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JUL 12 2026
UPCOMING · 79 DAYS PAST PDUFA

EMD Serono — pimicotinib

for tenosynovial giant cell tumor

NDA · Priority Review

About

Tenosynovial giant cell tumor is a benign but locally aggressive joint tumor that can cause severe pain, swelling, and limit movement. Pimicotinib is an oral drug designed to block a specific protein signal inside the tumor cells that drives their growth. By interrupting this growth signal, the drug may reduce tumor size and alleviate the debilitating symptoms of the condition.

Pivotal trial

NCT05804045 Phase 3 active not recruiting NCT05804045

The goal of this clinical trial is to assess the efficacy and safety of Pimicotinib (ABSK021) in patients with Tenosynovial Giant Cell Tumor (TGCT). The main questions it aims to answer are: * Whether the Pimicotinib(ABSK021) works well in patients with TGCT

Source: ClinicalTrials.gov

Also in development