The Front Room — a clinical regulatory commons
RSS
← Back to The Docket
JUL 12 2026
UPCOMING · 39 DAYS TO PDUFA

EMD Serono pimicotinib

for tenosynovial giant cell tumor

NDA · Priority Review

About

Tenosynovial giant cell tumor is a rare, typically benign growth that forms in the joints and soft tissues, often causing pain, swelling, and limited mobility. Pimicotinib is a drug that targets specific cellular pathways involved in the abnormal growth of these tumors. By blocking these pathways, pimicotinib may help reduce tumor size and alleviate symptoms, potentially improving joint function for patients.

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