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Ocrelizumab IV
Ocrelizumab IV is a CD20-targeting monoclonal antibody Small molecule drug developed by Hoffmann-La Roche. It is currently in Phase 3 development for Relapsing-remitting multiple sclerosis (RRMS), Primary progressive multiple sclerosis (PPMS). Also known as: RO4964913.
Ocrelizumab is a monoclonal antibody that depletes B cells by binding to CD20, reducing autoimmune-mediated inflammation.
Ocrelizumab IV is an antibody that binds to the B-lymphocyte antigen CD20, classified as a BINDING AGENT. It is used to treat conditions such as Relapsing-Remitting Multiple Sclerosis, Primary Progressive Multiple Sclerosis, and Rheumatoid Arthritis, among others.
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Baseline phase 3 → approval rate
+58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas). -
Immunology slight uplift
+1.0pp
Mature endpoint landscape (ACR, DAS28, PASI) makes immunology approvals slightly more predictable. -
Big-pharma sponsor
+3.0pp
Hoffmann-La Roche is a top-20 pharma sponsor — historical approval rates run ~3pp above average due to scale, regulatory experience, and trial-design quality.
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2028–2030 | — |
| EMA | EU | 2029–2031 | +0.7 yr |
| MHRA | GB | 2029–2031 | +0.7 yr |
| Health Canada | CA | 2029–2032 | +0.9 yr |
| TGA | AU | 2029–2032 | +1.2 yr |
| PMDA | JP | 2029–2032 | +1.5 yr |
| NMPA | CN | 2030–2033 | +2.3 yr |
| MFDS | KR | 2029–2032 | +1.4 yr |
| CDSCO | IN | 2029–2033 | +1.8 yr |
| ANVISA | BR | 2030–2033 | +2.3 yr |
Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).
Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.
At a glance
| Generic name | Ocrelizumab IV |
|---|---|
| Also known as | RO4964913 |
| Sponsor | Hoffmann-La Roche |
| Drug class | CD20-targeting monoclonal antibody |
| Target | CD20 |
| Modality | Small molecule |
| Therapeutic area | Immunology |
| Phase | Phase 3 |
Mechanism of action
Ocrelizumab targets CD20, a surface antigen expressed on B cells, leading to B cell depletion through antibody-dependent cellular cytotoxicity (ADCC) and direct induction of apoptosis. By eliminating B cells, the drug reduces the production of autoimmune antibodies and pro-inflammatory cytokines, thereby suppressing the autoimmune response underlying multiple sclerosis and other B cell-driven conditions.
Approved indications
- Relapsing-remitting multiple sclerosis (RRMS)
- Primary progressive multiple sclerosis (PPMS)
Common side effects
- Infusion-related reactions
- Upper respiratory tract infections
- Lower respiratory tract infections
- Nasopharyngitis
- Headache
- Immunosuppression/serious infections
Key clinical trials
- A Study to Evaluate the Efficacy and Safety of Fenebrutinib Compared With Ocrelizumab in Adult Participants With Primary Progressive Multiple Sclerosis (PHASE3)
- Ocrelizumab Discontinuation in Relapsing Multiple Sclerosis (PHASE4)
- A Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Ocrelizumab in Participants With Relapsing Multiple Sclerosis and Primary Progressive Multiple Sclerosis (PHASE4)
- Comparison Between ABP 692 and Ocrevus® (Ocrelizumab) (PHASE3)
- A Study to Evaluate the Efficacy and Safety of Ocrelizumab in Adults With Primary Progressive Multiple Sclerosis (PHASE3)
- An Extension Study to Assess Impact of Multiple Sclerosis (MS) on Physical Function and Provide Continued Ocrelizumab Treatment (PHASE3)
- A Study to Evaluate the Efficacy, Safety and Pharmacokinetics (PK) of a Higher Dose of Ocrelizumab in Adults With Relapsing Multiple Sclerosis (RMS) (PHASE3)
- Study of Ublituximab for Ocrelizumab Wearing-Off in Multiple Sclerosis (PHASE4)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Ocrelizumab IV CI brief — competitive landscape report
- Ocrelizumab IV updates RSS · CI watch RSS
- Hoffmann-La Roche portfolio CI
Frequently asked questions about Ocrelizumab IV
What is Ocrelizumab IV?
How does Ocrelizumab IV work?
What is Ocrelizumab IV used for?
Who makes Ocrelizumab IV?
Is Ocrelizumab IV also known as anything else?
What drug class is Ocrelizumab IV in?
What development phase is Ocrelizumab IV in?
What are the side effects of Ocrelizumab IV?
What does Ocrelizumab IV target?
Related
- Drug class: All CD20-targeting monoclonal antibody drugs
- Target: All drugs targeting CD20
- Manufacturer: Hoffmann-La Roche — full pipeline
- Therapeutic area: All drugs in Immunology
- Indication: Drugs for Relapsing-remitting multiple sclerosis (RRMS)
- Indication: Drugs for Primary progressive multiple sclerosis (PPMS)
- Also known as: RO4964913
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing