Bezuclastinib

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

Co-prescribed/Concomitant therapies

2 evidence topics · 2 sources

SUMMIT background therapy

“best supportive care (BSC)” (opens the source at this quote in a new tab)

SUMMIT protocol: maximum concomitant prednisone dose

“≤10 mg/day of prednisone” (opens the source at this quote in a new tab)