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Drug

Ofatumumab

Approved · EMA
Emerging researchLate-stage development

Also known as Arzerra, Kesimpta, Ofatumumabum.

RxNorm712566UNIIM95KG522R0
1
Research papers
9
Active clinical trials
3
Regulatory events
Latest activity
beta

Recent clinical, regulatory, research and industry developments relating to this drug.

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

Clinical trial2026-06-09Results expected Q4 2026 · ClinicalTrials.gov

A Randomized, Open Label, Multi-center, Active-comparator Study to Assess Efficacy, Safety & Tolerability of Ofatumumab 20mg sc Monthly Versus Continued Current Therapy in Relapsing-remitting Multiple Sclerosis After Elevation of Serum Neurofilament Light Levels (SOSTOS)

Clinical trial2026-05-29Results expected Q2 2027 · ClinicalTrials.gov

An Open-label, Single Arm, Multi-center Extension Study Evaluating Long-term Safety, Tolerability and Effectiveness of Ofatumumab in Subjects With Relapsing Multiple Sclerosis

Clinical trial2026-05-27Results expected Q3 2028 · ClinicalTrials.gov

Phase II Study of the Hyper-CVAD Regimen in Sequential Combination With Blinatumomab With or Without Inotuzumab Ozogamicin as Frontline Therapy for Adults With B-Cell Lineage Acute Lymphocytic Leukemia

Clinical trial2026-05-20Results expected Q4 2026 · ClinicalTrials.gov

Efficacy and Safety of Ofatumumab in AQP4-IgG Seropositive NMOSD: an Open-label, Single-arm, Multicentre Prospective Pilot Study

Clinical trial2026-04-30Primary completion · ClinicalTrials.gov

An Open-Label, Single-Arm Clinical Study to Evaluate the Safety and Preliminary Efficacy of CD20 Monoclonal Antibody Combined With NK042 Cell Injection in the Treatment of Multiple Sclerosis (MS).

Clinical trial2026-04-22Results expected Q4 2027 · ClinicalTrials.gov

A Single-arm, Prospective, Multicentre, Open-label Study to Evaluate Ofatumumab Treatment Effectiveness and Patient-reported Outcomes (PRO) in Patients With Relapsing Multiple Sclerosis (RMS) Transitioning From Fumarate-based RMS Approved Therapies or Fingolimod

Clinical trial2026-04-09Results posted · ClinicalTrials.gov

A 2-year Randomized, 3-arm, Double-blind, Non-inferiority Study Comparing the Efficacy and Safety of Ofatumumab and Siponimod Versus Fingolimod in Pediatric Patients With Multiple Sclerosis Followed by an Open-label Extension

Clinical trial2026-03-25Primary completion · ClinicalTrials.gov

Approval: Kesimpta (EMA)

Regulatory2021-03-26EMA

Drug Safety Update: Ofatumumab: screen for hepatitis B virus before treatment

Regulatory2014-12-11MHRA

Drug Safety Update: Ofatumumab▼: reminder of risk of serious and fatal infusion reactions

Regulatory2014-12-11MHRA

Ofatumumab as single-agent CD20 immunotherapy in fludarabine-refractory chronic lymphocytic leukemia.

Research2010-03-01Journal of clinical oncology : official journal of the American Society of Clinical Oncology

Profile

Identifiers & mechanism

Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.

Canonical name
Ofatumumab
Aliases & brands
ArzerraKesimptaOfatumumabum
RxNorm CUI
712566
UNII
M95KG522R0
Regulatory jurisdictions
emamhra

Regulatory timeline

3 events

The complete regulatory record, grouped by authority — approvals, safety advisories and label changes. Each authority shows its most recent events; expand one to read its full history.

Earliest approval
2021-03-26
Latest approval
2021-03-26
Authorities
EMA · MHRA
Total events
3
emaEuropean Medicines Agency· 1 event
2021-03-26Approval
Approval: Kesimpta (EMA)
Indication: Kesimpta is indicated for the treatment of adult patients with relapsing forms of multiple sclerosis (RMS) with active disease defined by clinical or imaging features (see… Show full indication

Kesimpta is indicated for the treatment of adult patients with relapsing forms of multiple sclerosis (RMS) with active disease defined by clinical or imaging features (see section 5.1).

Evidence ↗
mhraMedicines and Healthcare products Regulatory Agency· 2 events
2014-12-11Safety communicationSafety
Drug Safety Update: Ofatumumab▼: reminder of risk of serious and fatal infusion reactions
Evidence ↗
2014-12-11Safety communicationSafety
Drug Safety Update: Ofatumumab: screen for hepatitis B virus before treatment
Evidence ↗

Contains information from the European Medicines Agency (European Medicines Agency), © EMA, reused under CC BY 4.0.

Contains public sector information from the Medicines and Healthcare products Regulatory Agency (MHRA) licensed under the Open Government Licence (OGL v3).

Clinical trials

106 trials

The current development programme across all trial phases — status mix, phase distribution and the late-stage studies shaping the evidence base.

