NEXAVAR (sorafenib tosylate)
NEXAVAR is indicated for the treatment of Unresectable hepatocellular carcinoma; Advanced renal cell carcinoma; Locally recurrent or metastatic, progressive, differentiated thyroid carcinoma refractory to radioactive iodine treatment.
How NEXAVAR Works
Sorafenib acts by inhibiting multiple intracellular and cell surface kinases, including RAF, VEGFR, and PDGFR. These kinases are involved in critical biological processes such as tumor cell signaling, the development of new blood vessels, and programmed cell death. By blocking these targets, the drug decreases tumor cell proliferation and reduces tumor angiogenesis to inhibit cancer growth.
Development Insights
Details
- Status
- Prescription
- First Approved
- 2005-12-01
- Patent Cliff
- 2028
- Routes
- ORAL
- Dosage Forms
- TABLET
NEXAVAR Approval History
What NEXAVAR Treats
3 indicationsNEXAVAR is approved for 3 conditions since its original approval in 2005. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Unresectable hepatocellular carcinoma
- Advanced renal cell carcinoma
- Locally recurrent or metastatic, progressive, differentiated thyroid carcinoma refractory to radioactive iodine treatment
NEXAVAR 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.
NEXAVAR 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 NEXAVAR's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications NEXAVAR treats. First-in-class if their pivotal trials read out positive.
Drugs Similar to NEXAVAR
FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
55 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| 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 |
| 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 |
| 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 |
| NCT00826540 results posted | NCCTG-N054C NCI-2009-01177, U10CA025224 | Ph 2 | completed | Sorafenib and Bevacizumab in Treating Patients With Metastatic Colorectal Cancer |
| 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 |
| NCT02143401 | NCI-2014-01043 NCI-2014-01043, MC1315 | Ph 1 | completed | Navitoclax and Sorafenib Tosylate in Treating Patients With Relapsed or Refractory Solid Tumors |
| NCT01817751 results posted | MCC-14816 HM14816, NCI-2013-00705 | Ph 2 | completed | Sorafenib, Valproic Acid, and Sildenafil in Treating Patients With Recurrent High-Grade Glioma |
| NCT03565536 | UTC-NEXAVAR | Ph 2 | completed | Nexavar for Neoadjuvant Treatment of Anaplastic Thyroid Cancer |
| NCT01578109 | NCI-2012-00727 NCI-2012-00727, J11116 | Ph 1 | completed | Sorafenib Tosylate Before and After Donor Bone Marrow Transplant in Treating Patients With Acute Myeloid Leukemia |
| NCT02135874 results posted | 2013-0073 NCI-2014-02322, 2013-0073 | Ph 2 | completed | Clofarabine, Idarubicin, Cytarabine, Vincristine Sulfate, and Dexamethasone in Treating Patients With Newly Diagnosed or Relapsed Mixed Phenotype Acute Leukemia |
| NCT01004978 results posted | NCI-2011-01981 NCI-2011-01981, ECOG-E1208 | Ph 3 | completed | Chemoembolization With or Without Sorafenib Tosylate in Treating Patients With Liver Cancer That Cannot Be Removed by Surgery |
| NCT01624285 | 11-003311 NCI-2012-00911 | Ph 2 | completed | Sorafenib Tosylate Following a Liver Transplant in Treating Patients With Liver Cancer |
| NCT02066181 results posted | NCI-2014-00264 NCI-2014-00264, PA091105_A04PAMDREVW01 | Ph 3 | completed | Sorafenib Tosylate in Treating Patients With Desmoid Tumors or Aggressive Fibromatosis |
| NCT00981162 | I 150109 NCI-2009-01326, I 150109 | Ph 1 | completed | Sorafenib Tosylate and Everolimus in Treating Patients With Advanced Solid Tumors and Metastatic Pancreatic Cancer That Does Not Respond to Gemcitabine Hydrochloride |
| NCT01253070 results posted | NCI-2011-02618 NCI-2011-02618, CDR0000689593 | Ph 2 | completed | Sorafenib Tosylate and Chemotherapy in Treating Older Patients With Acute Myeloid Leukemia |
