Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Bezuclastinib Tablets (Formulation A)
Bezuclastinib · 2 trials · 12 indications
Selection of the recommended dose to be used in subsequent parts of the study.
Mean absolute change on the Mastocytosis Symptom Severity Daily Diary (MS2D2)
CTCAE v5
| Arm | Type | Description |
|---|---|---|
| (Part 1a) Bezuclastinib Dose 1 + BSC | EXPERIMENTAL | - |
| (Part 1a) Bezuclastinib Dose 2 + BSC | EXPERIMENTAL | - |
| (Part 1a) Placebo + BSC | PLACEBO_COMPARATOR | - |
| (Part 1b) Bezuclastinib Dose 1 + BSC | EXPERIMENTAL | - |
| (Part 1b) Bezuclastinib Dose 2 + BSC | EXPERIMENTAL | - |
| (Part 1b) Placebo + BSC | PLACEBO_COMPARATOR | - |
| (Part 2) Bezuclastinib Selected Dose + BSC | EXPERIMENTAL | - |
| (Part 2) Placebo + BSC | PLACEBO_COMPARATOR | - |
| (Part 3) Bezuclastinib + BSC | EXPERIMENTAL | - |
| (Prior Therapy Sub-study) Bezuclastinib | EXPERIMENTAL | - |
| bezuclastinib | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| Bezuclastinib Tablets (Formulation A) | DRUG | Bezuclastinib will be administered orally, once daily continuously for 28-day cycles |
| Bezuclastinib Tablets (Formulation B) | DRUG | Bezuclastinib will be administered orally, once daily continuously for 28-day cycles |
| Placebo Tablets | DRUG | Placebo will be administered orally, once daily continuously for 28-day cycles |
| bezuclastinib | DRUG | Bezuclastinib is administered as tablets to be taken orally, continuously in 28-day cycles. |
Key Inclusion Criteria: 1. Diagnosed with 1 of the following diagnoses according to the 2016 World Health Organization (WHO) classification for systemic mastocytosis (SM): * Indolent systemic mastocytosis (ISM), * Bone marrow mastocytosis (BMM) * Smoldering systemic mastocytosis (SSM) 2. ...
Bezuclastinib is an investigational small molecule kinase inhibitor being developed for advanced systemic mastocytosis (AdvSM) and smoldering systemic mastocytosis (SSM). It is currently in Phase 2 clinical trials for these hematologic conditions.
Bezuclastinib is a kinase inhibitor, belonging to the -tinib class of small molecule drugs. It is designed to target kinases involved in the growth and survival of mast cells, which are central to the pathology of systemic mastocytosis.
Bezuclastinib is being developed by Cogent Biosciences, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol COGT. The company is conducting clinical trials to evaluate the drug's efficacy and safety in systemic mastocytosis.
Bezuclastinib is in Phase 2 clinical development. It has received Breakthrough Therapy designation and Priority Review from the FDA, reflecting its potential to address serious conditions like advanced systemic mastocytosis.
Bezuclastinib is being studied in two Phase 2 trials: NCT04996875 (Apex) for advanced systemic mastocytosis and NCT05186753 (Summit) for indolent or smoldering systemic mastocytosis. Both are randomized, double-blind, placebo-controlled studies enrolling adults.
Yes, Bezuclastinib Tablets (Formulation A) is an alternative name for Bezuclastinib. The drug is also referred to as Bezuclastinib in combination with sunitinib in certain contexts, though the primary development focus is as a monotherapy.