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

2015201620172018201920202021202220232024202520262027

Phase	Registry id	Dates	Indication	Sponsor	Status	Outcome
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

Also used as a comparator or background therapy in 1 trial

Phase	Registry id	Dates	Indication	Sponsor	Status	Outcome
—	NCT06915766 Background	—	aggressive systemic mastocytosis, indolent systemic mastocytosis	Cogent Biosciences, Inc.	Available	No outcome recorded

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

Field	Value	Cited text
Known as	Bezuclastinib	ClinicalTrials.gov intervention name — accepted as the source's own label NCT05186753 ↗ 4 NCT04996875 ↗ NCT06208748 ↗ NCT06915766 ↗ NCT06948955 ↗
Known as	CGT9486	“CGT9486” NCT04996875 ↗ 2 NCT05208047 ↗ NCT02401815 ↗
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 ↗