Vinorelbine clinical trials
Vinorelbine is named as an intervention in 41 current clinical trials in our China, France, Spain, Italy, Canada, Australia, USA, Israel, UK, Japan, South Korea, Netherlands, Belgium, Germany, Poland, Taiwan, Denmark, Austria, Brazil, Turkey, Ireland, Sweden, Switzerland, Norway, Mexico, Singapore, Czechia, Portugal, India and Egypt registers. 22 are recruiting patients now. The most common phase is Phase 3. The sponsor with the most trials is AstraZeneca (2). The most-studied condition is Breast Cancer.
Where Vinorelbine is approved
All regulators →Of the three regulators tracked here, the first to approve Vinorelbine was Canada, on 10 May 1994. It is approved in 2 of the 3 regulators tracked here.
- 1 EU orphan designation, most recently for treatment of soft tissue sarcoma (11 Jan 2019, positive)
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.
What health systems spend on Vinorelbine
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 Vinorelbine works
All drug targets →- Tubulin inhibitor InhibitorTarget: TubulinChEMBL only
- Anaplastic large cell lymphomaPhase 3
- Breast cancerPhase 3
- Cervical cancerPhase 3
- Cervical carcinomaPhase 3
- Classic Hodgkin lymphomaPhase 3
- Lung adenocarcinomaPhase 3
- Lung cancerPhase 3
- Malignant pleural mesotheliomaPhase 3
- Non-Hodgkin lymphomaPhase 3
- Non-small cell lung carcinomaPhase 3
Mechanisms and diseases from ChEMBL via the Open Targets Platform (release 26.09), ChEMBL record CHEMBL553025, CC BY-SA 3.0. Targets checked against the IUPHAR/BPS Guide to PHARMACOLOGY (2026.3.1), ligand 7105, 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 Vinorelbine
All NICE appraisals →NICE, which decides whether the NHS in England should fund new medicines, has published 2 technology appraisals of Vinorelbine. 1 is current, and 1 of it recommends it for at least some patients. 1 older appraisal was replaced or withdrawn.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 |
|---|---|---|---|
| Guidance on the use of vinorelbine for the treatment of advanced breast cancer NICE TA54 | Not recommended Recommended | 13 Dec 2002 | 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 Vinorelbine
The package leaflet is the official guide for patients that comes with every medicine. These links go to the regulators that publish it.
- IEIreland: 4 products on the HPRA listEach product record links to the HPRA, which publishes the leaflet and SmPC.
- 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 Vinorelbine
- ATC code
- L01CA04
- ChEMBL
- CHEMBL553025
- DrugBank
- DB00361
- PubChem CID
- 5311497
- CAS number
- 71486-22-1
- FDA UNII
- Q6C979R91Y
- Wikidata
- Q420532
- Wikipedia
- Vinorelbine
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 Vinorelbine
41 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.
Vinorelbine 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)
4 single-substance products containing Vinorelbine on the HPRA medicines list.
- NAVELBINE 20 mg soft capsulePierre Fabre Medicament · PA0329/011/001 · Marketed
- NAVELBINE 30 mg soft capsulePierre Fabre Medicament · PA0329/011/002 · Marketed
- Vinorelbine Accord 20 mg soft capsulesAccord Healthcare Ireland Ltd. · PA2315/253/001 · Not marketed
- Vinorelbine Accord 30 mg soft capsulesAccord Healthcare Ireland Ltd. · PA2315/253/002 · Not marketed
Supply shortages
- Bendarelbin 10 mg/ml Konzentrat zur Herstellung einer InfusionslösungGermany (BfArM) · Production problem · 15 Oct 2025 to 31 Dec 2026
Conditions studied with Vinorelbine
41 conditionsAll 41 conditions
| Condition (as registered) | Trials |
|---|---|
| Breast Cancer | 7 |
| Metastatic Breast Cancer | 5 |
| Rhabdomyosarcoma | 3 |
| Triple Negative Breast Cancer | 3 |
| Carcinoma, Non-Small-Cell Lung | 2 |
| Advanced Breast Cancer | 2 |
| Alveolar Rhabdomyosarcoma | 2 |
| Botryoid-Type Embryonal Rhabdomyosarcoma | 2 |
