Ofatumumab
drugOn this page
Also known as 2F2ArzerraGSK-1841157GSK1841157GSKI841157HUMAX-CD20HUMAX-CD20 2F2HUMAX-CD20, 2F2Kesimpta
Summary
Ofatumumab (CHEMBL1201836) is an approved antibody (ATC L04AG12) targeting MS4A1; indicated across 28 conditions including b-cell chronic lymphocytic leukemia and neoplasm.
At a glance
- Status: Approved (max clinical phase 4)
- Modality: Antibody
- ATC class: L04AG12 (+1 more)
- Targets: 1 (MS4A1)
- Indications: 28 conditions
- Clinical trials: 145
Identifiers
Drug identity and classification
| Field | Value |
|---|---|
| ChEMBL ID | CHEMBL1201836 |
| Name | Ofatumumab |
| Type | Antibody |
| Max phase | 4 |
| ATC | L04AG12, L01FA02 |
Also known as: 2F2, Arzerra, GSK-1841157, GSK1841157, GSKI841157, HUMAX-CD20, HUMAX-CD20 2F2, HUMAX-CD20, 2F2, Kesimpta, Ofatumumab, OFATUMUMAB
Targets
Targets
Primary targets (GtoPdb curated mechanism): the Cancer dependency column is the DepMap CRISPR fitness signal (% of screened cell lines dependent on the target).
| Gene | Target | Action | pAffinity | Cancer dependency | UniProt |
|---|---|---|---|---|---|
| MS4A1 | CD20 (membrane-spanning 4-domains, subfamily A, member 1) | Binding | 9.92 | 0% | P11836 |
Bioactivity
No ChEMBL bioactivity rows at pChembl ≥ 5 (expected for biologics / antibodies).
Target pathways
Aggregated over 1 target gene(s): MS4A1.
Dominant GO biological processes
| GO term | Targets |
|---|---|
| store-operated calcium entry | 1 |
| humoral immune response | 1 |
| cell surface receptor signaling pathway | 1 |
| response to bacterium | 1 |
| B cell differentiation | 1 |
| B cell proliferation | 1 |
| B cell activation | 1 |
| B cell receptor signaling pathway | 1 |
| protein tetramerization | 1 |
| calcium ion import into cytosol | 1 |
| positive regulation of calcium ion import across plasma membrane | 1 |
Indications & clinical
Indications
28 indications (5 at ChEMBL trial phase 4). Phase below is the highest clinical-trial phase recorded for this drug against each disease — not the molecule’s overall approval status (that is in the Summary).
| Indication | Trial phase | MONDO | EFO |
|---|---|---|---|
| B-cell chronic lymphocytic leukemia | 4 | MONDO:0004948 | EFO:0000095 |
| neoplasm | 4 | MONDO:0005070 | EFO:0000616 |
| multiple sclerosis | 4 | MONDO:0005301 | MONDO:0005301 |
| relapsing-remitting multiple sclerosis | 4 | MONDO:0005314 | EFO:0003929 |
| leukemia | 3 | MONDO:0005059 | EFO:0000565 |
| rheumatoid arthritis | 3 | MONDO:0008383 | EFO:0000685 |
| diffuse large B-cell lymphoma | 3 | MONDO:0018905 | EFO:0000403 |
| non-Hodgkin lymphoma | 3 | MONDO:0018908 | EFO:0005952 |
| pemphigus vulgaris | 3 | MONDO:0008219 | EFO:0004719 |
| follicular lymphoma | 3 | MONDO:0018906 | MONDO:0018906 |
| pemphigus | 3 | MONDO:0006594 | EFO:1000749 |
| lymphoma | 2 | MONDO:0005062 | EFO:0000574 |
| Hodgkins lymphoma | 2 | MONDO:0004952 | EFO:0000183 |
| melanoma | 2 | MONDO:0005105 | EFO:0000756 |
| nephrotic syndrome | 2 | MONDO:0005377 | EFO:0004255 |
| mantle cell lymphoma | 2 | MONDO:0018876 | EFO:1001469 |
| lymphoid leukemia | 2 | MONDO:0005402 | EFO:0004289 |
| acute lymphoblastic leukemia | 2 | MONDO:0004967 | EFO:0000220 |
| Burkitt lymphoma | 2 | MONDO:0007243 | EFO:0000309 |
| AIDS | 2 | MONDO:0012268 | EFO:0000765 |
| Waldenstrom macroglobulinemia | 2 | MONDO:0100280 | EFO:0009441 |
| prolymphocytic leukemia | 1 | MONDO:0001023 | MONDO:0001023 |
| neuromyelitis optica | 1 | MONDO:0019100 | EFO:0004256 |
| B-cell non-Hodgkin lymphoma | 1 | MONDO:0015759 | EFO:1001938 |
4 further indication records had no mapped disease name (EFO/MeSH-only) or were duplicates, and are omitted.
