Pegargiminase is under clinical development by Polaris Pharmaceuticals and currently in Phase I for Relapsed Acute Myeloid Leukemia. According to GlobalData, Phase I drugs for Relapsed Acute Myeloid Leukemia have a 71% phase transition success rate (PTSR) indication benchmark for progressing into Phase II. GlobalData’s report assesses how Pegargiminase’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.

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 and leiomyosarcoma. 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.

For a complete picture of Pegargiminase’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.