| Embryonal Rhabdomyosarcoma | 2 |
| Cervical Cancer | 1 |
| Metastatic HER2-positive Breast Cancer | 1 |
| Breast Cancer, Metastatic | 1 |
| Neoplasms | 1 |
| Child | 1 |
| Adolescent | 1 |
| Non-small Cell Lung Cancer | 1 |
| Triple-Negative Breast Cancer | 1 |
| Relapsed/Refractory Large B-Cell Lymphoma | 1 |
| Refractory Breast Carcinoma | 1 |
| HR+HER2- Breast Cancer | 1 |
| Rhabdomyosarcoma Recurrent | 1 |
| Maintenance Treatment | 1 |
| HER2-negative Breast Cancer | 1 |
| Locally Advanced or Metastatic Breast Cancer | 1 |
| Advanced Non-Small Cell Lung Cancer | 1 |
| Advanced Non Small Cell Lung Cancer | 1 |
| MET Exon 14 Mutation | 1 |
| Non Small Cell Lung Cancer Metastatic | 1 |
| Interstitial Lung Disease (ILD) | 1 |
| Pediatric Cancer | 1 |
| NSCLC (Advanced Non-small Cell Lung Cancer) | 1 |
| Carcinoma, Non-Small -Cell Lung | 1 |
| Resectable Lung Non-Small Cell Carcinoma | 1 |
| Stage II Lung Cancer AJCC v8 | 1 |
| Stage IIIA Lung Cancer AJCC v8 | 1 |
| Stage IIIB Lung Cancer AJCC v8 | 1 |
| Metastatic Embryonal Rhabdomyosarcoma | 1 |
| Recurrent Breast Cancer | 1 |
| Advanced Malignancies | 1 |
| Fludzoparib" and Anti-angiogenic | 1 |
| HRD-positive/HER2-negative Advanced Breast Cancer | 1 |
Sponsors
lead sponsor per trial+ 17 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.
Related compounds
Questions about Vinorelbine trials
How many clinical trials are testing Vinorelbine?
41 current trials in our China, France, Spain, Italy, Canada, Australia, USA, Israel, UK, Japan, South Korea, Netherlands, Belgium, Germany, Poland, Taiwan, Denmark, Austria, Brazil, Turkey, Ireland, Sweden, Switzerland, Norway, Mexico, Singapore, Czechia, Portugal, India and Egypt registers name Vinorelbine (also registered as KW 2307) as a drug or biological intervention, as of the registry sync on 10 November 2026. Completed and withdrawn studies are not counted.
Are Vinorelbine trials recruiting patients?
Yes. 22 of the 41 trials are recruiting: 13 with sites in China, 7 with sites in France, 5 with sites in Spain, 5 with sites in Italy, 3 with sites in Canada, 3 with sites in Australia, 3 with sites in USA, 1 with sites in Israel, 3 with sites in UK, 2 with sites in Japan, 2 with sites in South Korea, 3 with sites in Netherlands, 3 with sites in Belgium, 2 with sites in Germany, 2 with sites in Poland, 1 with sites in Taiwan, 2 with sites in Denmark, 2 with sites in Austria, 1 with sites in Brazil, 1 with sites in Turkey, 1 with sites in Ireland, 1 with sites in Sweden, 1 with sites in Switzerland, 1 with sites in Norway, 1 with sites in Singapore, 1 with sites in Czechia and 1 with sites in Portugal. Eligibility and site contacts are on each trial's record. Only the study team can confirm whether a patient is eligible.
Who sponsors Vinorelbine clinical trials?
AstraZeneca (2), Sichuan Baili Pharmaceutical Co., Ltd (2), Sun Yat-sen University (2) and Qilu Pharmaceutical Co., Ltd (2), among 32 lead sponsors in total. The number in brackets is how many trials each organisation leads.
Are there Vinorelbine clinical trials in Ireland?
Yes. 2 trials 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 Vinorelbine licensed in Ireland?
Yes. The HPRA medicines list includes 4 single-substance products containing Vinorelbine, for example NAVELBINE 20 mg soft capsule (Pierre Fabre Medicament). A licence does not mean a product is currently marketed or reimbursed; see each product's record.
Is there a Vinorelbine shortage?
The registers we track list 1 entry for Vinorelbine: 1 German notice. Shortages are product- and country-specific; check with a pharmacist.
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 Vinorelbine 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 Vinorelbine 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 Vinorelbine (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.