Clinical trials
Total trials: 145.
Phase distribution
| Phase | Trials |
|---|---|
| PHASE2 | 70 |
| Not specified | 27 |
| PHASE3 | 25 |
| PHASE1/PHASE2 | 8 |
| PHASE4 | 7 |
| PHASE1 | 7 |
| EARLY_PHASE1 | 1 |
Top trials by phase / activity
| NCT | Phase | Status | Title |
|---|---|---|---|
| NCT05090371 | PHASE4 | ACTIVE_NOT_RECRUITING | A Multicenter Study of Continued Current Therapy vs Transition to Ofatumumab After Neurofilament (NfL) Elevation |
| NCT00802737 | PHASE4 | COMPLETED | Efficacy and Safety of Ofatumumab Retreatment and Maintenance Treatment in Patients With B-cell Chronic Lymphocytic Leukemia (CLL) |
| NCT04667117 | PHASE4 | COMPLETED | A Multicenter Study to Assess Response to Influenza Vaccine in Multiple Sclerosis Participants Treated With Ofatumumab |
| NCT04869358 | PHASE4 | COMPLETED | Exploring the Immune Response to SARS-CoV-2 COVID-19 Vaccines in Patients With Relapsing Multiple Sclerosis (RMS) Treated With Ofatumumab |
| NCT04878211 | PHASE4 | TERMINATED | A Open-label Study to Assess Response to COVID-19 Vaccine in Multiple Sclerosis Participants Treated With Ofatumumab |
| NCT05084638 | PHASE4 | COMPLETED | Study to Assess the Effect of Ofatumumab in Treatment Naïve, Very Early RRMS Patients Benchmarked Against Healthy Controls. |
| NCT05199571 | PHASE4 | COMPLETED | Study of Efficacy and Safety of Ofatumumab in Relapsing Multiple Sclerosis (RMS) Patients in China |
| NCT03650114 | PHASE3 | ACTIVE_NOT_RECRUITING | Long-term Safety, Tolerability and Effectiveness Study of Ofatumumab in Patients With Relapsing MS |
| NCT04926818 | PHASE3 | ACTIVE_NOT_RECRUITING | Efficacy and Safety of Ofatumumab and Siponimod Compared to Fingolimod in Pediatric Patients With Multiple Sclerosis |
| NCT06867991 | PHASE3 | RECRUITING | Safety and Efficacy of Combined B Cell Depleting theRapy And Daratumumab In Autoimmune Encephalitis |
| NCT00603525 | PHASE3 | TERMINATED | Investigating Clinical Efficacy of Ofatumumab in Adult Rheumatoid Arthritis (RA) Patients Who Had an Inadequate Response to TNF-α Antagonist Therapy |
| NCT00611455 | PHASE3 | TERMINATED | Investigating Clinical Efficacy of Ofatumumab in Adult Rheumatoid Arthritis (RA) Patients Who Had an Inadequate Response to MTX Therapy |
| NCT00748189 | PHASE3 | TERMINATED | Ofatumumab + Chlorambucil vs Chlorambucil Monotherapy in Previously Untreated Patients With Chronic Lymphocytic Leukemia |
| NCT01014208 | PHASE3 | COMPLETED | Ofatumumab Versus Rituximab Salvage Chemoimmunotherapy Followed by Autologous Stem Cell Transplant in Relapsed or Refractory Diffuse Large B Cell Lymphoma |
| NCT01039376 | PHASE3 | TERMINATED | Ofatumumab Maintenance Treatment vs No Further Treatment in Relapsed CLL Responding to Induction Therapy |
| NCT01077518 | PHASE3 | TERMINATED | Ofatumumab Bendamustine Combination Compared With Bendamustine Monotherapy in Indolent B-cell NHL Unresponsive to Rituxtherapy |
| NCT01200589 | PHASE3 | TERMINATED | Single Agent Ofatumumab Vs. Single Agent Rituximab in Indolent B-Cell Non Hodgkin Lymphoma Relapsed After Rituximab-Containing Therapy |
| NCT01313689 | PHASE3 | COMPLETED | Ofatumumab vs Physician’s Choice in Subjects With Bulky Fludarabine-Refractory Chronic Lymphocytic Leukemia |
| NCT01578707 | PHASE3 | COMPLETED | A Phase 3 Study of Ibrutinib (PCI-32765) Versus Ofatumumab in Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia |
| NCT01580228 | PHASE3 | COMPLETED | A Phase 3 Study Comparing Dinaciclib Versus Ofatumumab in Patients With Refractory Chronic Lymphocytic Leukemia (P07714) |
| NCT01659021 | PHASE3 | TERMINATED | Efficacy and Safety of Idelalisib in Combination With Ofatumumab for Previously Treated Chronic Lymphocytic Leukemia |
| NCT01678430 | PHASE3 | UNKNOWN | A Trial Looking at Ofatumumab for People With Chronic Lymphocytic Leukaemia Who Cannot Have More Intensive Treatment |
| NCT01920477 | PHASE3 | TERMINATED | Efficacy and Safety of Ofatumumab in Treatment of Pemphigus Vulgaris |
| NCT02004522 | PHASE3 | COMPLETED | A Phase 3 Study of Duvelisib Versus Ofatumumab in Patients With Relapsed or Refractory CLL/SLL (DUO) |
| NCT02049515 | PHASE3 | COMPLETED | A Phase 3 Extension Study of Duvelisib and Ofatumumab in Participants With CLL/SLL Previously Enrolled in Study IPI-145-07 |
| NCT02613910 | PHASE3 | TERMINATED | Long-Term Extension Study of Ofatumumab in Subjects With Pemphigus Vulgaris |
| NCT02792218 | PHASE3 | COMPLETED | Efficacy and Safety of Ofatumumab Compared to Teriflunomide in Patients With Relapsing Multiple Sclerosis |
| NCT02792231 | PHASE3 | COMPLETED | Efficacy and Safety of Ofatumumab Compared to Teriflunomide in Patients With Relapsing Multiple Sclerosis. |
| NCT04353492 | PHASE3 | COMPLETED | An Open-label Study Evaluating Ofatumumab Treatment Effectiveness and PROs in Subjects With RMS Transitioning From Fumarate-based RMS Approved Therapies or Fingolimod to Ofatumumab |
| NCT04486716 | PHASE3 | COMPLETED | A Single Arm Study Evaluating the Efficacy, Safety and Tolerability of Ofatumumab in Patients With Relapsing Multiple Sclerosis |
| NCT04510220 | PHASE3 | COMPLETED | 9-month Study to Assess the Efficacy of Ofatumumab on Microglia in Patients With Relapsing Forms of Multiple Sclerosis |
| NCT04788615 | PHASE3 | COMPLETED | Open Label Randomized Multicenter to Assess Efficacy & Tolerability of Ofatumumab 20mg vs. First Line DMT in RMS |
| NCT01361711 | PHASE2 | ACTIVE_NOT_RECRUITING | Alemtuzumab-Ofatumumab in Previously Untreated Symptomatic Chronic Lymphocytic Leukemia |
| NCT02877303 | PHASE2 | RECRUITING | Blinatumomab, Inotuzumab Ozogamicin, and Combination Chemotherapy as Frontline Therapy in Treating Patients With B Acute Lymphoblastic Leukemia |
| NCT03136146 | PHASE2 | RECRUITING | Combination Chemotherapy in Treating Patients With Relapsed or Refractory Acute Lymphoblastic Leukemia, Lymphoblastic Lymphoma, Burkitt Lymphoma/Leukemia, or Double-Hit Lymphoma/Leukemia |
| NCT05504694 | PHASE1/PHASE2 | RECRUITING | Ofatumumab in AQP4-IgG Seropositive NMOSD |
| NCT00092274 | PHASE1/PHASE2 | WITHDRAWN | Study of HuMax-CD20, a New Drug to Treat Early Stage Non-Hodgkin´s Follicular Lymphoma |
| NCT00093314 | PHASE1/PHASE2 | WITHDRAWN | HuMax-CD20 in Chronic Lymphocytic Leukemia |
| NCT00349349 | PHASE2 | COMPLETED | HuMax-CD20 in B-Cell Chronic Lymphocytic Leukemia (B-CLL) Patients Failing Fludarabine and Alemtuzumab |
| NCT00394836 | PHASE2 | COMPLETED | HuMax-CD20 i(Ofatumumab) n Follicular Lymphoma (FL) Patients Refractory to Rituximab |
Clinical evidence (CIViC)
No CIViC predictive evidence (expected for non-precision-medicine drugs).
Pharmacology
Pharmacogenomics
No PharmGKB pharmacogenomic data curated for this drug.
Related molecules
Related molecules
No competitor molecules sharing a primary target (ChEMBL phase ≥2 or PubChem drug-class).