Ocrelizumab
How it works: Removing B cells →
Ocrevus
EU: Approved in the EU since 2018US: FDA approved 2017
- Molecule type
- Antibody
- Mechanism (ChEMBL)
- B-lymphocyte antigen CD20 binding agent
- Targets
- B-lymphocyte antigen CD20
- Availability
- Authorised in all EU and EEA countries. Reimbursement is decided by each country.
Approvals
Safety communications
- EMA safety letter (DHPC) · 8 October 2026
Ocrevus: Adverse event;Post-authorisation measure Source
Most-reported side effects (FDA reports)
Reports to the FDA's adverse event system (FAERS) show what people and doctors reported while taking the medicine. They do not prove the medicine caused it, and they are not rates.
62,756 reports in total, 31,746 marked serious.
- Covid-1911,587
- Fatigue6,297
- Urinary tract infection3,818
- Headache3,311
- Multiple sclerosis3,123
- Multiple sclerosis relapse2,820
- Gait disturbance2,757
- Asthenia2,736
- Nasopharyngitis2,601
- Pain2,585
Trials
Key trials
Large trials with a reported result on their main goal.
- A Phase III, Non-Inferiority, Randomized, Open-Label, Parallel Group,
Completed · Phase 3 · Relapsing and progressive · Shown as good as the comparator
- A Study to Evaluate the Efficacy, Safety and Pharmacokinetics (PK) of
Running, not recruiting · Phase 3 · Progressive MS · Missed its main goal
- A Study to Evaluate the Efficacy, Safety and Pharmacokinetics (PK) of
Running, not recruiting · Phase 3 · Relapsing MS · Missed its main goal
- Efficacy and Safety of Xacrel® (Ocrelizumab) in Participants With Rela
Completed · Phase 3 · Relapsing MS · Shown as good as the comparator
- A Study to Evaluate the Efficacy and Safety of Ocrelizumab in Adults W
Running, not recruiting · Phase 3 · Progressive MS · Met its main goal
- Study to Evaluate the Effectiveness and Safety of Ocrelizumab in Parti
Terminated · Phase 3 · Relapsing MS · Stopped: not working
- Safety of Switching From Rituximab to Ocrelizumab in MS Patients
Completed · Phase 3 · Relapsing MS · Met its main goal
- A Study of Ocrelizumab in Comparison With Interferon Beta-1a (Rebif) i
Completed · Phase 3 · Relapsing MS · Met its main goal
- A Study of Ocrelizumab in Comparison With Interferon Beta-1a (Rebif) i
Completed · Phase 3 · Relapsing MS · Met its main goal
- A Study of Ocrelizumab in Participants With Primary Progressive Multip
Completed · Phase 3 · Progressive MS · Met its main goal
Running now
- A Study to Evaluate Pharmacokinetics, Safety, Tolerability, Immunogeni
Not yet recruiting · Phase 2 · Relapsing MS · Still running
- Non-interventional Study of Subcutaneous Ocrelizumab in Persons With R
Recruiting · Relapsing MS · Still running
- Brain Imaging and Immune Changes During Remibrutinib Treatment in Mult
Recruiting · Relapsing MS · Still running
- People With Multiple Sclerosis Treated With Ocrelizumab and GLP-1 Agon
Recruiting · Relapsing and progressive · Still running
- A Study to Assess Bioequivalence of Two Subcutaneous (SC) Formulations
Running, not recruiting · Phase 2 · Relapsing and progressive · Still running
- A Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharma
Running, not recruiting · Phase 4 · Relapsing and progressive · Still running
- The use of therapeutic monitoring of ocrelizumab serum concentrations
Recruiting · Phase 4 · Relapsing and progressive · Still running
- Comparative PK, PD, Efficacy, and Safety Assessment of the Proposed Oc
Running, not recruiting · Phase 3 · Relapsing and progressive · Still running
- A Comparative Study of Pharmacokinetics, Pharmacodynamics, Safety, and
Running, not recruiting · Phase 1 · Relapsing and progressive · Still running
- Effects of Ocrelizumab Treatment on Immune Cells in Lymph Nodes in Mul
Enrolling by invitation · Phase 4 · Relapsing MS · Still running
Other trials (41)
Completed small trials, dose-finding studies and trials in other diseases.
- IDP-023 g-NK Cells Plus Ocrelizumab in Patients With Progressive Multi
Suspended · Phase 1 · Progressive MS · Still running
- WOE of Anti-CD20 Therapies
Completed · Relapsing and progressive · No results found
- A Study To Determine The Effect Of Ocrelizumab On Leptomeningeal Infla
Withdrawn · Phase 4 · Progressive MS · Stopped
- Tenofovir Alafenamide for Treatment of Symptoms and Neuroprotection in
Withdrawn · Phase 2 · Relapsing MS · Stopped
- A Study Evaluating B Cell Levels In Infants Potentially Exposed To Ocr
Completed · Phase 4 · Early (CIS/RIS) · Results posted, not judged
- A Study to Investigate the Pharmacokinetics, Pharmacodynamics, Safety
Completed · Phase 3 · Relapsing and progressive · Results posted, not judged
- Personalized dosing of ocrelizumab in MS
Moved to EU CTIS registry · Phase 4 · Relapsing MS
- Ocrelizumab for Preventing Clinical Multiple Sclerosis in Individuals
Terminated · Phase 4 · Early (CIS/RIS) · Stopped
- Impact of ocrelizumab on patient-reported fatigue and quality of life
Completed (inferred) · Phase 4 · Relapsing MS · No results found
- OPEN-LABEL MULTICENTER STUDY TO DETERMINE THE EFFECT OF OCRELIZUMAB ON
Completed · Phase 4 · Progressive MS · No results found
Trials where it is given as background therapy
- A Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, an
Recruiting · Phase 2 · Progressive MS · Still running
For information only, not medical advice. Talk to your neurologist before changing treatment.
Hypotheses involving this medicine
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Lab studies
Lab studies in animals or cells. Results in animals often do not hold in people, and these studies never change the status of an idea.
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