Regorafenib clinical trials
Regorafenib is named as an intervention in 44 current clinical trials in our China, France, South Korea, Spain, Italy, Belgium, Australia, USA, Netherlands, Taiwan, Denmark, Switzerland, Portugal, Germany, Poland, Ireland, Sweden, Austria, Czechia, Norway, Israel, UK, Singapore, Japan and Canada registers. 25 are recruiting patients now. The most common phase is Phase 2. The sponsor with the most trials is Fudan University (3). The most-studied condition is Colorectal Cancer. The EU clinical trials register (CTIS) separately lists 2 authorised or ongoing trials.
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- 1 EU orphan designation, most recently for treatment of glioma (28 Jun 2019, withdrawn)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 8 Nov 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 (2026.3.1), 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.
Trials by status
Trials by phase
Clinical trials of Regorafenib
44 trialsRegisters list studies that are recruiting, about to open, active but closed to enrolment, or enrolling by invitation. The UK and USA registers cover industry-sponsored studies only. Trial titles and statuses are copied from the registry as published.
Regorafenib in the EU trials register (CTIS)
2 trialsAuthorised or ongoing trials in the EU Clinical Trials Information System that list a product containing Regorafenib. Many trials are registered in both CTIS and ClinicalTrials.gov, so these are shown separately rather than added to the count above. Trials with a site in Ireland are listed first.
| Study | Phase | Status | Sponsor | Countries |
|---|---|---|---|---|
|
Randomized study evaluating the impact of an innovative and cooperative pathway integrating oncogeriatric, pharmaceutical and pharmacological follow-up in elderly patients (>70 years old) presenting with cancer and treated with oral therapy _ POG
2025-523610-83-00 · Immune System Diseases
|
Phase 4 | Authorised | Institut Gustave Roussy | France |
|
The HCC patient-journey study: a prospective, adaptive, master protocol, to assess the value of the available sequences of treatment for patients with advanced hepatocellular carcinoma. The Journey of liver cancer patient - J-LI
2026-525898-39-00 · Neoplasms
|
Phase 3 | Authorised | Azienda Sanitaria Locale Napoli 1 Centro | Italy |
Regorafenib across our data
Ireland · EU · USThe same active substance in our other registers, matched by its exact name. Each entry links to the register record it comes from.
Licensed in Ireland (HPRA)
1 single-substance product containing Regorafenib on the HPRA medicines list.
- Stivarga 40 mg film-coated tabletsBayer Pharma AG · EU/1/13/858/001-002
Supply shortages
No entry for Regorafenib in the EMA, FDA or German BfArM shortage lists we track.
Conditions studied with Regorafenib
56 conditionsAll 56 conditions
| Condition (as registered) | Trials |
|---|---|
| Colorectal Cancer | 3 |
| Colorectal Cancer Metastatic | 3 |
| Hepatocellular Carcinoma (HCC) | 3 |
| GIST - Gastrointestinal Stromal Tumor | 2 |
| Hepatocellular Carcinoma | 2 |
| Metastatic Colorectal Cancer | 2 |
| Ewing Sarcoma | 2 |
| Carcinoma, Hepatocellular | 2 |
| Treatment Failure | 2 |
| Rhabdomyosarcoma | 1 |
| Diffuse Astrocytoma, IDH-Mutant | 1 |
| Glioblastoma, IDH-wildtype | 1 |
| Brain Metastases, Adult | 1 |
| Cervical Cancer | 1 |
| Pancreatic Cancer | 1 |
| Colorectal Cancer (CRC) | 1 |
| Breast Cancer | 1 |
| Lung Cancer | 1 |
| Solid Malignant Tumors | 1 |
| Advanced | 1 |
| Colorectal Cancer Liver Metastases | 1 |
| Regorafenib | 1 |
| KIT Gene Mutation | 1 |
| MCRC | 1 |
| Hepatocellular Carcinoma Non-resectable | 1 |
| Unresectable Advanced or Metastatic Colorectal Cancer | 1 |
| Digestive System Cancers | 1 |
| Colorectal Cancer Recurrent | 1 |
| Intrahepatic Cholangiocarcinoma (Icc) | 1 |
| HCC | 1 |
| HCC - Hepatocellular Carcinoma | 1 |
| Pancreatic Cancer Metastatic | 1 |
| Malignant Tumor | 1 |
| Hepato Cellular Carcinoma (HCC) | 1 |
| Metastatic Gastrointestinal Stromal Tumors (GIST) | 1 |
| Liver Metastases | 1 |
| Advanced Hepatocellular Carcinoma That Has Failed at Least One Prior Systemic Therapy | 1 |
| Glioblastoma | 1 |
| Metastatic Colorectal Cancer (mCRC) | 1 |
| Malignant Solid Tumor | 1 |
| Meningioma, Malignant | 1 |
| Cancer | 1 |
| Tumors | 1 |
| Neoplasm | 1 |
| Neoplasia | 1 |
| Rectal Cancer Stage II | 1 |
| Rectal Cancer Stage III | 1 |
| Melanoma Stage III | 1 |
| Melanoma Stage IV | 1 |
| Hepatic Insufficien | 1 |
| Disease Progression | 1 |
| Lenvatinib | 1 |
| Colorectal Cancer; Lung Cancer | 1 |
| Bone Sarcoma | 1 |
| Osteosarcoma | 1 |
| Chondrosarcoma | 1 |
Sponsors
lead sponsor per trial| Lead sponsor | Trials |
|---|---|
| Fudan University | 3 |
| Centre Hospitalier Universitaire de Besancon | 2 |
| Centre Leon Berard | 2 |
| Ju Hyun Shim | 2 |
| University of Birmingham | 1 |
| Exelixis | 1 |
| Neonc Technologies, Inc | 1 |
| Incyte Corporation | 1 |
| Bayer | 1 |
| Ningbo Newbay Technology Development Co., Ltd | 1 |
| Chinese PLA General Hospital | 1 |
| Sun Yat-sen University | 1 |
| Jian Li | 1 |
| Beijing Friendship Hospital | 1 |
| Ze-yang Ding, MD | 1 |
+ 24 more sponsors in the trial list above.
