Data updated: Jun 28, 2026
REGORAFENIB · Teva
Oncology
Approved 2012-09-27
REGORAFENIB is FDA-approved to treat 3 conditions (same as STIVARGA).
Source: FDA Label
1
Indication
--
Phase 3 Trials
13
Years on Market
Details
- Status
- Prescription
- First Approved
- 2012-09-27
- Routes
- ORAL
- Dosage Forms
- TABLET
REGORAFENIB Approval History
2026
Original
New Indication
New Form
Label Update
2 FDA actions from 2025 to 2025
Jul 2025 SUPPL
Label · Labeling
What REGORAFENIB Treats
3 indicationsREGORAFENIB is approved for 3 conditions since its original approval in 2025. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Metastatic colorectal cancer
- Locally advanced, unresectable or metastatic gastrointestinal stromal tumor
- Hepatocellular carcinoma
Same approved indications as STIVARGA (same active ingredient).
Source: FDA Label
Teva's other novel FDA approvals
Other CDER-designated drugs from the same sponsor (2016–2025).
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Clinical Trial Registry
143 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT03970447 GBM AGILE | GCAR-7213 | Ph 2, Ph 3 | recruiting | A Trial to Evaluate Multiple Regimens in Newly Diagnosed and Recurrent Glioblastoma |
| NCT07567222 | 2025-2774 | Ph 1 | recruiting | Clinical Study of Novel Therapeutic Vaccine for Advanced Solid Tumors |
| NCT06902246 | 20230806 | Ph 2 | withdrawn | Regorafenib and Yttrium-90 Radioembolization for Unresectable Hepatocellular Carcinoma |
| NCT05198934 CodeBreak300 | 20190172 2024-511187-81-00 | Ph 3 | completed | Sotorasib and Panitumumab Versus Investigator's Choice for Participants With Kirsten Rat Sarcoma (KRAS) p.G12C Mutation |
| NCT04116541 MegaMOST | ET19-073 (MegaMOST) 2023-510567-35-00, 2019-001494-88 | Ph 2 | recruiting | A Study Evaluating the Activity of Anti-cancer Treatments Targeting Tumor Molecular Alterations/Characteristics in Advanced / Metastatic Tumors. |
| NCT07379047 GISTAR-1 | NB003-04 | Ph 2, Ph 3 | recruiting | Efficacy and Safety of NB003 in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) |
| NCT05394740 | EPOC2104 | Ph 1, Ph 2 | completed | Clinical Study of Regorafenib and Nivolumab Plus Chemotherapy |
| NCT02693535 TAPUR | Pro00014171 | Ph 2 | recruiting | TAPUR: Testing the Use of Food and Drug Administration (FDA) Approved Drugs That Target a Specific Abnormality in a Tumor Gene in People With Advanced Stage Cancer |
| NCT07495579 REVIVE | KCSG HB25-15 HB25-15 | Ph 2 | not yet recruiting | Lenvatinib or Regorafenib for Advanced Hepatocellular Carcinoma After Immunotherapy (REVIVE) |
| NCT05395741 Regbone | Regbone | Ph 1, Ph 2 | active not recruiting | Regorafenib in Patients With Refractory Primary Bone Tumors |
| NCT03793361 EREMISS | EREMISS-1801 PHRC-K18-158, 2018-001574-22 | Ph 2 | completed | Phase II Study of Regorafenib as Maintenance Therapy |
| NCT01900743 REGO-SARC | REGO-SARC-1214 2012-005743-24 | Ph 2 | completed | Phase II Study of Regorafenib in Metastatic Soft Tissue Sarcoma |
| NCT02386397 BREGO | ICM2013/09 | Ph 1, Ph 2 | completed | Activity of Regorafenib in Combination With Chemotherapy in Patients With Advanced Biliary Tract Cancer |
| NCT07137390 | 2025-0412 NCI-2025-06043 | Ph 1, Ph 2 | withdrawn | A Trial of Regorafenib Plus Lorigerlimab as Neoadjuvant Therapy for Patients With pMMR/MSS, Resectable, Lung-limited Metastatic Colorectal Cancer |
| NCT04327700 results posted | IRB00064732 WFBCCC 55319, P30CA012197 | Ph 2 | terminated | Study Of Intrabucally Administered Electromagnetic Fields and Regorafenib |
| NCT04757363 | 20-540 | Ph 2 | active not recruiting | A Study of Nivolumab Combined With FOLFOX and Regorafenib in People Who Have HER2-Negative Esophagogastric Cancer |
