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Drug

Ocrelizumab

Approved · EMA
ClassB-lymphocyte antigen CD20 binding agentEmerging researchLate-stage development

Also known as Ocrevus, Ocrevus Zunovo, rhuMAb 2H7.

RxNorm1876366ChEMBLCHEMBL2108041ATCL04AG08UNIIA10SJL62JY
2
Research papers
26
Active clinical trials
B-lymphocyte antigen CD20
Primary target
1
Regulatory events
Latest activity
beta

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

An Open-Label, Single-Arm 4-Year Study to Evaluate Effectiveness and Safety of Ocrelizumab Treatment in Patients With Progressive Multiple Sclerosis

Clinical trial2026-07-23Results expected Q4 2026 · ClinicalTrials.gov

A Multicenter, Open-label, Single-arm Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Ocrelizumab in Chinese Patients With Relapsing Multiple Sclerosis and Primary Progressive Multiple Sclerosis

Clinical trial2026-07-06Results expected Q4 2027 · ClinicalTrials.gov

A Randomized, Open-label, Parallel-group, Non-inferiority Study Comparing Efficacy, Safety, and Tolerability of Remibrutinib After Switching From Ocrelizumab in Participants Living With Relapsing Multiple Sclerosis, Followed by Open-label Treatment With Remibrutinib

Clinical trial2026-06-26Results expected Q3 2029 · ClinicalTrials.gov

A Multi-center, Double-blind, Placebo-controlled, Phase II Study Evaluating the Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy of RO7268489, a Monoacylglycerol Lipase Inhibitor, as Add-on Therapy to Ocrelizumab, in Participants With Progressive Forms of Multiple Sclerosis

Clinical trial2026-06-23Results expected Q2 2028 · ClinicalTrials.gov

Randomized, Blinded Discontinuation Trial of Ocrelizumab in Early Relapsing Multiple Sclerosis (AMS05)

Clinical trial2026-06-23Results expected Q2 2030 · ClinicalTrials.gov

Danish Non-inferiority Study of Ocrelizumab and Rituximab in MS (DanNORMS): A Randomized Study Comparing the Efficacy of Ocrelizumab and Rituximab in Active Multiple Sclerosis

Clinical trial2026-06-10Primary completion · ClinicalTrials.gov

Efficacy, Safety and Cost-effectiveness of B Cell Tailored Ocrelizumab Versus Standard Ocrelizumab in Relapsing Remitting Multiple Sclerosis: a Randomized Controlled Trial

Clinical trial2026-06-10Results expected Q1 2027 · ClinicalTrials.gov

A Randomized, Double-blind, Parallel-group Study to Compare Pharmacokinetics, Pharmacodynamics, Clinical Effects, and Safety Between ABP 692 and Ocrevus® (Ocrelizumab) in Subjects With Relapsing-remitting Multiple Sclerosis

Clinical trial2026-06-09Results expected Q1 2027 · ClinicalTrials.gov

A Pilot Study of Ublituximab in People With MS Experiencing Wearing Off Phenomena While Receiving Treatment With Ocrelizumab

Clinical trial2026-05-06Results expected Q4 2028 · ClinicalTrials.gov

Approval: Ocrevus (EMA)

Regulatory2018-01-08EMA

Ocrelizumab versus Interferon Beta-1a in Relapsing Multiple Sclerosis.

Research2016-12-21The New England journal of medicine

Ocrelizumab versus Placebo in Primary Progressive Multiple Sclerosis.

Research2016-12-21The New England journal of medicine

Profile

Identifiers & mechanism

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

Canonical name
Ocrelizumab
Aliases & brands
OcrevusOcrevus ZunovorhuMAb 2H7
RxNorm CUI
1876366
ChEMBL ID
CHEMBL2108041
ATC codes
L04AG08
UNII
A10SJL62JY
Primary mechanism
B-lymphocyte antigen CD20 binding agent
Regulatory jurisdictions
ema

Pharmacology & targets

1 target

Known molecular targets and mechanisms supported by curated pharmacology databases.

B-lymphocyte antigen CD20
MS4A1 · P11836
BINDING AGENTB-lymphocyte antigen CD20 binding agent

Regulatory timeline

1 event

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
2018-01-08
Latest approval
2018-01-08
Authorities
EMA
Total events
1
emaEuropean Medicines Agency· 1 event
2018-01-08Approval
Approval: Ocrevus (EMA)
Indication: Treatment of adult patients with relapsing forms of multiple sclerosis (RMS) with active disease defined by clinical or imaging features. Treatment of adult patients with early… Show full indication

Treatment of adult patients with relapsing forms of multiple sclerosis (RMS) with active disease defined by clinical or imaging features. Treatment of adult patients with early primary progressive multiple sclerosis (PPMS) in terms of disease duration and level of disability, and with imaging features characteristic of inflammatory activity.

