Product Description
Ocrelizumab, a humanized monoclonal antibody that selectively targets CD20+ B-cells, profoundly suppresses acute inflammatory disease activity, representing a highly effective therapy for relapsing-remitting multiple sclerosis (RRMS). (Sourced from: https://pubmed.ncbi.nlm.nih.gov/34354358/)
Mechanisms of Action: CD20 Antagonist
Novel Mechanism: No
Modality: Antibody
Route of Administration: Intravenous
FDA Designation: *
Approval Status: Approved
Approved Countries: Argentina | Australia | Austria | Belgium | Bosnia | Brazil | Canada | Chile | Colombia | Croatia | Cyprus | Czech | Denmark | Dominican Republic | Ecuador | Egypt | Estonia | European Medicines Agency | Finland | France | Germany | Greece | Hong Kong | Hungary | Iceland | Ireland | Israel | Italy | Jordan | Latvia | Lebanon | Lithuania | Luxembourg | Mexico | Netherlands | New Zealand | Norway | Peru | Poland | Portugal | Romania | Russia | Saudi Arabia | Serbia | Slovakia | Slovenia | Spain | Sweden | Switzerland | Tunisia | Turkey | Ukraine | United Arab Emirates | United Kingdom | United States | Uruguay | Venezuela
Approved Indications: None
Known Adverse Events: None
Company: Hoffmann-La Roche
Company Location:
Company Founding Year: 1896
Additional Commercial Interests: None
Clinical Description
Countries in Clinic: Argentina, Australia, Austria, Belarus, Belgium, Bosnia, Brazil, Bulgaria, Canada, Colombia, Costa Rica, Croatia, Czech Republic, Denmark, Egypt, Estonia, Finland, France, Georgia, Germany, Greece, Guatemala, Hungary, India, Ireland, Israel, Italy, Kuwait, Latvia, Lebanon, Lithuania, Mexico, Morocco, Netherlands, New Zealand, North Macedonia, Norway, Panama, Peru, Poland, Portugal, Romania, Russia, Serbia, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom, United States, Unknown Location
Active Clinical Trial Count:
Recent & Upcoming Milestones
- Clinical Outcomes Reported - Hoffmann-La Roche presented P3 Multiple Sclerosis results on 2025-09-24 for Ocrelizumab
- Clinical Outcomes Reported - Hoffmann-La Roche presented P3 Multiple Sclerosis results on 2025-04-02 for Ocrelizumab
- Clinical Outcomes Reported - Hoffmann-La Roche presented P3 Multiple Sclerosis results on 2024-04-17 for Ocrelizumab
Highest Development Phases
Phase 3: Multiple Sclerosis|Multiple Sclerosis, Primary Progressive|Multiple Sclerosis, Progressive|Multiple Sclerosis, Relapsing-Remitting|Multiple Sclerosis, Secondary Progressive
Phase 1: Demyelinating Autoimmune Diseases
Trial ID |
Trial |
Phase |
Trial Status |
Disease |
Primary Completion Date |
Probability of Success |
Latest Trial Update Date |
Data Updated |
|---|---|---|---|---|---|---|---|---|
2023-505974-14-00 |
MN43964 | P3 |
Active, not recruiting |
Multiple Sclerosis |
2025-12-31 |
2025-05-02 |
Treatments |
|
NCT04688788 |
DanNORMS | P3 |
Active, not recruiting |
Multiple Sclerosis, Secondary Progressive|Multiple Sclerosis, Primary Progressive|Multiple Sclerosis, Relapsing-Remitting |
2026-05-05 |
2024-05-17 |
Patient Enrollment|Primary Completion Date|Primary Endpoints|Study Completion Date|Treatments|Trial Status |
|
2017-001313-93 |
2017-001313-93 | P3 |
