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.

openfdaRegulatory5 approval records · authority, jurisdiction and indication text as published.

Jurisdiction · authority	Cancer	Indication	Status	Approval date	Source
US FDA	—	Efficacy supplement 2022-09-22 (see label)	approved	Sep 22, 2022	openfda
US FDA	—	Efficacy supplement 2020-06-04 (see label)	approved	Jun 4, 2020	openfda
US FDA	Renal Cell Carcinoma	as a single agent, for the treatment of advanced renal cell carcinoma (RCC) after failure of one prior systemic therapy.	approved	Jan 27, 2012	openfda
US FDA	Renal Cell Carcinoma	in combination with avelumab, for the first-line treatment of patients with advanced renal cell carcinoma (RCC).	approved	Jan 27, 2012	openfda

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 13 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 51–57 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 Y253H + ABL1 Fusion2
Axitinib	Chronic Myeloid Leukemia, BCR-ABL1 Positive

Clinical trials

Trials with this intervention (160)

Most recently updated first, 50 per page.

clinicaltrialsPublishedShowing 101–150 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
NCT02354612	Open Label Continuation Study of TRC105 for Patients Who Have Completed a Prior TRC105 Trial	no longer available	—	—	Tracon Pharmaceuticals Inc.INDUSTRY	1	Feb 15, 2021	clinicaltrials
NCT04637204	Real-world Treatment Patterns and Outcomes Among aRCC Patients on Cabozantinib or Axitinib in England	completed

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 16 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)