ofatumumab
Trade name: arzerra
mAbapprovedOrphan Drug FDA
Approved
Oct 26, 2009
Ofatumumab is a fully human monoclonal antibody to CD20, which appears to provide rapid B-cell depletion. Under the brand name Kesimpta, it is approved for the treatment of multiple sclerosis in the United States as well as in the European Union and other regions. Under the brand name Arzerra, it is approved for the treatment of certain types of chronic lymphocytic leukemia (CLL) in the United States. It is sold by Novartis under license from Genmab. — Wikipedia
Clinical trial activity
132 trials · 95 clinical orgs · 2 marketing orgs
Phase 1
19
Phase 2
114
Phase 3
28
Phase 4
8
Earliest trial started Sep 1, 2004 (NCT00092274)
Timeline
2000s
- Jan 1, 2004
GlaxoSmithKline — Earliest Phase 1 Sponsor(trial)
- Jan 1, 2005
GlaxoSmithKline — Earliest Phase 2 Sponsor(trial)
- Jan 1, 2008
GlaxoSmithKline — Earliest Phase 3 Sponsor(trial)
- Mar 10, 2009
Orphan Drug Designation
- Oct 26, 2009
GlaxoSmithKline — Earliest FDA Approval
- Oct 26, 2009
GlaxoSmithKline — Marketing Organization
- Oct 26, 2009
GlaxoSmithKline — NDA Organization
- Oct 26, 2009
Novartis — Marketing Organization
- Oct 26, 2009
Novartis — NDA Secondary Org
Indications
Studied for
- Agammaglobulinemia · Phase 2
- Anti-N-Methyl-D-Aspartate Receptor Encephalitis · Phase 3
- Arthritis, Rheumatoid · Phase 3
- Burkitt Lymphoma · Phase 2
- Endoscopy · Phase 2
- Fatigue · Phase 2
- Fever · Phase 2
- Gonorrhea · Phase 1
- Graft vs Host Disease · Phase 1/Phase 2
- Hodgkin Disease · Phase 2
- Leukemia · Phase 3
- Leukemia, Lymphoid · Phase 1/Phase 2
- Leukemia-Lymphoma, Adult T-Cell · Phase 2
- Leukemia, Myeloid, Chronic, Atypical, BCR-ABL Negative · Phase 2
- Leukemia, Prolymphocytic · Phase 1/Phase 2
- Lymphadenopathy · Phase 2
- Lymphocytosis · Phase 2
- Lymphoma · Phase 2
- Lymphoma, B-Cell · Phase 2
- Lymphoma, B-Cell, Marginal Zone · Phase 2
- Lymphoma, Follicular · Phase 3
- Lymphoma, Large B-Cell, Diffuse · Phase 4
- Lymphoma, Large-Cell, Immunoblastic · Phase 2
- Lymphoma, Mantle-Cell · Phase 2
- Lymphoma, Non-Hodgkin · Phase 3
- Lymphoma, Primary Cutaneous Anaplastic Large Cell · Phase 2
- Melanoma · Phase 2
- Multiple Sclerosis · Phase 4
- Multiple Sclerosis, Relapsing-Remitting · Phase 4
- Nephrotic Syndrome · Phase 2
- Neuromyelitis Optica · Phase 1/Phase 2
- Paraproteinemias · Phase 2
- Pemphigus · Phase 3
- Precursor B-Cell Lymphoblastic Leukemia-Lymphoma · Phase 2
- Precursor Cell Lymphoblastic Leukemia-Lymphoma · Phase 2
- Squamous Intraepithelial Lesions · Phase 2
- Sweat · Phase 2
- Thrombocytopenia · Phase 2
- Waldenstrom Macroglobulinemia · Phase 2
Mechanism of action
- B-lymphocyte antigen CD20BINDING AGENT
B-lymphocyte antigen CD20 binding agent
- B-lymphocyte antigen CD20INHIBITOR
MS4A1 inhibitor
Approval history
- approvedAcceleratedOct 26, 2009
Chemistry & pharmacology
- Chirality
- Single Stereoisomer
- Inorganic
- No
- Polymer
- No
- Delivery
- Parenteral
- Availability
- Prescription Only
- Multi-specific
- No
Oral
No
Parenteral
Yes
Topical
No
Black box warning
Sources
- WikipediaOfatumumab ↗
- NCATSM95KG522R0 ↗
- ChEMBLCHEMBL1201836 ↗
Also known as
- 2f2
- 2f2
- 2f2
- arzerra
- arzerra
- arzerra
- arzerra
- arzerra
- gsk1841157
- gsk1841157
- humax-cd20
- humax-cd20
- humax-cd20
- humax-cd20
- humax-cd20 2f2
- humax-cd20, 2f2
