Bendamustine clinical trials
Bendamustine is named as an intervention in 53 current clinical trials in our China, USA, Italy, France, Canada, UK, Poland, Australia, Spain, Germany, Taiwan, South Korea, Israel, Czechia, Brazil, Belgium, Turkey, Japan, Austria, Mexico, Netherlands, Sweden, Portugal, Denmark, Switzerland, Singapore, Ireland and India registers. 25 are recruiting patients now. The most common phase is Phase 3. The sponsor with the most trials is BeOne Medicines (3). The most-studied condition is Chronic Lymphocytic Leukemia. The EU clinical trials register (CTIS) separately lists 2 authorised or ongoing trials.
Where Bendamustine is approved
All regulators →Of the three regulators tracked here, the first to approve Bendamustine was the US, on 20 Mar 2008. It is approved in 2 of the 3 regulators tracked here.
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.
Bendamustine patents and exclusivity
Expiry tracker →Protections still running for marketed products containing Bendamustine, as listed by the regulators. Expired patents and exclusivities, and discontinued products, are not shown.
- 28 listed patents; the last listed expires 29 Jul 2042 (US 12419867).
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 Bendamustine
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 Bendamustine works
All drug targets →- B-cell chronic lymphocytic leukemiaPhase 3
- Immunoblastic LymphadenopathyPhase 3
- Classic Hodgkin lymphomaPhase 3
- Diffuse large B-cell lymphomaPhase 3
- Follicular lymphomaPhase 3
- Indolent B-cell non-Hodgkin lymphomaPhase 3
- Mantle cell lymphomaPhase 3
- Marginal zone lymphomaPhase 3
- Neoplasm of mature B-cellsPhase 3
- Non-Hodgkin lymphomaPhase 3
Mechanisms and diseases from ChEMBL via the Open Targets Platform (release 26.09), ChEMBL record CHEMBL487253, CC BY-SA 3.0. Targets checked against the IUPHAR/BPS Guide to PHARMACOLOGY (2026.3.1), ligand 7478, 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 Bendamustine
All NICE appraisals →NICE, which decides whether the NHS in England should fund new medicines, has published 2 technology appraisals of Bendamustine. 2 are current, and 1 of these recommend it for at least some patients.
| Appraisal | NICE recommendation | Published | Status |
|---|---|---|---|
| Bendamustine for the first-line treatment of chronic lymphocytic leukaemia NICE TA216 | Recommended | 23 Feb 2011 | Current |
| Bendamustine for the treatment of indolent (low grade) non-Hodgkin's lymphoma that is refractory to rituximab (terminated appraisal) NICE TA206 | Terminated (no company submission) | 27 Oct 2010 | 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 Bendamustine
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.
- 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 Bendamustine
- ATC code
- L01AA09
- ChEMBL
- CHEMBL487253
- DrugBank
- DB06769
- PubChem CID
- 65628
- CAS number
- 16506-27-7
- FDA UNII
- 9266D9P3PQ
- Wikidata
- Q425745
- Wikipedia
- Bendamustine
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 Bendamustine
53 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.
Bendamustine in the EU trials register (CTIS)
2 trialsAuthorised or ongoing trials in the EU Clinical Trials Information System that list a product containing Bendamustine. 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 |
|---|---|---|---|---|
|
A Randomized, Double-Blind, Multicenter, Placebo-Controlled Phase 3 Study of Orelabrutinib in Combination with Rituximab and Bendamustine (BR) vs. BR in Subjects with Treatment-Naїve Mantle Cell Lymphoma
2025-524241-27-00 · CTIS ↗ · Neoplasms
|
Phase 3 | Ongoing | Innocare Pharma Inc | Poland, France, Czechia + 2 more |
|
A Phase I/II open label study of DJI136, a DLL3-targeted CAR-T therapy, in adult patients with ES-SCLC
2025-523276-23-00 · CTIS ↗ · Neoplasms
|
Phase 1 | Authorised | Novartis Pharma AG | Spain, France |
Bendamustine 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 Bendamustine on the HPRA medicines list.
- Bendamustine 100 mg Powder for Concentrate for Solution for InfusionTeva B.V. · PA1986/121/002 · Marketed
- Bendamustine 25 mg Powder for Concentrate for Solution for InfusionTeva B.V. · PA1986/121/001 · Marketed
- Bendamustine 25 mg powder for concentrate for solution for infusionAccord Healthcare Ireland Ltd. · PA2315/077/001 · Marketed
- Bendamustine 25 mg/ml concentrate for solution for infusionAccord Healthcare Ireland Ltd. · PA2315/077/003 · Marketed
- Bendamustine HCl 100 mg Powder for Concentrate for Solution for InfusionFresenius Kabi Deutschland GmbH · PA2059/028/002 · Marketed
Supply shortages
- Bendamustine Hydrochloride Injection, SolutionUS (FDA) · Resolved · updated 23 Jul 2026
- Bendamustin beta 180 mg/4 ml Konzentrat zur Herstellung einer InfusionslösungGermany (BfArM) · Production problem · 1 May 2022 to 31 Dec 2026
Conditions studied with Bendamustine
61 conditionsAll 61 conditions
| Condition (as registered) | Trials |
|---|---|
| Chronic Lymphocytic Leukemia | 9 |
| Small Lymphocytic Lymphoma | 5 |
| Lymphoma | 4 |
| Mantle Cell Lymphoma | 4 |
| Follicular Lymphoma (FL) | 3 |
| Follicular Lymphoma | 3 |
| Classical Hodgkin Lymphoma | 2 |
| Hodgkin Disease Refractory | 2 |
| Hodgkin Disease Recurrent | 2 |
| Waldenstrom Macroglobulinemia | 2 |
| Mantle Cell Lymphoma; Non-Hodgkin Lymphoma | 1 |
| Relapsed/Refractory Follicular Lymphoma | 1 |
| Antineutrophilic Cytoplasmic Antibody (ANCA)- Associated Vasculitis (AAV) | 1 |
| Idiopathic Inflammatory Myositis (IIM) | 1 |
| Systemic Sclerosis (SSc) | 1 |
| Systemic Lupus Erythematosus (SLE) | 1 |
| CLL | 1 |
| Lymphoma, Follicular | 1 |
| DLBCL | 1 |
| Diffuse Large B-Cell Lymphoma | 1 |
| Lymphoma, B-Cell | 1 |
| Precursor B-Cell Acute Lymphoblastic Leukemia | 1 |
| Lymphoma, Mantle Cell | 1 |
| Refractory Diffuse Large B Cell Lymphoma (DLBCL) | 1 |
| Relapsed Diffuse Large B Cell Lymphoma | 1 |
| High Grade B-cell Lymphoma (HGBCL) | 1 |
| Primary Mediastinal B-cell Lymphoma (PMBCL) | 1 |
| Primary Progressive Multiple Sclerosis | 1 |
| Secondary Progressive Multiple Sclerosis (SPMS) | 1 |
| Multiple Sclerosis | 1 |
| Multiple Sclerosis (MS) Primary Progressive | 1 |
| Advanced Solid Tumor | 1 |
| Hodgkin Lymphoma, Adult | 1 |
| Hodgkin Disease, Pediatric | 1 |
| Mantle Cell Lymphoma (MCL) | 1 |
| Waldenström's Macroglobulinemia (WM) | 1 |
| Diffuse Large B-Cell Lymphoma (DLBCL) | 1 |
| Marginal Zone Lymphoma(MZL) | 1 |
| Small Lymphocytic Lymppho | 1 |
| Relapsed/Refractory Chronic Lymphocytic Leukemia | 1 |
| Refractory or Relapsed Diffuse Large B Cell Lymphoma | 1 |
| Hodgkin Lymphoma | 1 |
| Newly Diagnosed Mantle Cell Lymphoma | 1 |
| Follicular Lymphoma ( FL) | 1 |
| Ineligible Or Refused Transplant Patients With Classical Hodgkin Lymphoma | 1 |
| Follicular Lymphoma Grade 3A | 1 |
| Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma | 1 |
| Chronic Lymphoid Leukemia | 1 |
| Marginal Zone Lymphoma | 1 |
| Relapsed Cancer | 1 |
| Refractory Cancer | 1 |
| Stage I Chronic Lymphocytic Leukemia | 1 |
| Stage II Chronic Lymphocytic Leukemia | 1 |
| Stage III Chronic Lymphocytic Leukemia | 1 |
| Stage IV Chronic Lymphocytic Leukemia | 1 |
| Grade 1 Follicular Lymphoma | 1 |
| Grade 2 Follicular Lymphoma | 1 |
| Grade 3a Follicular Lymphoma | 1 |
| Recurrent Follicular Lymphoma | 1 |
| B-cell Lymphoma | 1 |
| Lymphoma, Mantle-Cell | 1 |
Sponsors
lead sponsor per trial+ 24 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 Bendamustine trials
How many clinical trials are testing Bendamustine?
53 current trials in our China, USA, Italy, France, Canada, UK, Poland, Australia, Spain, Germany, Taiwan, South Korea, Israel, Czechia, Brazil, Belgium, Turkey, Japan, Austria, Mexico, Netherlands, Sweden, Portugal, Denmark, Switzerland, Singapore, Ireland and India registers name Bendamustine (also registered as CEP 18083) as a drug or biological intervention, as of the registry sync on 9 November 2026. Completed and withdrawn studies are not counted.
Are Bendamustine trials recruiting patients?
Yes. 25 of the 53 trials are recruiting: 13 with sites in China, 10 with sites in USA, 8 with sites in Italy, 7 with sites in France, 7 with sites in Canada, 7 with sites in UK, 6 with sites in Poland, 6 with sites in Australia, 5 with sites in Spain, 5 with sites in Germany, 3 with sites in Taiwan, 6 with sites in South Korea, 5 with sites in Israel, 3 with sites in Czechia, 5 with sites in Brazil, 3 with sites in Belgium, 5 with sites in Turkey, 3 with sites in Japan, 1 with sites in Austria, 1 with sites in Mexico, 3 with sites in Netherlands, 2 with sites in Sweden, 1 with sites in Portugal, 2 with sites in Denmark, 2 with sites in Switzerland and 1 with sites in India. Eligibility and site contacts are on each trial's record. Only the study team can confirm whether a patient is eligible.
Who sponsors Bendamustine clinical trials?
BeOne Medicines (3), Fate Therapeutics (3), Merck Sharp & Dohme LLC (3) and Ruijin Hospital (3), among 39 lead sponsors in total. The number in brackets is how many trials each organisation leads.
Are there Bendamustine 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 Bendamustine licensed in Ireland?
Yes. The HPRA medicines list includes 7 single-substance products containing Bendamustine, for example Bendamustine 100 mg Powder for Concentrate for Solution for Infusion (Teva B.V.). A licence does not mean a product is currently marketed or reimbursed; see each product's record.
Is there a Bendamustine shortage?
The registers we track list 2 entries for Bendamustine: US FDA: resolved; 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 Bendamustine 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 Bendamustine 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 Bendamustine (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.