NDAORALCAPSULEPriority Review
Approved
Aug 2019
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
2
Data completeness
4/8 — Partial
Priority Review
Drug data last refreshed 10h ago · AI intelligence enriched 3w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
TURALIO (pexidartinib hydrochloride) is an oral small-molecule tyrosine kinase inhibitor approved by the FDA in August 2019 for tenosynovial giant cell tumor (TGCT), a rare connective tissue neoplasm. The drug targets colony-stimulating factor 1 receptor (CSF1R) to inhibit tumor growth in patients with symptomatic, recurrent, or unresectable disease. It represents a significant therapeutic advance for a condition previously managed only through surgery.
$0.002BPart D
Peak12.0 years to LOETURALIO is in peak commercial stage with modest Medicare claims volume, suggesting a specialized orphan/rare disease franchise requiring focused medical affairs and niche field support rather than large-scale commercial infrastructure.
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 (2)
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
Career Relevance
TURALIO offers a specialized career path in rare/orphan disease commercialization with deep clinical expertise and high-touch stakeholder engagement. Working on this franchise prioritizes precision over volume, with emphasis on patient education, physician relationships, and payer navigation in a protected market.
Worked on TURALIO at Daiichi Sankyo? Share your interview experience or compensation data (+7 days Pro)
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.