- immunoglobulin g1, anti-(human cd20 (antigen))(human monoclonal humax-cd20 heavy chain), disulfide with human monoclonal humax-cd20 kappa-chain, dimer
- ofatumumab
- ofatumumab
- ofatumumab
- ofatumumab
- ofatumumab
- ofatumumab
- ofatumumab
- ofatumumab
- ofatumumab
- ofatumumab
- ofatumumabum
Clinical trials
| NCT ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT07189325 | Phase 3 | Sep 30, 2025 | University of Montpellier |
| NCT06869785 | Phase 3 | Mar 13, 2025 | Novartis |
| NCT06867991 | Phase 3 | Nov 8, 2024 | The First People's Hospital of Changzhou |
| NCT06444113 | Phase 4 | Aug 30, 2024 | Novartis |
| NCT05199571 | Phase 4 | Jul 22, 2022 | Novartis |
| NCT05504694 | Phase 1/Phase 2 (Phase 2) | Jun 28, 2022 | Henan Provincal People's Hospital, People's Liberation Army of China |
| NCT05090371 | Phase 4 | Nov 15, 2021 | Novartis |
| NCT05084638 | Phase 4 | Nov 5, 2021 | Novartis |
| NCT04926818 | Phase 3 | Oct 5, 2021 | Novartis |
| NCT04788615 | Phase 3 | Jul 23, 2021 | Novartis |
| NCT04878211 | Phase 4 | Jun 10, 2021 | Novartis |
| NCT04869358 | Phase 4 | May 27, 2021 | Novartis |
| NCT04667117 | Phase 4 | Dec 17, 2020 | Novartis |
| NCT04486716 | Phase 3 | Oct 19, 2020 | Novartis |
| NCT04510220 | Phase 3 | Aug 31, 2020 | Harvard University, Novartis |
| NCT04353492 | Phase 3 | Apr 27, 2020 | Novartis |
| NCT03650114 | Phase 3 | Dec 21, 2018 | Novartis |
| NCT03560739 | Phase 2 | Oct 22, 2018 | Novartis |
| NCT03488225 | Phase 2 | Mar 28, 2018 | Pfizer, University of Texas at Houston |
| NCT03249714 | Phase 2 | Mar 15, 2018 | Novartis |
Showing 20 of 132 trials
Page 1 / 7
Organizations
Research & Development (95)
| Organization | Org type | Trials | As lead sponsor | Phases | Earliest year |
|---|---|---|---|---|---|
| GlaxoSmithKline | For profit | 55 | 23 | 4 | 2004 |
| Novartis | For profit | 39 | 27 | 4 | 2008 |
| University of Texas at Houston | Academic/Hospital | 11 | 11 | 1 | 2010 |
| National Cancer Institute (NCI) | Government | 6 | 3 | 1 | 2011 |
| Celgene | For profit | 5 | 0 | 1 | 2010 |
| Cephalon | For profit | 5 | 1 | 1 | 2010 |
| Gilead Sciences | For profit | 4 | 3 | 3 | 2010 |
| Harvard University | Academic/Hospital | 4 | 4 | 2 | 2010 |
| National Comprehensive Cancer Network | Academic/Hospital | 4 | 0 | 1 | 2011 |
| University of Milan | Academic/Hospital | 4 | 1 | 1 | 2010 |
| Gruppo Italiano Malattie EMatologiche dell'Adulto | Academic/Hospital | 3 | 3 | 1 | 2010 |
| SCRI Development Innovations | For profit | 3 | 3 | 1 | 2010 |
| University of South Florida | Academic/Hospital | 3 | 3 | 1 | 2012 |
| Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea | Academic/Hospital | 2 | 2 | 1 | 2010 |
| Mayo Clinic | Academic/Hospital | 2 | 1 | 1 | 2010 |
| Nevada Cancer Institute | Academic/Hospital | 2 | 2 | 1 | 2010 |
| Ohio State University | Academic/Hospital | 2 | 0 | 1 | 2010 |
| Pfizer | For profit | 2 | 0 | 1 | 2011 |
| Pharmacyclics | For profit | 2 | 2 | 2 | 2010 |
| State University of New York, Buffalo | Academic/Hospital | 2 | 2 | 1 | 2011 |
95 organizations
Page 1 / 5
Marketing (4)
| Organization | Org type | Relationship | Date |
|---|---|---|---|
| GlaxoSmithKline | For profit | MKTG | Oct 26, 2009 |
| GlaxoSmithKline | For profit | NDA | Oct 26, 2009 |
| Novartis | For profit | MKTG | Oct 26, 2009 |
| Novartis | For profit | NDA2 | Oct 26, 2009 |