Evidence ↗

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

Clinical trials

63 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
63
registered trials across all phases
LATEST COMPLETION 2025
26
Active studies
9
Recruiting
50
Late-stage (III+)
20
Completed
17
Discontinued
PHASE DISTRIBUTIONn = 63
Phase 12Phase 1 / 24Phase 27Phase 2 / 31Phase 334Phase 415

Late-stage studies

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

Randomized, Blinded Discontinuation Trial of Ocrelizumab in Early Relapsing Multiple Sclerosis (AMS05)

RecruitingPH IVNational Institute of Allergy and Infectious Diseases (NIAID)n=1232030

A Pilot Study of Ublituximab in People With MS Experiencing Wearing Off Phenomena While Receiving Treatment With Ocrelizumab

RecruitingPH IVJohns Hopkins Universityn=502029

A Multicenter, Open-label, Single-arm Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Ocrelizumab in Chinese Patients With Relapsing Multiple Sclerosis and Primary Progressive Multiple Sclerosis

Active, not recruitingPH IVHoffmann-La Rochen=602028

Impact of Ocrelizumab on Cerebrospinal Fluid Biomarkers at Multiple Sclerosis Onset

Active, not recruitingPH IVUniversity of California, San Franciscon=302027

Identifying Ocrelizumab-resistant Lymphocytes in Lymphoid Tissue in Multiple Sclerosis

Enrolling by invitationPH IVUniversity of California, San Franciscon=52027

Recent completions

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

An Open-Label, Prospective, Single-arm, Multi-center Study to Assess Disease Activity and Biomarkers of Neuronal Damage in Minority Patients With Relapsing Multiple Sclerosis Receiving Treatment With Ocrelizumab

CompletedPH IVGenentech, Inc.n=1792025

A Single Arm, Open Label Multicentre Extension Study To Evaluate The Effectiveness And Safety Of Ocrelizumab In Patients With Multiple Sclerosis Previously Enrolled In A F. Hoffmann-La Roche Sponsored Ocrelizumab Phase IIIb/IV Clinical Trials

CompletedPH IIIKey trialHoffmann-La Rochen=1,0552025

A Phase IV Multicenter, Open-Label Study Evaluating B Cell Levels In Infants Potentially Exposed To Ocrelizumab During Pregnancy

CompletedPH IVHoffmann-La Rochen=702025

A Study To Investigate The Pharmacokinetics, Pharmacodynamics, Safety And Radiological And Clinical Effects Of Subcutaneous Ocrelizumab Versus Intravenous Ocrelizumab In Patients With Multiple Sclerosis

CompletedPH IIIHoffmann-La Rochen=2362025

A Phase Ib, Open-Label, Multicenter Study To Investigate The Pharmacokinetics, Safety, And Tolerability Of Subcutaneous Ocrelizumab Administration In Patients With Multiple Sclerosis

CompletedPH IHoffmann-La Rochen=1342025

A Phase IV Multicenter, Open-Label Study Evaluating B Cell Levels In Infants Of Lactating Women With CIS Or MS Receiving Ocrelizumab

CompletedPH IVHoffmann-La Rochen=262025

Research activity

2 papers

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

Most influential

Ocrelizumab versus Interferon Beta-1a in Relapsing Multiple Sclerosis.

The New England journal of medicine · 2017 · 1,424 cites

Ocrelizumab versus Placebo in Primary Progressive Multiple Sclerosis.

The New England journal of medicine · 2017 · 1,348 cites
Recent papers

Ocrelizumab versus Interferon Beta-1a in Relapsing Multiple Sclerosis.

The New England journal of medicine · 2017 · 1,424 cites

Ocrelizumab versus Placebo in Primary Progressive Multiple Sclerosis.

The New England journal of medicine · 2017 · 1,348 cites
Journals, researchers & institutions
Top journals
  • The New England journal of medicine2
Leading researchers
  • Arnold DL2
  • Bar-Or A2
  • Belachew S2
  • Chin P2
  • Comi G2
  • Fontoura P2
  • Garren H2
  • Giovannoni G2
Leading institutions
free-text, unnormalised
  • From Hospital Vall d'Hebron University1
  • From the University of California1
References & data sources
  • RxNorm (U.S. National Library of Medicine) — drug identity
  • ChEMBL (EMBL-EBI) & UniProt — pharmacology and targets
  • Europe PMC — research literature
  • ClinicalTrials.gov — clinical trials
  • Regulatory event sources are credited in the Regulatory Timeline above.