Drugs / Ofatumumab
Ofatumumab
also known as
HuMax-CD20 · GSK1841157 · OFA · Azerra · Arzerra · GSKI841157 · HUMAX-CD20 2F2 · Kesimpta · +5 more
Monoclonal antibody targets MS4A1
Regulatory milestones approvals, filings & regulatory actions · 6 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansions (4) | US (FDA) | KESIMPTA | — | 2014-04-17 – 2020-08-20 | fda.gov ↗ |
| Approved | EU (EMA) | Arzerra | — | 2010-04-19 | europa.eu ↗ |
| Approved | US (FDA) | KESIMPTA | — | 2009-10-26 | fda.gov ↗ |
Trials 121 · started per year
today
US approved 2009
EU approved 2010
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Also used as a comparator or background therapy in 13 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 01 trial | ||||||
| Phase 0 | NCT07546110 Background | May 2026 → Dec 2027 expected | multiple sclerosis | The Affiliated Hospital of Xuzhou Medical University | Not yet recruiting | No outcome recorded |
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT01458366 Background | Nov 2011 → Aug 2018 | non-Hodgkin lymphoma | Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University | Completed | No outcome recorded |
| Phase 24 trials | ||||||
| Phase 2 | NCT04189588 Comparator | Mar → Nov 2020 | — | TerSera Therapeutics LLC | Completed | No outcome recorded |
| Phase 2 | NCT02877303 Background | Nov 2016 → Nov 2026 expected | B-cell acute lymphoblastic leukemia, lymphoblastic lymphoma | M.D. Anderson Cancer Center | Recruiting | No outcome recorded |
| Phase 2 | NCT00494780 Comparator | Jun 2007 → Apr 2009 | follicular lymphoma | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 2 | NCT00410163 Comparator | Jan 2007 → Mar 2009 | B-cell chronic lymphocytic leukemia | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 37 trials | ||||||
| Phase 3 | NCT07189325 Comparator | Jun 2026 → Jun 2031 expected | relapsing-remitting multiple sclerosis | University Hospital, Montpellier | Recruiting | No outcome recorded |
| Phase 3 | NCT06869785 Comparator | Mar 2025 → Jan 2026 overdue | relapsing-remitting multiple sclerosis | Novartis Pharmaceuticals | Active not recruiting | No outcome recorded |
| Phase 3 | NCT04047628 Background | Dec 2019 → Oct 2026 expected | relapsing-remitting multiple sclerosis, secondary progressive multiple sclerosis | National Institute of Allergy and Infectious Diseases (NIAID) | Recruiting | No outcome recorded |
| Phase 3 | NCT02049515 Comparator | Dec 2013 → Jun 2020 | chronic lymphocytic leukemia/small lymphocytic lymphoma | SecuraBio | Completed | No outcome recorded |
| Phase 3 | NCT02004522 Comparator | Nov 2013 → May 2017 | chronic lymphocytic leukemia/small lymphocytic lymphoma | SecuraBio | Completed | No outcome recorded |
| Phase 3 | NCT01580228 Comparator | Aug 2012 → Dec 2014 | B-cell chronic lymphocytic leukemia | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 3 | NCT01578707 Comparator | Jun 2012 → Nov 2013 | chronic lymphocytic leukemia/small lymphocytic lymphoma | Pharmacyclics LLC. | Completed | No outcome recorded |
Press releases naming this drug 29 releases
| Date | Issuer | Release |
|---|---|---|
| 2025-09-24 | Novartis Pharmaceuticals | New Novartis data further support benefits of Kesimpta® in relapsing MS following switch from oral disease modifying therapies novartis.com ↗ |
| 2025-03-25 | Novartis Pharmaceuticals | Novartis to present new data at AAN, including seven-year disability outcomes and safety analysis of Kesimpta® in people with relapsing multiple sclerosis novartis.com ↗ |
| 2024-09-18 | Novartis Pharmaceuticals | New Novartis data in relapsing MS reinforce benefits of Kesimpta® for first-line and switch patients novartis.com ↗ |
| 2024-04-17 | Novartis Pharmaceuticals | Novartis Kesimpta® six-year efficacy data show substantial benefits in recently diagnosed treatment- naïve people with relapsing multiple sclerosis novartis.com ↗ |
| 2023-06-30 | Novartis Pharmaceuticals | Novartis publishes new five-year efficacy data on Kesimpta® (ofatumumab) for the treatment of relapsing multiple sclerosis novartis.com ↗ |
| 2023-04-20 | Novartis Pharmaceuticals | Novartis presents new five-year data on disability outcomes and safety of Kesimpta® (ofatumumab) in people living with relapsing multiple sclerosis novartis.com ↗ |
