TheraRadar
Data updated: May 26, 2026

KESIMPTA (ofatumumab)

CD20-directed Antibody Interactions Genetic Support
Immunology Approved 2009-10-26

KESIMPTA is indicated for the treatment of Clinically isolated syndrome; Relapsing-remitting multiple sclerosis; Active secondary progressive multiple sclerosis.

Source: FDA Label • Novartis • CD20-directed Cytolytic Antibody
Jump to: Indications Approvals Trials Competitors Similar Safety Patents

How KESIMPTA Works

Ofatumumab binds to CD20, a cell surface antigen found on pre-B and mature B lymphocytes. While the precise therapeutic mechanism in multiple sclerosis is unknown, the drug is presumed to exert its effects by binding to these specific B cells. This binding results in antibody-dependent cellular cytolysis and complement-mediated lysis, leading to the destruction of the targeted lymphocytes.

Source: FDA Label
5
Indications
--
Phase 3 Trials
5
Priority Reviews
16
Years on Market

Details

Status
Prescription
First Approved
2009-10-26
Patent Cliff
2023
Revenue
$1.2B (Q4-2025)

Pro Metrics

Patent cliff and revenue data

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Routes
SUBCUTANEOUS
Dosage Forms
SOLUTION

Companies

Novartis
Active Ingredient: OFATUMUMAB

KESIMPTA Approval History

2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
13 FDA actions from 2009 to 2026 · 4 indication expansions
Apr 2026 SUPPL
Label · Labeling
FDA Letter Label
Aug 2025 SUPPL
Label · Labeling
FDA Letter Label
Apr 2024 SUPPL
Label · Labeling
FDA Letter Label

What KESIMPTA Treats

3 indications

KESIMPTA is approved for 3 conditions since its original approval in 2009. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Clinically isolated syndrome
  • Relapsing-remitting multiple sclerosis
  • Active secondary progressive multiple sclerosis
Source: FDA Label

KESIMPTA Target & Pathway

Pro

Target

CD20 (B-Lymphocyte Antigen CD20) Cell Surface Marker

A protein found on the surface of B-cells but not stem cells or plasma cells. Anti-CD20 antibodies deplete B-cells, making them effective in B-cell cancers and autoimmune diseases where B-cells drive pathology.

KESIMPTA Competitive Set

Pro

Three rings of competition based on shared molecular targets and treated indications.

Direct competitors

3

Same target(s) AND same indication — head-to-head.

OCREVUS ZUNOVO
Roche
2024 1 indic.
BRIUMVI
TG THERAPEUTICS,
2022 3 indic.

MoA expansion candidates

10

Same target(s), different indications — where else is this mechanism being explored?

COLUMVI
Roche
2023 2 indic.
EPKINLY
GENMAB US,
2023 3 indic.

Indication competitors

10

Same indication, different mechanism — what else might this patient receive?

DIROXIMEL FUMARATE
ZYDUS
2025 4 indic.
TYRUKO
Novartis
2023 2 indic.
Unlock 17 more competitors across all three rings.
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Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.

What's emerging in KESIMPTA's indications

See all emerging drugs →

Phase 3 candidates targeting molecules with no FDA-approved drug, in indications KESIMPTA treats. First-in-class if their pivotal trials read out positive.

Frexalimab SAR441344
Sanofi
CD40LG · monoclonal antibody (anti-CD40L, Fc-engineered to avoid platelet activation) · 4 Phase 3 trials

Drugs Similar to KESIMPTA

3 of 13

FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.

BRIUMVI
UBLITUXIMAB-XIIY
3 shared
TG THERAPEUTICS, INC
Shared indications:
Clinically isolated syndromeRelapsing-remitting multiple sclerosisActive secondary progressive multiple sclerosis
GILENYA
FINGOLIMOD HYDROCHLORIDE
3 shared
Novartis
Shared indications:
Clinically isolated syndromeRelapsing-remitting multiple sclerosisActive secondary progressive multiple sclerosis
PONVORY
PONESIMOD
3 shared
VANDA PHARMS INC
Shared indications:
Clinically isolated syndromeRelapsing-remitting multiple sclerosisActive secondary progressive multiple sclerosis
View all 13 similar drugs Pro
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Clinical Trial Registry

93 trials
Trial Sponsor ID Phase Status Title
NCT03650114 ALITHIOS COMB157G2399 2023-507906-15 Ph 3 active not recruiting Long-term Safety, Tolerability and Effectiveness Study of Ofatumumab in Patients With Relapsing MS
NCT04926818 NEOS CBAF312D2301 Ph 3 active not recruiting Efficacy and Safety of Ofatumumab and Siponimod Compared to Fingolimod in Pediatric Patients With Multiple Sclerosis
NCT04353492 ARTIOS results posted COMB157G23101 2019-001341-40 Ph 3 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
NCT05090371 SOSTOS COMB157GUS09 Ph 4 active not recruiting A Multicenter Study of Continued Current Therapy vs Transition to Ofatumumab After Neurofilament (NfL) Elevation
NCT02135133 results posted 13-309 Ph 2 completed A Study of Idelalisib (GS1101, CAL101) + Ofatumumab in Previously Untreated CLL/SLL
NCT04788615 STHENOS COMB157G3301 2020-004505-32 Ph 3 completed Open Label Randomized Multicenter to Assess Efficacy & Tolerability of Ofatumumab 20mg vs. First Line DMT in RMS
NCT05084638 AGNOS results posted COMB157GUS10 Ph 4 completed Study to Assess the Effect of Ofatumumab in Treatment Naïve, Very Early RRMS Patients Benchmarked Against Healthy Controls.
NCT03136146 2016-0211 NCI-2018-01198, 2016-0211 Ph 2 recruiting Combination Chemotherapy in Treating Patients With Relapsed or Refractory Acute Lymphoblastic Leukemia, Lymphoblastic Lymphoma, Burkitt Lymphoma/Leukemia, or Double-Hit Lymphoma/Leukemia
NCT05504694 K202206-13 Ph 1, Ph 2 recruiting Ofatumumab in AQP4-IgG Seropositive NMOSD
NCT04510220 results posted 2020P002078 Ph 3 completed 9-month Study to Assess the Efficacy of Ofatumumab on Microglia in Patients With Relapsing Forms of Multiple Sclerosis
NCT05199571 results posted COMB157G2402 Ph 4 completed Study of Efficacy and Safety of Ofatumumab in Relapsing Multiple Sclerosis (RMS) Patients in China
NCT04486716 OLIKOS results posted COMB157GUS07 111,116 Ph 3 completed A Single Arm Study Evaluating the Efficacy, Safety and Tolerability of Ofatumumab in Patients With Relapsing Multiple Sclerosis
NCT01496976 results posted MCC-16622 COMB157BUS21T, RV-CLL-PI-0560 Ph 2 completed Ofatumumab, High Dose Methylprednisolone, Ofatumumab and Lenalidomide Consolidative Therapy for Untreated CLL/SLL
NCT01286272 results posted NCI-2011-02625 NCI-2011-02625, CALGB-50904 Ph 2 completed Ofatumumab and Bendamustine Hydrochloride With or Without Bortezomib in Treating Patients With Untreated Follicular Non-Hodgkin Lymphoma
NCT02877303 2014-0845 NCI-2017-00596, 2014-0845 Ph 2 recruiting Blinatumomab, Inotuzumab Ozogamicin, and Combination Chemotherapy as Frontline Therapy in Treating Patients With B Acute Lymphoblastic Leukemia
NCT01258933 results posted 2010-0266 NCI-2011-00274 Ph 2 terminated Ofatumumab for Minimal Residual Disease (MRD) and Maintenance Therapy
NCT06867991 RADIA RADIA-2024-11 Ph 3 recruiting Safety and Efficacy of Combined B Cell Depleting theRapy And Daratumumab In Autoimmune Encephalitis
NCT01361711 results posted NU 10H06 NCI-2011-00514, STU00044115 Ph 2 active not recruiting Alemtuzumab-Ofatumumab in Previously Untreated Symptomatic Chronic Lymphocytic Leukemia
NCT04878211 results posted COMB157GUS16 Ph 4 terminated A Open-label Study to Assess Response to COVID-19 Vaccine in Multiple Sclerosis Participants Treated With Ofatumumab
NCT04869358 KYRIOS results posted COMB157GDE01 Ph 4 completed Exploring the Immune Response to SARS-CoV-2 COVID-19 Vaccines in Patients With Relapsing Multiple Sclerosis (RMS) Treated With Ofatumumab
NCT01458366 results posted 11D.404 2011-61, JT 2211 Ph 1, Ph 2 completed Phase I/II Study of Bendamustine in Combination With Ofatumumab, Carboplatin and Etoposide
NCT01352312 11P.166 2011-23, OFT114197 Ph 1 terminated Combination of Pentostatin, Bendamustine and Ofatumumab for Treatment of Chronic Lymphocytic Leukemia and Lymphoma
NCT04667117 results posted COMB157GUS12 Ph 4 completed A Multicenter Study to Assess Response to Influenza Vaccine in Multiple Sclerosis Participants Treated With Ofatumumab
NCT01243190 results posted 2010-0241 NCI-2011-00745 Ph 2 completed Ofatumumab for High-Risk Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL)
NCT03488225 results posted 2015-0922 NCI-2018-00760, 2015-0922 Ph 2 terminated Combination Chemotherapy and Inotuzumab Ozogamicin in Treating Patients With B Acute Lymphoblastic Leukemia
NCT02199184 results posted 2014-0123 NCI-2014-01707, 2014-0123 Ph 2 completed 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
NCT01527149 results posted I 201611 NCI-2011-03562, I 201611 Ph 2 completed 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
NCT01145209 results posted 100141 10-H-0141 Ph 2 completed Ofatumumab-based Induction Chemoimmunotherapy in Previously Untreated Patients With CLL/SLL
NCT01060384 results posted 0514-09-FB Ph 1, Ph 2 completed Study of Lenalidomide and Ofatumumab for the Treatment of Relapsed or Refractory Non-Hodgkin's Lymphoma
NCT02049515 results posted IPI-145-12 2013-003639-31 Ph 3 completed A Phase 3 Extension Study of Duvelisib and Ofatumumab in Participants With CLL/SLL Previously Enrolled in Study IPI-145-07
NCT02004522 results posted IPI-145-07 2013-002405-61 Ph 3 completed A Phase 3 Study of Duvelisib Versus Ofatumumab in Patients With Relapsed or Refractory CLL/SLL (DUO)
NCT01465334 results posted 11-304 NCCN Protocol Number: NCCN-001, GSK Protocol Number: OFT115580 Ph 2 terminated Ofatumumab With High Dose Methylprednisone Followed by Ofatumumab and Alemtuzumab in 17p CLL
NCT01680965 results posted MCC-17071 Ph 1, Ph 2 completed Ofatumumab as Primary Therapy of Chronic Graft Versus Host Disease
NCT01555541 results posted 112525 NCI-2012-00863 Ph 2 completed 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
NCT02710643 FIL_MIRO FIL_MIRO Ph 2 completed "MIRO" Molecularly Oriented Immuno-radio-therapy
NCT01455051 GETH-CLL4 2010-024467-40 Ph 2 completed Ofatumumab as Part of Reduced Intensity Conditioning (RIC) Regimen for Patients With High Risk Chronic Lymphocytic Leukemia (CLL) Undergoing Allogeneic Hematopoietic Cell Transplantation
NCT03249714 results posted COMB157G1301 Ph 2 completed Efficacy and Safety of Ofatumumab Compared to Placebo in Patients With Relapsing Multiple Sclerosis Followed by Extended Treatment With Open-label Ofatumumab
NCT01481272 PLRG8 PLRG8 (OMB114361) 2010-023568-42 Ph 2 completed Ofatumumab With IVAC Salvage Chemotherapy in Diffuse Large B Cell Lymphoma Patients
NCT01190449 results posted CALGB-50901 CALGB-50901, GSK-CALGB-50901 Ph 2 completed Ofatumumab in Treating Patients With Previously Untreated Stage II, Stage III, or Stage IV Follicular Non-Hodgkin Lymphoma
NCT01444716 results posted 2011-0520 NCI-2018-01841, 2011-0520 Ph 2 completed Ofatumumab as Front-Line Therapy in Treating Elderly Participants With Chronic Lymphocytic Leukemia
NCT01613300 GELTAMO-O-CRT-2011 2011-004729-29 Ph 2 completed Study of OFATUMUMAB as Part of the Scheme of Reduced Intensity Conditioning in High Risk Non-Hodgkin Lymphoma B Patients
NCT01363128 results posted 2010-0708 NCI-2011-01061, 2010-0708 Ph 2 completed Combination Chemotherapy and Ofatumumab in Treating Patients With Acute Lymphoblastic Leukemia or Lymphoblastic Lymphoma
NCT01497496 results posted MCC-16631 COMB157AUS08T, RV-CLL-PI-0560 Ph 2 completed Ofatumumab/Methylprednisolone and Ofatumumab/Lenalidomide for Relapsed/Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL)
NCT01088048 results posted 101-07 Ph 1 completed 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
NCT01762202 CLL0911 CLL0911 2011-005329-27 Ph 2 completed Assessment of Efficacy and Safety of Front-line Fludarabine, Cyclophoshamide and Ofatumumab Chemoimmunotherapy in Young Patients With Chronic Lymphocytic Leukemia.
NCT02394119 OFA2 Ph 2 completed Ofatumumab Versus Rituximab in Children With Steroid and Calcineurin Inhibitor Dependent Idiopathic Nephrotic Syndrome
NCT02394106 OFA1 Ph 2 terminated Ofatumumab in Children With Drug Resistant Idiopathic Nephrotic Syndrome
NCT01329900 results posted 2009-0796 NCI-2011-01068 Ph 2 completed Chemotherapy Plus Ofatumumab Followed by G-CSF for Mobilization of Peripheral Blood Stem Cells in Patients With Non-Hodgkin's Lymphomas
NCT02689141 CLL2-BIO 2014-000590-39 Ph 2 completed Sequential Regimen of Bendamustin-Debulking Followed by Ofatumumab and Ibrutinib in CLL Patients (CLL2-BIO)
NCT01077518 A+B results posted 110918 2008-004177-17, COMB157E2301 Ph 3 terminated Ofatumumab Bendamustine Combination Compared With Bendamustine Monotherapy in Indolent B-cell NHL Unresponsive to Rituxtherapy

Showing 50 of 93 trials

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Key Completed Trials

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Completed studies with published results, ranked by significance

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Trial Timeline

ClinicalTrials.gov ↗ Pro

Full development history with FDA approval milestones

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Understanding FDA Approval Types
Count Type What it means
- ORIG Original approval - drug first enters market
- SUPPL - Efficacy New indication (new disease/condition approved)
- SUPPL - Labeling Label text changes (warnings, dosing updates)
- SUPPL - Manufacturing Production changes (new facility)
- SUPPL - Chemistry Formulation changes (new dosage strength)

Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.

KESIMPTA FDA Label Details

Indications & Usage

FDA Label (PDF)

KESIMPTA is indicated for the treatment of Clinically isolated syndrome; Relapsing-remitting multiple sclerosis; Active secondary progressive multiple sclerosis.

Pro Intelligence Preview

Deep insights for KESIMPTA

Revenue Insights

  • • Q4-2025: $1.2B
  • • Historical trend analysis

Patent Timeline

  • • Cliff: 2023
  • • Generic/biosimilar risk

Trial Analysis

  • • Clinical trial tracking
  • • Development stage analysis

Competitive Landscape

  • • 13 similar drugs
  • • Same target/indication analysis
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Full approval history • All patents • Revenue trends • Competitor analysis

Data Sources

FDA Approval: BLA125326 → Label: DailyMed → Trials: ClinicalTrials.gov →

Data sourced from official FDA and NIH databases. Click links to verify on original sources.