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 11h ago · AI intelligence enriched 1mo ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
FRUZAQLA (fruquintinib) is an oral small-molecule tyrosine kinase inhibitor approved by the FDA in November 2023 for the treatment of colorectal cancer. The drug targets VEGFR and other kinases involved in tumor angiogenesis and growth signaling. It represents a novel therapeutic option in the oncology space with a mechanism designed to inhibit tumor vasculature and progression.
$0.005BPart D
Growth9.1 years to LOEEarly-stage growth product with minimal initial penetration; commercial teams are actively building market share and infrastructure in a nascent product launch phase.
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 Study of Fruquintinib in Adults With Metastatic Colorectal Cancer in Poland
Started Aug 2026
110 enrolled
Metastatic Colorectal Cancer
Sac-TMT Combined With Fruquintinib as Second-Line Treatment in Patients With Advanced Gastric/Gastroesophageal Junction Adenocarcinoma
Started Jul 2026
45 enrolled
Gastric AdenocarcinomaGastroesophageal Junction (GEJ) AdenocarcinomaGastro-esophageal Junction Adenocarcinoma
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
A Multicenter, Phase Ib/II Clinical Trial to Evaluate the Efficacy and Safety of Concurrent Combination Therapy of S-531011 Plus Fruquintinib or S-531011 Plus Fruquintinib Plus Pembrolizumab in Patients With MSS/pMMR Colorectal Cancer
Started May 2026
68 enrolled
Metastatic Colorectal NeoplasmsMicrosatellite Stable / Proficient Mismatch Repair Colorectal Cancer
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)
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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.