Pegargiminase is under clinical development by Polaris Pharmaceuticals and currently in the Phase I, Phase II and Phase III 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 Pegargiminase’s likelihood of approval (LoA) and phase transition for Soft Tissue Sarcoma took place on 08 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.

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

Pegargiminase overview

Pegargiminase (ADI-PEG 20) is under development for the treatment of newly diagnosed glioblastoma multiforme, hepatocellular carcinoma (third line therapy), melanoma, mesothelioma, metastatic castration resistant prostate cancer, advanced gastrointestinal malignancies, small-cell lung cancer, soft tissue sarcomas, non-squamous non-small cell lung cancer, sarcomatoid cancers, glioma. It is administered as an intramuscular injection. ADI is a microbial enzyme that degrades arginine. It is also called pegylated arginine deiminase. It is developed by using the company's proprietary pegylation technology. It was also under development for the treatment of refractory acute myeloid leukemia, relapsed acute myeloid leukemia, pancreatic cancer, colorectal cancer, gastric cancer, hepatocellular carcinoma (HCC), hepatitis C, pediatric cancer including sarcoma, lymphoma and leukemia, ovarian cancer, HER2 negative metastatic breast cancer, peritoneal cancer,  metastatic uveal melanoma, head and neck squamous cell carcinoma, thymus cancer and nasopharyngeal carcinoma, non-Hodgkin lymphoma,  and bladder cancer .

Polaris Pharmaceuticals overview

Polaris Pharmaceuticals (Polaris), a subsidiary of Polaris Pharmaceutical Group Co Ltd, provides contract development and manufacturing services. The company’s services include expression and purification system development, analytical chemistry, fermentation, purification, process development, quality control and assurance, among others. Polaris is headquartered in San Diego, California, the US.

Quick View Pegargiminase LOA Data

Report Segments
  • Innovator
Drug Name
  • Pegargiminase
Administration Pathway
  • Intramuscular
Therapeutic Areas
  • Infectious Disease
  • Oncology
Key Developers
Highest Development Stage
  • Phase III

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.