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: BASEL SWITZERLAND V8
Company CEO: Severin Schwan
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: 39

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, Chronic Progressive|Multiple Sclerosis, Relapsing-Remitting

Phase 2: Affective Disorders, Psychotic|Psychotic Disorders|Schizophrenia

Phase 1: Demyelinating Autoimmune Diseases

Trial ID	Trial	Phase	Trial Status	Disease	Primary Completion Date	Probability of Success	Latest Trial Update Date	Data Updated
NCT04688788	DanNORMS	P3	Active, not recruiting	Multiple Sclerosis, Relapsing-Remitting\|Multiple Sclerosis, Chronic Progressive	2026-05-05		2024-05-17	Patient Enrollment\|Primary Completion Date\|Primary Endpoints\|Study Completion Date\|Treatments\|Trial Status
NCT03523858	CONSONANCE	P3	Active, not recruiting	Multiple Sclerosis, Chronic Progressive	2026-01-15	66%	2022-11-29	Patient Enrollment\|Primary Endpoints\|Treatments
NCT03599245	MN39158	P3	Completed	Multiple Sclerosis	2025-07-17	90%	2025-11-13
NCT03971487	OPA	P2	Recruiting	Psychotic Disorders\|Schizophrenia\|Affective Disorders, Psychotic	2025-06-30	57%	2024-02-08	Primary Completion Date\|Primary Endpoints\|Study Completion Date\|Treatments\|Trial Status
NCT06677710	IDP023-2-101	P1	Suspended	Multiple Sclerosis, Chronic Progressive\|Demyelinating Autoimmune Diseases	2026-12-31	50%	2025-05-01	Primary Endpoints\|Start Date\|Treatments\|Trial Status
NCT06846281	CLOU064C12306	P3	Recruiting	Multiple Sclerosis	2030-01-30	51%	2025-10-29	Primary Completion Date\|Primary Endpoints
NCT06675955	OleroMAX	P3	Recruiting	Multiple Sclerosis	2029-12-31	82%	2025-01-14
NCT05269004	OLERO	P3	Active, not recruiting	Multiple Sclerosis	2029-12-31	82%	2024-05-11
2023-506516-40-00	WN42086	P3	Active, not recruiting	Multiple Sclerosis, Relapsing-Remitting	2029-09-17	84%	2025-05-02	Treatments
2023-507633-21-01	MN45053	P3	Recruiting	Multiple Sclerosis	2029-07-31	82%	2025-05-02	Treatments
2023-507633-21-00	MN45053	P3	Withdrawn	Unknown	2029-07-31		2025-05-02	Treatments
2023-506515-18-00	BN42083	P3	Active, not recruiting	Multiple Sclerosis	2029-07-26	84%	2025-05-02	Treatments
2023-506467-34-00	BN42082	P3	Active, not recruiting	Multiple Sclerosis	2028-08-31		2025-05-02	Treatments
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	49%	2025-02-04	Primary Endpoints
NCT06847724	STRIVE-MS	P3	Recruiting	Multiple Sclerosis	2026-10-14		2025-11-04	Patient Enrollment\|Primary Completion Date\|Primary Endpoints\|Treatments
NCT04047628	BEAT-MS	P3	Recruiting	Multiple Sclerosis, Relapsing-Remitting\|Multiple Sclerosis, Chronic Progressive	2026-10-01	38%	2023-09-22
2023-506429-13-00	MN39159	P3	Active, not recruiting	Multiple Sclerosis	2026-09-29		2025-05-02	Treatments
2023-507313-94-00	WA39085	P2	Active, not recruiting	Multiple Sclerosis, Relapsing-Remitting	2029-12-01		2025-05-02	Treatments
NCT07074886	PORTAMENTO	P2	Recruiting	Multiple Sclerosis	2027-01-31	2%	2025-11-20	Primary Endpoints\|Start Date\|Treatments\|Trial Status
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	2030-09-07	55%	2025-05-02	Treatments

Recent News Events

Date	Type	Title
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
11/10/2025	News Article	Genentech's Fenebrutinib Shows Unprecedented Positive Phase III Results as the Potential First and Only BTK Inhibitor in Both Relapsing and Primary Progressive Multiple Sclerosis
10/23/2025	News Article	[Ad hoc announcement pursuant to Art. 53 LR] Roche continues strong sales growth momentum of 7% (CER) in the first nine months of 2025; full-year earnings outlook raised
10/07/2025	News Article	Progentos Therapeutics Names Paul Frohna Chief Medical Officer

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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: 2025-11-24 Latest Update Note: Clinical Trial Update