SORAFENIB TOSYLATE
Sorafenib tosylate helps patients with several types of advanced cancers, specifically those affecting the liver, kidneys, and thyroid. It is used for liver cancer that cannot be surgically removed and for kidney cancer that has reached an advanced stage. Additionally, it treats thyroid cancer that has spread or returned and no longer responds to radioactive iodine therapy.
How SORAFENIB TOSYLATE Works
This medication works by inhibiting multiple kinases both inside the cell and on the cell surface, which are involved in tumor growth and blood vessel formation. By targeting these specific proteins, the drug helps decrease the proliferation of cancer cells and reduces the blood supply to the tumor. This process also triggers apoptosis, or programmed cell death, within the tumor.
Development Insights
Details
- Status
- Prescription
- First Approved
- 2020-09-10
- Routes
- ORAL
- Dosage Forms
- TABLET
SORAFENIB TOSYLATE Approval History
What SORAFENIB TOSYLATE Treats
3 indicationsSORAFENIB TOSYLATE is approved for 3 conditions since its original approval in 2020. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Hepatocellular Carcinoma
- Renal Cell Carcinoma
- Thyroid Carcinoma
SORAFENIB TOSYLATE Target & Pathway
ProTarget
Receptors on blood vessel cells that respond to VEGF signals to form new blood vessels. Cancer cells exploit this pathway to ensure blood supply for tumor growth. Blocking VEGFRs prevents tumor angiogenesis and limits cancer progression.
Pathway Context
VEGFR on blood vessels is activated by VEGF to promote angiogenesis
A signaling protein that stimulates the formation of new blood vessels (angiogenesis). Tumors need blood supply to grow, so they secrete VEGF to create new vessels. Blocking VEGF starves tumors of oxygen and nutrients, inhibiting their growth.
SORAFENIB TOSYLATE Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Direct competitors
Same target(s) AND same indication — head-to-head.
MoA expansion candidates
Same target(s), different indications — where else is this mechanism being explored?
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
What's emerging in SORAFENIB TOSYLATE's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications SORAFENIB TOSYLATE treats. First-in-class if their pivotal trials read out positive.
Drugs Similar to SORAFENIB TOSYLATE
3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
279 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT03017326 PHITT | RG_15-114 | Ph 3 | active not recruiting | Paediatric Hepatic International Tumour Trial |
| NCT01840592 | 12-259 | Ph 2 | active not recruiting | Sorafenib Plus Doxorubicin in Patients With Advanced Hepatocellular Carcinoma With Disease Progression on Sorafenib |
| NCT02559778 PEDS-PLAN | NMTRC012 | Ph 2 | recruiting | Pediatric Precision Laboratory Advanced Neuroblastoma Therapy |
| NCT01871766 | RMS13 NCI-2013-00913 | Ph 2 | active not recruiting | Risk-Adapted Focal Proton Beam Radiation and/or Surgery in Patients With Low, Intermediate and High Risk Rhabdomyosarcoma Receiving Standard or Intensified Chemotherapy |
| NCT03164057 | AML16 NCI-2017-00928 | Ph 2 | active not recruiting | A Trial of Epigenetic Priming in Patients With Newly Diagnosed Acute Myeloid Leukemia |
| NCT01187199 | 2010-0486 NCI-2012-01788 | Ph 1 | active not recruiting | Phase I Trial of Bevacizumab and Temsirolimus in Combination With 1) Carboplatin, 2) Paclitaxel, 3) Sorafenib for the Treatment of Advanced Cancer |
| NCT03132454 | 2016-0772 NCI-2018-01194, 2016-0772 | Ph 1 | active not recruiting | Palbociclib and Sorafenib, Decitabine, or Dexamethasone in Treating Patients With Recurrent or Refractory Leukemia |
| NCT01303341 | NCI-2011-02597 NCI-2011-02597, CDR0000695355 | Ph 1 | active not recruiting | Riluzole and Sorafenib Tosylate in Treating Patients With Advanced Solid Tumors or Melanoma |
| NCT01861314 | NCI-2013-00999 NCI-2013-00999, OSU-11186 | Ph 1 | active not recruiting | Bortezomib, Sorafenib Tosylate, and Decitabine in Treating Patients With Acute Myeloid Leukemia |
