Quizartinib dihydrochloride is under clinical development by Daiichi Sankyo and currently in the Phase II and Pre-Registration 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 Quizartinib dihydrochloride’s likelihood of approval (LoA) and phase transition for Myeloproliferative Disorders took place on 04 Mar 2022, which decreased the likelihood that the drug progresses to the next phase in its clinical pathway and decreased the likelihood of final approval for this indication.

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

Quizartinib dihydrochloride overview

Quizartinib dihydrochloride (Vanflyta) belongs to the class of phenylureas, with potential antineoplastic activity. It is formulated as film coated tablets for oral route of administration. Vanflyta is indicated for the treatment of adult patients with relapsed/refractory FLT3-ITD acute myeloid leukemia (AML).

Quizartinib dihydrochloride (AC220) is under development for the treatment of relapsed and refractory acute myeloid leukemia (AML), myelodysplastic syndrome, myeloproliferative neoplasm and chronic myelomonocytic leukemia. The drug candidate is administered orally as a tablet and intravenous route. It targets FMS-like tyrosine kinase 3 (FLT3). It is developed using KINOME scan technology. It was also under development for advanced solid tumors.

Daiichi Sankyo overview

Daiichi Sankyo is a holding company, which carries out the research, development, manufacture, and marketing of pharmaceutical products. The company offers a wide range of prescription drugs, over the counter (OTC) drugs, vaccines, and others. Its portfolio encompasses medicines for cardiovascular, neurological, nephrological, diabetic, metabolic, and infectious diseases, and various types of cancers. Besides cancer, the company’s other research areas include rare diseases and immune disorders. Daiichi Sankyo sells its products through its group companies, and an extensive network of medical representatives. It has operations in North America, South and Central America, Europe, and Asia. Daiichi Sankyo is headquartered in Tokyo, Japan.

Quick View Quizartinib dihydrochloride LOA Data

Report Segments
  • Innovator (NME)
Drug Name
  • Quizartinib dihydrochloride
Administration Pathway
  • Intravenous
  • Oral
Therapeutic Areas
  • Oncology
Key Developers
Highest Development Stage
  • Marketed

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.