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 · 14 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed B-cell chronic lymphocytic leukemia 4 milestones | |||||
| Filed | EU (EMA) | Arzerra | B-cell chronic lymphocytic leukemia | 2015-10-27 | “In den USA und Europa wurden Zulassungsanträge für Arzerra (Ofatumumab) als Erhaltungstherapie bei Patienten mit rezidivierter chronischer lymphatischer Leukämie (CLL) eingereicht.” novartis.com ↗ |
| Filed | US (FDA) | Arzerra | B-cell chronic lymphocytic leukemia | 2015-10-27 | “In den USA und Europa wurden Zulassungsanträge für Arzerra (Ofatumumab) als Erhaltungstherapie bei Patienten mit rezidivierter chronischer lymphatischer Leukämie (CLL) eingereicht.” novartis.com ↗ |
| Filed | EU (EMA) | Arzerra | B-cell chronic lymphocytic leukemia | 2009-02-05 | “submission of a Marketing Authorisation Application (MAA) to the European Medicines Agency (EMEA) for Arzerra™ (ofatumumab) for the treatment of chronic lymphocytic leukaemia (CLL).” gsk.com ↗ |
| Filed | US (FDA) | Arzerra | B-cell chronic lymphocytic leukemia | 2009-01-29 | “announced today the submission of a Biologics License Application (BLA) to the US Food and Drug Administration (FDA) for Arzerra™(ofatumumab)” gsk.com ↗ |
| Filed relapsed/refractory diffuse large B-cell lymphoma 2 milestones | |||||
| Filed | US (FDA) | Arzerra | relapsed/refractory diffuse large B-cell lymphoma | 2015-10-27 | “Regulatory applications for Arzerra (ofatumumab) for use as maintenance therapy in patients with relapsed chronic lymphocytic leukemia (CLL) were submitted in the US and Europe.” novartis.com ↗ |
| Filed | EU (EMA) | Arzerra | relapsed/refractory diffuse large B-cell lymphoma | 2015-10-27 | “Regulatory applications for Arzerra (ofatumumab) for use as maintenance therapy in patients with relapsed chronic lymphocytic leukemia (CLL) were submitted in the US and Europe.” novartis.com ↗ |
| Filed relapsing-remitting multiple sclerosis 2 milestones | |||||
| Filed | EU (EMA) | — | relapsing-remitting multiple sclerosis | — | “Für Ofatumumab (OMB157) wurden Zulassungsanträge bei der FDA und EMA (Januar) für die Behandlung von schubförmig verlaufender multipler Sklerose (RMS) eingereicht.” novartis.com ↗ “Für Ofatumumab (OMB157) wurden Zulassungsanträge in den USA und der EU für die Behandlung von schubförmig verlaufender multipler Sklerose (RMS) eingereicht.” novartis.com ↗ “Ofatumumab (OMB157): une demande d’homologation a été déposée aux Etats-Unis et dans l’UE pour le traitement de la forme cyclique de la sclérose en plaques.” novartis.com ↗ “Ofatumumab (OMB157) a été soumis à la FDA et à l’EMA en janvier pour le traitement des formes cycliques de la SEP.” novartis.com ↗ “Ofatumumab (OMB157) was submitted to FDA and EMA (Jan) for treatment of RMS.” novartis.com ↗ “Ofatumumab (OMB157) was filed in the US and EU for treatment of RMS.” novartis.com ↗ |
| Filed | US (FDA) | — | relapsing-remitting multiple sclerosis | — | “Für Ofatumumab (OMB157) wurden Zulassungsanträge bei der FDA und EMA (Januar) für die Behandlung von schubförmig verlaufender multipler Sklerose (RMS) eingereicht.” novartis.com ↗ “Ofatumumab (OMB157): une demande d’homologation a été déposée aux Etats-Unis et dans l’UE pour le traitement de la forme cyclique de la sclérose en plaques.” novartis.com ↗ “Für Ofatumumab (OMB157) wurden Zulassungsanträge in den USA und der EU für die Behandlung von schubförmig verlaufender multipler Sklerose (RMS) eingereicht.” novartis.com ↗ “Ofatumumab (OMB157) a été soumis à la FDA et à l’EMA en janvier pour le traitement des formes cycliques de la SEP.” novartis.com ↗ “Ofatumumab (OMB157) was submitted to FDA and EMA (Jan) for treatment of RMS.” novartis.com ↗ “Ofatumumab (OMB157) was filed in the US and EU for treatment of RMS.” novartis.com ↗ |
| Approved Indication not stated 3 milestones | |||||
| 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 ↗ |
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News releases announcing trial results or a regulatory action · 53
| Date | Issuer | Release |
|---|---|---|
| 2025-09-24 | Novartis Pharmaceuticals | Results New Novartis data further support benefits of Kesimpta® in relapsing MS following switch from oral disease modifying therapies novartis.com ↗ |
