Data updated: May 26, 2026
OCREVUS (ocrelizumab)
CD20-directed Antibody Interactions Genetic Support
Trial Activity: Expansion 24 active trials
First-in-Class Breakthrough Therapy Priority Review Fast Track
Immunology
Approved 2017-03-28
OCREVUS is indicated for the treatment of Relapsing forms of multiple sclerosis (including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease); Primary progressive multiple sclerosis.
How OCREVUS Works
Ocrelizumab functions by binding to CD20, a cell surface antigen found on pre-B and mature B lymphocytes. While the precise therapeutic mechanism in multiple sclerosis is unknown, this binding leads to the destruction of these B cells. The process occurs through antibody-dependent cellular cytolysis and complement-mediated lysis.
Development Insights
Hoffmann-La Roche conducting 24 trials (47%)
31 indications explored (Broad Platform)
→ multiple sclerosis (19 trials)
→ multiple sclerosis, relapsing-remitting (7 trials)
→ relapsing multiple sclerosis (6 trials)
3
Indications
--
Phase 3 Trials
2
Priority Reviews
9
Years on Market
Details
- Status
- Prescription
- First Approved
- 2017-03-28
- Patent Cliff
- 2029
- Revenue
- $2.1B (Q4-2025)
- Routes
- INJECTION
- Dosage Forms
- INJECTABLE
OCREVUS Approval History
2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
15 FDA actions from 2017 to 2026 · 2 indication expansions
Nov 2017 SUPPL
Label
What OCREVUS Treats
2 indicationsOCREVUS is approved for 2 conditions since its original approval in 2017. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Relapsing forms of multiple sclerosis (including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease)
- Primary progressive multiple sclerosis
Source: FDA Label
OCREVUS Target & Pathway
ProTarget
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.
OCREVUS Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Direct competitors
3
Same target(s) AND same indication — head-to-head.
MoA expansion candidates
10
Same target(s), different indications — where else is this mechanism being explored?
Indication competitors
10
Same indication, different mechanism — what else might this patient receive?
Unlock 17 more competitors across all three rings.
Upgrade to Pro 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 OCREVUS's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications OCREVUS treats. First-in-class if their pivotal trials read out positive.
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Clinical Trial Registry
47 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT06846281 | CLOU064C12306 2023-509275-17 | Ph 3 | recruiting | Efficacy and Safety of Remibrutinib After Switching From Ocrelizumab in Participants Living With Relapsing Multiple Sclerosis. |
| NCT07389590 | IRB00449860 | Ph 4 | recruiting | Study of Ublituximab for Ocrelizumab Wearing-Off in Multiple Sclerosis |
| NCT05269004 OLERO | MN43964 2021-005746-15 | Ph 3 | active not recruiting | A Rollover Study to Evaluate the Long-Term Safety and Efficacy of Ocrelizumab In Patients With Multiple Sclerosis |
| NCT04544436 MUSETTE results posted | BN42082 2020-000893-69, 2023-506467-34-00 | Ph 3 | active not recruiting | A Study to Evaluate the Efficacy, Safety and Pharmacokinetics (PK) of a Higher Dose of Ocrelizumab in Adults With Relapsing Multiple Sclerosis (RMS) |
| NCT03523858 CONSONANCE | MN39159 2017-001313-93, 2023-506429-13-00 | Ph 3 | active not recruiting | A Study to Evaluate Ocrelizumab Treatment in Participants With Progressive Multiple Sclerosis |
| NCT07483450 | YN44938 | Ph 4 | recruiting | A Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Ocrelizumab in Participants With Relapsing Multiple Sclerosis and Primary Progressive Multiple Sclerosis |
| NCT07282574 Mintaka | BP46016 2025-521636-10-00 | Ph 2 | recruiting | A Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy of RO7268489 as Add-on Therapy to Ocrelizumab, in Participants With Progressive Forms of Multiple Sclerosis (MS) |
| NCT05285891 AMS05 | DAIT AMS05 | Ph 4 | recruiting | Ocrelizumab Discontinuation in Relapsing Multiple Sclerosis |
| NCT04998812 MINORE results posted | MN42988 2021-000062-14, 2024-510974-25-00 | Ph 4 | completed | A Study Evaluating B Cell Levels In Infants Potentially Exposed To Ocrelizumab During Pregnancy |
