sorafenib
Trade name: nexavar
Small moleculeapprovedOrphan Drug FDA
Approved
Dec 1, 2005
Sorafenib (BAY 43-9006), marketed as Nexavar by Bayer, is a drug approved for the treatment of advanced renal cell carcinoma (primary kidney cancer, hepatocellular carcinoma and for the treatment of patients with locally recurrent or metastatic, progressive, differentiated thyroid carcinoma (DTC) that is refractory to radioactive iodine treatment. It has also received "Fast Track" designation by the FDA for the treatment of advanced hepatocellular carcinoma (primary liver cancer), and has since performed well in Phase III trials. Sorafenib was shown to interact with multiple intracellular (CRAF, BRAF and mutant BRAF) and cell surface kinases (KIT, FLT- 3, VEGFR- 2, VEGFR- 3, and PDGFR- ß). Several of these kinases are thought to be involved in angiogenesis. Thus, sorafenib may inhibit tumor growth by a dual mechanism, acting either directly on the tumor (through inhibition of Raf and Kit signaling) and/or on tumor angiogenesis (through inhibition of VEGFR and PDGFR signaling). Sorafenib inhibited tumor growth of the murine renal cell carcinoma, RENCA, and several other human tumor xenografts in athymic mice. A reduction in tumor angiogenesis was seen in some tumor xenograft models. — NCATS
Clinical trial activity
667 trials · 433 clinical orgs · 7 marketing orgs
Phase 1
233
Phase 2
456
Phase 3
94
Phase 4
16
Earliest trial started Jul 1, 2002 (NCT00941863)
Timeline
2000s
2010s
- May 31, 2016
Mylan — Marketing Organization
2020s
- Nov 12, 2020
Teva — Marketing Organization
- Jun 7, 2022
Dr. Reddy's Laboratories — Marketing Organization
- Nov 9, 2022
Yabao Pharmaceutical Group — Marketing Organization
- Apr 12, 2023
Torrent Pharmaceuticals Limited — Marketing Organization
- Jan 27, 2025
Apotex — Marketing Organization
Indications
Approved for
Studied for
- Adenocarcinoma · Phase 3
- Adenoma, Liver Cell · Phase 1/Phase 2
- Adrenocortical Carcinoma · Phase 2
- Anemia · Phase 1
- Antineoplastic Agents · Phase 2
- Astrocytoma · Phase 1
- Bile Duct Neoplasms · Phase 2
- Biliary Tract Neoplasms · Phase 1/Phase 2
- Biological Availability · Phase 1
- Brain Neoplasms · Phase 2
- Breast Neoplasms · Phase 3
- Breast Neoplasms, Male · Phase 2
- Burkitt Lymphoma · Phase 1
- Carcinoid Tumor · Phase 1
- Carcinoma · Phase 3
- Carcinoma, Hepatocellular · Phase 4
- Carcinoma, Islet Cell · Phase 2
- Carcinoma, Non-Small-Cell Lung · Phase 3
- Carcinoma, Renal Cell · Phase 4
- Carcinoma, Small Cell · Phase 1
- Carcinoma, Squamous Cell · Phase 2
- Carcinoma, Transitional Cell · Phase 1
- Carcinoma, Verrucous · Phase 2
- Chemoembolization, Therapeutic · Phase 3
- Cholangiocarcinoma · Phase 1/Phase 2
- Colonic Neoplasms · Phase 2
- Colorectal Neoplasms · Phase 2
- Desmoplastic Small Round Cell Tumor · Phase 2
- Diabetes Mellitus, Type 1 · Phase 2
- Digestive System Diseases · Phase 3
- Digestive System Neoplasms · Phase 3
- Drug Interactions · Phase 2
- Drug-Related Side Effects and Adverse Reactions · Phase 4
- Drugs, Investigational · Phase 3
- Esophageal Neoplasms · Phase 2
- Fallopian Tube Neoplasms · Phase 2
- Fasting · Phase 1
- Fibrosarcoma · Phase 2
- Fibrosis · Phase 1
- Gallbladder Neoplasms · Phase 2
- Gastrinoma · Phase 2
- Gastrointestinal Stromal Tumors · Phase 2
- Glioblastoma · Phase 2
- Glioma · Phase 2
