CGT4859 is an investigational selective FGFR2/FGFR3 inhibitor in early clinical development for intrahepatic cholangiocarcinoma and other advanced solid tumors with FGFR2/3 alterations. It is being studied in Phase 1/2 programs focused on dose finding, PK, and anti-tumor activity. The candidate is not approved as a marketed therapy.
Cogent Biosciences has submitted a New Drug Application for bezuclastinib to treat systemic mastocytosis caused by the KIT D816V mutation, with FDA review underway and strong analyst support.
Cogent Biosciences is preparing parallel FDA submissions for bezuclastinib across three indications following positive pivotal trial results, with potential launches beginning in late 2026 and full commercialization expected by early 2027.
| NCT ID | Title | Status | Phase |
|---|---|---|---|
| NCT06777316 |
A Study of an FGFR2/3 Inhibitor (CGT4859) in Patients With Cholangiocarcinoma and Other Advanced Solid Tumors |
ACTIVE_NOT_RECRUITING | PHASE1/PHASE2 |