| NCT06047379 | NEO212-01 | Ph 1, Ph 2 | recruiting | Safety and Efficacy of NEO212 in Patients With Astrocytoma IDH-mutant, Glioblastoma IDH-wildtype or Brain Metastasis |
| NCT07223567 | 2025-0809 NCI-2025-08120 | Ph 2 | withdrawn | A Trial of Regorafenib Plus Lorigerlimab in Patients With Locally Recurrent or Regrowing pMMR/MSS Localized Rectal Cancer |
| NCT06820957 | AEWS2431 NCI-2025-00801, AEWS2431 | Ph 2, Ph 3 | active not recruiting | Testing a New Combination of Anti-cancer Drugs in Patients Newly Diagnosed With Ewing Sarcoma Who Have Cancer That Has Spread to Other Parts of the Body |
| NCT03712943 | MCC-19581 | Ph 1 | completed | Regorafenib and Nivolumab in Mismatch Repair (MMR) Refractory Colorectal Cancer |
| NCT05644379 | AK104-IIT-C-N1-0004 | Ph 1 | active not recruiting | A Study Evaluating Cadonilimab Injection in Combination With Regorafenib for the Advanced Hepatocellular Carcinoma |
| NCT07392866 | SHS006-II/III-01 | Ph 2, Ph 3 | not yet recruiting | A Clinical Study of SH006 Injection in Combination Therapy Versus Regorafenib in the Treatment of Advanced Hepatocellular Carcinoma |
| NCT04776148 results posted | 7902-017 MK-7902-017, LEAP-017 | Ph 3 | completed | Study of Lenvatinib (MK-7902/E7080) in Combination With Pembrolizumab (MK-3475) Versus Standard of Care in Participants With Metastatic Colorectal Cancer (MK-7902-017/E7080-G000-325/LEAP-017) |
| NCT04787341 PARERE | EUDRACT 2019-002834-35 | Ph 2 | active not recruiting | PAnitumumab REchallenge Followed by REgorafenib Versus the Reverse Sequence |
| NCT04362839 | 19417 NCI-2020-01818, 19417 | Ph 1 | completed | Regorafenib, Ipilimumab and Nivolumab for the Treatment of Chemotherapy Resistant Microsatellite Stable Metastatic Colorectal Cancer |
| NCT05672316 | 22351 NCI-2022-10069, 22351 | Ph 1, Ph 2 | active not recruiting | Botensilimab, Balstilimab and Regorafenib for the Treatment of Patients With Microsatellite Stable Metastatic Colorectal Cancer Who Have Progressed on Prior Chemotherapy |
| NCT04781192 | IIT-2020-RegoDurva | Ph 1, Ph 2 | active not recruiting | The Purpose of This Trial is to Determine if Regorafenib Plus Durvalumab (MEDI4736) is Safe and Effective in Treatment of Chemo Refractory Advanced Biliary Tract Cancers |
| NCT03994601 results posted | CA043-001 2021-004284-27 | Ph 1, Ph 2 | completed | An Investigational Immunotherapy Study of BMS-986288 Alone and in Combination With Nivolumab in Advanced Solid Cancers |
| NCT06087263 | 2023-0390 NCI-2023-08857 | Ph 2 | active not recruiting | Phase 2 Study to Evaluate the Efficacy of Regorafenib in Specific GIST Mutation Subsets (KIT Exon 17, 18, or 14 Mutation and SDHB Deficient GIST) in the Post-imatinib Second-line Setting. |
| NCT06006923 | HCC 23-041 | Ph 2 | terminated | Regorafenib in Combination With Pembrolizumab or Pembrolizumab for MSI-H Colorectal Cancer |
| NCT06095375 REGOMA-2 | IOV-GB-1-2021-REGOMA2 2021-001604-15 | Ph 1 | completed | Regorafenib With Temozolomide With or Without RT in MGMT-Methylated, IDH Wild-type GBM Patients |
| NCT03844620 | 2018-0233 NCI-2019-00246, 2018-0233 | Ph 2 | active not recruiting | Circulating Cell-Free Tumor DNA Testing in Guiding Treatment for Patients With Advanced or Metastatic Colorectal Cancer |
| NCT03042689 | 16-464 | Ph 1 | completed | Study of Regorafenib in Patients With Advanced Myeloid Malignancies |
| NCT06283134 | BJCT-CMU1H-02 | Ph 1 | not yet recruiting | A Clinical Study of BioTTT001 in Combination With Toripalimab and Regorafenib in Patients With Colorectal Cancer |
| NCT07300488 | MB07133-2025-01 | Ph 2, Ph 3 | active not recruiting | Efficacy and Safety of Pracytarabine Versus Regorafenib in the Treatment of Patients With Hepatocellular Carcinoma |
