Ozmosi | Ocrelizumab Drug Profile

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 Indications: None

Known Adverse Events: None

Company: Hoffmann-La Roche
Company Location:
Company Founding Year: 1896
Additional Commercial Interests: None

Clinical Description

Map of Global Clinical Trials for Ocrelizumab

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

Recent News Events

Date	Type	Title
01/29/2026	News Article	[Ad hoc announcement pursuant to Art. 53 LR] Roche reports strong 2025 results with 7% sales growth
01/26/2026	News Article	Samsung Epis Holdings Reports Fourth Quarter and Fiscal Year 2025 Financial Results
01/21/2026	News Article	AB Science receives Japanese patent protection for the use of masitinib in progressive forms of multiple sclerosis (MS) until 2041
11/10/2025	News Article	[Ad hoc announcement pursuant to Art. 53 LR] Roche's fenebrutinib shows unprecedented positive Phase III results as the potential first and only BTK inhibitor in both relapsing and primary progressive multiple sclerosis

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Ocrelizumab

Alternative Names: ocrelizumab, Ocrevus, RO4964913, PRO70769, RO-4964913, PRO-70769, RG1594, RG-1594, RG 1594 Clinical Status: Active Latest Update: 2026-03-09 Latest Update Note: Clinical Trial Update