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Pexidartinib · Turalio, PLX-3397

Small molecule · Inhibitor of CSF1R, KIT and FLT3 · developed by Daiichi Sankyo

Approved FDA, Aug 2019
1 Registered trials

What is Pexidartinib?

Pexidartinib is a small-molecule tyrosine kinase inhibitor targeting CSF1R, KIT, and FLT3 (with ITD mutation). It inhibits phosphorylation and proliferation of cells dependent on these receptors.

Summary written with AI from the sources listed at the end of this page.

At a glance

Also known as
Turalio, PLX-3397, CML-261
Drug type
Small molecule
Targets
CSF1R, KIT, FLT3
Mechanism
Inhibitor of CSF1R, KIT and FLT3
Pathways
cell proliferation inhibition
Therapy area
Oncology
Developer
Daiichi Sankyo Inc
In trials of
COGT
FDA status
Approved as Turalio (August 2, 2019), NDA211810 · FDA label
UNII
6783M2LV5X

✅ FDA-approved uses

From the indications section of the FDA label (version of Jan 16, 2025). Read the full label for the exact wording, limitations and safety information.

🧪 Clinical trials

TrialPhaseConditionStatusSponsor
NCT02401815 Phase 1/2 Gastrointestinal Stromal Tumors Completed COGT

Trials of the companies BioRadar tracks, from ClinicalTrials.gov, most advanced phase first.

Conditions studied

Gastrointestinal Stromal Tumors

Other drugs acting on CSF1R / KIT / FLT3

Axatilimab FDA approved Gilteritinib FDA approved Midostaurin FDA approved Regorafenib FDA approved Sunitinib FDA approved Barzolvolimab Phase 3 Bezuclastinib Phase 3 BMF-500 Phase 1 Briquilimab Phase 1/2 CDX 0158 Phase 1 CDX-301 Phase 2 CLN-049 Phase 1

Sources

Updated Oct 3, 2026.

Data: FDA (Drugs@FDA, Purple Book, DailyMed), NIH (NCI Thesaurus, GSRS, RxNorm), ClinicalTrials.gov • Informational purposes only, not medical or investment advice. • All drugs A–Z

This data is for informational purposes only, not investment advice. BioRadar does not provide buy/sell recommendations. Past performance does not guarantee future results. Always do your own due diligence.