| NCT02955940 | INCB 18424-270 2023-507225-42-00 | Ph 2 | active not recruiting | An Open-Label Study to Enable Continued Treatment Access for Subjects Previously Enrolled in Studies of Ruxolitinib |
| NCT03377361 CheckMate 9N9 results posted | CA209-9N9 2017-001830-24 | Ph 1, Ph 2 | completed | An Investigational Immuno-therapy Study Of Nivolumab In Combination With Trametinib With Or Without Ipilimumab In Participants With Previously Treated Cancer of the Colon or Rectum That Has Spread |
| NCT05600309 results posted | 4280A-007 China Extension MK-4280A-007 China Extension, jRCT2031210482 | Ph 3 | completed | A Study of Coformulated Favezelimab/Pembrolizumab (MK-4280A) Versus Standard of Care in Subjects With Previously Treated Metastatic PD-L1 Positive Colorectal Cancer (MK-4280A-007)-China Extension Study |
| NCT03829462 NEXT-REGIRI results posted | PROICM 2018-01 NEX | Ph 3 | active not recruiting | Assessing a Regorafenib-irinotecan Combination Versus Regorafenib Alone in Metastatic Colorectal Cancer Patients |
| NCT06454409 | 23713 NCI-2024-04611, 23713 | Ph 1 | suspended | Regorafenib in Combination With Venetoclax and Azacitidine for the Treatment of Patients With Relapsed or Refractory Acute Myeloid Leukemia |
| NCT05425940 STELLAR-303 | XL092-303 2021-003243-21 | Ph 3 | active not recruiting | Study of XL092 + Atezolizumab vs Regorafenib in Participants With Metastatic Colorectal Cancer |
| NCT04660812 ARC-9 | ARC-9 2020-005386-13 | Ph 1, Ph 2 | completed | An Open Label Study Evaluating the Efficacy and Safety of Etrumadenant (AB928) Based Treatment Combinations in Participants With Metastatic Colorectal Cancer. |
| NCT05064059 results posted | 4280A-007 MK-4280A-007, jRCT2031210482 | Ph 3 | completed | A Study of Coformulated Favezelimab/Pembrolizumab (MK-4280A) Versus Standard of Care in Subjects With Previously Treated Metastatic PD-L1 Positive Colorectal Cancer (MK-4280A-007) |
| NCT02389244 REGOBONE | UC-0150/1309 2013-003910-42 | Ph 2 | active not recruiting | A Phase II Study Evaluating Efficacy and Safety of Regorafenib in Patients With Metastatic Bone Sarcomas |
| NCT02657551 results posted | 15-350 | Ph 2 | active not recruiting | A Study Using Regorafenib as Second or Third Line Therapy in Metastatic Medullary Thyroid Cancer |
| NCT02098538 results posted | 13-244 | Ph 2 | completed | Regorafenib in Patients With Progressive, Recurrent/Metastatic Adenoid Cystic Carcinoma |
| NCT05366816 | 20201368 | Ph 2 | recruiting | ctDNA-Guided Sunitinib And Regorafenib Therapy for GIST |
| NCT05194293 | ACCRU-GI-1920 NCI-2021-12021, ACCRU-GI-1920 | Ph 2 | active not recruiting | Regorafenib and Durvalumab for the Treatment of High-Risk Liver Cancer |
| NCT02023333 | 13-211 | Ph 2 | completed | Regorafenib in Good Performance Status Patients With Newly Diagnosed Metastatic Colorectal Adenocarcinoma |
| NCT07134205 | JMT101-017 | Ph 3 | not yet recruiting | The Study of JMT101 Combined With Irinotecan as a ≥3rd-Line Treatment in Metastatic Colorectal Cancer |
Showing 50 of 143 trials
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Pro Active Pipeline
Ongoing clinical trials by development phase
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Pro Key Completed Trials
Completed studies with published results, ranked by significance
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Trial Timeline
Full development history with FDA approval milestones
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Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
REGORAFENIB FDA Label Details
Indications & Usage
REGORAFENIB is FDA-approved to treat 3 conditions — same approved indications as STIVARGA.
Looking for the branded version?
STIVARGA
Full clinical data, patents, trials, and competitive landscape for regorafenib.
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.