Drug · Small Molecule

Sunitinib

CI-DRUG-00000564Explore in graph →NCIt C71622 CHEMBL535 CIViC Approved

Regulatory

Approvals (39)

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

health-canada-dpdRegulatory39 approval records from 3 sources (hover a row badge for its dataset) · authority, jurisdiction and indication text as published.

Jurisdiction · authority	Cancer	Indication	Status	Approval date	Source
CA Health Canada	—	Marketed in Canada as NAT-SUNITINIB (DIN 02552906) under ATC L01EX01 SUNITINIB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	approvedsource: Marketed	Sep 30, 2025	health-canada-dpd
CA

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 18 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	33	14	43	361	39	CA, EU, US	Jan 26, 2006	2003-04
Malignant Kidney Neoplasm	Approved	Phase 4	10	1	18	116	1	US	Jan 26, 2006	2004-02
Malignant Lung Neoplasm	Phase4	Phase 4	2	1	2	24	0	—	—	2004-07
Malignant Breast Neoplasm	Phase4	Phase 4	1	0	0	15	0

Curated evidence

Clinical evidence (165)

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

civicCuratedShowing 1–50 of 165 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 Fusion1
Sorafenib + Sunitinib

Clinical trials

Trials with this intervention (387)

Most recently updated first, 50 per page.

clinicaltrialsPublishedShowing 1–50 of 387 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
NCT07218926	A Study of IDRX-42 (GSK6042981) Versus (vs) Sunitinib in Participants With Gastrointestinal Stromal Tumors After Imatinib Therapy	recruiting	Phase 3	450	GlaxoSmithKlineINDUSTRY	19	Sep 25, 2026	clinicaltrials
NCT05773274	Comparing Retreatment of 177Lu-DOTATATE PRRT Versus the Usual Treatment in Patients With Metastatic Unresectable Gastroenteropancreatic Neuroendocrine Tumors, NET RETREAT Trial

Molecule

Record

Kind: Small Molecule
Mechanism: Macrophage colony stimulating factor receptor inhibitor; Stem cell growth factor receptor inhibitor; Tyrosine-protein kinase receptor FLT3 inhibitor; Platelet-derived growth factor receptor inhibitor; Vascular endothelial growth factor receptor inhibitor; Tyrosine-protein kinase receptor RET inhibitor; Vascular endothelial growth factor receptor 2 inhibitor; Platelet-derived growth factor receptor beta inhibitor; Platelet-derived growth factor receptor alpha inhibitor; Vascular endothelial growth factor receptor 1 inhibitor; Vascular endothelial growth factor receptor 3 inhibitor
Targets: 9 genes
UNII: LVX8N1UT73
Aliases: 1H-Pyrrole-3-carboxamide, N-(2-(diethylamino)ethyl)-5-((Z)-(5-fluoro-1,2-dihydro-2-oxo-3H-indol-3-ylidene)methyl)-2,4-dimethyl-, AURO-SUNITINIB, EUGIA-SUNITINIB, NAT-SUNITINIB, NSC-736511, NSC-750690, SANDOZ SUNITINIB, SU-011248, SU011248, SU-11248, Sunitinib, Sunitinib accord, Sunitinib Malate, SUNITINIB MALATE, SUTENT, TARO-SUNITINIB, TEVA-SUNITINIB

Data updated 21 hours agoSource updated unknown

Identifiers

Codes (55)

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

System	Code	Label
ATC (WHO)	L01EX01

FLT3 D8353
Sunitinib	Acute Myeloid LeukemiaCURATED_BROADER	Predictive	C	Supports Sensitivity Response	1	submitted	EID4024 In a retrospective study of 15 acute myeloid leukemia patients, the patients with FLT3 D835 mutation (n=2) were associated with improved response to sunitinib treatment (2/2 vs. 2/7) compared to FLT3 … (full text at CIViC) PMID 15459012 · Fiedler et al., 2005 · Open in CIViC	civic
〃	Acute Myeloid LeukemiaCURATED_BROADER	Predictive	C	Supports Sensitivity Response	1	submitted	EID4025 In a phase I study of 29 acute myeloid leukemia patients, a patient with FLT3 D835Y mutation was associated with responsiveness to sunitinib monotherapy. After failure of first-line chemotherapy, the … (full text at CIViC) PMID 14654525 · O'Farrell et al., 2003 · Open in CIViC	civic
〃	Acute Myeloid LeukemiaCURATED_BROADER	Predictive	D	Supports Sensitivity Response	1	submitted	EID4026 In an in vitro study, Chinese hamster ovary cells transiently expressing FLT3 D835Y mutation demonstrated sensitivity to sunitinib treatment (IC50: 30-300nM) similar to Chinese hamster ovary cells exp… (full text at CIViC) PMID 12531805 · O'Farrell et al., 2003 · Open in CIViC	civic

