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Bezuclastinib

Nonadvanced systemic mastocytosis

Manufacturer
Cogent Biosciences
Regulatory submission
NDA submitted December 2025
Last updated
62 sources

Product information and disease descriptionPlace of product in therapyApproaches to treatment

Place in treatment, anticipated use, and care setting

1 evidence topic · 4 sources

Summary

The documented use of bezuclastinib is investigational. SUMMIT Part 2 evaluated 100 mg daily with best supportive care in nonadvanced SM with inadequate symptom control despite at least two anti-mediator therapies. Expanded-access protocols are described for eligible people with SM, subject to protocol-specific criteria. These trial and expanded-access arrangements do not constitute an approved routine-care indication.