| 2024-09-18 | Novartis Pharmaceuticals | Results New Novartis data in relapsing MS reinforce benefits of Kesimpta® for first-line and switch patients novartis.com ↗
Nearly 90% of first-line Kesimpta patients had no disability progression independent of relapse activity (PIRA) for up to six years in an analysis of open-label ALITHIOS extension study 1 |
| 2024-04-17 | Novartis Pharmaceuticals | Results Novartis Kesimpta® six-year efficacy data show substantial benefits in recently diagnosed treatment- naïve people with relapsing multiple sclerosis novartis.com ↗
Continuous Kesimpta ® treatment for up to six years showed sustained efficacy in recently diagnosed (≤3 years) treatment-naïve people living with relapsing multiple sclerosis (RMS) in an analysis of the ALITHIOS open-label extension study |
| 2023-06-30 | Novartis Pharmaceuticals | Results Novartis publishes new five-year efficacy data on Kesimpta® (ofatumumab) for the treatment of relapsing multiple sclerosis novartis.com ↗
Data showed the sustained efficacy of continuous Kesimpta ® (ofatumumab) treatment over five years in patients with relapsing forms of multiple sclerosis (RMS). |
| 2023-04-20 | Novartis Pharmaceuticals | Results Novartis presents new five-year data on disability outcomes and safety of Kesimpta® (ofatumumab) in people living with relapsing multiple sclerosis novartis.com ↗
The ALITHIOS open-label extension study showed continuous treatment with Kesimpta ® (ofatumumab) for up to five years in relapsing multiple sclerosis (RMS) patients was associated with reduced risk of disability progression versus those who switched later from teriflunomide to Kesimpta 1 |
| 2022-06-27 | Novartis Pharmaceuticals | Results 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 ↗
Earlier initiation with Kesimpta resulted in a more than three-fold increased likelihood of maintaining NEDA-3 throughout the study, highlighting the importance of earlier initiation with a high efficacy therapy 1 |
| 2022-04-05 | Novartis Pharmaceuticals | Results Novartis presents new four-year data on efficacy and safety of Kesimpta® (ofatumumab) in people living with relapsing multiple sclerosis novartis.com ↗
Data showed that continuous treatment with Kesimpta for up to four years was associated with fewer relapses as well as reduced risk of three-month and six-month confirmed disability worsening and less lesion activity versus those who switched |
| 2022-03-18 | Novartis Pharmaceuticals | Results New peer-reviewed research shows no increased risk of serious COVID-19 infections in Kesimpta® (ofatumumab)-treated adults with multiple sclerosis novartis.com ↗
Of the 1703 participants in ALITHIOS, 245 (14.3%) reported COVID-19, most cases were mild (44.1%) or moderate (46.5%) and the vast majority of patients recovered (98.4%). |
| 2022-03-02 | Novartis Pharmaceuticals | Results Novartis peer-reviewed safety and tolerability data further strengthens Kesimpta’s (ofatumumab) favorable benefit-risk profile in patients with relapsing multiple sclerosis novartis.com ↗
Immunoglobulin G (IgG) levels remained stable in patients treated up to 3.5 years and mean immunoglobulin M (IgM) levels decreased yet remained above the lower limit of normal in most patients treated with Kesimpta 1 |
| 2021-10-14 | Novartis Pharmaceuticals | Results 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 ↗
ALITHIOS Phase IIIb open-label extension study data also showed mean immunoglobulin M (IgM) levels declined over time but remained within the reference range for the majority of patients. |
| 2021-06-22 | Novartis Pharmaceuticals | Results 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 ↗
Today, Novartis disclosed new data showing mean IgG and IgM levels remain unchanged in adults with relapsing multiple sclerosis (RMS) treated with Kesimpta ® (ofatumumab) over 3.5 years. |
| 2021-04-16 | Novartis Pharmaceuticals | Results 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 | Regulatory 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 ↗
Novartis announced today that the European Commission has approved Kesimpta ® (ofatumumab) for the treatment of relapsing forms of multiple sclerosis (RMS) in adults with active disease defined by clinical or imaging features. |
| 2021-03-30 | Genmab | Regulatory Genmab Announces European Marketing Authorization for Kesimpta® (ofatumumab) in Relapsing Multiple Sclerosis genmab.com ↗