| 2022-06-27 | Novartis Pharmaceuticals | New Novartis extension phase data show nearly 80% of RMS patients treated with Kesimpta® (ofatumumab) had no evidence of disease activity (NEDA-3) novartis.com ↗ |
| 2022-04-05 | Novartis Pharmaceuticals | Novartis presents new four-year data on efficacy and safety of Kesimpta® (ofatumumab) in people living with relapsing multiple sclerosis novartis.com ↗ |
| 2022-03-18 | Novartis Pharmaceuticals | New peer-reviewed research shows no increased risk of serious COVID-19 infections in Kesimpta® (ofatumumab)-treated adults with multiple sclerosis novartis.com ↗ |
| 2022-03-02 | Novartis Pharmaceuticals | Novartis peer-reviewed safety and tolerability data further strengthens Kesimpta’s (ofatumumab) favorable benefit-risk profile in patients with relapsing multiple sclerosis novartis.com ↗ |
| 2021-10-14 | Novartis Pharmaceuticals | Kesimpta® (ofatumumab) data at ECTRIMS highlights preservation of IgG levels and safety experience over extended exposure (~3.5 years) in people living with relapsing multiple sclerosis novartis.com ↗ |
| 2021-06-22 | Novartis Pharmaceuticals | Kesimpta® (ofatumumab) data show long-term preservation of IgG/IgM levels and no increased risk of serious infections in people living with multiple sclerosis novartis.com ↗ |
| 2021-04-16 | Novartis Pharmaceuticals | Kesimpta® (ofatumumab) data at AAN showed reduction in disability progression independent of relapse activity in newly diagnosed patients with RMS novartis.com ↗ |
| 2021-03-30 | Novartis Pharmaceuticals | Novartis receives EU approval for Kesimpta® (ofatumumab), the first and only self-administered, targeted B-cell therapy for adult patients with relapsing multiple sclerosis novartis.com ↗ |
| 2021-02-16 | Novartis Pharmaceuticals | Novartis data show multiple sclerosis patients and nurses prefer Kesimpta® (ofatumumab) Sensoready® autoinjector pen novartis.com ↗ |
| 2021-01-29 | Novartis Pharmaceuticals | Novartis receives positive CHMP opinion for Kesimpta®* (ofatumumab), a self-administered treatment for adult patients with relapsing multiple sclerosis novartis.com ↗ |
| 2020-09-11 | Novartis Pharmaceuticals | Novartis presents data at ACTRIMS-ECTRIMS for Kesimpta® (ofatumumab) in newly diagnosed treatment-naïve adults with relapsing multiple sclerosis novartis.com ↗ |
| 2020-08-20 | Novartis Pharmaceuticals | FDA approves Novartis Kesimpta® (ofatumumab), the first and only self-administered, targeted B-cell therapy for patients with relapsing multiple sclerosis novartis.com ↗ |
| 2020-08-05 | Novartis Pharmaceuticals | Novartis announces NEJM publication of Phase III ASCLEPIOS trials demonstrating superior efficacy of ofatumumab in patients with relapsing multiple sclerosis novartis.com ↗ |
| 2020-06-02 | Novartis Pharmaceuticals | Novartis provides update on FDA review of ofatumumab, a self-administered, targeted B-cell therapy for patients with relapsing multiple sclerosis novartis.com ↗ |
| 2020-05-27 | Novartis Pharmaceuticals | Novartis announces new late-breaking ofatumumab data at EAN demonstrating robust efficacy and safety in the treatment of relapsing forms of multiple sclerosis (RMS) novartis.com ↗ |
| 2020-02-24 | Novartis Pharmaceuticals | Novartis announces FDA and EMA filing acceptance of ofatumumab, a novel B-cell therapy for patients with relapsing forms of multiple sclerosis (RMS) novartis.com ↗ |
| 2019-09-13 | Novartis Pharmaceuticals | Novartis Phase III ASCLEPIOS trials demonstrate robust efficacy of ofatumumab in patients with relapsing multiple sclerosis novartis.com ↗ |
| 2019-08-30 | Novartis Pharmaceuticals | Novartis ofatumumab demonstrates superiority versus Aubagio® in two head-to-head Phase III multiple sclerosis studies novartis.com ↗ |
| 2015-08-21 | Novartis Pharmaceuticals | Novartis acquires all remaining rights to GSK's Ofatumumab to develop treatments for MS and other autoimmune indications novartis.com ↗ |
| 2015-06-12 | Novartis Pharmaceuticals | Novartis drug Arzerra® improved median progression-free survival by 54% in patients with relapsed chronic lymphocytic leukemia novartis.com ↗ |
