Obinutuzumab clinical trials
Obinutuzumab is named as an intervention in 89 current clinical trials in our China, USA, France, Spain, Italy, Germany, Australia, Israel, UK, Poland, Brazil, Canada, Belgium, Austria, Czechia, South Korea, Denmark, Sweden, Taiwan, Mexico, Netherlands, Turkey, Japan, Switzerland, Ireland, Portugal, Norway and Egypt registers. 36 are recruiting patients now. The most common phase is Phase 2. The sponsor with the most trials is Hoffmann-La Roche (12). The most-studied condition is Chronic Lymphocytic Leukemia. The EU clinical trials register (CTIS) separately lists 7 authorised or ongoing trials.
Where Obinutuzumab is approved
All regulators →Of the three regulators tracked here, the first to approve Obinutuzumab was the US, on 1 Nov 2013. It is approved in 3 of the 3 regulators tracked here.
- 5 EU orphan designations, most recently for treatment of marginal zone lymphoma (19 Jun 2015, withdrawn)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.
What health systems spend on Obinutuzumab
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 Obinutuzumab works
All drug targets →- B-lymphocyte antigen CD20 binding agent Binding agentTarget: MS4A1 membrane spanning 4-domains A1✓ In ChEMBL and the Guide to Pharmacology
- Diffuse large B-cell lymphomaPhase 3
- Kidney disorderPhase 3
- Lupus nephritisPhase 3
- LymphomaPhase 3
- Marginal zone lymphomaPhase 3
- Neuromyelitis opticaPhase 3
- Systemic lupus erythematosusPhase 3
- Membranous glomerulonephritisPhase 2/3
- Nephrotic syndromePhase 2/3
- B-cell non-Hodgkin lymphomaPhase 2
Mechanisms and diseases from ChEMBL via the Open Targets Platform (release 26.09), ChEMBL record CHEMBL1743048, CC BY-SA 3.0. Targets checked against the IUPHAR/BPS Guide to PHARMACOLOGY (2026.3.1), ligand 6941, 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 Obinutuzumab
All NICE appraisals →NICE, which decides whether the NHS in England should fund new medicines, has published 5 technology appraisals of Obinutuzumab. 4 are current, and 4 of these recommend it for at least some patients. 1 older appraisal was replaced or withdrawn.
| Appraisal | NICE recommendation | Published | Status |
|---|---|---|---|
| Obinutuzumab with mycophenolate mofetil for treating lupus nephritis NICE TA1131 | Recommended | 12 Feb 2026 | Current |
| Obinutuzumab with bendamustine for treating follicular lymphoma after rituximab NICE TA629 | Recommended | 13 May 2020 | Current |
| Obinutuzumab for untreated advanced follicular lymphoma NICE TA513 | Recommended | 21 Mar 2018 | Current |
| Obinutuzumab in combination with chlorambucil for untreated chronic lymphocytic leukaemia NICE TA343 | Optimised | 2 Jun 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 Obinutuzumab
The package leaflet is the official guide for patients that comes with every medicine. These links go to the regulators that publish it.
- IEIreland: 1 product on the HPRA listEach product record links to the HPRA, which publishes the leaflet and SmPC.
- EUEuropean Union: GazyvaroEMA 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 Obinutuzumab
- ATC code
- L01XC15
- ChEMBL
- CHEMBL1743048
- DrugBank
- DB08935
- CAS number
- 949142-50-1
- FDA UNII
- O43472U9X8
- Wikidata
- Q389496
- Wikipedia
- Obinutuzumab
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 Obinutuzumab
89 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.
Obinutuzumab in the EU trials register (CTIS)
7 trialsAuthorised or ongoing trials in the EU Clinical Trials Information System that list a product containing Obinutuzumab. 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.
Obinutuzumab 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)
1 single-substance product containing Obinutuzumab on the HPRA medicines list.
- Gazyvaro 1,000 mg concentrate for solution for infusionRoche Registration GmbH · EU/1/14/937/001
Supply shortages
No entry for Obinutuzumab in the EMA, FDA or German BfArM shortage lists we track.
