OKI-219 is under clinical development by OnKure and currently in Phase I for Human Epidermal Growth Factor Receptor 2 Positive Breast Cancer (HER2+ Breast Cancer). According to GlobalData, Phase I drugs for Human Epidermal Growth Factor Receptor 2 Positive Breast Cancer (HER2+ Breast Cancer) have an 84% phase transition success rate (PTSR) indication benchmark for progressing into Phase II. GlobalData’s report assesses how OKI-219’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.

OKI-219 overview

OKI-219 is under development for the treatment of PI3K alpha H1047R mutated solid tumors including human epidermal growth factor receptor 2 positive, negative breast cancer and colorectal cancer (CRC). The therapeutic candidate acts by targeting phosphatidylinositol 4,5 bisphosphate 3 kinase catalytic subunit alpha isoform with a mutant H1047R. It is administered by oral route.

OnKure overview

OnKure is a drug developer that discovers and develops epigenetic therapies for the treatment of cancer. The company offers production of specific histone deacetylases inhibitors. The company inhibitor OKI-219 for breast cancer is in pipeline. The company offers inhibitors for PI3K which is the most commonly mutated oncogene in cancer. OnKure also offers Bocodepsin a novel oral Class I histone deacetylase (HDAC) inhibitor for the treatment of a wide range of solid and hematological malignancies. It collaborates with veteran consultants and advisors for pre-clinical and clinical development activities. OnKure is headquartered in Longmont, Colorado, the US.

For a complete picture of OKI-219’s drug-specific PTSR and LoA scores, buy the report here.

Data Insights


The gold standard of business intelligence.

Blending expert knowledge with cutting-edge technology, GlobalData’s unrivalled proprietary data will enable you to decode what’s happening in your market. You can make better informed decisions and gain a future-proof advantage over your competitors.


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 clinical development (PTSR), as well as how likely the drug will be approved (LoA). This is based on a combination of machine learning and a proprietary algorithm to process data points from various databases found on GlobalData’s Pharmaceutical Intelligence Center.