Drug · Small Molecule

Sorafenib

CI-DRUG-00000556Explore in graph →NCIt C61948 CHEMBL1336 CIViC Approved

Regulatory

Approvals (13)

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

emaRegulatory2 approval records · authority, jurisdiction and indication text as published.

Jurisdiction · authority	Cancer	Indication	Status	Approval date	Source
EU EMA	—	Hepatocellular carcinomaSorafenib Accord is indicated for the treatment of hepatocellular carcinoma (see section 5.1). Renal cell carcinomaSorafenib Accord is indicated for the treatment of patients with advanced renal cell carcinoma who have failed prior interferon-alpha or interleukin-2 based therapy or are considered unsuitable for such therapy.	approved	Nov 9, 2022	ema

Health Canada records are DIN-level: one row per marketed product (brand, strength, form). The Drug Product Database does not publish indications, so no cancer is stated for these rows, and a cancelled or dormant DIN is the status of that one product — not a withdrawal of the molecule.

Data updated 14 hours 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	Recruiting	Phase 3	Trials	Approvals	Jurisdictions	First approval	First trial
All cancers	Approved	Phase 4	30	12	78	408	13	CA, EU, US	Dec 1, 2005	2002-07
Malignant Liver Neoplasm	Approved	Phase 4	12	3	49	165	1	US	Dec 1, 2005	2002-08
Malignant Thyroid Gland Neoplasm	Approved	Phase 2	2	1	0	8	1	US	Dec 1, 2005	2006-02
Malignant Kidney Neoplasm	Approved	Phase 3	1	1	11	42	1

Curated evidence

Clinical evidence (96)

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

civicCuratedShowing 1–50 of 96 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
PDGFRA Fusion2
Sorafenib	Acute Myeloid Leukemia

Clinical trials

Trials with this intervention (443)

Most recently updated first, 50 per page.

clinicaltrialsPublishedShowing 1–50 of 443 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
NCT07836530	Study Comparing BGB-B2033 With Sorafenib or Lenvatinib in Relapsed Hepatocellular Carcinoma	not yet recruiting	Phase 3	492	BeOne MedicinesINDUSTRY	0	Sep 23, 2026	clinicaltrials
NCT03533582	Cisplatin and Combination Chemotherapy in Treating Children and Young Adults With Hepatoblastoma or Liver Cancer After Surgery	active not recruiting

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: 5T62Q3B36J
Aliases: APO-SORAFENIB, BA4 43 9006, BAY 43 9006, BAY 43-9006, BAY 439006, BAY439006, NEXAVAR, Sorafenib, Sorafenib Accord, Sorafenib Tosylate, SORAFENIB TOSYLATE

Data updated 17 hours agoSource updated unknown

Identifiers

Codes (7)

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

System	Code	Label
ATC (WHO)	L01EX02	SORAFENIB
DIN (Health Canada)	02284227

FLT3 D8352
Sorafenib	Acute Myeloid LeukemiaCURATED_BROADER	Predictive	B	Supports Resistance	4	accepted	EID1039 13 patients with relapsed or chemo-refractory FLT3-ITD+ AML were treated with sorafenib (200-400 mg twice daily). 12 patients responded, but sorafenib response was lost in most patients after 72 (rang… (full text at CIViC) PMID 22368270 · Man et al., 2012 · Open in CIViC	civic
Quizartinib + SorafenibSubstitutes	Acute Myeloid LeukemiaCURATED_BROADER	Predictive	B	Supports Resistance	4	accepted	EID1038 In an in-vitro study using an in vitro saturation mutagenesis assay, 4 residues with AC220 (quizartinib) resistance-conferring mutations in the kinase domain of FLT3-ITD were identified. Mutations at … (full text at CIViC) PMID 22504184 · Smith et al., 2012 · Open in CIViC	civic

FLT3 D835Y4
AG1295 + AGS324 + KW2449 + Linifanib + Ponatinib + Quizartinib + R406 + Sorafenib + SunitinibSubstitutes	Acute Myeloid LeukemiaCURATED_BROADER	Predictive	D	Does Not Support Sensitivity Response	3	accepted	EID11086 A panel of 13 FLT3 tyrosine kinase inhibitors was tested against Ba/F3 cells transfected with FLT3 D835Y using MTT growth/survival assay, and results were compared to Ba/F3 cells transfected with FLT3… (full text at CIViC) PMID 28077790 · Nguyen et al., 2017 · Open in CIViC	civic
Sorafenib	Acute Myeloid LeukemiaCURATED_BROADER	Predictive	C	Supports Sensitivity Response	3	submitted	EID12625 A patient (29/M) had 2 weeks with oral cavity ulcer and nasal bleeding and was diagnosed with AML with marrow including 91.5 % blasts with morphologic features of AML-M5. Karyotype was abnormal (47, … (full text at CIViC) PMID 27408351 · Yue et al., 2016 · Open in CIViC	civic
〃	Acute Myeloid LeukemiaCURATED_BROADER	Predictive	D	Does Not Support Sensitivity Response	4	submitted	EID11096 Ba/F3 cells with FLT3 D835Y were transplanted into mice. The cells were stably transfected with luciferase and this was used to monitor disease progression with luciferin injections to visualize biolu… (full text at CIViC) PMID 28077790 · Nguyen et al., 2017 · Open in CIViC	civic
〃	Acute Myeloid LeukemiaCURATED_BROADER	Predictive	D	Supports Sensitivity Response	2	submitted	EID12813 Ba/F3 cells expressing FLT3 D835Y and treated with sorafenib demonstrated a dose-dependent inhibition of cell proliferation. Ba/F3 cells transformed with FLT3 D835Y showed a 50% inhibition of cell pro… (full text at CIViC) PMID 17229632 · Lierman et al., 2007 · Open in CIViC	civic