| NCT01015833 results posted | NCI-2011-01989 NCI-2011-01989, CDR0000659348 | Ph 3 | completed | Sorafenib Tosylate With or Without Doxorubicin Hydrochloride in Treating Patients With Locally Advanced or Metastatic Liver Cancer |
| NCT01664182 results posted | NCI-2012-01289 NCI-2012-01289, PHII-122 | Ph 2 | completed | Trebananib With or Without Bevacizumab, Pazopanib Hydrochloride, Sorafenib Tosylate, or Sunitinib Malate in Treating Patients With Advanced Kidney Cancer |
| NCT00867321 results posted | NCCTG-N0745 NCI-2009-01178, CDR0000637866 | Ph 1, Ph 2 | completed | Bevacizumab and Sorafenib as First-Line Therapy in Treating Patients With Locally Advanced or Metastatic Liver Cancer |
| NCT02050919 results posted | IRB00009464 NCI-2013-02414, IRB00009464 | Ph 2 | completed | Sorafenib Tosylate, Combination Chemotherapy, Radiation Therapy, and Surgery in Treating Patients With High-Risk Stage IIB-IV Soft Tissue Sarcoma |
| NCT01900002 results posted | 2012-0870 NCI-2013-01667, Y-90 | Ph 2 | completed | Sorafenib Tosylate and Yttrium Y 90 Glass Microspheres in Treating Patients With Liver Cancer That Cannot Be Removed by Surgery |
| NCT01620216 results posted | IRB00007195 NCI-2012-01084, CA180-392 | Ph 2 | terminated | Targeted Therapy in Treating Patients With Relapsed or Refractory Acute Lymphoblastic Leukemia or Acute Myelogenous Leukemia |
| NCT01666756 | 11043 NCI-2012-01324, 5P01CA154295-02 | Ph 1 | completed | Chinese Herbal Formulation PHY906 and Sorafenib Tosylate in Treating Patients With Advanced Liver Cancer |
| NCT01531361 | 2011-1183 NCI-2012-00217, 2011-1183 | Ph 1 | completed | Vemurafenib With Sorafenib Tosylate or Crizotinib in Treating Patients With Advanced Malignancies With BRAF Mutations |
| NCT00622466 results posted | STU 082010-161 ONYX-SCCC-112007-035, CDR0000587470 | Ph 2 | terminated | Sorafenib and Paclitaxel in Treating Patients With Metastatic Breast Cancer |
| NCT02779283 | IRB00011766 NCI-2016-00083, IRB00011766 | Ph 1 | completed | Personalized Kinase Inhibitor Therapy Combined With Chemotherapy in Treating Patients With Newly Diagnosed Acute Myeloid Leukemia and Acute Lymphoblastic Leukemia |
| NCT01075555 | CDR0000666232 FFCD-PRODIGE-11, FFCD-0803 | Ph 3 | completed | Sorafenib Tosylate With or Without Pravastatin in Treating Patients With Liver Cancer and Cirrhosis |
| NCT01497444 | N1153 NCCTG-N1153, CDR0000720022 | Ph 1 | completed | Sorafenib Tosylate and Hypoxia-Activated Prodrug TH-302 in Treating Patients With Advanced Kidney Cancer or Liver Cancer That Cannot Be Removed By Surgery |
| NCT01075113 | MCC-12122 NCI-2010-00185 | Ph 1 | completed | Sorafenib and Vorinostat in Treating Patients With Advanced Liver Cancer |
| NCT00687674 results posted | CDR0000597065 P30CA015083, MC078A | Ph 1 | terminated | Sorafenib, Lenalidomide, and Dexamethasone in Treating Patients With Relapsed or Refractory Multiple Myeloma |
| NCT00941967 | CDR0000638394 CLCC-GONEXT-PRODIGE-10, VA 2007/40 | Ph 2 | completed | Sorafenib With or Without Gemcitabine and Oxaliplatin in Treating Patients With Locally Advanced, Unresectable, or Metastatic Liver Cancer |
| NCT00869570 | SAKK 41/08 SWS-SAKK-41-08, 2008-006312-38 | Ph 1, Ph 2 | completed | External-Beam Radiation Therapy, Capecitabine, and Sorafenib in Treating Patients With Locally Advanced Rectal Cancer |
| NCT01005199 | SAKK 77/08 and SASL 29 SWS-SAKK-77/08, SWS-SASL-29 | Ph 2 | completed | Sorafenib Tosylate With or Without Everolimus in Treating Patients With Localized, Unresectable, or Metastatic Liver Cancer |
| NCT00822848 | IRB00004653 P30CA069533, OHSU-4653 | Ph 1 | completed | Sorafenib, Epirubicin, Ifosfamide, and Radiation Therapy Followed By Surgery in Treating Patients With High-Risk Stage II or Stage III Soft Tissue Sarcoma |