Genmab A/S (Nasdaq: GMAB) announced today that the European Commission (EC) has granted Novartis marketing authorization for the use of Kesimpta® (ofatumumab) in the treatment of relapsing forms of multiple sclerosis (RMS) in adults with active disease defined by clinical or imaging features. |
| 2021-02-16 | Novartis Pharmaceuticals | Results Novartis data show multiple sclerosis patients and nurses prefer Kesimpta® (ofatumumab) Sensoready® autoinjector pen novartis.com ↗ |
| 2021-01-29 | Novartis Pharmaceuticals | Regulatory Novartis receives positive CHMP opinion for Kesimpta®* (ofatumumab), a self-administered treatment for adult patients with relapsing multiple sclerosis novartis.com ↗ |
| 2021-01-29 | Genmab | Regulatory CHMP Issues Positive Opinion Recommending Ofatumumab in Relapsing Multiple Sclerosis genmab.com ↗
The positive CHMP opinion for subcutaneous ofatumumab in relapsing multiple sclerosis is an important step in potentially bringing this product to patients in Europe who will benefit from the efficacy and ease of dosing that ofatumumab will provide. |
| 2020-09-11 | Novartis Pharmaceuticals | Results 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 | Regulatory 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 | Results Novartis announces NEJM publication of Phase III ASCLEPIOS trials demonstrating superior efficacy of ofatumumab in patients with relapsing multiple sclerosis novartis.com ↗
Both studies met the primary endpoints where ofatumumab showed a significant reduction in the number of confirmed relapses, evaluated as the annualized relapse rate (ARR) 1 . |
| 2020-06-02 | Novartis Pharmaceuticals | Regulatory Novartis provides update on FDA review of ofatumumab, a self-administered, targeted B-cell therapy for patients with relapsing multiple sclerosis novartis.com ↗
Novartis today announced that it has received notice from the US Food and Drug Administration (FDA) that the agency has extended its review of the Supplemental Biologics License Application (sBLA) for ofatumumab (OMB 157), a self-administered, targeted B-cell therapy for patients with relapsing multiple sclerosis. |
| 2020-05-27 | Novartis Pharmaceuticals | Results 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 ↗
A post hoc analysis showed 47.0% and 87.8% of patients treated with ofatumumab achieved no evidence of disease activity (NEDA-3) within the first (0–12 months) and second year (12–24 months) of treatment, respectively 1 |
| 2020-02-24 | Novartis Pharmaceuticals | Regulatory 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 | Results Novartis Phase III ASCLEPIOS trials demonstrate robust efficacy of ofatumumab in patients with relapsing multiple sclerosis novartis.com ↗
Data from both studies show ofatumumab (OMB157) was superior to Aubagio ®* (teriflunomide) in patients with relapsing forms of MS (RMS)[1]. |
| 2019-08-30 | Novartis Pharmaceuticals | Results Novartis ofatumumab demonstrates superiority versus Aubagio® in two head-to-head Phase III multiple sclerosis studies novartis.com ↗
In both head-to-head studies, ofatumumab demonstrated superiority over Aubagio ® * (teriflunomide) in patients with relapsing forms of multiple sclerosis (RMS)[1]. |
| 2018-10-04 | Verastem, Inc. | Results Verastem Oncology Announces Publication of the Phase 3 DUO Study Results in the Journal Blood verastem.com ↗
Verastem, Inc. (Nasdaq: VSTM) (Verastem Oncology or the Company), focused on developing and commercializing medicines to improve the survival and quality of life of cancer patients, today announced that the results of the Phase 3 DUO™ study, which evaluated COPIKTRA™ (duvelisib) capsules versus ofatumumab in patients with relapsed or refractory chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL), was published online in the peer-reviewed journal Blood . |
| 2017-12-10 | Verastem, Inc. | Results Verastem Announces Clinical Data from the Pivotal Phase 3 DUO™ Study: Duvelisib Significantly Improves Progression Free Survival in Relapsed or Refractory Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma verastem.com ↗
The DUO Study Achieves Primary Endpoint, Demonstrating Statistically Significant Improvement in PFS for Duvelisib Versus Ofatumumab (HR=0.52, p<0.0001) |
