Axitinib clinical trials
Axitinib is named as an intervention in 25 current clinical trials in our China, Australia, Canada, Israel, USA, France, Spain, Italy, Mexico, Denmark, Japan, South Korea, Netherlands, Ireland, UK, Belgium, Poland, Taiwan, Germany, Austria, Czechia and Egypt registers. 16 are recruiting patients now. The most common phase is Phase 2. The sponsor with the most trials is Pfizer (2). The most-studied condition is Metastatic Renal Cell Carcinoma. The EU clinical trials register (CTIS) separately lists 3 authorised or ongoing trials.
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- 1 EU orphan designation, most recently for treatment of renal-cell carcinoma (23 Feb 2011, withdrawn)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 8 Nov 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 (2026.3.1), 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.
Trials by status
Trials by phase
Clinical trials of Axitinib
25 trialsRegisters list studies that are recruiting, about to open, active but closed to enrolment, or enrolling by invitation. The UK and USA registers cover industry-sponsored studies only. Trial titles and statuses are copied from the registry as published.
Axitinib in the EU trials register (CTIS)
3 trialsAuthorised or ongoing trials in the EU Clinical Trials Information System that list a product containing Axitinib. Many trials are registered in both CTIS and ClinicalTrials.gov, so these are shown separately rather than added to the count above. Trials with a site in Ireland are listed first.
| Study | Phase | Status | Sponsor | Countries |
|---|---|---|---|---|
|
Randomized study evaluating the impact of an innovative and cooperative pathway integrating oncogeriatric, pharmaceutical and pharmacological follow-up in elderly patients (>70 years old) presenting with cancer and treated with oral therapy _ POG
2025-523610-83-00 · Immune System Diseases
|
Phase 4 | Authorised | Institut Gustave Roussy | France |
|
Sequence Strategy of Immuneoncology (IO-IO) vs IO-tyrosine kinase inhibitors (TKI) followed by TKI in metastatic renal cell carcinoma (mRCC): A randomized phase 3 study Meet uro and FICOG trial. COMBO-Seq trial.
2025-523903-31-00 · Neoplasms
|
Phase 3 | Authorised | Fondazione IRCCS Istituto Nazionale Dei Tumori | Italy |
|
TAILOR-PANC: Molecularly Tailored Therapy versus Standard Care in Advanced Pancreatic Cancer (DPCG-02)
2025-522431-34-00 · CTIS ↗ · Neoplasms
|
Phase 2 | Authorised | Region Hovedstaden | Denmark |
Axitinib across our data
Ireland · EU · USThe same active substance in our other registers, matched by its exact name. Each entry links to the register record it comes from.
Licensed in Ireland (HPRA)
7 single-substance products containing Axitinib on the HPRA medicines list.
- Axitinib Accord 1 mg Film-coated tabletAccord Healthcare S.L.U. · EU/1/24/1847/001-005
- Axitinib Accord 3 mg Film-coated tabletAccord Healthcare S.L.U. · EU/1/24/1847/006-010
- Axitinib Accord 5 mg Film-coated tabletAccord Healthcare S.L.U. · EU/1/24/1847/011-015
- Inlyta 3 mg film-coated tabletsPfizer Europe MA EEIG · EU/1/12/777/007-009
- Inlyta 5 mg film-coated tabletsPfizer Europe MA EEIG · EU/1/12/777/004-006
Supply shortages
No entry for Axitinib in the EMA, FDA or German BfArM shortage lists we track.
