US FDA United States — FDA approvals (Drugs@FDA)
| Product | Strength | Form · route | Applicant | Status | First approved |
|---|
| FRUZAQLA | 1MG; 5MG | capsule · oral | TAKEDA PHARMS USA | Prescription | 8 Nov 2023 |
EMA European Union — centrally authorised medicines
Fruzaqla Takeda Pharmaceuticals International AG Ireland · Authorised · authorised 20 Jun 2024 · ATC L01EK
Therapeutic indication (EMA)
Fruzaqla as monotherapy is indicated for the treatment of adult patients with metastatic colorectal cancer (mCRC) who have been previously treated with available standard therapies, including fluoropyrimidine-, oxaliplatin-, and irinotecan based chemotherapies, anti VEGF agents, and anti EGFR agents, and who have progressed on or are intolerant to treatment with either trifluridine tipiracil or regorafenib.
Canada Canada — marketed products (Health Canada)
| Brand | DIN | Strength | Form · route | Company |
|---|
| FRUZAQLA | 02551454 | 1 MG | CAPSULE · ORAL | TAKEDA CANADA INC |
| FRUZAQLA | 02551462 | 5 MG | CAPSULE · ORAL | TAKEDA CANADA INC |
Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.