| NCT04039607 CheckMate 9DW | CA209-9DW | Ph 3 | active not recruiting | A Study of Nivolumab in Combination With Ipilimumab in Participants With Advanced Hepatocellular Carcinoma |
| NCT05068752 results posted | HRI-Vemurafenib-Sorafenib-001 | Ph 2 | completed | Phase II Trial of Vemurafenib and Sorafenib in Pancreatic Cancer |
| NCT02298348 N2013-02 | NANT 2013-02 | Ph 1 | active not recruiting | Sorafenib and Cyclophosphamide/Topotecan in Patients With Relapsed and Refractory Neuroblastoma |
| NCT07463651 TROPHY-15 | TROPHY-15 2025D0545700 | Ph 3 | recruiting | MRD-guided Maintenance Post-HCT: Gilteritini vs Sorafenib |
| NCT03298451 HIMALAYA results posted | D419CC00002 2024-512212-21-00, 2016-005126-11 | Ph 3 | active not recruiting | Study of Durvalumab and Tremelimumab as First-line Treatment in Patients With Advanced Hepatocellular Carcinoma |
| NCT04720716 | CIBI310C301 | Ph 3 | completed | A Study to Compare the Effectiveness and Safety of IBI310 Combined With Sintilimab Versus Sorafenib in the First-line Treatment of Advanced HCC |
| NCT05468359 | ANGIO-A | Ph 1, Ph 2 | recruiting | Safety and Efficacy of Cyclophosphamide, Sorafenib, Bevacizumab, and Atezolizumab in Pediatric Solid Tumor Patients |
| NCT00939627 results posted | NCI-2012-02847 NCI-2012-02847, MCC-15780 | Ph 2 | completed | Phase II Randomized Trial of the Combination of Cetuximab and Sorafenib or Single Agent Cetuximab |
| NCT01946529 results posted | ESFT13 NCI-2013-01657 | Ph 2 | active not recruiting | Therapeutic Trial for Patients With Ewing Sarcoma Family of Tumor and Desmoplastic Small Round Cell Tumors |
| NCT05669339 | UF-GI-015 OCR43006, IRB202300226 | Ph 2 | recruiting | AD HOC Trial: Artificial Intelligence-Based Drug Dosing In Hepatocellular Carcinoma |
| NCT04770896 IMbrave251 | MO42541 | Ph 3 | active not recruiting | A Study of Atezolizumab With Lenvatinib or Sorafenib Versus Lenvatinib or Sorafenib Alone in Hepatocellular Carcinoma Previously Treated With Atezolizumab and Bevacizumab |
| NCT06227221 | 2023ZLNL001 | Ph 2 | not yet recruiting | Efficacy and Safety of Sorafenib in New-Onset Type 1 Diabetes Mellitus |
| NCT02143726 results posted | A091302 U10CA180821, NCI-2014-00623 | Ph 2 | active not recruiting | Sorafenib Tosylate With or Without Everolimus in Treating Patients With Advanced, Radioactive Iodine Refractory Hurthle Cell Thyroid Cancer |
| NCT01903694 | JOUVE PHRC K 2009 | Ph 3 | completed | Randomized Trial Sorafenib-Pravastatin Versus Sorafenib Alone for the Palliative Treatment of Child-Pugh A Hepatocellular Carcinoma |
| NCT03211416 results posted | I 35316 NCI-2017-01114, I 35316 | Ph 1, Ph 2 | completed | Sorafenib Tosylate and Pembrolizumab in Treating Patients With Advanced or Metastatic Liver Cancer |
| NCT01730937 results posted | RTOG-1112 NCI-2012-02057, U10CA021661 | Ph 3 | completed | Sorafenib Tosylate With or Without Stereotactic Body Radiation Therapy in Treating Patients With Liver Cancer |
| NCT00826540 results posted | NCCTG-N054C NCI-2009-01177, U10CA025224 | Ph 2 | completed | Sorafenib and Bevacizumab in Treating Patients With Metastatic Colorectal Cancer |
| NCT05117957 | SOPT study 2021 | Ph 2 | completed | Efficacy and Safety of Sorafenib in Previously Treated Advanced Hepatocellular Carcinoma: SOPT Study |
| NCT01658878 CheckMate040 results posted | CA209-040 2012-001514-42 | Ph 1, Ph 2 | completed | An Immuno-therapy Study to Evaluate the Effectiveness, Safety and Tolerability of Nivolumab or Nivolumab in Combination With Other Agents in Patients With Advanced Liver Cancer |
| NCT03533582 | AHEP1531 NCI-2017-01910, AHEP1531 | Ph 3 | active not recruiting | Cisplatin and Combination Chemotherapy in Treating Children and Young Adults With Hepatoblastoma or Liver Cancer After Surgery |
| NCT03247088 | 2016-0592 NCI-2018-01607, 2016-0592 | Ph 1, Ph 2 | active not recruiting | Sorafenib, Busulfan and Fludarabine in Treating Patients With Recurrent or Refractory Acute Myeloid Leukemia Undergoing Donor Stem Cell Transplant |
