NDAORALCAPSULEPriority Review
Approved
Aug 2019
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
3
Mechanism of Action
1 receptor (CSF1R), KIT proto-oncogene receptor tyrosine kinase (KIT), and FMS-like tyrosine kinase 3 (FLT3) harboring an internal tandem duplication (ITD) mutation. Overexpression of the CSF1R ligand promotes cell proliferation and accumulation in the synovium. In vitro, pexidartinib inhibited…
Clinical Trials (3)
A Long-term Study Evaluating Hepatotoxicity Associated With TURALIO™ (Pexidartinib) Treatment
Started Jan 2021
30 enrolled
HepatotoxicityTenosynovial Giant Cell Tumor
Study to Evaluate Discontinuation and Re-Treatment in Participants With Tenosynovial Giant Cell Tumor (TGCT) Previously Treated With Pexidartinib
Started Oct 2020
32 enrolled
Tenosynovial Giant Cell Tumor
A Study of the Efficacy and Safety of Pexidartinib in Adult Subjects With TGCT
Started Sep 2020
40 enrolled
Tenosynovial Giant Cell Tumor
Loss of Exclusivity
LOE Date
Jul 24, 2038
150 months away
Patent Expiry
Jul 24, 2038
Exclusivity Expiry
Aug 2, 2026