FLT3 D835H2
Sunitinib	Acute Myeloid LeukemiaCURATED_BROADER	Predictive	C	Supports Sensitivity Response	—	submitted	EID4027 In a retrospective study of 15 acute myeloid leukemia patients, the patients with FLT3 D835 mutation (n=2) were associated with improved response to sunitinib treatment (2/2 vs. 2/7) compared to FLT3 … (full text at CIViC) PMID 15459012 · Fiedler et al., 2005 · Open in CIViC	civic
〃	Acute Myeloid LeukemiaCURATED_BROADER	Predictive	D	Supports Sensitivity Response	—	submitted	EID4028 In an in vitro study, Chinese hamster ovary cells transiently expressing FLT3 D835H mutation demonstrated sensitivity to sunitinib treatment (IC50: 30-300nM) similar to Chinese hamster ovary cells exp… (full text at CIViC) PMID 12531805 · O'Farrell et al., 2003 · Open in CIViC	civic

FLT3 D835V5
Cytarabine + SunitinibCombination	Acute Myeloid LeukemiaCURATED_BROADER	Predictive	D	Supports Sensitivity Response	2	accepted	EID3009 SU11248 + Cytarabin has a synergic effect on Murine Ba/F3 cells with FLT3 D835V mutation (Combination Index = 0.59 for ED50, Combination Index = 0.71 for ED75, Combination Index = 0.82 for ED90) PMID 15304385 · Yee et al., 2004 · Open in CIViC	civic
Daunorubicin + SunitinibCombination	Acute Myeloid LeukemiaCURATED_BROADER	Predictive	D	Supports Sensitivity Response	2	accepted	EID3010 SU11248 + Daunorubicin has a synergic effect on Murine Ba/F3 cells with FLT3 D835V mutation. (Combination Index = 0.82 for ED50, Combination Index = 0.72 for ED75, Combination Index = 0.64 for ED90) PMID 15304385 · Yee et al., 2004 · Open in CIViC	civic
Sunitinib	Acute Myeloid LeukemiaCURATED_BROADER	Predictive	C	Supports Sensitivity Response	—	accepted	EID4022 In a retrospective study of 15 acute myeloid leukemia patients, the patients with FLT3 D835 mutation (n=2) were associated with improved response to sunitinib treatment (2/2 vs. 2/7) compared to FLT3 … (full text at CIViC) PMID 15459012 · Fiedler et al., 2005 · Open in CIViC	civic
〃	Acute Myeloid LeukemiaCURATED_BROADER	Predictive	D	Does Not Support Sensitivity Response	3	accepted	EID3008 Murine Ba/F3 cells with FLT3 D835V mutation were assessed as not sensitive to SU11248 (Sunitinib) with dose required to inhibit proliferation of cells to 50% of untreated controls ED50 = 110nM. PMID 15304385 · Yee et al., 2004 · Open in CIViC	civic
〃	Acute Myeloid LeukemiaCURATED_BROADER	Predictive	D	Supports Sensitivity Response	—	submitted	EID4023 In an in vitro study, Chinese hamster ovary cells transiently expressing FLT3 D835V mutation demonstrated sensitivity to sunitinib treatment (IC50: 30-300nM) similar to Chinese hamster ovary cells exp… (full text at CIViC) PMID 12531805 · O'Farrell et al., 2003 · Open in CIViC	civic

