Stivarga
An oral targeted therapy used to treat advanced colorectal, liver, and gastrointestinal cancers.
Where Regorafenib is approved
All regulators →Of the three regulators tracked here, the first to approve Regorafenib was the US, on 27 Sep 2012. It is approved in 3 of the 3 regulators tracked here.
- 1 EU orphan designation, most recently for treatment of glioma (28 Jun 2019, withdrawn)
From the regulators' own registers: FDA Drugs@FDA, the EMA medicines list and Health Canada's Notice of Compliance database. Dates are the first listed approval of a product containing only this substance; combination products and nationally authorised EU medicines are not counted.
Regorafenib patents and exclusivity
Expiry tracker →Protections still running for marketed products containing Regorafenib, as listed by the regulators. Expired patents and exclusivities, and discontinued products, are not shown.
- 4 listed patents; the last listed expires 9 Jul 2032 (US 9957232).
- Latest patent on the drug substance itself: 9 Jul 2032 (US 9957232).
Reproduced from the FDA Orange Book and Purple Book (checked 12 Oct 2026) and the European Commission's Union Register of medicinal products (CC BY 4.0; the EU expiry date is calculated exactly as the Commission's register displays it). Listed patents and dates are as submitted to or published by the regulator and may not reflect litigation, invalidation, settlements, lapsed fees or later extensions. This is not legal advice or a freedom-to-operate opinion, and it does not say when a generic or biosimilar will launch.
What health systems spend on Regorafenib
All medicines →From NHSBSA Prescription Cost Analysis (Open Government Licence v3.0) and CMS State Drug Utilization Data. Both are gross amounts: neither system publishes its discounts or rebates per drug. Products combining several substances are not counted here.
How Regorafenib works
All drug targets →- Tyrosine-protein kinase ABL inhibitor InhibitorTarget: ABL1 ABL proto-oncogene 1, non-receptor tyrosine kinaseChEMBL only
- Serine/threonine-protein kinase RAF inhibitor InhibitorTarget: RAF1 Raf-1 proto-oncogene, serine/threonine kinaseChEMBL only
- Stem cell growth factor receptor inhibitor InhibitorTarget: KIT KIT proto-oncogene, receptor tyrosine kinaseChEMBL only
- Fibroblast growth factor receptor 1 inhibitor InhibitorTarget: FGFR1 fibroblast growth factor receptor 1ChEMBL only
- MAP kinase p38 beta inhibitor InhibitorTarget: MAPK11 mitogen-activated protein kinase 11ChEMBL only
- Fibroblast growth factor receptor 2 inhibitor InhibitorTarget: FGFR2 fibroblast growth factor receptor 2ChEMBL only
- Tyrosine-protein kinase FRK inhibitor InhibitorTarget: FRK fyn related Src family tyrosine kinaseChEMBL only
- Discoidin domain-containing receptor 2 inhibitor InhibitorTarget: DDR2 discoidin domain receptor tyrosine kinase 2ChEMBL only
- Serine/threonine-protein kinase B-raf inhibitor InhibitorTarget: BRAF B-Raf proto-oncogene, serine/threonine kinase✓ In ChEMBL and the Guide to Pharmacology
- Tyrosine-protein kinase TIE-2 inhibitor InhibitorTarget: TEK TEK receptor tyrosine kinaseChEMBL only
- Platelet-derived growth factor receptor inhibitor InhibitorTarget: Platelet-derived growth factor receptorChEMBL only
- Vascular endothelial growth factor receptor inhibitor InhibitorTarget: Vascular endothelial growth factor receptor✓ In ChEMBL and the Guide to Pharmacology
- Tyrosine-protein kinase receptor RET inhibitor InhibitorTarget: RET ret proto-oncogeneChEMBL only
- Ephrin type-A receptor 2 inhibitor InhibitorTarget: EPHA2 EPH receptor A2ChEMBL only
- Nerve growth factor receptor Trk-A inhibitor InhibitorTarget: NTRK1 neurotrophic receptor tyrosine kinase 1ChEMBL only
- Colon carcinomaPhase 3
- Esophageal cancerPhase 3
- Gastrointestinal stromal tumorPhase 3
- Hepatocellular carcinomaPhase 3
- Liver cancerPhase 3
- Malignant colon neoplasmPhase 3
- Ewing sarcomaPhase 2/3
- Colorectal carcinomaPhase 2/3
- GlioblastomaPhase 2/3
- Klatskin's tumorPhase 2
Mechanisms and diseases from ChEMBL via the Open Targets Platform (release 26.09), ChEMBL record CHEMBL1946170, CC BY-SA 3.0. Targets checked against the IUPHAR/BPS Guide to PHARMACOLOGY (2026.3), ligand 5891, CC BY-SA 4.0. Trial phases are not approvals: approved uses are shown from the regulators' own records where we hold them.