| 2015-05-31 | Gilead Sciences | Zydelig® in Combination With Ofatumumab Improves Progression-Free Survival in Previously-Treated Patients With Chronic Lymphocytic Leukemia gilead.com ↗ |
| 2015-04-27 | Novartis Pharmaceuticals | Novartis announces Phase III study of Arzerra® met primary endpoint of improved progression-free survival in patients with relapsed CLL novartis.com ↗ |
| 2015-04-15 | Novartis Pharmaceuticals | Data in The Lancet show Novartis drug Arzerra® plus chlorambucil improved median progression-free survival by 71% in CLL patients novartis.com ↗ |
Evidence & citations 18 cited values
Every value below carries the sentence it was read from. 142 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | ofatumumab | “Ofatumumab is a human monoclonal antibody that binds to a unique CD20 epitope on the surface of B lymphocytes, resulting in efficient lysis of CD20-expressing cells via...” PMID 25103870 ↗ Aug 2014130“This study will evaluate whether ofatumumab is excreted at quantifiable levels and at which concentrations in breast milk of lactating women with RMS).” NCT06444113 ↗ “Ofatumumab is a unique monoclonal antibody that targets a distinct small loop epitope on the CD20 molecule.” PMID 18390837 ↗ Apr 2008 “Ofatumumab will be administered by IV infusion” NCT03280160 ↗ “Ofatumumab 300 mg IV day -8” NCT01612988 ↗ “ofatumumab (Kesimpta®)” NCT04047628 ↗ “Kesimpta (ofatumumab)” NCT03535298 ↗ |
| Known as | Arzerra | “Arzerra” NCT04189588 ↗ |
| Known as | Azerra | “Ofatumumab (Azerra) + bendamustine (Trenda)” NCT01131247 ↗1“Ofatumumab (Azerra)” NCT01125787 ↗ |
| Known as | GSK1841157 | “A Phase I/II, a Single Arm, Open-label Study of Ofatumumab (GSK1841157) in Patients With Previously Treated Chronic Lymphocytic Leukemia” NCT01077622 ↗3“Ofatumumab (GSK1841157), a clear colorless liquid, is supplied in a glass vial.” NCT00742144 ↗ “ofatumumab (GSK1841157) infusion” NCT01563055 ↗ “ofatumumab (GSK1841157) infusion” NCT00748189 ↗ |
| Known as | GSKI841157 | ChEMBL registry synonym — accepted as the source's own label CHEMBL1201836 ↗ |
| Known as | HuMax-CD20 | “This trial consists of a double-blind, placebo controlled, dose escalation part with randomization to trial treatment within each of three sequential cohorts (Part A), and a...” NCT00291928 ↗4“A Single-Arm, International, Multi-Center Trial of HuMax-CD20 (Ofatumumab), a Fully Human Monoclonal Anti-CD20 Antibody, in Patients With Follicular Lymphoma Who Are Refractory...” NCT00394836 ↗ “Ofatumumab (HuMax-CD20) is a human monoclonal antibody targeting a distinct small-loop epitope on the CD20 molecule.” PMID 20194866 ↗ Mar 2010 |
| Known as | HUMAX-CD20 2F2 | ChEMBL registry synonym — accepted as the source's own label CHEMBL1201836 ↗ |
| Known as | Kesimpta | ChEMBL registry synonym — accepted as the source's own label CHEMBL1201836 ↗ |
| Known as | Kesimpta (ofatumumab) | “Kesimpta (ofatumumab)” NCT03535298 ↗ |
| Known as | OFA | “BACKGROUND: Ofatumumab (OFA) is a fully humanized, anti-CD20 antibody approved for use in chronic lymphocytic leukemia (CLL).” PMID 28687625 ↗ Jul 20173“the fully humanized anti-CD20 antibody ofatumumab (OFA) induced remission in children with MRNS” PMID 31993781 ↗ Jan 2020 “Ofatumumab (OFA), a fully humanized anti-CD20 monoclonal antibody” NCT05504694 ↗ “integration of Ofatumumab (OFA), a 2nd generation anti-CD20 moAb” PMID 38167647 ↗ Jan 2024 |
| Known as | Ofatumumab (HuMax-CD20; ARZERRA) | “Ofatumumab (HuMax-CD20; ARZERRA)” NCT01221103 ↗ |
| Known as | ofatumumab (Kesimpta) | “ofatumumab (Kesimpta®)” NCT04047628 ↗ |
| Known as | OMB | “There is currently a need for data regarding whether treatment with ofatumumab (OMB) impacts humoral immune response to vaccines, including the influenza vaccine, in patients...” PMID 40107181 ↗ Mar 2025 |
| Known as | OMB157 | “Participants received non-live COVID-19 mRNA vaccine at least two weeks prior to start of ofatumumab (OMB157) (20 mg subcutaneous).” NCT04878211 ↗ |
| Action | Deplete | “Treatment caused immediate and profound B-cell depletion” PMID 18390837 ↗ Apr 2008 |
| Modality | Monoclonal antibody | “novel fully human anti-CD20 monoclonal antibody” PMID 18390837 ↗ Apr 2008 |
| Route | Intravenous | “intravenous ofatumumab” PMID 24443277 ↗ Jan 2014 |
| Target | MS4A1 | “B-lymphocyte antigen CD20 binding agent” CHEMBL1201836 ↗ |