- Gliosarcoma · Phase 2
- Glucagonoma · Phase 2
- Graft vs Host Disease · Phase 2
- Hamartoma · Phase 2
- Head and Neck Neoplasms · Phase 2
- Healthy Volunteers · Phase 1
- Hematopoietic Stem Cell Transplantation · Phase 4
- Hepatectomy · Phase 4
- Hepatitis B · Phase 2
- Hepatitis C · Phase 2
- Hepatitis C, Chronic · Phase 1
- Hepatoblastoma · Phase 3
- Hepatopulmonary Syndrome · Phase 2
- Herpesvirus 8, Human · Phase 1
- Hodgkin Disease · Phase 1
- Hypertension, Portal · Phase 2
- Insulinoma · Phase 2
- Intestinal Neoplasms · Phase 2
- Keloid · Phase 2
- Kidney Diseases · Phase 2
- Kidney Neoplasms · Phase 3
- Klatskin Tumor · Phase 2
- Leiomyosarcoma · Phase 2
- Leukemia · Phase 3
- Leukemia, Biphenotypic, Acute · Phase 1/Phase 2
- Leukemia, Eosinophilic, Acute · Phase 1
- Leukemia, Lymphocytic, Chronic, B-Cell · Phase 2
- Leukemia-Lymphoma, Adult T-Cell · Phase 2
- Leukemia, Monocytic, Acute · Phase 2/Phase 3
- Leukemia, Myelogenous, Chronic, BCR-ABL Positive · Phase 2
- Leukemia, Myeloid · Phase 3
- Leukemia, Myeloid, Acute · Phase 4
- Leukemia, Myeloid, Chronic, Atypical, BCR-ABL Negative · Phase 1
- Leukemia, Myeloid, Chronic-Phase · Phase 1
- Leukemia, Myelomonocytic, Acute · Phase 1
- Leukemia, Myelomonocytic, Chronic · Phase 2
- Leukemia, Myelomonocytic, Juvenile · Phase 1
- Leukemia, Promyelocytic, Acute · Phase 1
- Liver Cirrhosis · Phase 2
- Liver Diseases · Phase 3
- Liver Neoplasms · Phase 4
- Liver Neoplasms, Experimental · Phase 1/Phase 2
- Lung Neoplasms · Phase 2
- Lymphoma · Phase 1/Phase 2
- Lymphoma, B-Cell, Marginal Zone · Phase 1
- Lymphoma, Follicular · Phase 1
- Lymphoma, Large B-Cell, Diffuse · Phase 1
- Lymphoma, Large-Cell, Anaplastic · Phase 2
- Lymphoma, Large-Cell, Immunoblastic · Phase 2
- Lymphoma, Mantle-Cell · Phase 2
- Lymphoma, Non-Hodgkin · Phase 2
- Lymphoma, Primary Cutaneous Anaplastic Large Cell · Phase 1
- Lymphoma, T-Cell · Phase 2
- Lymphoma, T-Cell, Peripheral · Phase 2
- Lymphomatoid Granulomatosis · Phase 1
- Melanoma · Phase 3
- Mesothelioma · Phase 2
- Molecular Mechanisms of Pharmacological Action · Phase 2
- Multiple Endocrine Neoplasia Type 2a · Phase 2
- Multiple Endocrine Neoplasia Type 2b · Phase 2
- Multiple Myeloma · Phase 2
- Mutation · Phase 2
- Myelodysplastic Syndromes · Phase 2/Phase 3
- Myeloproliferative Disorders · Phase 2
- Nasopharyngeal Neoplasms · Phase 2
- Neoplasm Metastasis · Phase 4
- Neoplasms · Phase 4
- Neoplasms by Histologic Type · Phase 3
- Neoplasms by Site · Phase 3
- Neoplasms, Glandular and Epithelial · Phase 3
- Neoplasms, Squamous Cell · Phase 1/Phase 2
- Neuroblastoma · Phase 1
- Neuroendocrine Tumors · Phase 2
- Neurofibroma · Phase 2
- Neurofibroma, Plexiform · Phase 1
- Neurofibromatosis 1 · Phase 1
- Neurofibrosarcoma · Phase 2
- Oligodendroglioma · Phase 1
- Osteosarcoma · Phase 2
- Ovarian Neoplasms · Phase 2
- Pancreatic Neoplasms · Phase 3
- Pediatrics · Phase 2
- Pharmacokinetics · Phase 1
- Precursor B-Cell Lymphoblastic Leukemia-Lymphoma · Phase 2
- Precursor Cell Lymphoblastic Leukemia-Lymphoma · Phase 1
- Primary Myelofibrosis · Phase 1
- Prostatic Neoplasms · Phase 2
- Prostatic Neoplasms, Castration-Resistant · Phase 1
- Protein Kinase Inhibitors · Phase 2
- Pulmonary Arterial Hypertension · Phase 1
- Quality of Life · Phase 2/Phase 3
- Radiotherapy · Phase 3
- Rectal Neoplasms · Phase 1
