Inlyta
An oral targeted therapy used to treat advanced kidney cancer.
Where Axitinib is approved
All regulators →Of the three regulators tracked here, the first to approve Axitinib was the US, on 27 Jan 2012. It is approved in 3 of the 3 regulators tracked here.
- 1 EU orphan designation, most recently for treatment of renal-cell carcinoma (23 Feb 2011, withdrawn)
From the regulators' own registers: FDA Drugs@FDA, the EMA medicines list and Health Canada's Notice of Compliance database. Dates are the first listed approval of a product containing only this substance; combination products and nationally authorised EU medicines are not counted.
Axitinib patents and exclusivity
Expiry tracker →Protections still running for marketed products containing Axitinib, as listed by the regulators. Expired patents and exclusivities, and discontinued products, are not shown.
- 4 listed patents; the last listed expires 12 Jul 2037 (US 10869924, including a 6-month paediatric extension).
- Latest patent on the drug substance itself: 14 Jun 2031 (US 8791140, with paediatric extension).
Reproduced from the FDA Orange Book and Purple Book (checked 5 Oct 2026) and the European Commission's Union Register of medicinal products (CC BY 4.0; the EU expiry date is calculated exactly as the Commission's register displays it). Listed patents and dates are as submitted to or published by the regulator and may not reflect litigation, invalidation, settlements, lapsed fees or later extensions. This is not legal advice or a freedom-to-operate opinion, and it does not say when a generic or biosimilar will launch.
What health systems spend on Axitinib
All medicines →From NHSBSA Prescription Cost Analysis (Open Government Licence v3.0) and CMS State Drug Utilization Data. Both are gross amounts: neither system publishes its discounts or rebates per drug. Products combining several substances are not counted here.
How Axitinib works
All drug targets →- Vascular endothelial growth factor receptor inhibitor InhibitorTarget: Vascular endothelial growth factor receptor✓ In ChEMBL and the Guide to Pharmacology
- Age-related macular degenerationPhase 3
- Diabetic retinopathyPhase 3
- Kidney cancerPhase 3
- Malignant pancreatic neoplasmPhase 3
- Pancreatic adenocarcinomaPhase 3
- Pancreatic neoplasmPhase 3
- Renal cell adenocarcinomaPhase 3
- Wet macular degenerationPhase 3
- Neuroendocrine neoplasmPhase 2/3
- Non-small cell lung carcinomaPhase 2/3
Mechanisms and diseases from ChEMBL via the Open Targets Platform (release 26.09), ChEMBL record CHEMBL1289926, CC BY-SA 3.0. Targets checked against the IUPHAR/BPS Guide to PHARMACOLOGY (2026.3), ligand 5659, CC BY-SA 4.0. Trial phases are not approvals: approved uses are shown from the regulators' own records where we hold them.
NICE appraisals of Axitinib
All NICE appraisals →NICE, which decides whether the NHS in England should fund new medicines, has published 1 technology appraisal of Axitinib. 1 is current, and 1 of it recommends it for at least some patients.
| Appraisal | NICE recommendation | Published | Status |
|---|---|---|---|
| Axitinib for treating advanced renal cell carcinoma after failure of prior systemic treatment NICE TA333 | Recommended | 25 Feb 2015 | Current |
NICE decisions apply to the NHS in England. In Ireland the HSE decides on reimbursement, advised by the National Centre for Pharmacoeconomics. Titles, categories and dates link to the guidance on nice.org.uk. © NICE 2026 technology appraisal guidance. Available from www.nice.org.uk/guidance. All rights reserved. Subject to Notice of rights. NICE guidance is prepared for the National Health Service in England. All NICE guidance is subject to regular review and may be updated or withdrawn. NICE accepts no responsibility for the use of its content in this product/publication.
Patient leaflets for Axitinib
The package leaflet is the official guide for patients that comes with every medicine. These links go to the regulators that publish it.
- IEIreland: 7 products on the HPRA listEach product record links to the HPRA, which publishes the leaflet and SmPC.
- EUEuropean Union: Inlyta, Axitinib Accord (generic)EMA product information: package leaflet and summary of product characteristics in every EU language.
- UKUnited Kingdom: Search MHRA ProductsPatient information leaflets and SmPCs for UK-licensed products.
- USUnited States: Search DailyMedFDA-approved labels, including patient and medication guides.
Leaflets differ between brands and countries; always read the one that comes with your own medicine. This is regulatory information, not medical advice.
Reference identifiers for Axitinib
- ATC code
- L01XE17
- ChEMBL
- CHEMBL1289926
- DrugBank
- DB06626
- PubChem CID
- 6450551
- CAS number
- 319460-85-0
- FDA UNII
- C9LVQ0YUXG
- Wikidata
- Q4830631
- Wikipedia
- Axitinib
Codes that identify this medicine in other databases, from Wikidata (CC0), matched by its ChEMBL ID. The ATC code is the WHO classification of what the medicine is used for.
What Inlyta is used for
INLYTA is a kinase inhibitor indicated: • in combination with avelumab, for the first-line treatment of patients with advanced renal cell carcinoma (RCC). ( 1.1 ) • in combination with pembrolizumab, for the first-line treatment of patients with advanced RCC. ( 1.1 ) • as a single agent, for the treatment of advanced renal cell carcinoma (RCC) after failure of one prior systemic therapy. ( 1.2 ) 1.1 First-Line Advanced Renal Cell Carcinoma INLYTA in combination with avelumab is indicated for the first-line treatment of patients with advanced renal cell carcinoma (RCC). INLYTA in combination with pembrolizumab is indicated for the first-line treatment of patients with advanced RCC. 1.2 Second-Line Advanced Renal Cell Carcinoma INLYTA as a single agent is indicated for the treatment of advanced RCC after failure of one prior systemic therapy.
How it works
12.1 Mechanism of Action Axitinib has been shown to inhibit receptor tyrosine kinases including vascular endothelial growth factor receptors (VEGFR)-1, VEGFR-2, and VEGFR-3 at therapeutic plasma concentrations. These receptors are implicated in pathologic angiogenesis, tumor growth, and cancer progression. VEGF-mediated endothelial cell proliferation and survival were inhibited by axitinib in vitro and in mouse models. Axitinib was shown to inhibit tumor growth and phosphorylation of VEGFR-2 in tumor xenograft mouse models.
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How this page is built
The facts on this page are pulled directly from official U.S. FDA datasets — they are not written from memory. Each field below names the dataset it came from, so you can check it yourself.
- FDA Drug Label (openFDA) ↗ Indications, mechanism of action and pharmacologic class
- Drugs@FDA ↗ First FDA approval date and the company holding the application
- FDA Drug Shortage Database ↗ Current US supply / shortage status
Plain-English summaries and drug-class explainers are written and reviewed by Sreepriya Prasannan (MSc Digital Transformation of Life Sciences (Innopharma Education / Griffith College); MSc & BSc Botany). Data is retrieved automatically from the sources above and cross-checked with AI-assisted verification (Anthropic's Claude) — brand and generic names are matched against the exact FDA product record so that a combination product or a different formulation cannot be mistaken for the drug on this page. An editor reviews the result before publication. We describe this in full in our editorial standards and corrections policy. The FDA data on this page was last retrieved on 5 Oct 2026. How every register is built: methodology · fixes we have made: corrections log.