Completed |
Multiple Sclerosis, Progressive |
2025-11-03 |
67% |
2025-05-06 |
Treatments|Trial Status |
NCT06677710 |
IDP023-2-101 | P1 |
Suspended |
Multiple Sclerosis, Primary Progressive|Multiple Sclerosis, Secondary Progressive|Demyelinating Autoimmune Diseases |
2026-12-31 |
50% |
2025-05-01 |
Primary Endpoints|Start Date|Treatments|Trial Status |
NCT07074886 |
PORTAMENTO | P2 |
Recruiting |
Multiple Sclerosis |
2027-01-31 |
12% |
2025-11-20 |
Primary Endpoints|Start Date|Treatments|Trial Status |
2023-507633-21-00 |
MN45053 | P3 |
Withdrawn |
Unknown |
2029-07-31 |
2025-05-02 |
Treatments |
|
2023-509275-17-00 |
CLOU064C12306 | P3 |
Not yet recruiting |
Multiple Sclerosis |
2031-06-13 |
|||
2023-505980-36-00 |
WA40404 | P3 |
Active, not recruiting |
Multiple Sclerosis, Primary Progressive |
2030-09-07 |
66% |
2025-05-02 |
Treatments |
NCT06675955 |
OleroMAX | P3 |
Recruiting |
Multiple Sclerosis |
2029-12-31 |
69% |
2025-01-14 |
|
2023-506516-40-00 |
WN42086 | P3 |
Active, not recruiting |
Multiple Sclerosis, Relapsing-Remitting |
2029-09-17 |
70% |
2025-05-02 |
Treatments |
2023-507633-21-01 |
MN45053 | P3 |
Recruiting |
Multiple Sclerosis |
2029-07-31 |
69% |
2025-05-02 |
Treatments |
2023-506515-18-00 |
BN42083 | P3 |
Active, not recruiting |
Multiple Sclerosis, Primary Progressive |
2029-07-26 |
64% |
2025-05-02 |
Treatments |
NCT06846281 |
CLOU064C12306 | P3 |
Recruiting |
Multiple Sclerosis |
2029-07-20 |
58% |
2026-02-20 |
|
2023-506467-34-00 |
BN42082 | P3 |
Active, not recruiting |
Multiple Sclerosis |
2028-08-31 |
2025-05-02 |
Treatments |
|
NCT05269004 |
OLERO | P3 |
Active, not recruiting |
Multiple Sclerosis |
2027-12-31 |
69% |
2026-02-03 |
Primary Completion Date|Primary Endpoints|Study Completion Date |
2020-002981-15 |
DanNORMS | P3 |
Active, not recruiting |
Multiple Sclerosis |
2027-12-15 |
2022-03-13 |
Treatments |
|
2024-512914-16-00 |
20230309 | P3 |
Not yet recruiting |
Multiple Sclerosis, Relapsing-Remitting |
2027-07-02 |
2025-05-02 |
Treatments |
|
2022-501622-37-00 |
2022-501622-37-00 | P3 |
Recruiting |
Multiple Sclerosis |
2027-02-19 |
2025-05-02 |
Treatments |
|
NCT05906992 |
CT-P53 3.1 | P3 |
Recruiting |
Multiple Sclerosis, Relapsing-Remitting |
2027-02-01 |
2024-05-23 |
Primary Endpoints|Start Date|Treatments|Trial Status |
|
NCT06700343 |
Ocrelizumab | P3 |
Recruiting |
Multiple Sclerosis, Relapsing-Remitting |
2027-01-15 |
63% |
2025-02-04 |
Primary Endpoints |
NCT03523858 |
CONSONANCE | P3 |
Active, not recruiting |
Multiple Sclerosis, Progressive |
2026-11-12 |
67% |
2026-01-31 |
Primary Completion Date|Primary Endpoints|Study Completion Date|Treatments |
NCT06847724 |
STRIVE-MS | P3 |
Recruiting |
Multiple Sclerosis |
2026-10-14 |
2025-11-04 |
Patient Enrollment|Primary Completion Date|Primary Endpoints|Treatments |
|
2024-517980-22-00 |
CN45320 | P2 |
Not yet recruiting |
Multiple Sclerosis |
2029-12-16 |
12% |
||
2023-507313-94-00 |
WA39085 | P2 |
Active, not recruiting |
Multiple Sclerosis, Relapsing-Remitting |
2029-12-01 |
2025-05-02 |
Treatments |
|
NCT07282574 |
Mintaka | P2 |
Recruiting |
Multiple Sclerosis, Progressive |
2028-05-30 |
2% |
2026-02-04 |