| NCT04387734 MOBILE-RMS | RO-IIS-2019-20273 | Ph 4 | active not recruiting | Effects of Ocrevus in Relapsing Multiple Sclerosis |
| NCT04548999 GAVOTTE | BN42083 2020-000894-26, 2023-506515-18-00 | Ph 3 | active not recruiting | A Study to Evaluate the Efficacy, Safety and Pharmacokinetics (PK) of a Higher Dose of Ocrelizumab in Adults With Primary Progressive Multiple Sclerosis (PPMS) |
| NCT04544449 FENtrepid | GN41791 2019-003919-53, 2022-502611-10-00 | Ph 3 | active not recruiting | A Study to Evaluate the Efficacy and Safety of Fenebrutinib Compared With Ocrelizumab in Adult Participants With Primary Progressive Multiple Sclerosis |
| NCT06495593 OCREFINA | ML45461 | Ph 4 | enrolling by invitation | Effects of Ocrelizumab Treatment on Immune Cells in Lymph Nodes in Multiple Sclerosis |
| NCT04035005 O'HAND results posted | WA40404 2018-001511-73, 2023-505980-36-00 | Ph 3 | active not recruiting | A Study to Evaluate the Efficacy and Safety of Ocrelizumab in Adults With Primary Progressive Multiple Sclerosis |
| NCT06675955 OleroMAX | MN45053 2023-507633-21-01 | Ph 3 | recruiting | An Extension Study to Assess Impact of Multiple Sclerosis (MS) on Physical Function and Provide Continued Ocrelizumab Treatment |
| NCT04377555 | ML42071 | Ph 4 | completed | Prospective Study to Assess Disease Activity and Biomarkers in Minority Participants With Relapsing Multiple Sclerosis (RMS) After Initiation and During Treatment With Ocrelizumab |
| NCT05123703 Operetta 2 | WN42086 2020-004128-41, 2023-506516-40-00 | Ph 3 | active not recruiting | A Study to Evaluate Safety and Efficacy of Ocrelizumab in Comparison With Fingolimod in Children and Adolescents With Relapsing-Remitting Multiple Sclerosis (RRMS) |
| NCT04466150 IMPACT MS | RO-IIS-2018-10828 | Ph 4 | active not recruiting | Impact of Ocrelizumab on Cerebrospinal Fluid Biomarkers at Multiple Sclerosis Onset |
| NCT04998851 SOPRANINO results posted | MN42989 2021-000063-79 | Ph 4 | completed | A Study Evaluating B Cell Levels In Infants Of Lactating Women With CIS Or MS Receiving Ocrelizumab |
| NCT07321093 MUSCAT | BCD-281-2/MUSCAT | Ph 3 | recruiting | A Study of the Efficacy and Safety of BCD-281 in Patients With Relapsing-Remitting Multiple Sclerosis |
| NCT04075266 results posted | WA39085 2016-002667-34 | Ph 2 | active not recruiting | A Study of Ocrelizumab in Children and Adolescents With Relapsing-Remitting Multiple Sclerosis |
| NCT03599245 | MN39158 2017-004886-29 | Ph 3 | completed | This is an Extension Study of the Roche P-trials to Investigate Safety and Effectiveness of Ocrelizumab in Participants With Multiple Sclerosis (MS) |
| NCT04688788 DanNORMS | DanNORMS_version 3.2 | Ph 3 | active not recruiting | Non-inferiority Study of Ocrelizumab and Rituximab in Active Multiple Sclerosis |
| NCT03972306 | CN41144 | Ph 1 | completed | A Study To Investigate The Pharmacokinetics, Safety, And Tolerability Of Subcutaneous Ocrelizumab Administration In Participants With Multiple Sclerosis |
| NCT04578639 OVERLORD-MS | 2020-001205-23 | Ph 3 | active not recruiting | Ocrelizumab VErsus Rituximab Off-Label at the Onset of Relapsing MS Disease |
| NCT03477500 RAM-MS | 2017-001362-25 | Ph 3 | active not recruiting | Randomized Autologous heMatopoietic Stem Cell Transplantation Versus Alemtuzumab, Cladribine or Ocrelizumab for RRMS (RAM-MS) |
| NCT04925557 results posted | 00003884 | Ph 2, Ph 3 | terminated | Study to Assess the Efficacy of Mayzent on Microglia in Secondary Progressive Multiple Sclerosis |
| NCT06677710 | IDP023-2-101 | Ph 1 | suspended | IDP-023 g-NK Cells Plus Ocrelizumab in Patients With Progressive Multiple Sclerosis |
| NCT04261790 results posted | IRB00230800 | Ph 4 | completed | Effects of Ocrelizumab on B-cell Tolerance Defect in Relapsing Multiple Sclerosis |
| NCT03853746 results posted | IRB00201318 | Ph 4 | completed | Short-term B-cell Depletion in Relapsing Multiple Sclerosis |
| NCT03085810 results posted | MA30143 2016-002937-31 | Ph 3 | terminated | Study to Evaluate the Effectiveness and Safety of Ocrelizumab in Participants With Early Stage Relapsing Remitting Multiple Sclerosis (RRMS) |
