Cabazitaxel clinical trials
Cabazitaxel is named as an intervention in 10 current clinical trials in our Australia, USA, France, Spain, UK, Germany, Italy, Canada, Japan, South Korea, Taiwan, Netherlands, Belgium, Switzerland, Poland, Turkey, Israel, Sweden, Austria, China, Denmark, Singapore, Egypt, Norway, Ireland, Portugal, India and Brazil registers. 5 are recruiting patients now. The most common phase is Phase 3. The sponsor with the most trials is Amgen (2). The most-studied condition is Metastatic Castration-resistant Prostate Cancer.
Where Cabazitaxel is approved
All regulators →Of the three regulators tracked here, the first to approve Cabazitaxel was the US, on 17 Jun 2010. It is approved in 3 of the 3 regulators tracked here.
- 1 EU orphan designation, most recently for treatment of ovarian cancer (28 Jul 2026, positive)
- 1 EU safety letter (DHPC), latest: medication error for Cabazitaxel Accord, 28 Oct 2020
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.
Cabazitaxel patents and exclusivity
Expiry tracker →Protections still running for marketed products containing Cabazitaxel, as listed by the regulators. Expired patents and exclusivities, and discontinued products, are not shown.
- 4 listed patents; the last listed expires 27 Apr 2031 (US 12453712, including a 6-month 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 Cabazitaxel
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 Cabazitaxel works
All drug targets →- Tubulin inhibitor InhibitorTarget: Tubulin✓ In ChEMBL and the Guide to Pharmacology
- Transitional cell carcinomaPhase 2/3
- Adrenal cortex carcinomaPhase 2
- Bladder transitional cell carcinomaPhase 2
- Colorectal cancerPhase 2
- Gastric adenocarcinomaPhase 2
- Gastric cancerPhase 2
- Germ cell tumorPhase 2
- GlioblastomaPhase 2
- Head and neck cancerPhase 2
- Head and neck squamous cell carcinomaPhase 2
Mechanisms and diseases from ChEMBL via the Open Targets Platform (release 26.09), ChEMBL record CHEMBL1201748, CC BY-SA 3.0. Targets checked against the IUPHAR/BPS Guide to PHARMACOLOGY (2026.3.1), ligand 6798, 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 Cabazitaxel
All NICE appraisals →NICE, which decides whether the NHS in England should fund new medicines, has published 2 technology appraisals of Cabazitaxel. 1 is current, and 1 of it recommends it for at least some patients. 1 older appraisal was replaced or withdrawn.
| Appraisal | NICE recommendation | Published | Status |
|---|---|---|---|
| Cabazitaxel for hormone-relapsed metastatic prostate cancer treated with docetaxel NICE TA391 | Recommended | 25 May 2016 Updated 24 Aug 2016 | 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 Cabazitaxel
The package leaflet is the official guide for patients that comes with every medicine. These links go to the regulators that publish it.
- IEIreland: 5 products on the HPRA listEach product record links to the HPRA, which publishes the leaflet and SmPC.
- EUEuropean Union: Jevtana, Cabazitaxel 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 Cabazitaxel
- ATC code
- L01CD04
- ChEMBL
- CHEMBL1201748
- DrugBank
- DB06772
- PubChem CID
- 9854073
- CAS number
- 183133-96-2
- FDA UNII
- 51F690397J
- Wikidata
- Q412963
- Wikipedia
- Cabazitaxel
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 Cabazitaxel
10 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.
Cabazitaxel 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)
5 single-substance products containing Cabazitaxel on the HPRA medicines list.