- Recurrence · Phase 3
- Rhabdomyosarcoma · Phase 2
- Salivary Gland Neoplasms · Phase 2
- Sarcoma · Phase 2
- Sarcoma, Ewing · Phase 2
- Sarcoma, Kaposi · Phase 1
- Sarcoma, Myeloid · Phase 3
- Sarcoma, Synovial · Phase 2
- Small Cell Lung Carcinoma · Phase 2
- Somatostatinoma · Phase 2
- Sorafenib · Phase 4
- Squamous Cell Carcinoma of Head and Neck · Phase 2
- Stomach Neoplasms · Phase 2
- Testicular Neoplasms · Phase 2
- Thrombosis · Phase 3
- Thyroid Cancer, Papillary · Phase 2
- Thyroid Carcinoma, Anaplastic · Phase 2
- Thyroid Neoplasms · Phase 3
- Tongue Neoplasms · Phase 2
- Ureteral Neoplasms · Phase 1
- Urethral Neoplasms · Phase 2
- Urinary Bladder · Phase 2
- Urinary Bladder Neoplasms · Phase 2
- Uterine Cervical Neoplasms · Phase 1/Phase 2
- Uterine Neoplasms · Phase 2
- Vipoma · Phase 2
- Waldenstrom Macroglobulinemia · Phase 1
- Wilms Tumor · Phase 2
Mechanism of action
VEGF-receptor 2 and Fibroblast growth factor receptor 1 antagonist
Vascular endothelial growth factor receptor inhibitor
FLT3 inhibitor
- Stem cell growth factor receptorINHIBITOR
KIT inhibitor
- Tyrosine-protein kinase receptor RETINHIBITOR
RET inhibitor
PDGFRA antagonist
PDGFRB inhibitor
- Serine/threonine-protein kinase RAFINHIBITOR
RAF1 inhibitor
BRAF inhibitor
Approval history
- approvedPriority reviewDec 1, 2005
Chemistry & pharmacology
Loading structure…
SMILES
CNC(=O)c1cc(Oc2ccc(NC(=O)Nc3ccc(Cl)c(C(F)(F)F)c3)cc2)ccn1- Mol. weight
- 464.83 g/mol
- Lipinski Ro5
- 1 violation(s)
- Rule of 3
- No
- Chirality
- Achiral Molecule
- Inorganic
- No
- Polymer
- No
- Delivery
- Oral
- Availability
- Prescription Only
Oral
Yes
Parenteral
No
Topical
No
Sources
- ChEMBLCHEMBL1336 ↗
- WikipediaSorafenib ↗
- NCATS9ZOQ3TZI87 ↗
- ChEMBLCHEMBL1200485 ↗
Also known as
- 4-(4-(3-(4-chloro-3-trifluoromethylphenyl)ureido)phenoxy)pyridine-2-carboxyllic acid methyamide-4-methylbenzenesulfonate
- 4-(4-((((4-chloro-3-(trifluoromethyl)phenyl)amino)carbonyl)amino)phenoxy)-n-methyl-2-pyridinecarboxamide
- 4-(4-((((4-chloro-3-(trifluoromethyl)phenyl)amino)carbonyl)amino)phenoxy)-n-methyl-2-pyridinecarboxamide
- bay 43-9006
- bay 43-9006
- bay 43-9006
- bay 43-9006
- bay 43-9006
- bay 43-9006
- bay 43-9006
- bay-43-9006
- bay-43-9006
- bay 545-9085
- bay 545-9085
- bay-545-9085
- bay-545-9085
- bay-54-9085
- bay-54-9085
- n-(4-chloro-3-(trifluoromethyl)phenyl)-n'-(4-(2-(n-methylcarbamoyl)-4-pyridyloxy)phenyl)urea
- n-(4-chloro-3-(trifluoromethyl)phenyl)-n'-(4-(2-(n-methylcarbamoyl)-4-pyridyloxy)phenyl)urea
- nexavar
- nexavar
- nexavar
- nexavar
- nexavar
- nexavar
- sorafenib
- sorafenib
- sorafenib
- sorafenib
- sorafenib
- sorafenib
- sorafenib
- sorafenib
- sorafenib
- sorafenib
- sorafenib
- sorafenib n-oxide
- sorafenib tosilate
- sorafenib tosylate
- sorafenib tosylate
- sorafenib tosylate
- sorafenib tosylate
- sorafenib tosylate
- sorafenibum
- sorafenibum
- sorefenib
- suranix
Clinical trials
| NCT ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT07264010 | Phase 2/Phase 3 (Phase 3) | Dec 1, 2025 | Southern Medical University |
| NCT06972641 | Phase 2/Phase 3 (Phase 3) | Jun 10, 2025 | Jiao Tong University |
| NCT06797427 | Early Phase 1 (Phase 1) | Feb 10, 2025 | Clinical Trial Consultants AB, Disruptive Pharma |
| NCT06474663 | Phase 1 | Dec 31, 2024 | University of Texas at Houston |