| NCT03755791 COSMIC-312 results posted | XL184-312 2024-516479-34-00 | Ph 3 | active not recruiting | Study of Cabozantinib in Combination With Atezolizumab Versus Sorafenib in Participants With Advanced Hepatocellular Carcinoma (HCC) Who Have Not Received Previous Systemic Anticancer Therapy |
| NCT01371981 results posted | NCI-2011-02670 NCI-2011-02670, CDR0000701850 | Ph 3 | active not recruiting | Bortezomib and Sorafenib Tosylate in Treating Patients With Newly Diagnosed Acute Myeloid Leukemia |
| NCT05033522 ALIVE | MBI-003-LIVE | Ph 2, Ph 3 | suspended | Immunotherapy for Advanced Liver Cancer |
| NCT03412773 results posted | BGB-A317-301 2017-002423-19, CTR20170882 | Ph 3 | completed | A Study of Tislelizumab Versus Sorafenib in Participants With Unresectable Hepatocellular Carcinoma (HCC) |
| NCT05822752 LIVIGNO-1 | M24-147 2022-502948-13-00 | Ph 2 | active not recruiting | Study to Evaluate Adverse Events, and Change in Disease Activity, When Intravenously (IV) Infused With Livmoniplimab in Combination With IV Infused Budigalimab in Adult Participants With Hepatocellular Carcinoma (HCC) |
| NCT06474663 | 2024-0302 NCI-2024-05386 | Ph 1 | withdrawn | A Phase I Study Investigating the Combination of Cladribine, Low Dose Cytarabine and Sorafenib Alternating With Decitabine in Pediatric Relapsed and Refractory Acute Leukemias |
| NCT01754987 results posted | 12D.424 JT 2306 | Ph 1, Ph 2 | completed | A Study of Vitamin C in the Treatment of Liver Cancer to Determine if it is Safe and Effective |
| NCT00639262 | 07P.381 2006-58, JT 1208 | Ph 1 | completed | Combination of Sorafenib and Radiation for Brain Metastases and Primary Brain Tumors |
| NCT03899428 | VICI-5 | Ph 2 | recruiting | Immune Checkpoint Therapy vs Target Therapy in Reducing Serum HBsAg Levels in Patients With HBsAg+ Advanced Stage HCC |
| NCT04710641 OUTREACH2 | MNA-3521-014-RNDZ | Ph 2 | completed | Radomised Phase II Study of MTL-CEBPA Plus Sorafenib or Sorafenib Alone |
| NCT04709380 | NCC2509 | Ph 3 | terminated | Phase III RCT of Radiotherapy Plus Toripalimab Versus Sorafenib in Advanced Hepatocellular Carcinoma With PVTT |
| NCT02576509 results posted | CA209-459 | Ph 3 | completed | An Investigational Immuno-therapy Study of Nivolumab Compared to Sorafenib as a First Treatment in Patients With Advanced Hepatocellular Carcinoma |
| NCT03439891 results posted | 174523 NCI-2018-00051 | Ph 2 | completed | Sorafenib and Nivolumab in Treating Participants With Unresectable, Locally Advanced or Metastatic Liver Cancer |
| NCT06482086 | 202314711 | Ph 2 | recruiting | Efficacy of Organoid-Based Drug Screening to Guide Treatment for Locally Advanced Thyroid Cancer |
| NCT03009461 | MPVTT | Ph 2 | completed | Sorafenib Plus Hepatic Arterial Infusion Versus Sorafenib for HCC with Major Portal Vein Tumor Thrombosis |
| NCT02143401 | NCI-2014-01043 NCI-2014-01043, MC1315 | Ph 1 | completed | Navitoclax and Sorafenib Tosylate in Treating Patients With Relapsed or Refractory Solid Tumors |
| NCT06690697 | 2411091-1 | Ph 2 | recruiting | Combination of Toripalimab and JS004 Therapy for ccRCC |
| NCT03606590 | EF-30 | Ph 2 | completed | Effect of Tumor Treating Fields (TTFields, 150kHz) Concomitant with Sorafenib for Advanced Hepatocellular Carcinoma (HCC) (HEPANOVA) |
| NCT05594095 | BCTOP-L-M05 | Ph 2 | recruiting | SNF Platform Study of HR+/ HER2-advanced Breast Cancer |
| NCT01906216 SELECT | XHDD-001 | Ph 3 | completed | Sorafenib Chemoembolization Evaluation Controlled Trial |
Showing 50 of 279 trials
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
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.
SORAFENIB TOSYLATE FDA Label Details
Indications & Usage
SORAFENIB TOSYLATE is indicated for the treatment of Hepatocellular Carcinoma; Renal Cell Carcinoma; Thyroid Carcinoma.
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NEXAVAR
Full clinical data, patents, trials, and competitive landscape for sorafenib tosylate.
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment