NDAORALCAPSULEPriority Review
Approved
Aug 2019
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
4
Data completeness
4/8 — Partial
Priority Review
Drug data last refreshed 22h ago · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
TURALIO (pexidartinib hydrochloride) is an oral small-molecule kinase inhibitor approved for tenosynovial giant cell tumor (TGCT), a rare benign but locally aggressive joint tumor. The drug targets colony-stimulating factor 1 receptor (CSF1R), which is implicated in the pathogenesis of TGCT. It represents a significant advance in treating a condition previously managed only through surgery.
$0.002BPart D
Peak12.2 years to LOETURALIO is in peak commercial phase with established uptake in a niche indication; teams are focused on market penetration and maintaining patient loyalty in a non-competitive space.
Mechanism of Action
Mechanism of action data is being enriched from DailyMed and FDA sources. Check back soon for updated drug intelligence.
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (4)
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
Phase 3 Study of Pexidartinib for Pigmented Villonodular Synovitis (PVNS) or Giant Cell Tumor of the Tendon Sheath (GCT-TS)
Started May 2015
120 enrolled
Pigmented Villonodular SynovitisGiant Cell Tumors of the Tendon SheathTenosynovial Giant Cell Tumor
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.