- Cabazitaxel EVER Pharma 10 mg/ml concentrate for solution for infusionEVER Valinject GmbH · PA1774/004/001 · Marketed
- Cabazitaxel Accord 20 mg/ml concentrate for solution for infusionAccord Healthcare S.L.U. · EU/1/20/1448/001
- JEVTANA 60 mg concentrate and solvent for solution for infusionSanofi Winthrop Industrie · EU/1/11/676/001
- Cabazitaxel Fresenius Kabi 20 mg/ml concentrate for solution for infusionFresenius Kabi Deutschland GmbH · PA2059/082/001 · Not marketed
- Cabazitaxel MSN 60 mg concentrate and solvent for solution for infusionMSN Labs Europe Limited · PA23250/002/001 · Not marketed
Supply shortages
No entry for Cabazitaxel in the EMA, FDA or German BfArM shortage lists we track.
Conditions studied with Cabazitaxel
13 conditionsAll 13 conditions
| Condition (as registered) | Trials |
|---|---|
| Metastatic Castration-resistant Prostate Cancer | 5 |
| Prostatic Neoplasms, Castration-Resistant | 1 |
| Metastatic Castration-resistant Prostate Neoplasms | 1 |
| Metastatic Hormone-sensitive Prostate Cancer | 1 |
| Adenocarcinoma of Prostate | 1 |
| Progression of Prostate Cancer | 1 |
| Metastatic Castration-resistant Prostate Cancer (mCRPC) | 1 |
| Metastatic Hormone-Sensitive Prostate Cancer (mHSPC) | 1 |
| Castration Levels of Testosterone | 1 |
| Castration-Resistant Prostate Carcinoma | 1 |
| Metastatic Prostate Carcinoma in the Soft Tissue | 1 |
| Prostate Carcinoma Metastatic in the Bone | 1 |
| mCRPC | 1 |
Sponsors
lead sponsor per trialBy country register
A trial with sites in more than one country appears in each of those registers.
Related compounds
Questions about Cabazitaxel trials
How many clinical trials are testing Cabazitaxel?
10 current trials in our Australia, USA, France, Spain, UK, Germany, Italy, Canada, Japan, South Korea, Taiwan, Netherlands, Belgium, Switzerland, Poland, Turkey, Israel, Sweden, Austria, China, Denmark, Singapore, Egypt, Norway, Ireland, Portugal, India and Brazil registers name Cabazitaxel (also registered as RPR-116258A) as a drug or biological intervention, as of the registry sync on 9 November 2026. Completed and withdrawn studies are not counted.
Are Cabazitaxel trials recruiting patients?
Yes. 5 of the 10 trials are recruiting: 3 with sites in Australia, 3 with sites in USA, 2 with sites in France, 3 with sites in Spain, 2 with sites in UK, 2 with sites in Germany, 2 with sites in Italy, 2 with sites in Canada, 2 with sites in Japan, 2 with sites in South Korea, 2 with sites in Taiwan, 3 with sites in Netherlands, 3 with sites in Belgium, 3 with sites in Switzerland, 1 with sites in Poland, 1 with sites in Turkey, 1 with sites in Israel, 2 with sites in Sweden, 2 with sites in Austria, 1 with sites in China, 1 with sites in Singapore, 1 with sites in Egypt, 1 with sites in Norway, 1 with sites in Portugal, 1 with sites in India and 1 with sites in Brazil. Eligibility and site contacts are on each trial's record. Only the study team can confirm whether a patient is eligible.
Who sponsors Cabazitaxel clinical trials?
Amgen (2), Merck Sharp & Dohme LLC (1), AstraZeneca (1) and Janssen Research & Development, LLC (1), among 9 lead sponsors in total. The number in brackets is how many trials each organisation leads.
Are there Cabazitaxel 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 Cabazitaxel licensed in Ireland?
Yes. The HPRA medicines list includes 5 single-substance products containing Cabazitaxel, for example Cabazitaxel EVER Pharma 10 mg/ml concentrate for solution for infusion (EVER Valinject GmbH). A licence does not mean a product is currently marketed or reimbursed; see each product's record.
Is there a Cabazitaxel shortage?
Not in the lists we track: Cabazitaxel 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 Cabazitaxel 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 Cabazitaxel 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 Cabazitaxel (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 9 Nov 2026. How every register is built: methodology · fixes we have made: corrections log.