Conditions studied with Axitinib
50 conditionsAll 50 conditions
| Condition (as registered) | Trials |
|---|---|
| Metastatic Renal Cell Carcinoma | 4 |
| Advanced Renal Cell Carcinoma | 3 |
| Stage III Renal Cell Cancer AJCC v8 | 2 |
| Stage IV Renal Cell Cancer AJCC v8 | 2 |
| Carcinoma, Renal Cell | 2 |
| Renal Cancer | 2 |
| Renal Cell Carcinoma | 2 |
| Clear Cell Renal Cell Carcinoma | 2 |
| Cancer | 2 |
| Tumors | 2 |
| Neoplasia | 2 |
| Neoplasms | 2 |
| Unresectable Renal Cell Carcinoma | 1 |
| Advanced Malignancies | 1 |
| NSCLC | 1 |
| Ovarian Cancer | 1 |
| Urothelial Cancer | 1 |
| Renal Neoplasm | 1 |
| Neoadjuvant | 1 |
| First-line Treatment | 1 |
| Non Clear Cell Renal Cell Carcinoma | 1 |
| Sarcomatoid Renal Cell Carcinoma | 1 |
| Collecting Duct Carcinoma | 1 |
| Radiation Therapy | 1 |
| Targeted Therapy | 1 |
| Immunotherapy | 1 |
| Renal Cancer Metastatic | 1 |
| Melanoma | 1 |
| Mucosal Melanoma | 1 |
| Metastatic Melanoma | 1 |
| Non-clear Renal Cell Carcinoma | 1 |
| Immune Checkpoint Inhibitors | 1 |
| Cytoreductive Nephrectomy | 1 |
| Clear Cell Renal Cell Cancer (ccRCC) | 1 |
| Oligometastatic Clear Cell Renal Cell Carcinoma | 1 |
| Advanced Renal Cell Carcinoma (RCC) | 1 |
| PTC | 1 |
| Atorvastatin | 1 |
| Targeted Therapy Combined With Immunotherapy | 1 |
| Metastatic Kidney Cancer | 1 |
| Metastatic Kidney Carcinoma | 1 |
| Metastatic Renal Cell Carcinoma (mRCC) | 1 |
| Neoplasm | 1 |
| Lymphoma, Non-Hodgkin | 1 |
| Multiple Myeloma | 1 |
| Advanced Solid Tumors | 1 |
| Malignant Neoplasms | 1 |
| Malignant Neoplasm of Kidney, Except Renal Pelvis | 1 |
| Metastatic Endometrial Cancer | 1 |
| TFE3-Rearranged Renal Cell Carcinoma | 1 |
Sponsors
lead sponsor per trial+ 8 more sponsors in the trial list above.
By country register
A trial with sites in more than one country appears in each of those registers. CTIS does not publish a recruiting flag; its trials may also appear in the registers above.
Related compounds
Questions about Axitinib trials
How many clinical trials are testing Axitinib?
25 current trials in our China, Australia, Canada, Israel, USA, France, Spain, Italy, Mexico, Denmark, Japan, South Korea, Netherlands, Ireland, UK, Belgium, Poland, Taiwan, Germany, Austria, Czechia and Egypt registers name Axitinib (also registered as AG 013736) as a drug or biological intervention, as of the registry sync on 10 November 2026. Completed and withdrawn studies are not counted.
Are Axitinib trials recruiting patients?
Yes. 16 of the 25 trials are recruiting: 8 with sites in China, 2 with sites in Australia, 2 with sites in Canada, 1 with sites in Israel, 1 with sites in USA, 1 with sites in France, 1 with sites in Spain, 2 with sites in Italy, 1 with sites in Mexico, 1 with sites in Denmark, 1 with sites in Japan, 1 with sites in South Korea, 2 with sites in Netherlands, 1 with sites in Ireland, 1 with sites in Germany, 1 with sites in Austria and 1 with sites in Czechia. Eligibility and site contacts are on each trial's record. Only the study team can confirm whether a patient is eligible.
Who sponsors Axitinib clinical trials?
Pfizer (2), Peking University Cancer Hospital & Institute (2), NRG Oncology (1) and MedImmune LLC (1), among 23 lead sponsors in total. The number in brackets is how many trials each organisation leads.
Are there Axitinib clinical trials in Ireland?
Yes. 1 trial in our Ireland register (ClinicalTrials.gov). Some may be the same study registered in both. See the Irish clinical trials register for sites and contacts.
Is Axitinib licensed in Ireland?
Yes. The HPRA medicines list includes 7 single-substance products containing Axitinib, for example Axitinib Accord 1 mg Film-coated tablet (Accord Healthcare S.L.U.). A licence does not mean a product is currently marketed or reimbursed; see each product's record.
Is there a Axitinib shortage?
Not in the lists we track: Axitinib has no entry in the EMA, FDA or German BfArM shortage registers as of their latest sync.
Where does this information come from?
Every trial, status, phase and sponsor on this page is copied from public ClinicalTrials.gov records by a daily sync. Nothing here describes how Axitinib works or whether it is effective, and it is not medical advice.
How this page is built
Everything on this page is copied from public ClinicalTrials.gov registry records — it is not written from memory, and nothing here describes how Axitinib works or whether it is effective. Each trial links to its own record so you can check it yourself.
- ClinicalTrials.gov (U.S. National Library of Medicine) ↗ Trial IDs, titles, intervention names and synonyms, phase, overall status, lead sponsor and conditions for every trial on this page
This page is built automatically: a daily sync job reads the registry records behind our country trial registers, collects every trial that lists Axitinib (or a registered synonym) as a drug or biological intervention, and tabulates the registry fields directly. Placebos and generic comparators are excluded. There is no AI drafting and no per-compound editorial pass, and the page has not been clinically reviewed. The “last verified” date above is the timestamp of that sync, not a review date. Our general editorial approach is described in our editorial standards and corrections policy. The ClinicalTrials.gov data on this page was last retrieved on 10 Nov 2026. How every register is built: methodology · fixes we have made: corrections log.