| NCT00676715 results posted | ACT4422g 2007-006338-32, WA21493 | Ph 2 | completed | A Study of the Efficacy and Safety of Ocrelizumab in Patients With Relapsing-Remitting Multiple Sclerosis |
| NCT04877457 CELLO results posted | 2000029952 ML42790 | Ph 4 | terminated | Ocrelizumab for Preventing Clinical Multiple Sclerosis in Individuals With Radiologically Isolated Disease. |
| NCT02688985 results posted | ML29966 2015-004616-37 | Ph 3 | completed | Study to Explore the Mechanism of Action of Ocrelizumab and B-Cell Biology in Participants With Relapsing Multiple Sclerosis (RMS) or Primary Progressive Multiple Sclerosis (PPMS) |
| NCT05210621 CONSONANCE EX | 21-PP-23 | Ph 3 | active not recruiting | LONG-TERM EFFECTIVENESS AND SAFETY EVALUATION OF OCRELIZUMAB |
| NCT01412333 results posted | WA21093 2010-020315-36 | Ph 3 | completed | A Study of Ocrelizumab in Comparison With Interferon Beta-1a (Rebif) in Participants With Relapsing Multiple Sclerosis |
| NCT01247324 results posted | WA21092 2010-020337-99 | Ph 3 | completed | A Study of Ocrelizumab in Comparison With Interferon Beta-1a (Rebif) in Participants With Relapsing Multiple Sclerosis |
| NCT05208840 LEGATO | ML42302 | Ph 4 | withdrawn | A Study To Determine The Effect Of Ocrelizumab On Leptomeningeal Inflammation In Multiple Sclerosis |
| NCT01194570 results posted | WA25046 2010-020338-25 | Ph 3 | completed | A Study of Ocrelizumab in Participants With Primary Progressive Multiple Sclerosis |
| NCT04971005 COAST | inims-009 | Ph 2 | terminated | Ocrelizumab or Alemtuzumab Compared With Autologous Hematopoietic Stem Cell Transplantation in Multiple Sclerosis - a Phase-2 Randomised Controlled Trial |
| NCT02861014 results posted | MA30005 2015-005597-38 | Ph 3 | completed | A Study of Ocrelizumab in Participants With Relapsing Remitting Multiple Sclerosis (RRMS) Who Have Had a Suboptimal Response to an Adequate Course of Disease-Modifying Treatment (DMT) |
| NCT03835728 results posted | STU-2018-0185 | Ph 2 | terminated | Efficacy of Ocrelizumab in Autoimmune Encephalitis |
| NCT02980042 results posted | 16-1354 | Ph 3 | completed | Safety of Switching From Rituximab to Ocrelizumab in MS Patients |
| NCT00626197 BELONG results posted | ACT4072g WA20500 | Ph 3 | terminated | A Study to Evaluate Ocrelizumab in Patients With Nephritis Due to Systemic Lupus Erythematosus (BELONG) |
| NCT00673920 FEATURE results posted | ACT4394g WA20496 | Ph 3 | terminated | A Study to Evaluate Ocrelizumab Compared With Placebo in Patients With Rheumatoid Arthritis Who Have an Inadequate Response to Methotrexate Therapy |
| NCT00808210 results posted | ACT4562g GA00931 | Ph 2 | terminated | A Study to Evaluate Ocrelizumab in Combination With Methotrexate Compared With Infliximab Plus Methotrexate in Patients With Active Rheumatoid Arthritis Currently Responding Inadequately to Etanercept or Adalimumab |
| NCT02637856 results posted | MN30035 | Ph 3 | completed | A Study of Ocrelizumab in Participants With Relapsing Remitting Multiple Sclerosis (RRMS) Who Have Had a Suboptimal Response to an Adequate Course of Disease-Modifying Treatment (DMT) |
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Pro Active Pipeline
Ongoing clinical trials by development phase
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Pro Key Completed Trials
Completed studies with published results, ranked by significance
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Trial Timeline
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.
OCREVUS FDA Label Details
Indications & Usage
FDA Label (PDF)OCREVUS is indicated for the treatment of Relapsing forms of multiple sclerosis (including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease); Primary progressive multiple sclerosis.
Pro Intelligence Preview
Deep insights for OCREVUS
Revenue Insights
- • Q4-2025: $2.1B
- • Historical trend analysis
Patent Timeline
- • Cliff: 2029
- • Generic/biosimilar risk
Trial Analysis
- • 51 total trials
- • Stage: Expansion
Competitive Landscape
- • Competitor tracking
- • Same target/indication analysis
Unlock Full Intelligence
Full approval history • All patents • Revenue trends • Competitor analysis
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment