Kesimpta

(Ofatumumab)

ApprovedMonoclonal antibody

Ofatumumab is used to treat certain types of blood cancer (chronic lymphocytic leukemia) and multiple sclerosis by helping the immune system target and destroy specific disease-causing cells.[2] Kesimpta is currently approved and in use across 10 indications[4].[1]

Kesimpta is one of 240 biologic programs targeting Acute Lymphoblastic Leukemia. It is currently in Approved.

Indications

129

Total Trials

Active Trials

239

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[4][1]

Indication

Acute Lymphoblastic LeukemiaCompleted

Secondary Progressive Multiple SclerosisUnknown

PemphigusActive, not recruiting

ToxicityActive, not recruiting

Recurrent Acute Lymphoblastic LeukemiaRecruiting

EffectivenessCompleted

Multiple SclerosisCompleted

Chronic Lymphocytic LeukemiaCompleted

LAMActive, not recruiting

NMOSDRecruiting

Acute Lymphoblastic LeukemiaPhase 2

Completed

Secondary Progressive Multiple SclerosisPreclinical

Unknown

PemphigusPreclinical

Active, not recruiting

ToxicityPreclinical

Active, not recruiting

Recurrent Acute Lymphoblastic LeukemiaPhase 2

Recruiting

EffectivenessPhase 3

Completed

Multiple SclerosisApproved

Completed

Chronic Lymphocytic LeukemiaApproved

Completed

LAMApproved

Active, not recruiting

NMOSDPhase 2

Recruiting

Competition

Competitive Landscape

163 competitors in Acute Lymphoblastic Leukemia

#DrugCompanyPhaseTrials

Oncovin

Eli Lilly

Phase 3

75 2

Adriamycin

Pfizer

Phase 3

40 3

Kesimpta

Novartis

Approved

4 4

Oncaspar

SServier

Phase 3

48 5

Cerubidine

EEastern Cooperative Oncology Group

Phase 3

43 6

Fludara

Sanofi

Phase 3

15 7

Medrol

Pfizer

Phase 3

12 8

Iclusig

Takeda

Phase 3

12 9

Cellcept

Roche

Phase 3

11 10

Neupogen

EEastern Cooperative Oncology Group

Phase 3

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q4 2026

Phase 2Recruiting

Acute Lymphoblastic Leukemia

NCT02877303

Recruiting

Multiple Sclerosis

NCT07353216

Q1 2027

Post-ApprovalActive, not recruiting

LAM

NCT05090371

Q2 2027

Phase 2Active, not recruiting

Chronic Lymphocytic Leukemia

NCT01361711

Q3 2027

Phase 2Recruiting

Recurrent Acute Lymphoblastic Leukemia

NCT03136146

Clinical

Trials by Indication[1]

Chronic Lymphocytic Leukemia32 trials

Ofatumumab for Patients With Previously Untreated Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma

Completed·SSCRI Development Innovations, LLC·Phase 2·NCT01113632·77 enrolled

Alemtuzumab-Ofatumumab in Previously Untreated Symptomatic Chronic Lymphocytic Leukemia

Active, not recruiting·NNorthwestern University·Phase 2·NCT01361711·53 enrolled

A Phase 3 Study of Ibrutinib (PCI-32765) Versus Ofatumumab in Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia

Completed·PPharmacyclics LLC.·Phase 3·NCT01578707·391 enrolled

Show 29 more trials

Assessment of Efficacy and Safety of Front-line Fludarabine, Cyclophoshamide and Ofatumumab Chemoimmunotherapy in Young Patients With Chronic Lymphocytic Leukemia.

Completed·GGruppo Italiano Malattie EMatologiche dell'Adulto·Phase 2·NCT01762202·80 enrolled

Ofatumumab for High-Risk Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL)

Completed·MM.D. Anderson Cancer Center·Phase 2·NCT01243190·44 enrolled

Efficacy and Safety of Idelalisib in Combination With Ofatumumab for Previously Treated Chronic Lymphocytic Leukemia

Terminated· Gilead logo

Gilead·Phase 3·NCT01659021·261 enrolled

Study to Investigate Idelalisib in Combination With Chemotherapeutic Agents, Immunomodulatory Agents and Anti-CD20 Monoclonal Antibody (mAb) in Participants With Relapsed or Refractory Indolent B-cell Non-Hodgkin's Lymphoma, Mantle Cell Lymphoma or Chronic Lymphocytic Leukemia

Completed· Gilead logo

Gilead·Phase 1·NCT01088048·241 enrolled

Efficacy and Safety of Ofatumumab Retreatment and Maintenance Treatment in Patients With B-cell Chronic Lymphocytic Leukemia (CLL)

Completed· GSK logo

GSK·Phase 4·NCT00802737·29 enrolled

Treatment of Chronic Lymphocytic Leukemia in Patients Previously Exposed to Rituximab

Completed·MMedical University of South Carolina·Phase 2·NCT01123356·21 enrolled

Ofatumumab in Japanese Patients With CD20 Positive Follicular Lymphoma or Chronic Lymphocytic Leukemia

Completed· GSK logo

GSK·Phase 1·NCT00742144·6 enrolled

Ofatumumab as Front-Line Therapy in Treating Elderly Participants With Chronic Lymphocytic Leukemia

Completed·MM.D. Anderson Cancer Center·Phase 2·NCT01444716·34 enrolled

Buparlisib and Ofatumumab or Ibrutinib in Treating Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia

Terminated·EEmory University·Phase 1·NCT02614508·1 enrolled

Trial of Pentostatin Plus Cyclophosphamide With Ofatumumab (PCO) in Older Patients With Chronic Lymphocytic Leukemia

Completed·NNiguarda Hospital·Phase 2·NCT01681563·47 enrolled

Ofatumumab and Dinaciclib in Treating Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma, or B-Cell Prolymphocytic Leukemia

Completed·NNational Cancer Institute (NCI)·Phase 1/2·NCT01515176·36 enrolled

An Open-Label Phase 2 Study of Ofatumumab (Arzerra) in Combination With Oral GSK2110183 in the Treatment of Relapsed and Refractory Chronic Lymphocytic Leukemia (CLL)

Completed·UUniversity Health Network, Toronto·Phase 2·NCT01532700·28 enrolled

A Phase I/II, a Single Arm, Open-label Study of Ofatumumab (GSK1841157) in Patients With Previously Treated Chronic Lymphocytic Leukemia

Completed· GSK logo

GSK·Phase 2·NCT01077622·10 enrolled

Ofatumumab and Bendamustine for Previously Treated Chronic Lymphocytic Leukemia (CLL)

Terminated·GGeorgetown University·Phase 2·NCT01010568·10 enrolled

PH2 Trial in Patients With Relapsed/Refractory Chronic Lymphocytic Leukemia (CLL) With a Combination of Bendamustine & Ofatumumab

Withdrawn·NNevada Cancer Institute·Phase 2·NCT01131247·37 enrolled

Ofatumumab Added to Dexamethasone in Subjects With Relapsed or Refractory Chronic Lymphocytic Leukemia

Completed·—·Phase 2·NCT01310101·33 enrolled

Clinical Protocol for the Treatment of Patients With Previously Untreated Chronic Lymphocytic Leukemia With a Combination of Bendamustine and Ofatumumab

Terminated·NNevada Cancer Institute·Phase 2·NCT01125787·1 enrolled

A Phase 3 Study Comparing Dinaciclib Versus Ofatumumab in Patients With Refractory Chronic Lymphocytic Leukemia (P07714)

Completed· Merck & Co. logo

Merck & Co.·Phase 3·NCT01580228·44 enrolled

Combination of Pentostatin, Bendamustine and Ofatumumab for Treatment of Chronic Lymphocytic Leukemia and Lymphoma

Terminated·SSidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University·Phase 1·NCT01352312·10 enrolled

Ofatumumab, Pentostatin, and Cyclophosphamide in Treating Patients With Untreated Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma

Completed·MMayo Clinic·Phase 2·NCT01024010·82 enrolled

Ofatumumab and High-dose Methylprednisolone in Patients With Chronic Lymphocytic Leukemia (CLL)

Completed·JJanuario Castro, M.D.·Phase 2·NCT01191190·21 enrolled

A Phase I/II, Open-label Study of Ofatumumab Added to Chlorambucil in Previously Untreated Japanese Patients With Chronic Lymphocytic Leukemia

Completed· GSK logo

GSK·Phase 2·NCT01563055·10 enrolled

Ofatumumab vs Physician's Choice in Subjects With Bulky Fludarabine-Refractory Chronic Lymphocytic Leukemia

Completed· Novartis logo

Novartis·Phase 3·NCT01313689·122 enrolled

Ofatumumab + Chlorambucil vs Chlorambucil Monotherapy in Previously Untreated Patients With Chronic Lymphocytic Leukemia

Terminated· Novartis logo

Novartis·Phase 3·NCT00748189·447 enrolled

HuMax-CD20 in B-Cell Chronic Lymphocytic Leukemia (B-CLL) Patients Failing Fludarabine and Alemtuzumab

Completed· GSK logo

GSK·Phase 2·NCT00349349·223 enrolled

Rapid Infusion of Ofatumumab in Patients With Previously Treated Chronic Lymphocytic Leukemia

Completed·SSCRI Development Innovations, LLC·Phase 2·NCT01848145·34 enrolled

Lenalidomide and Ofatumumab in Treating Participants With Previously Treated Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma

Completed·MM.D. Anderson Cancer Center·Phase 2·NCT01002755·36 enrolled

Ofatumumab Cardiac Repolarization (QTc) Study in Fludarabine-Refractory Chronic Lymphocytic Leukemia Subjects

Completed· GSK logo

GSK·Phase 1·NCT01110031·12 enrolled

Ofatumumab as Part of Reduced Intensity Conditioning (RIC) Regimen for Patients With High Risk Chronic Lymphocytic Leukemia (CLL) Undergoing Allogeneic Hematopoietic Cell Transplantation

Completed·GGrupo Espanol de trasplantes hematopoyeticos y terapia celular·Phase 2·NCT01455051·25 enrolled

Lymphoma20 trials

Study of Lenalidomide and Ofatumumab for the Treatment of Relapsed or Refractory Non-Hodgkin's Lymphoma

Completed·UUniversity of Nebraska·Phase 1/2·NCT01060384·46 enrolled

Chemotherapy Plus Ofatumumab Followed by G-CSF for Mobilization of Peripheral Blood Stem Cells in Patients With Non-Hodgkin's Lymphomas

Completed·MM.D. Anderson Cancer Center·Phase 2·NCT01329900·50 enrolled

Ofatumumab With IVAC Salvage Chemotherapy in Diffuse Large B Cell Lymphoma Patients

Completed·PPolish Lymphoma Research Group·Phase 2·NCT01481272·77 enrolled

Show 17 more trials

Ofatumumab in Nodular Lymphocyte Predominant Hodgkin Lymphoma (NLPHL)

Completed·UUniversity of Cologne·Phase 2·NCT01187303·28 enrolled

Ofatumumab for Initial Systemic Treatment of Indolent B-cell Lymphoma

Completed·MMassachusetts General Hospital·Phase 2·NCT01239394·43 enrolled

Single Agent Ofatumumab Vs. Single Agent Rituximab in Indolent B-Cell Non Hodgkin Lymphoma Relapsed After Rituximab-Containing Therapy

Terminated· Novartis logo

Novartis·Phase 3·NCT01200589·438 enrolled

Ofatumumab In Older Patients With Untreated Low Or Intermediate Risk Indolent B-Cell Lymphomas

Withdrawn·UUNC Lineberger Comprehensive Cancer Center·Phase 2·NCT01263418

Phase II Study of Ofatumumab Plus Ifosfamide, Carboplatin, Etoposide (ICE) or Dexamethasone, Cytarabine, Cisplatin (DHAP) Chemotherapy Regimen in Relapsed/ Refractory Diffuse Large B Cell Lymphoma (DLBCL)

Completed· GSK logo

GSK·Phase 2·NCT00823719·61 enrolled

Ofatumumab and Bortezomib for Patients With Low-grade B-cell Non-hodgkin Lymphoma That Relapse After Rituximab

Terminated·—·Phase 2·NCT01119794·10 enrolled

Ofatumumab Versus Rituximab Salvage Chemoimmunotherapy Followed by Autologous Stem Cell Transplant in Relapsed or Refractory Diffuse Large B Cell Lymphoma

Completed· GSK logo

GSK·Phase 3·NCT01014208·447 enrolled

Recombinant Human IL-18 and Ofatumumab After PBSCT for Lymphoma

Completed·MMichael John Robertson·Phase 1·NCT01768338·9 enrolled

Ofatumumab and Fresh Frozen Plasma in Patients With Chronic Lymphocytic Lymphoma

Completed·JJoseph Tuscano·Phase 2·NCT01716208·12 enrolled

Study of Ofatumumab and ESHAP for the Treatment of Hodgkin's Lymphoma

Completed·GGrupo Español de Linfomas y Transplante Autólogo de Médula Ósea·Phase 2·NCT01195766·64 enrolled

Patients With Relapsed or Refractory Diffuse Large B Cell Non Hodgkin Lymphomas

Terminated·OOncology Specialists, S.C.·Phase 2·NCT01078922·11 enrolled

Ofatumumab and Bendamustine Hydrochloride With or Without Bortezomib in Treating Patients With Untreated Follicular Non-Hodgkin Lymphoma

Completed·NNational Cancer Institute (NCI)·Phase 2·NCT01286272·135 enrolled

Study to Evaluate the Efficacy and Safety of Treatment With Bendamustine in Combination With Ofatumumab in Previously Untreated Patients With Indolent B-Cell Non-Hodgkin's Lymphoma (NHL)

Completed·CCephalon·Phase 2·NCT01108341·50 enrolled

Study of OFATUMUMAB as Part of the Scheme of Reduced Intensity Conditioning in High Risk Non-Hodgkin Lymphoma B Patients

Completed·GGrupo Español de Linfomas y Transplante Autólogo de Médula Ósea·Phase 2·NCT01613300·33 enrolled

Ofatumumab in Patients With Relapsed/Progressive Diffused Large B-Cell Lymphoma (DLBCL) Ineligible for or Relapse/Progression After Transplant

Completed· GSK logo

GSK·Phase 2·NCT00622388·81 enrolled

Ofatumumab in Treating Patients With Previously Untreated Stage II, Stage III, or Stage IV Follicular Non-Hodgkin Lymphoma

Completed·AAlliance for Clinical Trials in Oncology·Phase 2·NCT01190449·51 enrolled

Ofatumumab and Bendamustine Followed by Maintenance Ofatumumab for Rituximab Relapsed Indolent B-cell Non-Hodgkin's Lymphoma (B-NHL)

Completed· Novartis logo

Novartis·Phase 2·NCT01294579·49 enrolled

Multiple Sclerosis15 trials

A Multicenter Study to Assess Response to Influenza Vaccine in Multiple Sclerosis Participants Treated With Ofatumumab

Completed· Novartis logo

Novartis·Phase 4·NCT04667117·63 enrolled

Time and Motion Study for Ocrelizumab and Ofatumumab Administration in Relapsing Multiple Sclerosis

Completed· Novartis logo

Novartis··NCT04676555·2 enrolled

Exploring the Immune Response to SARS-CoV-2 COVID-19 Vaccines in Patients With Relapsing Multiple Sclerosis (RMS) Treated With Ofatumumab

Completed· Novartis logo

Novartis·Phase 4·NCT04869358·34 enrolled

Show 12 more trials

9-month Study to Assess the Efficacy of Ofatumumab on Microglia in Patients With Relapsing Forms of Multiple Sclerosis

Completed·—·Phase 3·NCT04510220·10 enrolled

Study of Efficacy and Safety of Ofatumumab in Relapsing Multiple Sclerosis (RMS) Patients in China

Completed· Novartis logo

Novartis·Phase 4·NCT05199571·99 enrolled

A Open-label Study to Assess Response to COVID-19 Vaccine in Multiple Sclerosis Participants Treated With Ofatumumab

Terminated· Novartis logo

Novartis·Phase 4·NCT04878211·24 enrolled

Retinal Atrophy and Neurofilament Light Chain in People With Multiple Sclerosis Taking Ofatumumab

Enrolling by invitation·JJohns Hopkins University··NCT06167642·75 enrolled

Efficacy and Safety of Ofatumumab and Siponimod Compared to Fingolimod in Pediatric Patients With Multiple Sclerosis

Active, not recruiting· Novartis logo

Novartis·Phase 3·NCT04926818·129 enrolled

Ofatumumab Dose-finding in Relapsing Remitting Multiple Sclerosis (RRMS) Patients

Completed· GSK logo

GSK·Phase 2·NCT00640328·38 enrolled

Efficacy and Safety of Ofatumumab Compared to Teriflunomide in Patients With Relapsing Multiple Sclerosis

Completed· Novartis logo

Novartis·Phase 3·NCT02792218·930 enrolled

Efficacy and Safety of Ofatumumab Compared to Teriflunomide in Patients With Relapsing Multiple Sclerosis.

Completed· Novartis logo

Novartis·Phase 3·NCT02792231·955 enrolled

A Single Arm Study Evaluating the Efficacy, Safety and Tolerability of Ofatumumab in Patients With Relapsing Multiple Sclerosis

Completed· Novartis logo

Novartis·Phase 3·NCT04486716·111 enrolled

Exploring the Efficacy and Safety of Ofatumumab in Patients With Relapsing Multiple Sclerosis (RMS) and Its Impact on Serum Neurofilament Light Chain (sNfL) Levels

Recruiting·TThird Affiliated Hospital, Sun Yat-Sen University··NCT07353216·80 enrolled

Efficacy and Safety of Ofatumumab Compared to Placebo in Patients With Relapsing Multiple Sclerosis Followed by Extended Treatment With Open-label Ofatumumab

Completed· Novartis logo

Novartis·Phase 2·NCT03249714·64 enrolled

Switch to Ofatumumab and Level of Immunoglobulins

Not yet recruiting·UUniversity Hospital, Lille··NCT07625800·115 enrolled

Acute Lymphoblastic Leukemia4 trials

Blinatumomab, Inotuzumab Ozogamicin, and Combination Chemotherapy as Frontline Therapy in Treating Patients With B Acute Lymphoblastic Leukemia

Recruiting·MM.D. Anderson Cancer Center·Phase 2·NCT02877303·80 enrolled

Augmented Berlin-Frankfurt-Munster Therapy Plus Ofatumumab for Young Adults With Acute Lymphoblastic Leukemia or Lymphoblastic Lymphoma

Terminated·MM.D. Anderson Cancer Center·Phase 2·NCT02419469·1 enrolled

Combination Chemotherapy and Ofatumumab in Treating Patients With Acute Lymphoblastic Leukemia or Lymphoblastic Lymphoma

Completed·MM.D. Anderson Cancer Center·Phase 2·NCT01363128·72 enrolled

Show 1 more trial

Dose Adjusted EPOCH Regimen in Combination With Ofatumumab or Rituximab in Treating Patients With Newly Diagnosed or Relapsed or Refractory Burkitt Lymphoma or Relapsed or Refractory Acute Lymphoblastic Leukemia

Completed·MM.D. Anderson Cancer Center·Phase 2·NCT02199184·14 enrolled

CLL3 trials

Ofatumumab With High Dose Methylprednisone Followed by Ofatumumab and Alemtuzumab in 17p CLL

Terminated·—·Phase 2·NCT01465334·30 enrolled

Ofatumumab With Fludarabine and Cyclophosphamide in B-CLL Patients

Completed· GSK logo

GSK·Phase 2·NCT00410163·61 enrolled

GIMEMA CLL0809 Study (BendOfa)

Completed·GGruppo Italiano Malattie EMatologiche dell'Adulto·Phase 2·NCT01244451·49 enrolled

42 more indications

Diffuse Large B-Cell Lymphoma3 trials

Intensive Consolidation and Stem Cell Mobilization Therapy Followed by Autologous Stem Cell Transplantation in High-risk Patients With Relapsed/Refractory Diffuse Large B-Cell Lymphoma

Completed·CC. Babis Andreadis·Phase 2·NCT01555541·19 enrolled

Study of Mini-Chop Plus Ofatumumab To Treat Cd 20+ Diffuse Large B-Cell Lymphoma In Patients Aged Over 80 Years

Completed·TThe Lymphoma Academic Research Organisation·Phase 2·NCT01195714·120 enrolled

Study of Bendamustine and Ofatumumab in Elderly Patients With Newly Diagnosed Diffuse Large B-Cell Lymphoma Who Are Poor Candidates for R-CHOP Chemotherapy

Completed·SSCRI Development Innovations, LLC·Phase 2·NCT01626352·22 enrolled

Pemphigus Vulgaris3 trials

Long-Term Extension Study of Ofatumumab in Subjects With Pemphigus Vulgaris

Terminated· GSK logo

GSK·Phase 3·NCT02613910·1 enrolled

Efficacy and Safety of Ofatumumab in Treatment of Pemphigus Vulgaris

Terminated· Novartis logo

Novartis·Phase 3·NCT01920477·35 enrolled

Efficacy and Safety Evaluation of Anti-CD20 Monoclonal Antibody Combined with Azathioprine and Corticosteroids in the Treatment of Pemphigus Vulgaris

Completed·CChao Ji··NCT06654817·38 enrolled

Mantle Cell Lymphoma3 trials

Ofatumumab in Combination With Cyclophosphamide, Doxorubicin Hydrochloride, Vincristine Sulfate, and Dexamethasone Alternating With Ofatumumab in Combination With Cytarabine and Methotrexate in Treating Patients With Newly Diagnosed Mantle Cell Lymphoma

Completed·RRoswell Park Cancer Institute·Phase 2·NCT01527149·37 enrolled

Ofatumumab With or Without Bendamustine for Patients With Mantle Cell Lymphoma Ineligible for Autologous Stem Cell Transplant

Completed·MMemorial Sloan Kettering Cancer Center·Phase 2·NCT01437709·30 enrolled

Ofatumumab and Bortezomib in Subjects With Relapsed CD20+Diffuse Large B Cell, Follicular, or Mantle Cell Lymphoma

Terminated·OOHSU Knight Cancer Institute·Phase 2·NCT01397591·3 enrolled

Idiopathic Nephrotic Syndrome2 trials

Ofatumumab Versus Rituximab in Children With Steroid and Calcineurin Inhibitor Dependent Idiopathic Nephrotic Syndrome

Completed·IIstituto Giannina Gaslini·Phase 2·NCT02394119·140 enrolled

Ofatumumab in Children With Drug Resistant Idiopathic Nephrotic Syndrome

Terminated·IIstituto Giannina Gaslini·Phase 2·NCT02394106·13 enrolled

Follicular Lymphoma2 trials

HuMax-CD20 i(Ofatumumab) n Follicular Lymphoma (FL) Patients Refractory to Rituximab

Completed· GSK logo

GSK·Phase 2·NCT00394836·116 enrolled

Ofatumumab (Humax-CD20) With CHOP (Cyclophosphamide,Doxorubicin, Vincristine, Predisolone) in Follicular Lymphoma (FL) Patients

Completed· GSK logo

GSK·Phase 2·NCT00494780·59 enrolled

Rheumatoid Arthritis2 trials

Investigating Clinical Efficacy of Ofatumumab in Adult Rheumatoid Arthritis (RA) Patients Who Had an Inadequate Response to MTX Therapy

Terminated· GSK logo

GSK·Phase 3·NCT00611455·265 enrolled

Investigating Clinical Efficacy of Ofatumumab in Adult Rheumatoid Arthritis (RA) Patients Who Had an Inadequate Response to TNF-α Antagonist Therapy

Terminated· GSK logo

GSK·Phase 3·NCT00603525·169 enrolled

Effectiveness2 trials

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

Completed· Novartis logo

Novartis·Phase 3·NCT04353492·562 enrolled

Long-term Safety, Tolerability and Effectiveness Study of Ofatumumab in Patients With Relapsing MS

Active, not recruiting· Novartis logo

Novartis·Phase 3·NCT03650114·1,882 enrolled

CLL/SLL2 trials

A Phase 3 Extension Study of Duvelisib and Ofatumumab in Participants With CLL/SLL Previously Enrolled in Study IPI-145-07

Completed·SSecuraBio·Phase 3·NCT02049515·99 enrolled

A Study of Idelalisib (GS1101, CAL101) + Ofatumumab in Previously Untreated CLL/SLL

Completed·—·Phase 2·NCT02135133·27 enrolled

Efficacy and Safety2 trials

Efficacy and Safety Study of PCI-32765 Combine With Ofatumumab in CLL

Completed·PPharmacyclics LLC.·Phase 1/2·NCT01217749·71 enrolled

Long-term Efficacy and Safety of Repeated Ofatumumab Treatment Courses in RA Patients Who Previously Received Ofatumumab or Placebo in Trial Hx-CD20-403

Terminated· GSK logo

GSK·Phase 2·NCT00655824·124 enrolled

TIA1 trial

Sequential Regimen of Bendamustin-Debulking Followed by Ofatumumab and Ibrutinib in CLL Patients (CLL2-BIO)

Completed·GGerman CLL Study Group·Phase 2·NCT02689141·66 enrolled

Waldenstrom macroglobulinemia1 trial

Ofatumumab and Bortezomib in Treating Patients With Previously Untreated Waldenstrom Macroglobulinemia

Terminated·RRoswell Park Cancer Institute·Phase 2·NCT01536067·3 enrolled

NMOSD1 trial

Ofatumumab in AQP4-IgG Seropositive NMOSD

Recruiting·TTang-Du Hospital·Phase 1/2·NCT05504694·5 enrolled

LAM1 trial

A Multicenter Study of Continued Current Therapy vs Transition to Ofatumumab After Neurofilament (NfL) Elevation

Active, not recruiting· Novartis logo

Novartis·Phase 4·NCT05090371·136 enrolled

Pregnancy1 trial

A Study to Learn More About The Safety of Diroximel Fumarate (VUMERITY®) in Participants Who Took it During Pregnancy And About the Health of Their Babies

Recruiting· Biogen logo

Biogen··NCT05688436·1,178 enrolled

Randomized1 trial

Open Label Randomized Multicenter to Assess Efficacy & Tolerability of Ofatumumab 20mg vs. First Line DMT in RMS

Completed· Novartis logo

Novartis·Phase 3·NCT04788615·185 enrolled

Treatment1 trial

Study to Assess the Effect of Ofatumumab in Treatment Naïve, Very Early RRMS Patients Benchmarked Against Healthy Controls.

Completed· Novartis logo

Novartis·Phase 4·NCT05084638·180 enrolled

Indolent B-cell Non-Hodgkin's Lymphoma1 trial

Drug-drug Interaction Study of Ofatumumab With Bendamustine in Subjects With Indolent B-cell Non-Hodgkin's Lymphoma

Completed· Novartis logo

Novartis·Phase 1·NCT01691807·30 enrolled

Maintenance Treatment1 trial

Ofatumumab Maintenance Treatment vs No Further Treatment in Relapsed CLL Responding to Induction Therapy

Terminated· Novartis logo

Novartis·Phase 3·NCT01039376·480 enrolled

Minimal Residual Disease1 trial

Ofatumumab for Minimal Residual Disease (MRD) and Maintenance Therapy

Terminated·MM.D. Anderson Cancer Center·Phase 2·NCT01258933·4 enrolled

Chronic Lymphocytic Leukaemia (CLL)1 trial

Ofatumumab Plus Bendamustine in Frontline and Relapsed Chronic Lymphocytic Leukaemia (CLL)

Completed· Novartis logo

Novartis·Phase 2·NCT01520922·99 enrolled

Elderly Patients1 trial

Ofatumumab Induction and Maintenance in Elderly Patients With Poor Risk CLL in the Context of Allogeneic Transplantation

Completed·TTechnische Universität Dresden·Phase 2·NCT01809847·20 enrolled

Richter's Syndrome1 trial

Study of Cyclophosphamide, Hydroxydaunorubicin, Oncovin, Prednisone (CHOP) With Ofatumumab in Patients With Richter's Syndrome

Completed·UUniversity of Oxford·Phase 2·NCT01171378·43 enrolled

Autoimmune Encephalitis1 trial

Safety and Efficacy of Combined B Cell Depleting theRapy And Daratumumab In Autoimmune Encephalitis

Recruiting·TThe First People's Hospital of Changzhou·Phase 3·NCT06867991·200 enrolled

Monotherapy1 trial

Ofatumumab Bendamustine Combination Compared With Bendamustine Monotherapy in Indolent B-cell NHL Unresponsive to Rituxtherapy

Terminated· Novartis logo

Novartis·Phase 3·NCT01077518·346 enrolled

Methylprednisolone1 trial

Ofatumumab, High Dose Methylprednisolone, Ofatumumab and Lenalidomide Consolidative Therapy for Untreated CLL/SLL

Completed·HH. Lee Moffitt Cancer Center and Research Institute·Phase 2·NCT01496976·45 enrolled

Macroglobulinemia1 trial

A Phase II Trial of Ofatumumab in Subjects With Waldenstrom's Macroglobulinemia

Completed· GSK logo

GSK·Phase 2·NCT00811733·37 enrolled

Prospective1 trial

ITAKOS - Italian Observation, Multicenter, Prospective Study of Ofatumumab in RRMS Patients

Active, not recruiting· Novartis logo

Novartis··NCT06345157·379 enrolled

Active, not recruiting·UUniversity of Southern California··NCT05171972·40 enrolled

TED1 trial

"MIRO" Molecularly Oriented Immuno-radio-therapy

Completed·FFondazione Italiana Linfomi - ETS·Phase 2·NCT02710643·110 enrolled

Relapsed or Refractory1 trial

A Phase 3 Study of Duvelisib Versus Ofatumumab in Patients With Relapsed or Refractory CLL/SLL (DUO)

Completed·SSecuraBio·Phase 3·NCT02004522·319 enrolled

Demyelinating Diseases1 trial

Effects of Ofatumumab Treatment on Immune Cells and Meningeal Lymphatic Drainage in Patients With Demyelinating Diseases

Unknown status·TTianjin Medical University General Hospital··NCT05414487·34 enrolled

Relapsing-Remitting Multiple Sclerosis1 trial

Ofatumumab Subcutaneous Administration in Subjects With Relapsing-Remitting Multiple Sclerosis

Completed· GSK logo

GSK·Phase 2·NCT01457924·232 enrolled

Chronic Lymphocytic Leukemia/small Lymphocytic Lymphoma1 trial

Ofatumumab/Methylprednisolone and Ofatumumab/Lenalidomide for Relapsed/Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL)

Completed·HH. Lee Moffitt Cancer Center and Research Institute·Phase 2·NCT01497496·29 enrolled

Metastatic Melanoma1 trial

Anti-CD20 (Cluster of Differentiation Antigen 20) Therapy to Treat Metastatic Melanoma

Completed·MMedical University of Vienna·Phase 2·NCT01376713·10 enrolled

Chronic Graft Versus Host Disease1 trial

Ofatumumab as Primary Therapy of Chronic Graft Versus Host Disease

Completed·HH. Lee Moffitt Cancer Center and Research Institute·Phase 1/2·NCT01680965·44 enrolled

Chronic Lymphocytic Leukaemia1 trial

A Trial Looking at Ofatumumab for People With Chronic Lymphocytic Leukaemia Who Cannot Have More Intensive Treatment

Unknown status·UUniversity of Liverpool·Phase 3·NCT01678430·670 enrolled

Recurrent Acute Lymphoblastic Leukemia1 trial

Lead-In and Phase II Study of Clofarabine, Etoposide, Cyclophosphamide [CEC], Liposomal Vincristine (VCR), Dexamethasone and Bortezomib in Relapsed/Refractory Acute Lymphoblastic Leukemia (ALL) and Lymphoblastic Lymphoma (LL)

Recruiting·MM.D. Anderson Cancer Center·Phase 2·NCT03136146·42 enrolled

Relapsing Multiple Sclerosis1 trial

An Open-label, Randomized, Parallel Group, Non-inferiority Study to Investigate the Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of a New Maintenance Dosing Regimen of Ofatumumab, Followed by Extended Treatment in Participants With Relapsing Multiple Sclerosis