| 2017-09-06 | Verastem, Inc. | Results Verastem Announces Positive Top-line Data from the Pivotal Phase 3 DUO™ Study in Relapsed or Refractory Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma verastem.com ↗
Median PFS in the subset of patients with 17p deletion randomized to duvelisib was also significantly higher (12.7 months compared to 9.0 months for ofatumumab; HR of 0.41, p=0.0011). |
| 2015-06-12 | Novartis Pharmaceuticals | Results Novartis drug Arzerra® improved median progression-free survival by 54% in patients with relapsed chronic lymphocytic leukemia novartis.com ↗
Arzerra significantly improved PFS when added to fludarabine + cyclophosphamide (median 28.9 mos vs 18.8 mos) after initial treatment stopped working |
| 2015-05-31 | Gilead Sciences | Results Zydelig® in Combination With Ofatumumab Improves Progression-Free Survival in Previously-Treated Patients With Chronic Lymphocytic Leukemia gilead.com ↗
Gilead Sciences, Inc. (Nasdaq:GILD) today announced results from the Phase 3 clinical Study 119 of an investigational use of Zydelig ® (idelalisib) in combination with ofatumumab in previously-treated patients with chronic lymphocytic leukemia (CLL). |
| 2015-04-27 | Novartis Pharmaceuticals | Results Novartis announces Phase III study of Arzerra® met primary endpoint of improved progression-free survival in patients with relapsed CLL novartis.com ↗
Positive top-line results seen with Arzerra plus fludarabine and cyclophosphamide in chronic lymphocytic leukemia (CLL) patients when initial treatment stopped working |
| 2015-04-15 | Novartis Pharmaceuticals | Results Data in The Lancet show Novartis drug Arzerra® plus chlorambucil improved median progression-free survival by 71% in CLL patients novartis.com ↗ |
| 2014-07-31 | GlaxoSmithKline | Results GSK and Genmab announce positive interim result for phase III study of ofatumumab as maintenance therapy for relapsed CLL gsk.com ↗
The interim analysis demonstrated that treatment with ofatumumab (Arzerra™) met the primary endpoint of improving progression free survival (PFS). |
| 2014-07-03 | GlaxoSmithKline | Regulatory GSK and Genmab receive EU authorisation for Arzerra gsk.com ↗ |
| 2014-06-27 | GlaxoSmithKline | Results GSK and Genmab announce top-line results from a Phase III study of ofatumumab versus physicians’ choice for bulky fludarabine-refractory CLL gsk.com ↗ |
| 2014-05-23 | GlaxoSmithKline | Regulatory GSK and Genmab receive FDA approval for Arzerra® (ofatumumab) gsk.com ↗ |
| 2014-05-19 | GlaxoSmithKline | Results motherapy for the treatment of relapsed or refractory diffuse large b-cell lymphoma gsk.com ↗
We are disappointed that the ORCHARRD study did not meet its primary endpoint. |
| 2014-04-17 | GlaxoSmithKline | Regulatory GSK and Genmab receive FDA approval for Arzerra gsk.com ↗
Issued: London UK GlaxoSmithKline plc (LSE: GSK) and Genmab A/S (OMX: GEN) announced today that the U.S. Food and Drug Administration (FDA) has approved a Supplemental Biologic License Application (sBLA) for the use of Arzerra® (ofatumumab), a CD20-directed cytolytic monoclonal antibody, in combination with chlorambucil for the treatment of previously untreated patients with chronic lymphocytic leukaemia (CLL) for whom fludarabine-based therapy is considered inappropriate. |
| 2013-12-17 | GlaxoSmithKline | Regulatory GSK and Genmab Receive Priority Review from FDA for Arzerra® (ofatumumab) as 1st Line Treatment for Chronic Lymphocytic Leukaemia (CLL) gsk.com ↗ |
| 2013-10-18 | GlaxoSmithKline | Regulatory Regulatory update – GSK and Genmab announce submission to US regulatory authorities for Arzerra® (ofatumumab) as 1st line treatment of Chronic Lymphocytic Leukaemia (CLL) gsk.com ↗ |
| 2013-10-04 | GlaxoSmithKline | Regulatory Regulatory update – GSK and Genmab announce European submission to regulatory authorities for Arzerra® (ofatumumab) as 1st line treatment of Chronic Lymphocytic Leukaemia (CLL) gsk.com ↗ |
| 2013-09-13 | GlaxoSmithKline | Regulatory FDA grants GSK and Genmab’s Arzerra® (ofatumumab) Breakthrough Therapy designation for previously untreated chronic lymphocytic leukaemia gsk.com ↗
