Drug · Small Molecule

Sorafenib Tosylate

CI-DRUG-00000557Explore in graph →NCIt C2194 CHEMBL1200485 CIViC Approved

Regulatory

Approvals (9)

Each record names the authority, jurisdiction, indication text and status. A drug approved in one jurisdiction for one indication is not 'approved' in general.

openfdaRegulatory9 approval records · authority, jurisdiction and indication text as published.

Jurisdiction · authority	Cancer	Indication	Status	Approval date	Source
US FDA	—	Efficacy supplement 2017-12-22 (see label)	approved	Dec 22, 2017	openfda
US FDA	—	Efficacy supplement 2013-11-22 (see label)	approved	Nov 22, 2013

Data updated 17 days agoSource updated unknown

Derived

Development pipeline

Most advanced stage across all cancers, then per top-level cancer reached through trial conditions or approval indications. Approval in any ingested jurisdiction outranks trial phase; counts are interventional studies.

Scope	Stage	Max phase	Active	Phase 3	Trials	Approvals	Jurisdictions	First approval	First trial
All cancers	Approved	Phase 3	3	11	134	9	US	Dec 1, 2005	2004-08
Malignant Kidney Neoplasm	Approved	Phase 3	0	2	14	1	US	Dec 1, 2005	2004-09
Malignant Liver Neoplasm	Approved	Phase 3	0	5	26	1	US	Dec 1, 2005	2005-10
Malignant Thyroid Gland Neoplasm	Approved	Phase 2	0	0	4	1

Curated evidence

Clinical evidence (1)

CIViC items in which this therapy appears, grouped by cancer context, then molecular profile. 50 items per page.

civicCuratedShowing 1–1 of 1 evidence items · levels, directions and significance as curated at the source; each row links to its CIViC record.

Therapy	Cancer	Type	Level	Direction · significance	Rating (1–5)	Status	Evidence	Source
PDGFB Rearrangement1
Sorafenib Tosylate

Clinical trials

Trials with this intervention (135)

Most recently updated first, 50 per page.

clinicaltrialsPublishedShowing 101–135 of 135 studies · status and phase as posted by the registrant; each row links to the study record.

NCT	Title	Status	Phase	Enrollment (n)	Sponsor	Countries	Last update	Source
NCT00281957	Sorafenib With Either Temsirolimus or Tipifarnib in Treating Patients With Stage IV Malignant Melanoma That Cannot Be Removed By Surgery	completed	Phase 2	109	National Cancer Institute (NCI)NIH	1	May 20, 2014	clinicaltrials
NCT00303966	Sorafenib in Treating Patients With Relapsed Chronic Lymphocytic Leukemia	terminated

Molecule

Record

Kind: Small Molecule
Mechanism: Serine/threonine-protein kinase RAF inhibitor; Platelet-derived growth factor receptor beta inhibitor; Stem cell growth factor receptor inhibitor; Tyrosine-protein kinase receptor FLT3 inhibitor; Serine/threonine-protein kinase B-raf inhibitor; Vascular endothelial growth factor receptor inhibitor; Tyrosine-protein kinase receptor RET inhibitor
Targets: 9 genes
UNII: 9ZOQ3TZI87
Aliases: 4-(4-(3-(4-Chloro-3-trifluoromethylphenyl)ureido)phenoxy)pyridine-2-carboxyllic Acid Methyamide-4-methylbenzenesulfonate Tosylate, BAY 43-9006 Tosylate, BAY 54 9085, BAY 54-9085, BAY 549085, BAY549085, Nexavar, Sorafenib, Sorafenib accord, Sorafenib tosilate, Sorafenib Tosylate

Data updated 17 hours agoSource updated unknown

Identifiers

Codes (0)

Upstream identifiers kept as first-class codes; each links to its registry where a stable public URL exists.

Data not yet available

No cross-reference code recorded yet beyond the record identifiers above.

Regulatory status is jurisdiction-specific and time-bound. Nothing on this page is a treatment recommendation.