Active, not recruiting· Novartis logo

Novartis·Phase 3·NCT06869785·196 enrolled

Acute Lymphoblastic Leukemia in Remission1 trial

Phase II Study of the Hyper-CVAD Regimen in Sequential Combination With Inotuzumab Ozogamicin as Frontline Therapy for Adults With B-Cell Lineage Acute Lymphocytic Leukemia

Terminated·MM.D. Anderson Cancer Center·Phase 2·NCT03488225·4 enrolled

Unspecified2 trials

Study to Evaluate SC Route of Administration of Ofatumumab in RA Patients

Completed· GSK logo

GSK·Phase 1·NCT00686868·35 enrolled

WOE of Anti-CD20 Therapies

Completed· Novartis logo

Novartis··NCT06121349·157 enrolled

Regulatory

FDA Approval Timeline[5]

Oct 26, 2009

KESIMPTA, ARZERRA

NDA BLA125326

Oct 26, 2009

KESIMPTA

BLA BLA125326

Sep 23, 2010

KESIMPTA, ARZERRA

NDA BLA125326

Sep 20, 2011

KESIMPTA, ARZERRA

NDA BLA125326

Sep 24, 2013

KESIMPTA, ARZERRA

NDA BLA125326

Apr 17, 2014

KESIMPTA, ARZERRA

NDA BLA125326

Jan 19, 2016

KESIMPTA, ARZERRA

NDA BLA125326

Aug 30, 2016

KESIMPTA, ARZERRA

NDA BLA125326

Aug 20, 2020

KESIMPTA, ARZERRA

NDA BLA125326

Sep 2, 2022

KESIMPTA, ARZERRA

NDA BLA125326

Jan 19, 2024

KESIMPTA, ARZERRA

NDA BLA125326

Apr 12, 2024

KESIMPTA, ARZERRA

NDA BLA125326

Aug 18, 2025

KESIMPTA, ARZERRA

NDA BLA125326

Apr 1, 2026

KESIMPTA, ARZERRA

NDA BLA125326

Sources

References

[1]
ClinicalTrials.gov — 129 trial records for Ofatumumab. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Kesimpta drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — Ofatumumab compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for Ofatumumab. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA BLA125326). U.S. Food & Drug Administration.
[6]
SEC EDGAR — Novartis company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: B-Lymphocyte Antigen CD20 Binding Agent[3]
Modality: Monoclonal antibody[3]
Highest Phase: Approved[1]
Company: Novartis

Kesimpta

Status by Indication[4][1]

Competitive Landscape

Expected Milestones

Q4 2026

Q1 2027

Q2 2027

Q3 2027

Trials by Indication[1]

Chronic Lymphocytic Leukemia32 trials

Lymphoma20 trials

Multiple Sclerosis15 trials

Acute Lymphoblastic Leukemia4 trials

CLL3 trials

Diffuse Large B-Cell Lymphoma3 trials

Pemphigus Vulgaris3 trials

Mantle Cell Lymphoma3 trials

Idiopathic Nephrotic Syndrome2 trials

Follicular Lymphoma2 trials

Rheumatoid Arthritis2 trials

Effectiveness2 trials

CLL/SLL2 trials

Efficacy and Safety2 trials

TIA1 trial

Waldenstrom macroglobulinemia1 trial

NMOSD1 trial

LAM1 trial

Pregnancy1 trial

Randomized1 trial

Treatment1 trial

Indolent B-cell Non-Hodgkin's Lymphoma1 trial

Maintenance Treatment1 trial

Minimal Residual Disease1 trial

Chronic Lymphocytic Leukaemia (CLL)1 trial

Elderly Patients1 trial

Richter's Syndrome1 trial

Autoimmune Encephalitis1 trial

Monotherapy1 trial

Methylprednisolone1 trial

Macroglobulinemia1 trial

Prospective1 trial

Carboplatin1 trial

Immunotherapy1 trial

Toxicity1 trial

TED1 trial

Relapsed or Refractory1 trial

Demyelinating Diseases1 trial

Relapsing-Remitting Multiple Sclerosis1 trial

Chronic Lymphocytic Leukemia/small Lymphocytic Lymphoma1 trial

Metastatic Melanoma1 trial

Chronic Graft Versus Host Disease1 trial

Chronic Lymphocytic Leukaemia1 trial

Recurrent Acute Lymphoblastic Leukemia1 trial

Relapsing Multiple Sclerosis1 trial

Acute Lymphoblastic Leukemia in Remission1 trial

Unspecified2 trials

FDA Approval Timeline[5]

References

Drug Info

Quick Facts

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