GlaxoSmithKline plc (LSE:GSK) and Genmab A/S (OMX: GEN) announced today that the US Food and Drug Administration (FDA) has granted Breakthrough Therapy designation for Arzerra® (ofatumumab) in combination with chlorambucil for the treatment of patients with chronic lymphocytic leukaemia (CLL) who have not received prior treatment and are inappropriate for fludarabine-based therapy. |
| 2013-05-29 | GlaxoSmithKline | Results GSK and Genmab announce positive top-line results from pivotal trial of ARZERRA® (ofatumumab) combined with chlorambucil in previously untreated chronic lymphocytic leukaemia gsk.com ↗
A 9.3 month improvement in the time a patient lived without worsening of their disease (median PFS) was seen in patients randomised to ofatumumab and chlorambucil compared to patients randomised to chlorambucil alone (22.4 months vs 13.1 months; HR: 0.57; p<0.001). |
| 2010-08-08 | GlaxoSmithKline | Results GSK and Genmab announce topline results from the concluded pivotal trial of Arzerra (ofatumumab) in fludarabine and alemtuzumab refractory chronic lymphocytic leukemia gsk.com ↗
The objective response rate (ORR), as determine by an Independent Review Committee, in the study was 51%. |
| 2010-04-18 | GlaxoSmithKline | Regulatory GlaxoSmithKline receives conditional marketing authorisation in the EU for Arzerra® (ofatumumab) gsk.com ↗
GlaxoSmithKline (GSK) and Genmab AS confirmed today that the European Commission (EC) has granted a conditional marketing authorisation for Arzerra® (ofatumumab) for the treatment of refractory chronic lymphocytic leukaemia (CLL). |
| 2009-10-26 | GlaxoSmithKline | Regulatory GSK and Genmab receive accelerated approval for Arzerra™ gsk.com ↗
Today, GlaxoSmithKline (GSK) and Genmab A/S (OMX: GEN) announced the accelerated approval of Arzerra TM (ofatumumab) from the US Food and Drug Administration for use in patients with chronic lymphocytic leukemia (CLL) that is refractory to fludarabine and alemtuzumab. |
| 2009-08-16 | GlaxoSmithKline | Results GlaxoSmithKline and Genmab announce results from a study of Arzerra in rituximab refractory follicular NHL gsk.com ↗
The overall response rate (ORR) in the 1000 mg treatment arm was 10%, including one complete response and 8 partial responses. |
| 2009-07-28 | GlaxoSmithKline | Results GlaxoSmithKline and Genmab announce top-line results for ofatumumab in rheumatoid arthritis gsk.com ↗
The study met the primary endpoint, ACR20 at 24 weeks, which indicates a 20 percent or greater improvement in the number of swollen and tender joints, as well as improvements in other disease-activity measures. |
| 2009-06-16 | GlaxoSmithKline | Regulatory FDA extends review of Arzerra™ (ofatumumab) gsk.com ↗
GlaxoSmithKline and Genmab A/S today announced that the United States Food and Drug Administration (FDA) informed the companies that the agency has extended the action date for the ofatumumab BLA application by three months. |
| 2009-06-04 | GlaxoSmithKline | Results Positive results with Revolade™ and Arzerra™ for difficult-to-treat blood disorders gsk.com ↗
Based on an assessment from an independent endpoint review committee, ofatumumab demonstrated a 58 percent response rate in patients resistant to fludarabine and alemtuzumab (FA-ref). |
| 2009-05-28 | GlaxoSmithKline | Regulatory FDA advisory panel makes favorable recommendation for ARZERRA (ofatumumab) gsk.com ↗
The committee's positive vote in support of ofatumumab is a potential milestone for patients with CLL. |
| 2009-02-05 | GlaxoSmithKline | Regulatory GlaxoSmithKline and Genmab seek European marketing authorisation of Arzerra™ (ofatumumab) in advanced stage blood cancer gsk.com ↗
GlaxoSmithKline and Genmab A/S announced today the submission of a Marketing Authorisation Application (MAA) to the European Medicines Agency (EMEA) for Arzerra™ (ofatumumab) for the treatment of chronic lymphocytic leukaemia (CLL). |
| 2009-01-29 | GlaxoSmithKline | Regulatory GlaxoSmithKline and Genmab submit Arzerra (Ofatumumab) application to FDA for the treatment of advanced stage blood cancer gsk.com ↗
GlaxoSmithKline (GSK) and Genmab A/S (OMX: GEN) announced today the submission of a Biologics License Application (BLA) to the US Food and Drug Administration (FDA) for Arzerra™(ofatumumab) to treat patients whose chronic lymphocytic leukaemia (CLL) is resistant (refractory) to previous therapies. |
All press releases naming this drug 61 releases
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 ↗ |