NDAORALCAPSULEPriority Review
Approved
Nov 2023
Lifecycle
Growth
Competitive Pressure
0/100
Clinical Trials
20
Data completeness
5/8 — Partial
Priority Review
Drug data last refreshed 20h ago · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
FRUZAQLA (fruquintinib) is an oral small-molecule kinase inhibitor approved by the FDA in November 2023 for treating multiple solid tumors and hematologic malignancies. The drug targets angiogenesis and tumor growth through inhibition of vascular endothelial growth factor receptors (VEGFRs). It is indicated across 13 cancer types including colorectal, gastric, lung, breast, and lymphoid malignancies.
$5MPart D
Growth9.3 years to LOEEarly-stage product in growth phase with minimal Part D penetration suggests significant market expansion opportunity and need for commercial infrastructure build-out.
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 (20)
A Clinical Study of Iparomlimab and Tuvonralimab Combined With Fruquintinib and Heterogeneous Radiotherapy Versus Fruquintinib as Third-Line and Subsequent-Line Treatment for Metastatic Colorectal Cancer
Started May 2026
60 enrolled
Metastatic Colorectal Cancer (CRC)mCRC
Trial of 5-Fluorouracil (5FU)-Based Therapy in Combination With Fruquintinib in Patients With Locally Advanced Unresectable or Metastatic Colorectal Cancer
Started Jan 2026
50 enrolled
Metastatic Colorectal Cancer (CRC)
Phase Ib/II Study of QL1706 + Fruquintinib + SCRT vs. Standard Third-Line Therapy in Unresectable Liver-Metastatic pMMR/MSS Colorectal Cancer: Safety, Tolerability, and Efficacy.
Started Jan 2026
76 enrolled
Colorectal Cancer
A Study to Test DSP107 in Combination With Atezolizumab in Comparison With Fruquintinib as a New Treatment for Colorectal Cancer.
Started Jan 2026
90 enrolled
Colorectal Cancer
Trifluridine/Tipiracil + Fruquintinib Versus Trifluridine/Tipiracil Alone for Metastatic Oeso-gastric Adenocarcinoma
Started Dec 2025
324 enrolled
Metastatic Oesogastric Adenocarcinoma
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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.