NICE appraisals of Regorafenib
All NICE appraisals →NICE, which decides whether the NHS in England should fund new medicines, has published 5 technology appraisals of Regorafenib. 5 are current, and 3 of these recommend it for at least some patients.
| Appraisal | NICE recommendation | Published | Status |
|---|---|---|---|
| Regorafenib for previously treated metastatic colorectal cancer NICE TA866 | Recommended | 8 Feb 2023 | Current |
| Regorafenib for previously treated advanced hepatocellular carcinoma NICE TA555 | Optimised | 9 Jan 2019 | Current |
| Regorafenib for previously treated advanced hepatocellular carcinoma NICE TA514 | Not recommended | 21 Mar 2018 | Current |
| Regorafenib for previously treated unresectable or metastatic gastrointestinal stromal tumours NICE TA488 | Optimised | 15 Nov 2017 | Current |
| Regorafenib for metastatic colorectal cancer after treatment for metastatic disease (terminated appraisal) NICE TA334 | Terminated (no company submission) | 25 Feb 2015 | Current |
NICE decisions apply to the NHS in England. In Ireland the HSE decides on reimbursement, advised by the National Centre for Pharmacoeconomics. Titles, categories and dates link to the guidance on nice.org.uk. © NICE 2026 technology appraisal guidance. Available from www.nice.org.uk/guidance. All rights reserved. Subject to Notice of rights. NICE guidance is prepared for the National Health Service in England. All NICE guidance is subject to regular review and may be updated or withdrawn. NICE accepts no responsibility for the use of its content in this product/publication.
Patient leaflets for Regorafenib
The package leaflet is the official guide for patients that comes with every medicine. These links go to the regulators that publish it.
- IEIreland: 1 product on the HPRA listEach product record links to the HPRA, which publishes the leaflet and SmPC.
- EUEuropean Union: StivargaEMA product information: package leaflet and summary of product characteristics in every EU language.
- UKUnited Kingdom: Search MHRA ProductsPatient information leaflets and SmPCs for UK-licensed products.
- USUnited States: Search DailyMedFDA-approved labels, including patient and medication guides.
Leaflets differ between brands and countries; always read the one that comes with your own medicine. This is regulatory information, not medical advice.
Reference identifiers for Regorafenib
- ATC code
- L01XE21
- ChEMBL
- CHEMBL1946170
- DrugBank
- DB08896
- PubChem CID
- 11167602
- CAS number
- 755037-03-7
- FDA UNII
- 24T2A1DOYB
- Wikidata
- Q3891664
- Wikipedia
- Regorafenib
Codes that identify this medicine in other databases, from Wikidata (CC0), matched by its ChEMBL ID. The ATC code is the WHO classification of what the medicine is used for.
What Stivarga is used for
STIVARGA is a kinase inhibitor indicated for the treatment of adult patients with: • Metastatic colorectal cancer (CRC) who have been previously treated with fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy, an anti-VEGF therapy, and, if RAS wild-type, an anti-EGFR therapy. ( 1.1 ) • Locally advanced, unresectable or metastatic gastrointestinal stromal tumor (GIST) who have been previously treated with imatinib mesylate and sunitinib malate. ( 1.2 ) • Hepatocellular carcinoma (HCC) who have been previously treated with sorafenib ( 1.3 ) 1.1 Colorectal Cancer STIVARGA is indicated for the treatment of adult patients with metastatic colorectal cancer (CRC) who have been previously treated with fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy, an anti-VEGF therapy, and, if RAS wild-type, an anti-EGFR therapy. 1.2 Gastrointestinal Stromal Tumors STIVARGA is…
How it works
12.1 Mechanism of Action Regorafenib is a small molecule inhibitor of multiple membrane-bound and intracellular kinases involved in normal cellular functions and in pathologic processes such as oncogenesis, tumor angiogenesis, metastasis and tumor immunity. In in vitro biochemical or cellular assays, regorafenib or its major human active metabolites M-2 and M-5 inhibited the activity of RET, VEGFR1, VEGFR2, VEGFR3, KIT, PDGFR-alpha, PDGFR-beta, FGFR1, FGFR2, TIE2, DDR2, TrkA, Eph2A, RAF-1, BRAF, BRAF V600E, SAPK2, PTK5, Abl and CSF1R at concentrations of regorafenib that have been achieved clinically. In in vivo models, regorafenib demonstrated anti-angiogenic activity in a rat tumor model …
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How this page is built
The facts on this page are pulled directly from official U.S. FDA datasets — they are not written from memory. Each field below names the dataset it came from, so you can check it yourself.
- FDA Drug Label (openFDA) ↗ Indications, mechanism of action and pharmacologic class
- Drugs@FDA ↗ First FDA approval date and the company holding the application
- FDA Drug Shortage Database ↗ Current US supply / shortage status
Plain-English summaries and drug-class explainers are written and reviewed by Sreepriya Prasannan (MSc Digital Transformation of Life Sciences (Innopharma Education / Griffith College); MSc & BSc Botany). Data is retrieved automatically from the sources above and cross-checked with AI-assisted verification (Anthropic's Claude) — brand and generic names are matched against the exact FDA product record so that a combination product or a different formulation cannot be mistaken for the drug on this page. An editor reviews the result before publication. We describe this in full in our editorial standards and corrections policy. The FDA data on this page was last retrieved on 6 Oct 2026. How every register is built: methodology · fixes we have made: corrections log.