| NCT01502410 results posted | NCI-2012-00106 NCI-2012-00106, COG-ADVL1121 | Ph 2 | completed | Sorafenib Tosylate in Treating Younger Patients With Relapsed or Refractory Rhabdomyosarcoma, Wilms Tumor, Liver Cancer, or Thyroid Cancer |
| NCT02035527 | OSU-13141 NCI-2013-02086 | Ph 1 | completed | Sorafenib Tosylate, Cisplatin, and Docetaxel in Treating Patients With Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck |
| NCT00621686 results posted | NCCTG-N0776 NCI-2009-00832, CDR0000587614 | Ph 2 | completed | Bevacizumab and Sorafenib in Treating Patients With Recurrent Glioblastoma Multiforme |
| NCT00722072 results posted | IRB00004318 P30CA069533, OHSU-4318 | Ph 2 | terminated | Sorafenib and Fulvestrant in Treating Patients With Locally Advanced or Metastatic Breast Cancer That Did Not Respond to Aromatase Inhibitor Therapy |
| NCT01011010 | LCCC 0902 P30CA016086, CDR0000648296 | Ph 1 | completed | Sorafenib Tosylate and Chemoembolization With Doxorubicin Hydrochloride and Mitomycin in Treating Patients With Liver Cancer That Cannot Be Removed By Surgery |
| NCT00881751 results posted | 101282 MUSC-101282, GENENTECH-AVF4481s | Ph 2 | completed | Bevacizumab and Erlotinib or Sorafenib as First-Line Therapy in Treating Patients With Advanced Liver Cancer |
| NCT01276210 | VICC RAD1060 NCI-2010-02407 | Ph 1 | completed | Sorafenib Tosylate and Stereotactic Radiosurgery in Treating Patients With Brain Metastases |
| NCT01383343 | NCI-2011-02595 NCI-2011-02595, CDR0000702751 | Ph 1 | completed | Sorafenib Tosylate, Bevacizumab, Irinotecan Hydrochloride, Leucovorin Calcium, and Fluorouracil in Treating Patients With Metastatic Colorectal Cancer |
| NCT00828074 results posted | 08103 P30CA033572, CHNMC-08103 | Ph 1, Ph 2 | completed | Sorafenib and Vinorelbine in Treating Women With Stage IV Breast Cancer |
| NCT01008566 | NCI-2012-03186 NCI-2012-03186, PHI-64 | Ph 1 | completed | Cixutumumab and Sorafenib Tosylate in Treating Patients With Advanced Liver Cancer |
| NCT01450384 | MCC-13874 NCI-2011-03035, P30CA016059 | Ph 1 | completed | Pemetrexed Disodium and Sorafenib Tosylate in Treating Patients With Advanced Solid Tumors |
| NCT02599337 | 150230 | Ph 1 | completed | Bioequivalence Study of Sorafenib Tablet and Nexavar |
| NCT01093222 results posted | NCI-2011-02027 NCI-2011-02027, SWOG-S0941 | Ph 2 | completed | Sorafenib Tosylate and Erlotinib Hydrochloride in Treating Patients With Locally Advanced, Unresectable, or Metastatic Gallbladder Cancer or Cholangiocarcinoma |
| NCT00844168 | 6697 NCI-2009-01659 | Ph 1 | completed | Sorafenib Tosylate in Treating Patients With Liver Cancer Who Have Undergone a Liver Transplant |
| NCT01158287 | 06-41 ICORG ICORG-06-41, EUDRACT-2008-005062-31 | Ph 2 | completed | Sorafenib. ICORG 06-41, V4 |
| NCT00726986 results posted | CASE8507 P30CA043703, CASE8507 | Ph 2 | terminated | Sorafenib, Cisplatin, and Etoposide in Treating Patients With Extensive-Stage Small Cell Lung Cancer |
Showing 50 of 55 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.
NEXAVAR FDA Label Details
Indications & Usage
FDA Label (PDF)NEXAVAR is indicated for the treatment of Unresectable hepatocellular carcinoma; Advanced renal cell carcinoma; Locally recurrent or metastatic, progressive, differentiated thyroid carcinoma refractory to radioactive iodine treatment.
Pro Intelligence Preview
Deep insights for NEXAVAR
Revenue Insights
- • Quarterly revenue tracking
- • Historical trend analysis
Patent Timeline
- • Cliff: 2028
- • 4 active patents
Trial Analysis
- • 55 total trials
- • Stage: Declining
Competitive Landscape
- • 2 similar drugs
- • Same target/indication analysis
Full approval history • All patents • Revenue trends • Competitor analysis
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