Bezuclastinib

Name: Bezuclastinib in Nonadvanced systemic mastocytosis: Access and distribution
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

Access and distribution

1 evidence topic · 1 source

Expanded access

“Cogent has initiated Bezuclastinib Expanded Access Protocols (EAP) for patients with GIST or SM who meet disease-specific protocol inclusion and exclusion criteria.” (opens the source at this quote in a new tab)
“EAP@cogentbio.com” (opens the source at this quote in a new tab)