Belimumab clinical trials
Belimumab is named as an intervention in 12 current clinical trials in our China, USA, Spain, UK, Germany, France, Brazil, Japan, Italy, Mexico, South Korea, Australia, Netherlands, Belgium, Canada, Israel, Denmark, Poland and Portugal registers. 10 are recruiting patients now. The most common phase is Phase 2. The sponsor with the most trials is GlaxoSmithKline (5). The most-studied condition is Systemic Lupus Erythematosus. The EU clinical trials register (CTIS) separately lists 1 authorised or ongoing trial.
Where Belimumab is approved
All regulators →Of the three regulators tracked here, the first to approve Belimumab was the US, on 9 Mar 2011. It is approved in 3 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.
What health systems spend on Belimumab
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 Belimumab works
All drug targets →- Tumor necrosis factor ligand superfamily member 13B inhibitor InhibitorTarget: TNFSF13B TNF superfamily member 13bChEMBL only
- Anti-neutrophil cytoplasmic antibody-associated vasculitisPhase 3
- Autoimmune thrombocytopenic purpuraPhase 3
- Granulomatosis with polyangiitisPhase 3
- Interstitial lung diseasePhase 3
- Microscopic polyangiitisPhase 3
- Autoimmune polyendocrinopathyPhase 2/3
- DermatomyositisPhase 2/3
- Idiopathic inflammatory myopathyPhase 2/3
- PolymyositisPhase 2/3
- Systemic sclerosisPhase 2/3
Mechanisms and diseases from ChEMBL via the Open Targets Platform (release 26.09), ChEMBL record CHEMBL1789843, CC BY-SA 3.0. Targets checked against the IUPHAR/BPS Guide to PHARMACOLOGY (2026.3.1), ligand 6887, 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 Belimumab
All NICE appraisals →NICE, which decides whether the NHS in England should fund new medicines, has published 3 technology appraisals of Belimumab. 3 are current, and 2 of these recommend it for at least some patients.
| Appraisal | NICE recommendation | Published | Status |
|---|---|---|---|
| Belimumab for treating lupus nephritis (terminated appraisal) NICE TA806 | Terminated (no company submission) | 13 Jul 2022 | Current |
| Belimumab for treating active autoantibody-positive systemic lupus erythematosus NICE TA752 | Optimised | 15 Dec 2021 | Current |
| Belimumab for treating active autoantibody-positive systemic lupus erythematosus NICE TA397 | Optimised | 22 Jun 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 Belimumab
The package leaflet is the official guide for patients that comes with every medicine. These links go to the regulators that publish it.
- IEIreland: 3 products on the HPRA listEach product record links to the HPRA, which publishes the leaflet and SmPC.
- EUEuropean Union: BenlystaEMA 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 Belimumab
- ATC code
- L04AA26
- ChEMBL
- CHEMBL1789843
- DrugBank
- DB08879
- CAS number
- 356547-88-1
- FDA UNII
- 73B0K5S26A
- Wikidata
- Q1996249
- Wikipedia
- Belimumab
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 Belimumab
12 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.
Belimumab in the EU trials register (CTIS)
1 trialAuthorised or ongoing trials in the EU Clinical Trials Information System that list a product containing Belimumab. 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 multicenter, randomized clinical trial comparing the efficacy and safety of certolizumab pegol and belimumab in patients with moderate or severe activity of systemic lupus erythematosus (CERT-SLE)
2024-517753-27-01 · CTIS ↗ · Immune System Diseases
|
Phase 3 | Authorised | Narodowy Instytut Geriatrii Reumatologii I Rehabilitacji Im Prof. Dr Hab. Med. Eleonory Reicher | Poland |
Belimumab 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)
3 single-substance products containing Belimumab on the HPRA medicines list.
- Benlysta 120 mg powder for concentrate for solution for infusionGlaxoSmithKline (Ireland) Limited · EU/1/11/700/001-002
- Benlysta 200 mg solution for injection in pre-filled penGlaxoSmithKline (Ireland) Limited · EU/1/11/700/003-005
- Benlysta 200 mg solution for injection in pre-filled syringeGlaxoSmithKline (Ireland) Limited · EU/1/11/700/006-007
Supply shortages
No entry for Belimumab in the EMA, FDA or German BfArM shortage lists we track.
Conditions studied with Belimumab
13 conditionsAll 13 conditions
| Condition (as registered) | Trials |
|---|---|
| Systemic Lupus Erythematosus | 3 |
| Lung Diseases, Interstitial | 1 |
| Systemic Sclerosis Associated Interstitial Lung Disease | 1 |
| Scleroderma, Systemic | 1 |
| Connective Tissue Diseases | 1 |
| Antiphospholipid Syndrome (APS) | 1 |
| Sjogren's Syndrome | 1 |
| Pediatric ALL | 1 |
| Systemic Lupus Erythematosus (SLE) | 1 |
| Lupus Nephritis (LN) | 1 |
| Chronic Lymphoid Leukemia in Relapse | 1 |
| Kidney Transplant Rejection | 1 |
| Autoimmune Hepatitis | 1 |
Sponsors
lead sponsor per trialBy 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 Belimumab trials
How many clinical trials are testing Belimumab?
12 current trials in our China, USA, Spain, UK, Germany, France, Brazil, Japan, Italy, Mexico, South Korea, Australia, Netherlands, Belgium, Canada, Israel, Denmark, Poland and Portugal registers name Belimumab (also registered as GSK1550188) as a drug or biological intervention, as of the registry sync on 9 November 2026. Completed and withdrawn studies are not counted.
Are Belimumab trials recruiting patients?
Yes. 10 of the 12 trials are recruiting: 7 with sites in China, 4 with sites in USA, 4 with sites in Spain, 4 with sites in UK, 2 with sites in Germany, 3 with sites in France, 3 with sites in Brazil, 3 with sites in Japan, 2 with sites in Italy, 2 with sites in Mexico, 3 with sites in South Korea, 3 with sites in Australia, 2 with sites in Netherlands, 2 with sites in Belgium, 2 with sites in Canada, 2 with sites in Israel, 1 with sites in Denmark and 1 with sites in Poland. Eligibility and site contacts are on each trial's record. Only the study team can confirm whether a patient is eligible.
Who sponsors Belimumab clinical trials?
GlaxoSmithKline (5), Sichuan Baili Pharmaceutical Co., Ltd (1), Ruijin Hospital (1) and Peking Union Medical College Hospital (1), among 8 lead sponsors in total. The number in brackets is how many trials each organisation leads.
Is Belimumab licensed in Ireland?
Yes. The HPRA medicines list includes 3 single-substance products containing Belimumab, for example Benlysta 120 mg powder for concentrate for solution for infusion (GlaxoSmithKline (Ireland) Limited). A licence does not mean a product is currently marketed or reimbursed; see each product's record.
Is there a Belimumab shortage?
Not in the lists we track: Belimumab 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 Belimumab 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 Belimumab 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 Belimumab (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.