Drug · Small Molecule

Axitinib

CI-DRUG-00000090Explore in graph →NCIt C38718 CHEMBL1289926 CIViC Approved

Regulatory

Approvals (11)

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	Renal Cell Carcinoma	Axitinib Accord is indicated for the treatment of adult patients with advanced renal cell carcinoma (RCC) after failure of prior treatment with sunitinib or a cytokine.	approved	Sep 19, 2024	ema
EU EMA	Renal Cell Carcinoma	Inlyta is indicated for the treatment of adult patients with advanced renal cell carcinoma (RCC) after failure of prior treatment with sunitinib or a cytokine.	approved	Sep 3, 2012	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 16 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 3	35	18	10	147	11	CA, EU, US	Jan 27, 2012	2002-11
Malignant Kidney Neoplasm	Approved	Phase 3	22	10	5	53	4	EU, US	Jan 27, 2012	Dec 12, 2007
Malignant Lung Neoplasm	Phase3	Phase 3	1	0	1	6	0	—	—	2005-02
Malignant Ovarian Neoplasm	Phase3	Phase 3	1	0	1	2	0

Curated evidence

Clinical evidence (57)

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

civicCuratedShowing 1–50 of 57 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
ABL1 T315I + ABL1 Fusion5
Axitinib + Ponatinib

Clinical trials

Trials with this intervention (160)

Most recently updated first, 50 per page.

clinicaltrialsPublishedShowing 51–100 of 160 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
NCT04562441	NPC - AXEL Study : Axitinib-Avelumab	completed	Phase 2	13	Chinese University of Hong KongOTHER	1	Jan 10, 2025	clinicaltrials
NCT05097599	StrataPATH™ (Precision Indications for Approved Therapies)(StrataPATH)	terminated	Phase 2

Molecule

Record

Kind: Small Molecule
Mechanism: Vascular endothelial growth factor receptor inhibitor
Targets: 3 genes
UNII: C9LVQ0YUXG
Aliases: AG 013736, AG-013736, AG013736, AG-13736, Axitinib, Axitinib Accord, Inlyta, INLYTA, N-methyl-2-((3-((1E)-2-(pyridin-2-yl)ethenyl)-1H-indazol-6-yl)sulfanyl)benzamide, NSC-757441

Data updated 19 hours agoSource updated unknown

Identifiers

Codes (11)

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

System	Code	Label
ATC (WHO)	L01EK01	AXITINIB
DIN (Health Canada)	02389630	INLYTA
DIN (Health Canada)

ABL1 E255V + ABL1 Fusion2
Axitinib	Chronic Myeloid Leukemia, BCR-ABL1 PositiveALIAS	Predictive	D	Supports Resistance	2	accepted	EID4441 In a proliferation assay measuring tritiated thymidine incorporation in the presence of axitinib, Ba/F3 cells carrying the BCR-ABL1 variant showed increased incorporation when harboring fusions with t… (full text at CIViC) PMID 25686603 · Pemovska et al., 2015 · Open in CIViC	civic
〃	Chronic Myeloid Leukemia, BCR-ABL1 PositiveALIAS	Predictive	D	Supports Resistance	2	accepted	EID4442 In an in vitro study, a pro-B Ba/F3 cell line expressing E255V mutation in the ABL1 portion of the BCR-ABL1 fusion protein (overexpression) demonstrated resistance to axitinib treatment (IC50: 1015nM)… (full text at CIViC) PMID 26582647 · Zabriskie et al., 2016 · Open in CIViC	civic

ABL1 F317L + ABL1 Fusion2
Axitinib	Chronic Myeloid Leukemia, BCR-ABL1 PositiveALIAS	Predictive	D	Supports Resistance	2	accepted	EID4390 In a proliferation assay measuring tritiated thymidine incorporation in the presence of axitinib, Ba/F3 cells carrying the BCR-ABL1 variant showed increased incorporation when harboring fusions with t… (full text at CIViC) PMID 25686603 · Pemovska et al., 2015 · Open in CIViC	civic
〃	Chronic Myeloid Leukemia, BCR-ABL1 PositiveALIAS	Predictive	D	Supports Resistance	2	accepted	EID4391 In an in vitro study, a pro-B Ba/F3 cell line expressing F317L mutation in the ABL1 portion of the BCR-ABL1 fusion protein (overexpression) demonstrated resistance to axitinib treatment (IC50: 1170nM)… (full text at CIViC) PMID 26582647 · Zabriskie et al., 2016 · Open in CIViC	civic

ABL1 G250E + ABL1 Fusion2
Axitinib	Chronic Myeloid Leukemia, BCR-ABL1 PositiveALIAS	Predictive	D	Supports Resistance	2	accepted	EID4320 In a proliferation assay measuring tritiated thymidine incorporation in the presence of axitinib, Ba/F3 cells carrying the BCR-ABL1 variant showed higher incorporation when harboring fusions with the … (full text at CIViC) PMID 25686603 · Pemovska et al., 2015 · Open in CIViC	civic
〃	Chronic Myeloid Leukemia, BCR-ABL1 PositiveALIAS	Predictive	D	Supports Resistance	2	accepted	EID4321 In an in vitro study, pro-B Ba/F3 cell line expressing G250E mutation in the ABL1 portion of the BCR-ABL1 fusion protein (overexpression) demonstrated resistance to axitinib treatment (IC50: 1120.7nM)… (full text at CIViC) PMID 26582647 · Zabriskie et al., 2016 · Open in CIViC	civic

ABL1 M351T + ABL1 Fusion2
Axitinib	Chronic Myeloid Leukemia, BCR-ABL1 PositiveALIAS	Predictive	D	Supports Resistance	2	accepted	EID4399 In an in vitro study, pro-B Ba/F3 cell line expressing M351T mutation in the ABL1 portion of the BCR-ABL1 fusion protein (overexpression) demonstrated resistance to axitinib treatment (IC50: 920.2nM),… (full text at CIViC) PMID 26582647 · Zabriskie et al., 2016 · Open in CIViC	civic
〃	Chronic Myeloid Leukemia, BCR-ABL1 PositiveALIAS	Predictive	D	Does Not Support Resistance	2	accepted	EID7769 In a proliferation assay measuring tritiated thymidine incorporation in the presence of axitinib, Ba/F3 cells carrying the BCR-ABL1 variant showed decreased incorporation when harboring fusions with t… (full text at CIViC) PMID 25686603 · Pemovska et al., 2015 · Open in CIViC	civic

ABL1 Q252H + ABL1 Fusion2
Axitinib	Chronic Myeloid Leukemia, BCR-ABL1 PositiveALIAS	Predictive	D	Supports Resistance	2	accepted	EID4323 In a proliferation assay measuring tritiated thymidine incorporation in the presence of axitinib, Ba/F3 cells carrying the BCR-ABL1 variant showed increased incorporation when harboring fusions with t… (full text at CIViC) PMID 25686603 · Pemovska et al., 2015 · Open in CIViC	civic
〃	Chronic Myeloid Leukemia, BCR-ABL1 PositiveALIAS	Predictive	D	Supports Resistance	2	accepted	EID4324 In an in vitro study, pro-B Ba/F3 cell line expressing Q252H mutation in the ABL1 portion of the BCR-ABL1 fusion protein (overexpression) demonstrated resistance to axitinib treatment (IC50: 967.4nM),… (full text at CIViC) PMID 26582647 · Zabriskie et al., 2016 · Open in CIViC	civic