FLT3 E588_Y589INSKYFYVDFRE3
Sunitinib	Acute Myeloid LeukemiaCURATED_BROADER	Predictive	C	Supports Sensitivity Response	—	submitted	EID4735 In a retrospective study of 15 acute myeloid leukemia patients, the patients with FLT3 internal tandem duplication mutation (n=2) were associated with improved response to sunitinib treatment. The pat… (full text at CIViC) PMID 15459012 · Fiedler et al., 2005 · Open in CIViC	civic
〃	Acute Myeloid LeukemiaCURATED_BROADER	Predictive	C	Supports Sensitivity Response	—	submitted	EID4736 In a phase I study of 29 acute myeloid leukemia patients, patients with FLT3 internal tandem duplication (ITD) mutation (n=3) were associated with improved response to sunitinib monotherapy compared … (full text at CIViC) PMID 14654525 · O'Farrell et al., 2003 · Open in CIViC	civic
〃	Acute Myeloid LeukemiaCURATED_BROADER	Predictive	D	Supports Sensitivity Response	—	submitted	EID4737 In an in vitro study, leukemia M4;11 (endogenous), myeloid 32D (overexpression) and Chinese hamster ovary (transient expression) cell lines expressing FLT3 internal tandem duplication mutation demonst… (full text at CIViC) PMID 12531805 · O'Farrell et al., 2003 · Open in CIViC	civic

FLT3 V592_D593INSDFREY3
Sunitinib	Acute Myeloid LeukemiaCURATED_BROADER	Predictive	C	Supports Sensitivity Response	—	submitted	EID4739 In a retrospective study of 15 acute myeloid leukemia patients, the patients with FLT3 internal tandem duplication mutation (n=2) were associated with improved response to sunitinib treatment. The pat… (full text at CIViC) PMID 15459012 · Fiedler et al., 2005 · Open in CIViC	civic
〃	Acute Myeloid LeukemiaCURATED_BROADER	Predictive	C	Supports Sensitivity Response	—	submitted	EID4740 In a phase I study of 29 acute myeloid leukemia patients, patients with FLT3 internal tandem duplication (ITD) mutation (n=3) were associated with improved response to sunitinib monotherapy compared … (full text at CIViC) PMID 14654525 · O'Farrell et al., 2003 · Open in CIViC	civic
〃	Acute Myeloid LeukemiaCURATED_BROADER	Predictive	D	Supports Sensitivity Response	—	submitted	EID4741 In an in vitro study, leukemia M4;11 (endogenous), myeloid 32D (overexpression) and Chinese hamster ovary (transient expression) cell lines expressing FLT3 internal tandem duplication mutation demonst… (full text at CIViC) PMID 12531805 · O'Farrell et al., 2003 · Open in CIViC	civic

KIT N822K2
Sorafenib + SunitinibSubstitutes	Acute Myeloid LeukemiaCURATED_BROADER	Predictive	D	Does Not Support Sensitivity Response	3	accepted	EID7370 In a preclinical trial, the AML cell line Kasumi-1 with the KIT mutation N822K was treated with the tyrosine kinase inhibitors (TKI) ponatinib, sorafenib, and sunitinib. Ponatinib was much more effect… (full text at CIViC) PMID 21482694 · Gozgit et al., 2011 · Open in CIViC	civic
Sunitinib	Acute Myeloid LeukemiaCURATED_BROADER	Predictive	D	Does Not Support Sensitivity Response	3	rejected	EID7371 In a preclinical trial, Kasumi-1 AML cell lines with the KIT mutation N822K were treated with the tyrosine kinase inhibitors (TKI) ponatinib, sorafenib, and sunitinib. Ponatinib was much more effectiv… (full text at CIViC) PMID 21482694 · Gozgit et al., 2011 · Open in CIViC	civic

KIT D579del2
Sunitinib	Gastrointestinal Stromal Tumor	Predictive	C	Supports Resistance	2	accepted	EID4142 Patient 74 from a larger cohort of genotyped patients (n= 78) with imatinib resistant or intolerant gastrointestinal stromal tumors (GISTs) harbored a primary (pre-imatinib treatment) KIT D579 deletio… (full text at CIViC) PMID 18955458 · Heinrich et al., 2008 · Open in CIViC	civic
〃	Gastrointestinal Stromal Tumor	Predictive	C	Supports Resistance	—	submitted	EID4143 In a retrospective study of 1124 sunitinib-treated gastrointestinal stromal tumor patients, patients with primary KIT exon 11 mutations (n=143) were associated with decreased progression free surviva… (full text at CIViC) PMID 26772734 · Reichardt et al., 2016 · Open in CIViC	civic