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Restrict the search for
pexidartinib
to a specific field?
Status:
Possibly Marketed Outside US
Source:
NCT04619927: Phase 4 Interventional Recruiting Peripheral Arterial Disease
(2021)
Source URL:
Class:
PROTEIN
Status:
Possibly Marketed Outside US
Source:
NCT02710747: Phase 4 Interventional Unknown status Heart Valve Disease
(2015)
Source URL:
Class:
PROTEIN
Status:
US Approved Rx
(2019)
Source:
NDA211810
(2019)
Source URL:
First approved in 2019
Source:
NDA211810
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Targets:
Conditions:
Pexidartinib (PLX3397) is a small-molecule receptor tyrosine kinase (RTK) inhibitor with potential antineoplastic activity. Pexidartinib binds to and inhibits phosphorylation of stem cell factor receptor (KIT), colony-stimulating factor-1 receptor (CSF1R) and FMS-like tyrosine kinase 3 (FLT3), which may result in the inhibition of tumor cell proliferation and down-modulation of macrophages, osteoclasts and mast cells involved in the osteolytic metastatic disease. FDA has granted Breakthrough Therapy Designation to pexidartinib (PLX3397) for the treatment of tenosynovial giant cell tumor (TGCT) where surgical removal of the tumor would be associated with potentially worsening functional limitation or severe morbidity. In addition to Breakthrough Therapy Designation, pexidartinib (PLX3397) has been granted Orphan Drug Designation by FDA for the treatment of pigmented villonodular synovitis (PVNS) and giant cell tumor of the tendon sheath (GCT-TS). It also has received Orphan Designation from the European Commission for the treatment of TGCT.
