AG-019 is under clinical development by Precigen and currently in Phase II for Type 1 Diabetes (Juvenile Diabetes). According to GlobalData, Phase II drugs for Type 1 Diabetes (Juvenile Diabetes) have a 56% phase transition success rate (PTSR) indication benchmark for progressing into Phase III. GlobalData’s report assesses how AG-019’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.

AG-019 overview

AG-019 is under development for type 1 diabetes. The drug candidate is administered by oral route as capsule. It is developed based on using Topact technology platform. The drug candidate is composed of ActoBiotics delivering the autoantigen human proinsulin (hPINS) and the tolerance-enhancing cytokine human interleukin-10 (hIL-10).

Precigen overview

Precigen, formerly Intrexon Corp, is a clinical stage biotechnology company that develops synthetic biology solutions. It offers clinical and pre clinical products. The company clinical products include PRGN-3006, PRGN-3005, AG019, PRGN-2009, PRGN-2012 and PRGN-3007. The company’s pre clinical product portfolio comprises of PRGN-3008, PRGN-5001,PRGN-2010, PRGN-2011, PRGN-5002, PRGN-2013, AG017, PRGN-3009 and PRGN-3010. Precigen provides treatment in areas of immuno-oncology, autoimmune disorders, infectious diseases, solid tumors, celiac disease, heart failure, ovarian cancer and type 1 diabetes. It therapeutics platforms include UltraCAR-T, AdenoVerse therapies, ActoBiotics, multifunctional therapeutics, UltraVector, AdenoVerse, AttSite, UltraPorator and RheoSwitch, among others. It erves customers worldwide. Precigen is headquartered in Germantown, Maryland, the US.

For a complete picture of AG-019’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.