Bezuclastinib

Name: Bezuclastinib in Nonadvanced systemic mastocytosis: Generic, brand name and therapeutic class of product
Published: 2026-09-14T15:39:06-04:00

Nonadvanced systemic mastocytosis

Manufacturer: Cogent Biosciences
Regulatory submission: NDA submitted December 2025
Launch: Anticipated in the second half of 2026
Last updated: September 17, 2026

Section

Product information and disease description Product description Product information

Generic, brand name and therapeutic class of product

2 evidence topics · 2 sources

Product and manufacturer

“Generic Name: bezuclastinib” (opens the source at this quote in a new tab)
“Sponsor: Cogent Biosciences, Inc.” (opens the source at this quote in a new tab)

Manufacturer: Cogent Biosciences

“Cogent Biosciences, Inc. (Nasdaq: COGT), a biotechnology company focused on developing precision therapies for genetically defined diseases, today announced it has submitted its New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for bezuclastinib in NonAdvanced Systemic Mastocytosis (NonAdvSM).” (opens the source at this quote in a new tab)

Brand name

No evidence found.