FLT3 ITD6
Hematopoietic Cell Transplantation + SorafenibSequential	Acute Myeloid LeukemiaCURATED_BROADER	Predictive	B	Supports Sensitivity Response	5	submitted	EID9070 This study was a randomised phase 3 trial to compare sorafenib maintenance with non-maintenance post-transplantation for patients with FLT3-ITD acute myeloid leukaemia undergoing allogeneic haematopoi… (full text at CIViC) PMID 32791048 · Xuan et al., 2020 · Open in CIViC	civic
AG1295 + AGS324 + Crenolanib + FLT3 Tyrosine Kinase Inhibitor TTT-3002 + KW2449 + Lestaurtinib + Linifanib + Midostaurin + Ponatinib + Quizartinib + R406 + Sorafenib + SunitinibSubstitutes	Acute Myeloid LeukemiaCURATED_BROADER	Predictive	D	Supports Sensitivity Response	3	submitted	EID11084 A panel of FLT3 tyrosine kinase inhibitors was tested against Ba/F3 cells transfected with FLT3-ITD using MTT growth/survival assay. Each of the 13 TKIs inhibited proliferation of FLT3-ITD cells in a … (full text at CIViC) PMID 28077790 · Nguyen et al., 2017 · Open in CIViC	civic
Sorafenib	Acute Myeloid LeukemiaCURATED_BROADER	Predictive	B	Supports Sensitivity Response	4	accepted	EID298 Sorafenib is effective in patients with FLT3 internal tandem repeats, but not in wild type or D835 mutation. PMID 18230792 · Zhang et al., 2008 · Open in CIViC	civic
〃	Acute Myeloid LeukemiaCURATED_BROADER	Predictive	B	Supports Sensitivity Response	2	accepted	EID1040 13 patients with relapsed or chemo-refractory FLT3-ITD+ AML were treated with sorafenib (200-400 mg twice daily). 12 patients showed clearance or near clearance of bone marrow myeloblasts after 27 (ra… (full text at CIViC) PMID 22368270 · Man et al., 2012 · Open in CIViC	civic
〃	Acute Myeloid LeukemiaCURATED_BROADER	Predictive	C	Supports Sensitivity Response	1	accepted	EID1555 Six children with relapsed or refractory FLT3-ITD-positive AML received initial therapy with sorafenib (alone or in combination with clofarabine and cytarabine). Four of the patients initially achiev… (full text at CIViC) PMID 23969938 · Baker et al., 2013 · Open in CIViC	civic
Hematopoietic Cell Transplantation + SorafenibSequential	Acute Myeloid LeukemiaCURATED_BROADER	Predictive	B	Supports Sensitivity Response	4	submitted	EID9069 The SORMAIN trial provides evidence that an inhibition of FLT3 through sorafenib significantly reduces the risk of relapse and death after allogeneic hematopoietic stem cell transplantation for FLT3-I… (full text at CIViC) PMID 32673171 · Burchert et al., 2020 · Open in CIViC	civic

FLT3 ITD & Y842C3
Ponatinib + SorafenibSubstitutes	Acute Myeloid LeukemiaCURATED_BROADER	Predictive	D	Supports Resistance	4	submitted	EID8895 Proliferation of Ba/F3 cells with FLT3 double mutations was studied for the activity of ponatinib and sorafenib. Compared to control cells with native FLT3-ITD mutant (IC50: 3.0nM), cells with double … (full text at CIViC) PMID 23430109 · Smith et al., 2013 · Open in CIViC	civic
Selinexor + SorafenibCombination	Acute Myeloid LeukemiaCURATED_BROADER	Predictive	D	Supports Resistance	4	submitted	EID9081 To study pro-apoptotic effects against AML cells harboring FLT3-ITD and/or TKD mutations by selinexor, apoptosis induction was assessed as the percentage of annexin V–positive cells by flow cytometry.… (full text at CIViC) PMID 29773601 · Zhang et al., 2018 · Open in CIViC	civic
Sorafenib	Acute Myeloid LeukemiaCURATED_BROADER	Predictive	D	Supports Resistance	4	submitted	EID8913 Murine pro-B lymphocyte lines Ba/F3 cells with FLT3-ITD were exposed to sorafenib with increasing low doses (i.e., 1-5 nmol/L) of sorafenib for up to 3 months, and further exposed for an additional 3 … (full text at CIViC) PMID 24619500 · Zhang et al., 2014 · Open in CIViC	civic

FLT3 Y572del2
Crenolanib + Lestaurtinib + Midostaurin + Ponatinib + Quizartinib + SorafenibSubstitutes	Acute Myeloid LeukemiaCURATED_BROADER	Predictive	D	Supports Sensitivity Response	5	submitted	EID9306 The construct supported IL-3 independent growth of Ba/F3 cells. It showed FLT-3 autophosphorylation and downstream signaling via STAT5, AKT, and ERK1/2 pathways. With IL-3 deprivation, the cells showe… (full text at CIViC) PMID 33914060 · Young et al., 2021 · Open in CIViC	civic
Sorafenib	Acute Myeloid LeukemiaCURATED_BROADER	Predictive	D	Supports Sensitivity Response	4	submitted	EID12862 Ba/F3 cell lines expressing the variant FLT3 Y572del showed sensitivity to sorafenib comparable to the FLT3-ITD construct (Figure 4). PMID 33914060 · Young et al., 2021 · Open in CIViC	civic