Phuturdex › Drugs › Bezuclastinib
Drugs in development · updated 11 November 2026
Bezuclastinib: clinical trials and development status
Other names and codes: CGT9486
As of 11 November 2026 Bezuclastinib is in 4 active clinical trials (recruiting or ongoing, phases I–III) for 21 diseases. The most advanced phase is III.
Authorisation
- EU no (EMA)
- Italy not in the AIFA register
- Germany not available
- US no (FDA)
Sources: EMA, AIFA register (open data), FDA. For Germany only the EU centralised authorisation is shown: the national BfArM register is not one of our sources.
Map of sites in Europe with recruitment status, every trial and an email when something changes. Full access free until 31 March 2027, no card needed.
What it is
An orally bioavailable protein tyrosine kinase inhibitor of mutated forms of the tumor-associated antigen mast/stem cell factor receptor c-Kit (SCFR), with potential antineoplastic activity. Upon oral administration, bezuclastinib binds to and inhibits specific c-Kit mutants. This may result in an inhibition of tumor cell proliferation in cancer cell types that overexpress these c-Kit mutations. c-Kit, a transmembrane protein and receptor tyrosine kinase, is overexpressed in solid tumors and hematological malignancies; it plays a key role in the regulation of cell differentiation and proliferation.
Diseases studied
For each disease: the drug’s most advanced phase and active trials, with the reference trial on ClinicalTrials.gov.
| Disease | Most advanced phase | Active trials | Reference trial |
|---|---|---|---|
| Gastrointestinal stromal tumor | III | 2 | NCT05208047 |
| Metastasis | III | 1 | NCT05208047 |
| Hematologic Diseases | II | 2 | NCT05186753 |
| Hypersensitivity | II | 2 | NCT05186753 |
| Immune Complex Diseases | II | 2 | NCT05186753 |
| Immune System Diseases | II | 2 | NCT05186753 |
| Mastocytosis | II | 2 | NCT05186753 |
| Systemic mastocytosis | II | 2 | NCT05186753 |
| Acute myeloid leukemia | II | 1 | NCT04996875 |
| Chronic myelomonocytic leukemia | II | 1 | NCT04996875 |
| Connective tissue neoplasm | II | 1 | NCT04996875 |
| Hematologic neoplasm | II | 1 | NCT04996875 |
| Leukemia | II | 1 | NCT04996875 |
| Mast cell leukemia | II | 1 | NCT04996875 |
| Myeloid leukemia | II | 1 | NCT04996875 |
| Myeloproliferative disorders | II | 1 | NCT04996875 |
| Neoplasm | II | 1 | NCT04996875 |
| Sarcoma | II | 1 | NCT06208748 |
| Skin disease | II | 1 | NCT04996875 |
| Soft tissue neoplasm | II | 1 | NCT04996875 |
| Urticaria pigmentosa | II | 1 | NCT04996875 |
Sites in Europe
90 sites of the active trials in 16 European countries, 4 recruiting.
- Italy15
- France13
- Germany13
- Spain12
- United Kingdom9
- Netherlands6
- Poland6
- Czechia3
- and 8 more
Sites declared by the sponsors on ClinicalTrials.gov; region worked out by Phuturdex from the geographic point. The list of sites with city and recruitment status is in the app. See the sites →
Everything on Bezuclastinib
In Phuturdex you get every trial with sponsors, countries and dates, development events, FDA and EMA approvals, patents and exclusivities, orphan designations and safety alerts, with PDF and Excel export. Free until 31 March 2027.
Open in Phuturdex →Source: Phuturdex analysis of ClinicalTrials.gov (U.S. National Library of Medicine), FDA and EMA data, updated 11 November 2026. Active trials = recruiting or ongoing, phases I–III. Diseases are those named by each trial (NLM MeSH terms). The estimated launch, when shown, refers to the United States and is a Phuturdex calculation described on the Method page, not official data: the drug may already be marketed in other countries.