Evicenter
P&T meetings

Bezuclastinib

Nonadvanced systemic mastocytosis

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

Product information and disease descriptionProduct description

Phase of product development

5 evidence topics · 7 sources

Orphan designation and approval status

“Date Designated: 03/17/2023” (opens the source at this quote in a new tab)

“Orphan Designation: Treatment of Mastocytosis” (opens the source at this quote in a new tab)

“FDA Orphan Approval Status: Not FDA Approved for Orphan Indication” (opens the source at this quote in a new tab)

Regulatory submission: NDA submitted December 2025

“December 30, 2025” (opens the source at this quote in a new tab)

“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)

FDA review timeline and advisory committee

“Prescription Drug User Fee Act (PDUFA) target action date of December 30, 2026.” (opens the source at this quote in a new tab)

“there is no plan to hold an advisory committee” (opens the source at this quote in a new tab)

Breakthrough Therapy Designation: designated populations

“NonAdvanced Systemic Mastocytosis (NonAdvSM) patients previously treated with avapritinib as well as in patients with Smoldering Systemic Mastocytosis” (opens the source at this quote in a new tab)

Launch: Anticipated in the second half of 2026

“pending regulatory approval, the company expects to launch bezuclastinib commercially in the United States in the second half of 2026.” (opens the source at this quote in a new tab)

“Pending FDA approval(s), launch bezuclastinib in the second half of 2026” (opens the source at this quote in a new tab)

“The Company’s NDA for NonAdvanced Systemic Mastocytosis is under FDA review, with a PDUFA target action date of December 30, 2026” (opens the source at this quote in a new tab)

“ready for the potential launches later this year” (opens the source at this quote in a new tab)