Bezuclastinib

Name: Bezuclastinib in Nonadvanced systemic mastocytosis: Product comparison
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

Product comparison

2 evidence topics · 1 source

Comparator assessment of avapritinib by IQWiG: assessed population

“Adult patients with indolent systemic mastocytosis (ISM) with moderate to severe symptoms inadequately controlled on symptomatic treatment” (opens the source at this quote in a new tab)

Comparator assessment of avapritinib by IQWiG: assessment result

“Added benefit not proven” (opens the source at this quote in a new tab)