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Drugs in development · updated 30 October 2026

Gilteritinib: clinical trials and development status

Other names and codes: Xospata

NLM verified identityApproved in the US (FDA)Authorised in the EU (EMA) since 24 October 2019

As of 30 October 2026 Gilteritinib is in 32 active clinical trials (recruiting or ongoing, phases I–III) for 16 diseases. The most advanced phase is III.

32Active trials
IIIMost advanced phase
16Diseases studied

Summary updated every week · data as of 30 October 2026. In Phuturdex you can follow Gilteritinib and get an email at every change or safety alert.

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Diseases studied

For each disease: the drug’s most advanced phase and active trials, with the reference trial on ClinicalTrials.gov.

DiseaseMost advanced phaseActive trialsReference trial
Acute myeloid leukemiaIII25NCT04293562
Myelodysplastic SyndromesII4NCT05564390
Myeloid leukemiaI–II2NCT06235801
Acute biphenotypic leukaemiaII1NCT02115295
Blast CrisisII1NCT02115295
Chronic myelomonocytic leukemiaI–II1NCT04140487
Leukemia, Myelogenous, Chronic, BCR-ABL PositiveII1NCT02115295
Multiple myelomaI–II1NCT04988555
Myelodysplastic–myeloproliferative diseasesI–II1NCT04140487
Myeloproliferative disordersII1NCT05564390
NeoplasmI–II1NCT05520567
Precursor lymphoblastic lymphoma/leukemiaI–II1NCT04988555
Non-small-cell lung carcinomaI2NCT07140016
Hematologic neoplasmI1NCT06001788
LeukemiaI1NCT06001788
Lung neoplasmI1NCT06225427

Everything on Gilteritinib

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Source: Phuturdex analysis of ClinicalTrials.gov (U.S. National Library of Medicine), FDA and EMA data, updated 30 October 2026. Active trials = recruiting or ongoing, phases I–III. Diseases are those named by each trial (NLM MeSH terms). The estimated launch, when shown, is a Phuturdex calculation described on the Method page, not official data.

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