Gilteritinib fumarate is a Small Molecule owned by Astellas Pharma, and is involved in 27 clinical trials, of which 15 were completed, 9 are ongoing, and 3 are planned.

Gilteritinib is an inhibitor of the receptor tyrosine kinases (RTKs) FMS-related tyrosine kinase 3 (FLT3, STK1, or FLK2). This results in an inhibition of FLT3 mediated signal transduction pathways and reduction of tumor cell proliferation in cancer cell types that overexpress these RTKs. FLT3 is overexpressed or mutated in a variety of cancer cell types, plays a key role in tumor cell growth and survival.

The revenue for Gilteritinib fumarate is expected to reach a total of $11.5bn through 2038. This change impacts the valuation of this asset and is an important factor to understand the current value of the drug in a clinical process. View the complete picture with the Gilteritinib fumarate NPV Report.

Gilteritinib fumarate is originated and owned by Astellas Pharma.

Gilteritinib fumarate Overview

Gilteritinib fumarate (Xospata) is a pyrazine carboxamide derivative, acts as an anti-neoplastic agent. It is formulated as film coated tablets for oral route of administration. Xospata is indicated for the treatment of  FLT3 mutation-positive refractory and relapsed acute myeloid leukemia in adults.

Gilteritinib fumarate (ASP-2215) is under development for the treatment of relapsed or refractory acute myeloid leukemia, post-chemo maintenance acute myeloid leukemia, post-HSCT maintenance acute myeloid leukemia, newly diagnosed acute myeloid leukemia with high intensity induction of chemotherapy and newly diagnosed acute myeloid leukemia with low intensity induction of chemotherapy. It was also under developement for newly diagnosed FLT3 mutation-positive (FLT3mut+) acute myeloid leukemia (AML) patients who were ineligible for intensive induction chemotherapy.

Astellas Pharma Overview

Astellas Pharma (Astellas) discovers, develops, manufactures, and commercializes a wide range of pharmaceuticals. The company’s product portfolio comprises marketed products for the treatment of a wide range of urological diseases, infectious diseases, cancer, nephrology, and metabolic diseases, immunodeficiency diseases, and transplantation. Its pipeline possesses drug candidates for the treatment of urothelial cancer; gastric cancer; gastroesophageal junction cancer; anemia associated with chronic kidney disease (CKD) in dialysis; Rheumatoid arthritis and non-dialysis patients; menopause-related vasomotor symptoms (MR-VMS) such as hot flashes and night sweats; and acute myeloid leukemia (AML), among others. It operates in the Americas, Australia, Europe, and Asia and Oceania through a network of subsidiaries and affiliates. Astellas is headquartered in Tokyo, Japan.

The company reported revenues of (Yen) JPY1,296,163 million for the fiscal year ended March 2022 (FY2022), an increase of 3.7% over FY2021. In FY2022, the company’s operating margin was 12.4%, compared to an operating margin of 11.7% in FY2021. In FY2022, the company recorded a net margin of 9.6%, compared to a net margin of 9.7% in FY2021. The company reported revenues of JPY380,394 million for the second quarter ended September 2022, a decrease of 0.4% over the previous quarter.

Quick View – Gilteritinib fumarate

Report Segments
  • Innovator (NME)
Drug Name
  • Gilteritinib fumarate
Administration Pathway
  • Oral
Therapeutic Areas
  • Oncology
Key Companies
Highest Development Stage
  • Marketed

GlobalData, the leading provider of industry intelligence, provided the underlying data, research, and analysis used to produce this article.

To create this model, GlobalData takes into account factors including patent law, known and projected regulatory approval processes, cash flows, potential applicable patients, drug margins, company expenses, and pricing estimates. Combining these data points with GlobalData’s world class analysis creates high value models that companies can use to help in evaluation processes for each drug or company.

The rNPV method integrates the probability of a drug reaching a clinical stage into the cash flow at that time, which provides a more accurate rNPV, as it considers the probability that the drug never makes it through the clinical pathway to commercialization. GlobalData’s rNPV model uses proprietary likelihood of approval (LoA)and phase transition success rate(PTSR) data for the indication in the highest development stage, which can be found on GlobalData’s Pharmaceutical Intelligence Center.