| NCT06309485 | Phase 2 | Aug 31, 2024 | Government of China |
| NCT06227221 | Phase 2 | Jun 30, 2024 | Central South University |
| NCT06690697 | Phase 2 | Jun 1, 2024 | Fudan University |
| NCT06532084 | Phase 2 | May 22, 2024 | Pavlov First Saint Petersburg State Medical University |
| NCT06221683 | Phase 2 | Jan 1, 2024 | Soochow University |
| NCT05822752 | Phase 2 | Sep 21, 2023 | AbbVie |
| NCT05873244 | Phase 2 | Aug 21, 2023 | Chinese University of Hong Kong |
| NCT05669339 | Phase 1 | Mar 31, 2023 | University of Florida |
| NCT05673824 | Phase 4 | Feb 7, 2023 | Fudan University, LinkDoc Technology (Beijing) Co. Ltd. |
| NCT06527495 | Phase 1/Phase 2 (Phase 2) | Jan 1, 2023 | Assiut University |
| NCT06030895 | Phase 4 | Dec 12, 2022 | Damanhour University |
| NCT05468359 | Phase 1/Phase 2 (Phase 2) | Nov 7, 2022 | St. Jude Children's Hospital |
| NCT05117957 | Phase 2 | Jan 2, 2022 | National Cancer Center, Korea |
| NCT05113290 | Phase 4 | Dec 1, 2021 | Jiao Tong University |
| NCT04710641 | Phase 2 | Dec 1, 2021 | Mina Alpha Limited |
| NCT05313958 | Phase 2/Phase 3 (Phase 3) | Dec 1, 2021 | Central South University, Guangzhou Medical University, Jiangxi Children's Hospital, Maternal and Child Health Hospital of Foshan, Nanchang University, Shantou University, Southern Medical University, Sun Yat-Sen University |
Showing 20 of 667 trials
Page 1 / 34
Organizations
Research & Development (433)
| Organization | Org type | Trials | As lead sponsor | Phases | Earliest year |
|---|---|---|---|---|---|
| Bayer | For profit | 167 | 54 | 5 | 2002 |
| National Cancer Institute (NCI) | Government | 138 | 95 | 4 | 2004 |
| University of Texas at Houston | Academic/Hospital | 31 | 25 | 2 | 2005 |
| Amgen | For profit | 24 | 4 | 3 | 2002 |
| Sun Yat-Sen University | Academic/Hospital | 23 | 19 | 4 | 2009 |
| Cornell University | Academic/Hospital | 16 | 10 | 3 | 2005 |
| Novartis | For profit | 16 | 4 | 3 | 2006 |
| Fudan University | Academic/Hospital | 14 | 8 | 4 | 2007 |
| Harvard University | Academic/Hospital | 11 | 8 | 3 | 2006 |
| Mayo Clinic | Academic/Hospital | 11 | 3 | 2 | 2005 |
| University of Chicago | Academic/Hospital | 11 | 4 | 4 | 2004 |
| University of Toronto | Academic/Hospital | 11 | 8 | 2 | 2004 |
| Guangzhou Medical University | Academic/Hospital | 10 | 1 | 3 | 2014 |
| SCRI Development Innovations | For profit | 10 | 10 | 3 | 2006 |
| Southwest Oncology Group | Academic/Hospital | 9 | 0 | 2 | 2004 |
| University of Pennsylvania | Academic/Hospital | 9 | 7 | 3 | 2005 |
| Jiao Tong University | Academic/Hospital | 8 | 5 | 5 | 2008 |
| Ohio State University | Academic/Hospital | 8 | 4 | 2 | 2004 |
| Peking University | Academic/Hospital | 8 | 3 | 3 | 2008 |
| Pfizer | For profit | 8 | 5 | 3 | 2007 |
433 organizations
Page 1 / 22
Marketing (9)
| Organization | Org type | Relationship | Date |
|---|---|---|---|
| Apotex | For profit | MKTG | Jan 27, 2025 |
| Bayer | For profit | NDA | Dec 20, 2005 |
| Bayer | For profit | MKTG | Dec 1, 2005 |
| Dr. Reddy's Laboratories | For profit | MKTG | Jun 7, 2022 |
| Mylan | For profit | MKTG | May 31, 2016 |
| Mylan | For profit | SYN | Sep 10, 2020 |
| Teva | For profit | MKTG | Nov 12, 2020 |
| Torrent Pharmaceuticals Limited | For profit | MKTG | Apr 12, 2023 |
| Yabao Pharmaceutical Group | For profit | MKTG | Nov 9, 2022 |