Conditions studied with Obinutuzumab
81 conditionsAll 81 conditions
| Condition (as registered) | Trials |
|---|---|
| Chronic Lymphocytic Leukemia | 17 |
| Small Lymphocytic Lymphoma | 11 |
| Follicular Lymphoma | 7 |
| Marginal Zone Lymphoma | 6 |
| Lupus Nephritis | 4 |
| Lymphoma | 4 |
| Mantle Cell Lymphoma | 4 |
| Large B-cell Lymphoma | 3 |
| Chronic Lymphoid Leukemia | 2 |
| Chronic Lymphocytic Leukemia (CLL) | 2 |
| Lymphoma, Non-Hodgkin | 2 |
| B-cell Lymphoma | 2 |
| Primary Membranous Nephropathy | 2 |
| Diffuse Large B Cell Lymphoma (DLBCL) | 2 |
| Newly Diagnosed | 2 |
| Relapsed/Refractory Follicular Lymphoma | 1 |
| Diffuse Large B-cell Lymphoma | 1 |
| Mature B-Cell Malignancies | 1 |
| CLL | 1 |
| Leukemia, Lymphocytic, Chronic, B-Cell | 1 |
| B-Cell Non-Hodgkin Lymphoma | 1 |
| Relapsed B-Cell Non-Hodgkin Lymphoma | 1 |
| Refractory B-Cell Non-Hodgkin Lymphoma | 1 |
| Systemic Lupus Erythematosus | 1 |
| Non-Hodgkin Lymphoma | 1 |
| Follicular Lymphoma (FL) | 1 |
| Lupus Nephritis - WHO Class III | 1 |
| Lupus Nephritis - WHO Class IV | 1 |
| Refractory Systemic Lupus Erythematosus | 1 |
| SLE | 1 |
| Mature B-cell Malignancies | 1 |
| Cancer | 1 |
| Solid Tumor | 1 |
| Melanoma | 1 |
| Renal Cell Carcinoma | 1 |
| B-cell Malignancy | 1 |
| Relapsed Cancer | 1 |
| Refractory Cancer | 1 |
| Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma | 1 |
| Non-Hodgkin's Lymphoma | 1 |
| Mature B-Cell Non-Hodgkin Lymphoma | 1 |
| Relapsed or Refractory Aggressive B-Cell Non-Hodgkins Lymphoma | 1 |
| Relapsed/Refractory Large B-cell Lymphoma (LBCL) | 1 |
| Relapsed/Refractory Diffuse Large B-Cell Lymphoma (DLBCL) | 1 |
| Marginal Zone Lymphoma(MZL) | 1 |
| Immune Thrombocytopenia | 1 |
| Treatment | 1 |
| Refractory Diffuse Large B-Cell Lymphoma (DLBCL) | 1 |
| Mantle Cell Lymphoma (MCL) | 1 |
| Follicular Lymphoma ( FL) | 1 |
| PCNSL (Primary CNS Lymphoma) | 1 |
| Central Nervous System Lymphoma | 1 |
| Secondary Central Nervous System Lymphoma (SCNSL) | 1 |
| Follicular Lymphoma Grade 3A | 1 |
| Intermediate-to-High-Risk Mantle Cell Lymphoma | 1 |
| the Efficacy and Safety | 1 |
| TP53 | 1 |
| Large B-Cell Lymphoma (LBCL) | 1 |
| High-grade B-cell Lymphoma | 1 |
| Minimal Change Disease (MCD) | 1 |
| Waldenström's Macroglobulinemia | 1 |
| Lymphoma, Large B-Cell, Diffuse | 1 |
| Membranous Nephropathy | 1 |
| Systemic Sclerosis in Adults | 1 |
| Richter Syndrome | 1 |
| Granulomatosis With Polyangiitis | 1 |
| Cryoglobulinemic Vasculitis (CV) | 1 |
| Lymphoma, Mantle-Cell | 1 |
| Nephrotic Syndrome，Idiopathic | 1 |
| CLL Transformation | 1 |
| Grade 1 Follicular Lymphoma | 1 |
| Grade 2 Follicular Lymphoma | 1 |
| Grade 3a Follicular Lymphoma | 1 |
| Recurrent Follicular Lymphoma | 1 |
| Extensive Stage Small Cell Lung Cancer | 1 |
| Relapsed /Refractory DLBCL | 1 |
| Mantle Cell Lymphoma Refractory | 1 |
| Indolent Non-hodgkin Lymphoma | 1 |
| Refractory Lymphoma | 1 |
| B-cell Lymphomas | 1 |
| Relapsed/Refractory Large B-cell Lymphoma | 1 |
Sponsors
lead sponsor per trial+ 32 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 Obinutuzumab trials
How many clinical trials are testing Obinutuzumab?
89 current trials in our China, USA, France, Spain, Italy, Germany, Australia, Israel, UK, Poland, Brazil, Canada, Belgium, Austria, Czechia, South Korea, Denmark, Sweden, Taiwan, Mexico, Netherlands, Turkey, Japan, Switzerland, Ireland, Portugal, Norway and Egypt registers name Obinutuzumab (also registered as GA101) as a drug or biological intervention, as of the registry sync on 9 November 2026. Completed and withdrawn studies are not counted.
Are Obinutuzumab trials recruiting patients?
Yes. 36 of the 89 trials are recruiting: 16 with sites in China, 11 with sites in USA, 11 with sites in France, 7 with sites in Spain, 7 with sites in Italy, 8 with sites in Germany, 8 with sites in Australia, 5 with sites in Israel, 5 with sites in UK, 4 with sites in Poland, 6 with sites in Brazil, 5 with sites in Canada, 2 with sites in Belgium, 4 with sites in Austria, 2 with sites in Czechia, 4 with sites in South Korea, 2 with sites in Denmark, 2 with sites in Sweden, 3 with sites in Taiwan, 2 with sites in Mexico, 1 with sites in Netherlands, 2 with sites in Japan and 1 with sites in Ireland. Eligibility and site contacts are on each trial's record. Only the study team can confirm whether a patient is eligible.
Who sponsors Obinutuzumab clinical trials?
Hoffmann-La Roche (12), BeOne Medicines (6), Ruijin Hospital (6) and Institute of Hematology & Blood Diseases Hospital, China (5), among 47 lead sponsors in total. The number in brackets is how many trials each organisation leads.
Are there Obinutuzumab clinical trials in Ireland?
Yes. 3 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 Obinutuzumab licensed in Ireland?
Yes. The HPRA medicines list includes 1 single-substance product containing Obinutuzumab, for example Gazyvaro 1,000 mg concentrate for solution for infusion (Roche Registration GmbH). A licence does not mean a product is currently marketed or reimbursed; see each product's record.
Is there a Obinutuzumab shortage?
Not in the lists we track: Obinutuzumab 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 Obinutuzumab 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 Obinutuzumab 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 Obinutuzumab (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.