The Front Room — a clinical regulatory commons
RSS
← Back to The Docket
JUL 12 2026
UPCOMING · 19 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 growth that forms in joints and tendon sheaths, often causing pain, swelling, and limited movement. Pimicotinib is an oral drug designed to block a specific cellular signal (CSF-1R) that the tumor cells rely on to survive and multiply. By interrupting this signal, pimicotinib may shrink these tumors and alleviate the symptoms that interfere with joint function.

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