By country register
A trial with sites in more than one country appears in each of those registers. CTIS does not publish a recruiting flag; its trials may also appear in the registers above.
Related compounds
Questions about Regorafenib trials
How many clinical trials are testing Regorafenib?
44 current trials in our China, France, South Korea, Spain, Italy, Belgium, Australia, USA, Netherlands, Taiwan, Denmark, Switzerland, Portugal, Germany, Poland, Ireland, Sweden, Austria, Czechia, Norway, Israel, UK, Singapore, Japan and Canada registers name Regorafenib (also registered as Stivarga, BAY73-4506) as a drug or biological intervention, as of the registry sync on 9 November 2026. Completed and withdrawn studies are not counted.
Are Regorafenib trials recruiting patients?
Yes. 25 of the 44 trials are recruiting: 16 with sites in China, 5 with sites in France, 1 with sites in South Korea, 1 with sites in Spain, 3 with sites in Italy, 1 with sites in Belgium, 2 with sites in Australia, 2 with sites in USA, 2 with sites in Netherlands, 1 with sites in Taiwan, 1 with sites in Denmark, 2 with sites in Switzerland, 1 with sites in Portugal, 1 with sites in Germany, 1 with sites in Ireland, 1 with sites in Sweden, 1 with sites in Austria, 1 with sites in Czechia, 1 with sites in Norway, 1 with sites in Israel and 1 with sites in Canada. Eligibility and site contacts are on each trial's record. Only the study team can confirm whether a patient is eligible.
Who sponsors Regorafenib clinical trials?
Fudan University (3), Centre Hospitalier Universitaire de Besancon (2), Centre Leon Berard (2) and Ju Hyun Shim (2), among 39 lead sponsors in total. The number in brackets is how many trials each organisation leads.
Are there Regorafenib clinical trials in Ireland?
Yes. 1 trial in our Ireland register (ClinicalTrials.gov). Some may be the same study registered in both. See the Irish clinical trials register for sites and contacts.
Is Regorafenib licensed in Ireland?
Yes. The HPRA medicines list includes 1 single-substance product containing Regorafenib, for example Stivarga 40 mg film-coated tablets (Bayer Pharma AG). A licence does not mean a product is currently marketed or reimbursed; see each product's record.
Is there a Regorafenib shortage?
Not in the lists we track: Regorafenib has no entry in the EMA, FDA or German BfArM shortage registers as of their latest sync.
Where does this information come from?
Every trial, status, phase and sponsor on this page is copied from public ClinicalTrials.gov records by a daily sync. Nothing here describes how Regorafenib works or whether it is effective, and it is not medical advice.
How this page is built
Everything on this page is copied from public ClinicalTrials.gov registry records — it is not written from memory, and nothing here describes how Regorafenib works or whether it is effective. Each trial links to its own record so you can check it yourself.
- ClinicalTrials.gov (U.S. National Library of Medicine) ↗ Trial IDs, titles, intervention names and synonyms, phase, overall status, lead sponsor and conditions for every trial on this page
This page is built automatically: a daily sync job reads the registry records behind our country trial registers, collects every trial that lists Regorafenib (or a registered synonym) as a drug or biological intervention, and tabulates the registry fields directly. Placebos and generic comparators are excluded. There is no AI drafting and no per-compound editorial pass, and the page has not been clinically reviewed. The “last verified” date above is the timestamp of that sync, not a review date. Our general editorial approach is described in our editorial standards and corrections policy. The ClinicalTrials.gov data on this page was last retrieved on 9 Nov 2026. How every register is built: methodology · fixes we have made: corrections log.