Drug · Small Molecule
Fruquintinib
CI-DRUG-00000763Explore in graph →CHEMBL4303214 Approved
Regulatory
Approvals (4)
Each record names the authority, jurisdiction, indication text and status. A drug approved in one jurisdiction for one indication is not 'approved' in general.
- Source
- EMA — European public assessment reports (centrally authorised medicines)
- Dataset
- EMA medicines data (xlsx)
- Version
- ema-medicines-2026-09-30T06:01
- Retrieved
- Sep 30, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Evidence
- regulatory
- License
- EMA copyright — reproduction and distribution permitted for non-commercial and commercial purposes provided EMA is acknowledged as the source (https://www.ema.europa.eu/en/about-us/legal-notice)
- Run
- ING-EMA-20260930-000001
| Jurisdiction · authority | Cancer | Indication | Status | Approval date | Source |
|---|---|---|---|---|---|
| EU EMA | Malignant Colorectal Neoplasm | 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. | approved | Jun 20, 2024 | ema |
Health Canada records are DIN-level: one row per marketed product (brand, strength, form). The Drug Product Database does not publish indications, so no cancer is stated for these rows, and a cancelled or dormant DIN is the status of that one product — not a withdrawal of the molecule.
Data updated 11 hours agoSource updated unknown
Derived
Development pipeline
Most advanced stage across all cancers, then per top-level cancer reached through trial conditions or approval indications. Approval in any ingested jurisdiction outranks trial phase; counts are interventional studies.
| Scope | Stage | Max phase | Active | Recruiting | Phase 3 | Trials | Approvals | Jurisdictions | First approval | First trial |
|---|---|---|---|---|---|---|---|---|---|---|
| All cancers | Approved | Phase 4 | 43 | 25 | 11 | 83 | 4 | CA, EU, US | Nov 8, 2023 | 2011-01 |
| Malignant Gastric Neoplasm | Phase3 | Phase 3 | 4 | 1 | 1 | 5 | 0 | — | — | 2022-12 |
| Malignant Colon Neoplasm | Phase3 | Phase 3 | 3 | 1 | 1 | 5 | 0 | — | — | Dec 11, 2017 |
| Malignant Uterine Corpus Neoplasm | Phase3 | Phase 3 | 2 | 1 | 1 | 3 | 0 |
Curated evidence
Clinical evidence (0)
CIViC items in which this therapy appears, grouped by cancer context, then molecular profile. 50 items per page.
Data not yet available
Clinical trials
Trials with this intervention (89)
Most recently updated first, 50 per page.
- Source
- ClinicalTrials.gov
- Dataset
- ClinicalTrials.gov API v2 studies
- Retrieved
- Sep 15, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
| NCT | Title | Status | Phase | Enrollment (n) | Sponsor | Countries | Last update | Source |
|---|---|---|---|---|---|---|---|---|
| NCT07819019 | A Phase II Study of Irinotecan Liposome Plus Fruquintinib and Sintilimab in Second-Line PD-L1-Positive Advanced Gastric Cancer | not yet recruiting | Phase 2 | 20 | Cancer Hospital Chinese Academy of Medical Science, Shenzhen CenterOTHER | 0 | Sep 14, 2026 | clinicaltrials |
| NCT07791758 | A Clinical Trial of LBL-024 Combination Drug in Patients With Metastatic Colorectal Carcinoma |