drugset
Drugs / Bezuclastinib
last change Jun 2026 re-read 9 days ago

Bezuclastinib

also known as CGT9486 · PLX9486

Small molecule targets KIT via inhibition

Developed for
gastrointestinal stromal tumor · aggressive systemic mastocytosis · isolated bone marrow mastocytosis · mast cell leukemia · metastatic malignant neoplasm · Smouldering systemic mastocytosis · systemic mastocytosis with an associated clonal hematologic non-mast cell lineage disease
Investigated by
Cogent Biosciences, Inc. · Dana-Farber Cancer Institute · Plexxikon · Sarcoma Alliance for Research through Collaboration · The Life Raft Group

Trials 6

today NCT06208748 · Ph 2 NCT05186753 · Ph 2 NCT05208047 · Ph 3 NCT04996875 · Ph 2 NCT02401815 · Ph 1/2
2015201620172018201920202021202220232024202520262027
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 1/21 trial
Phase 1/2 NCT02401815 Mar 2015 → May 2020 gastrointestinal stromal tumor Cogent Biosciences, Inc. Completed No outcome recorded
Phase 23 trials
Phase 2 NCT06208748 Aug 2024 → Jun 2026 overdue gastrointestinal stromal tumor Sarcoma Alliance for Research through Collaboration Active not recruiting No outcome recorded
Phase 2 NCT05186753 Jun 2022 → May 2025 overdue Smouldering systemic mastocytosis, isolated bone marrow mastocytosis Cogent Biosciences, Inc. Active not recruiting No outcome recorded
Phase 2 NCT04996875 Nov 2021 → Sep 2025 overdue aggressive systemic mastocytosis, mast cell leukemia, systemic mastocytosis with an associated clonal hematologic non-mast cell lineage disease Cogent Biosciences, Inc. Recruiting No outcome recorded
Phase 31 trial
Phase 3 NCT05208047 Apr 2022 → Sep 2025 overdue gastrointestinal stromal tumor, metastatic malignant neoplasm Cogent Biosciences, Inc. Recruiting No outcome recorded
Phase not stated1 trial
— NCT06948955 — gastrointestinal stromal tumor Cogent Biosciences, Inc. Available No outcome recorded
Comparator or background therapy1 trial
— NCT06915766 Background — aggressive systemic mastocytosis, indolent systemic mastocytosis Cogent Biosciences, Inc. Available No outcome recorded

Evidence & citations 7 cited values

Every value below carries the sentence it was read from. 8 sources stand behind the page.

FieldValueCited text
Known as Bezuclastinib ClinicalTrials.gov intervention name — accepted as the source's own label NCT06915766 ↗
4

NCT04996875 ↗

NCT05186753 ↗

NCT06948955 ↗

NCT06208748 ↗
Known as CGT9486 “CGT9486” NCT04996875 ↗
2

NCT02401815 ↗

NCT05208047 ↗
Known as PLX9486 “CGT9486 (fka PLX9486) is designed to block KIT gene mutations.” NCT02401815 ↗
Action Inhibit “CGT9486 (fka PLX9486) is designed to block KIT gene mutations.” NCT02401815 ↗
Modality Small molecule — CHEMBL5095229 ↗
Route Oral “Participants will receive CGT9486 250 milligrams (mg) orally once daily (QD) in 28-day dosing cycles.” NCT02401815 ↗
Target KIT “CGT9486 (fka PLX9486) is designed to block KIT gene mutations.” NCT02401815 ↗