Ofatumumab clinical trials
Ofatumumab is named as an intervention in 12 current clinical trials in our USA, China, France, Sweden, Canada, India, Germany, Spain, Belgium, Poland, Austria, Portugal, Turkey, Mexico, Taiwan, Australia, Israel, Italy, UK, Netherlands, Denmark, Switzerland, Czechia, Norway, Japan and Brazil registers. 5 are recruiting patients now. The most common phase is Observational. The sponsor with the most trials is Novartis Pharmaceuticals (4). The most-studied condition is Multiple Sclerosis.
Where Ofatumumab is approved
All regulators →Of the three regulators tracked here, the first to approve Ofatumumab was the US, on 26 Oct 2009. It is approved in 3 of the 3 regulators tracked here.
- 1 EU orphan designation, most recently for treatment of chronic lymphocytic leukaemia (7 Nov 2008, withdrawn)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 Ofatumumab
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 Ofatumumab 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
- Autoimmune encephalitisPhase 3
- Diffuse large B-cell lymphomaPhase 3
- Indolent B-cell non-Hodgkin lymphomaPhase 3
- Non-Hodgkin lymphomaPhase 3
- Pemphigus vulgarisPhase 3
- Rheumatoid arthritisPhase 3
- Richter transformationPhase 2
- Waldenstrom macroglobulinemiaPhase 2
- Acute lymphoblastic leukemiaPhase 2
- Classic Hodgkin lymphomaPhase 2
Mechanisms and diseases from ChEMBL via the Open Targets Platform (release 26.09), ChEMBL record CHEMBL1201836, CC BY-SA 3.0. Targets checked against the IUPHAR/BPS Guide to PHARMACOLOGY (2026.3.1), ligand 6778, 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 Ofatumumab
All NICE appraisals →NICE, which decides whether the NHS in England should fund new medicines, has published 4 technology appraisals of Ofatumumab. 2 are current, and 1 of these recommend it for at least some patients. 2 older appraisals were replaced or withdrawn.
| Appraisal | NICE recommendation | Published | Status |
|---|---|---|---|
| Ofatumumab for treating relapsing multiple sclerosis NICE TA699 | Recommended | 19 May 2021 | Current |
| Ofatumumab with chemotherapy for treating chronic lymphocytic leukaemia (terminated appraisal) NICE TA470 | Terminated (no company submission) | 23 Aug 2017 | 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 Ofatumumab
The package leaflet is the official guide for patients that comes with every medicine. These links go to the regulators that publish it.
- IEIreland: 2 products on the HPRA listEach product record links to the HPRA, which publishes the leaflet and SmPC.
- EUEuropean Union: KesimptaEMA 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 Ofatumumab
- ATC code
- L01XC10
- ChEMBL
- CHEMBL1201836
- DrugBank
- DB06650
- CAS number
- 679818-59-8
- FDA UNII
- M95KG522R0
- Wikidata
- Q410656
- Wikipedia
- Ofatumumab
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 Ofatumumab
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.
Ofatumumab 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)
2 single-substance products containing Ofatumumab on the HPRA medicines list.
- Kesimpta 20 mg solution for injection in pre-filled penNovartis Europharm Limited · EU/1/21/1532/003-004
- Kesimpta 20 mg solution for injection in pre-filled syringeNovartis Europharm Limited · EU/1/21/1532/001-002
Supply shortages
No entry for Ofatumumab in the EMA, FDA or German BfArM shortage lists we track.
Conditions studied with Ofatumumab
13 conditionsAll 13 conditions
| Condition (as registered) | Trials |
|---|---|
| Multiple Sclerosis | 4 |
| Relapsing Multiple Sclerosis | 1 |
| Multiple Sclerosis (MS) | 1 |
| Relapsing-Remitting Multiple Sclerosis | 1 |
| Neuromyelitis Optica Spectrum Disorder | 1 |
| Anti-N-Methyl-D-Aspartate Receptor Encephalitis | 1 |
| Narcolepsy Type 1 (NT1) | 1 |
| Multiple Sclerosis, Relapsing-Remitting | 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 |
| Pregnancy | 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 Ofatumumab trials
How many clinical trials are testing Ofatumumab?
12 current trials in our USA, China, France, Sweden, Canada, India, Germany, Spain, Belgium, Poland, Austria, Portugal, Turkey, Mexico, Taiwan, Australia, Israel, Italy, UK, Netherlands, Denmark, Switzerland, Czechia, Norway, Japan and Brazil registers name Ofatumumab (also registered as OMB157) as a drug or biological intervention, as of the registry sync on 10 November 2026. Completed and withdrawn studies are not counted.
Are Ofatumumab trials recruiting patients?
Yes. 5 of the 12 trials are recruiting: 4 with sites in China and 1 with sites in France. Eligibility and site contacts are on each trial's record. Only the study team can confirm whether a patient is eligible.
Who sponsors Ofatumumab clinical trials?
Novartis Pharmaceuticals (4), Biogen (1), Tang-Du Hospital (1) and The First People's Hospital of Changzhou (1), among 9 lead sponsors in total. The number in brackets is how many trials each organisation leads.
Is Ofatumumab licensed in Ireland?
Yes. The HPRA medicines list includes 2 single-substance products containing Ofatumumab, for example Kesimpta 20 mg solution for injection in pre-filled pen (Novartis Europharm Limited). A licence does not mean a product is currently marketed or reimbursed; see each product's record.
Is there a Ofatumumab shortage?
Not in the lists we track: Ofatumumab 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 Ofatumumab 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 Ofatumumab 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 Ofatumumab (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.