of the gastroesophageal junction, epithelial ovarian, peritoneal, or fallopian tube carcinoma, adenocarcinoma, carcinosarcomas and biliary tract cancer, small cell-lung cancer and urothelial cell cancer. It is a small molecule administered orally in the form of capsule. It acts by targeting the enzyme arginase 1 and 2.

Calithera Biosciences overview

Calithera Biosciences (Calithera) is a clinical-stage bio-pharmaceutical company that discovers and develops novel small molecule drugs directed against tumor metabolism and tumor immunology targets for the treatment of cancer. The company’s product pipeline includes CB-839, a glutaminase inhibitor in tumor metabolism to treat solid tumors, NCB001158, a small molecule arginase inhibitor based on tumor immunology technology that activates the body’s own immune system to attack and kill cancer cells for the treatment of hematology and oncology diseases, CB-280, a arginase inhibitor used for treating Cystic Fibrosis, CB-708, a CD73 inhibitor against immuno-oncology conditions and IL4I1 Inhibitor CB-668 against immuno-oncology conditions. The company works in collaboration with bio-pharmaceutical companies such as Incyte Corp, Bristol-Myers Squibb (BMS), and Mars Symbiosciences Inc. Calithera is headquartered in South San Francisco, California, the US.

Quick View Numidargistat LOA Data

Report Segments
  • Innovator
Drug Name
  • Numidargistat
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.