Last reviewed 2026-04-20 · How we verify

Truseltiq (INFIGRATINIB)

Truseltiq (INFIGRATINIB) is a small molecule drug developed by QED Therapeutics and currently owned by Helsinn Healthcare. It targets fibroblast growth factor receptor 2 (FGFR2) and is approved by the FDA for the treatment of unresectable locally advanced or metastatic cholangiocarcinoma with FGFR2 fusion. Truseltiq is a patented medication with no generic manufacturers available. The safety considerations for Truseltiq include its potential side effects, which may include hepatotoxicity and gastrointestinal disorders. Truseltiq was approved in 2019.

At a glance

Approved indications

• Unresectable locally advanced or metastatic cholangiocarcinoma with FGFR2 fusion

Common side effects

No common side effects on file.

Key clinical trials

• A Study to Evaluate the Efficacy and Safety of Infigratinib in Children and Adolescents With Achondroplasia (PHASE3)
• Infigratinib for the Treatment of Advanced or Metastatic Solid Tumors in Patients With FGFR Gene Mutations (PHASE2)
• Interventional Study of Infigratinib in Children < 3 Years Old With Achondroplasia (ACH) (PHASE2)
• Study of Infigratinib in Combination With Tamoxifen in Hormone Receptor Positive, HER2 Negative, FGFR Altered Advanced Breast Cancer (PHASE1)
• BGJ398 in Non-Muscle-Invasive Urothelial Carcinoma of the Bladder (NA)
• Open-Label, Long-Term, Extension Study of Infigratinib in Children With Hypochondroplasia (PHASE2)
• An Interventional Study of Infigratinib in Children With Hypochondroplasia (PHASE2,PHASE3)
• Extension Study of Infigratinib in Children With Achondroplasia (ACH) (PHASE2)

Patents

Primary sources

Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.