Development programme
CLINICALTRIALS.GOV · LIVE REGISTRY
106
registered trials across all phases
LATEST COMPLETION 2026
9
Active studies
5
Recruiting
31
Late-stage (III+)
74
Completed
23
Discontinued
PHASE DISTRIBUTIONn = 106
Early Phase 11Phase 17Phase 1 / 26Phase 261Phase 324Phase 47

Late-stage studies

Phase III+ trials still open or recently active — where late-stage evidence is being generated.

A Randomized, Open Label, Multi-center, Active-comparator Study to Assess Efficacy, Safety & Tolerability of Ofatumumab 20mg sc Monthly Versus Continued Current Therapy in Relapsing-remitting Multiple Sclerosis After Elevation of Serum Neurofilament Light Levels (SOSTOS)

Active, not recruitingPH IVNovartis Pharmaceuticalsn=1362027

AGNOS: An 18-month, Open-label, Multi-Center Phase IV Study to Assess the Effect of Ofatumumab 20mg SC Monthly in Treatment Naïve, Very Early Relapsing Remitting Multiple Sclerosis Patients Benchmarked Against Healthy Controls on Select Outcomes.

CompletedPH IVNovartis Pharmaceuticalsn=1802026

A 12-month, Open-label, Prospective, Multicenter, Interventional, Single-arm Study Assessing the Efficacy and Safety of Ofatumumab 20 mg Subcutaneous (s.c.) Injection in Relapsing Multiple Sclerosis (RMS) Patients in China

CompletedPH IVNovartis Pharmaceuticalsn=992025

An Open-label Multicenter Study to Assess Response to Influenza Vaccine in Participants With Multiple Sclerosis Treated With Ofatumumab 20 mg Subcutaneously

CompletedPH IVNovartis Pharmaceuticalsn=632023

Tracking the Immune Response to SARS-CoV-2 modRNA Vaccines in an Open-label Multicenter Study in Participants With Relapsing Multiple Sclerosis Treated With Ofatumumab s.c. (KYRIOS)

CompletedPH IVNovartis Pharmaceuticalsn=342023

Recent completions

Trials that read out recently, adding to the completed evidence base.

AGNOS: An 18-month, Open-label, Multi-Center Phase IV Study to Assess the Effect of Ofatumumab 20mg SC Monthly in Treatment Naïve, Very Early Relapsing Remitting Multiple Sclerosis Patients Benchmarked Against Healthy Controls on Select Outcomes.

CompletedPH IVNovartis Pharmaceuticalsn=1802026

Open-Label Rater-Blind Randomized Multi-Center Parallel-Arm Active- Comparator Study to Assess the Efficacy and Tolerability of Ofatumumab 20mg SC Monthly vs. First Line DMT - Physician's Choice in the Treatment of Newly Diagnosed RMS

CompletedPH IIINovartis Pharmaceuticalsn=1852025

A Randomized Phase II Trial of Ofatumumab and Bendamustine vs. Ofatumumab, Bortezomib (NSC # 681239) and Bendamustine in Patients With Untreated Follicular Lymphoma

CompletedPH IINational Cancer Institute (NCI)n=1352025

A Single-arm, Prospective, Multicentre, Open-label Study to Evaluate Ofatumumab Treatment Effectiveness and Patient-reported Outcomes (PRO) in Patients With Relapsing Multiple Sclerosis (RMS) Transitioning From Fumarate-based RMS Approved Therapies or Fingolimod

CompletedPH IIINovartis Pharmaceuticalsn=5622025

A 12-month, Open-label, Prospective, Multicenter, Interventional, Single-arm Study Assessing the Efficacy and Safety of Ofatumumab 20 mg Subcutaneous (s.c.) Injection in Relapsing Multiple Sclerosis (RMS) Patients in China

CompletedPH IVNovartis Pharmaceuticalsn=992025

A Single-arm, Prospective, Multi-center Study to Explore Maintained Efficacy With Ofatumumab Therapy in Patients With Relapsing Multiple Sclerosis Who Discontinue Intravenously Delivered Anti-CD20 Monoclonal Antibody (aCD20 mAb) Therapy (OLIKOS)

CompletedPH IIINovartis Pharmaceuticalsn=1112024

Research activity

1 papers

Key research shaping understanding of this drug, combining the latest publications with the most influential evidence.

Most influential

Ofatumumab as single-agent CD20 immunotherapy in fludarabine-refractory chronic lymphocytic leukemia.

Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2010 · 412 cites
Recent papers

Ofatumumab as single-agent CD20 immunotherapy in fludarabine-refractory chronic lymphocytic leukemia.

Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2010 · 412 cites
Major research themes1
Drug Resistance, Neoplasm1
Journals, researchers & institutions
Top journals
  • Journal of clinical oncology : official journal of the American Society of Clinical Oncology1
Leading researchers
  • Chan G1
  • Davis R1
  • Dyer MJ1
  • Furman RR1
  • Hellmann A1
  • Hillmen P1
  • Kipps TJ1
  • Kozak T1
Leading institutions
free-text, unnormalised
  • The University of Texas M.D. Anderson Cancer Center1
References & data sources
  • RxNorm (U.S. National Library of Medicine) — drug identity
  • Europe PMC — research literature
  • ClinicalTrials.gov — clinical trials
  • Regulatory event sources are credited in the Regulatory Timeline above.