Drugs / Ocrelizumab
Ocrelizumab
also known as
Ocrevus · OCR · CYB704 · Ocrelizumab (EU) · ocrelizumab (Ocrevus) · Ocrelizumab (US) · Ocrelizumab component of ocrevus zunovo · Ocrelizumab-ocsq · +7 more
Monoclonal antibody targets MS4A1
Regulatory milestones approvals, filings & regulatory actions · 4 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansions (2) | US (FDA) | OCREVUS | — | 2020-12-14 – 2026-05-08 | fda.gov ↗ |
| Approved | EU (EMA) | Ocrevus | — | 2018-01-08 | europa.eu ↗ |
| Approved | US (FDA) | OCREVUS | — | 2017-03-28 | fda.gov ↗ |
Trials 57 · a red edge is where a trial was stopped
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 13 trials | ||||||
| Phase 1 | NCT07606521 | Oct 2026 → Dec 2027 expected | multiple sclerosis | Polpharma Biologics International AG | Not yet recruiting | No outcome recorded |
| Phase 1 | NCT07667322 | Dec 2024 → Feb 2028 expected | multiple sclerosis | Hoffmann-La Roche | Recruiting | No outcome recorded |
| Phase 1 | NCT03972306 | Aug 2019 → Jun 2025 | multiple sclerosis | Hoffmann-La Roche | Completed | No outcome recorded |
| Phase 1/23 trials | ||||||
| Phase 1/2 | NCT02720120 | Oct 2005 → Feb 2013 | rheumatoid arthritis | Hoffmann-La Roche | Terminated | No outcome recorded |
| Phase 1/2 | NCT02723071 | May 2005 → Jan 2008 | non-Hodgkin lymphoma | Hoffmann-La Roche | Completed | No outcome recorded |
| Phase 1/2 | NCT00077870 | Feb 2004 → Dec 2006 | rheumatoid arthritis | Genentech, Inc. | Completed | No outcome recorded |
| Phase 26 trials | ||||||
| Phase 2 | NCT07503340 | Aug 2026 → Aug 2029 expected | relapsing-remitting multiple sclerosis | Hoffmann-La Roche | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT04767698 | Oct 2021 → May 2022 | multiple sclerosis | Johns Hopkins University | Terminated | No outcome recorded |
| Phase 2 | NCT04075266 | Jan 2020 → Oct 2023 overdue | multiple sclerosis | Hoffmann-La Roche | Active not recruiting | No outcome recorded |
| Phase 2 | NCT00808210 | Mar 2009 → Nov 2012 | rheumatoid arthritis | Genentech, Inc. | Terminated | No outcome recorded |
| Phase 2 | NCT00779220 | Oct 2008 → Feb 2010 | rheumatoid arthritis | Chugai Pharmaceutical | Terminated | No outcome recorded |
| Phase 2 | NCT00676715 | Jul 2008 → Mar 2012 | relapsing-remitting multiple sclerosis | Genentech, Inc. | Completed | No outcome recorded |
| Phase 328 trials | ||||||
| Phase 3 | NCT06847724 | Jun 2025 → Nov 2026 expected | multiple sclerosis | Sandoz | Active not recruiting | No outcome recorded |
| Phase 3 | NCT06700343 | Jan 2025 → Jan 2027 expected | relapsing-remitting multiple sclerosis | Amgen | Active not recruiting | No outcome recorded |
| Phase 3 | NCT06675955 | Dec 2024 → Dec 2029 expected | multiple sclerosis | Hoffmann-La Roche | Recruiting | No outcome recorded |
| Phase 3 | NCT05906992 | Jan 2024 → Feb 2027 expected | relapsing-remitting multiple sclerosis | Celltrion | Recruiting | No outcome recorded |
| Phase 3 | NCT05999604 | Nov 2023 → Nov 2029 expected | multiple sclerosis | Fondation Ophtalmologique Adolphe de Rothschild | Recruiting | No outcome recorded |
| Phase 3 | NCT05123703 | May 2022 → Jun 2025 overdue | relapsing-remitting multiple sclerosis | Hoffmann-La Roche | Active not recruiting | No outcome recorded |
| Phase 3 | NCT05269004 | May 2022 → Dec 2027 expected | multiple sclerosis | Hoffmann-La Roche | Active not recruiting | No outcome recorded |
| Phase 3 | NCT05210621 | Mar 2022 → Feb 2026 overdue | multiple sclerosis | Centre Hospitalier Universitaire de Nice | Active not recruiting | No outcome recorded |
| Phase 3 | NCT04035005 | Aug 2019 → Jan 2025 overdue | primary progressive multiple sclerosis | Hoffmann-La Roche | Active not recruiting | No outcome recorded |
| Phase 3 | NCT03691077 | Nov 2018 → May 2024 | primary progressive multiple sclerosis | Assistance Publique - Hôpitaux de Paris | Unknown | No outcome recorded |
| Phase 3 | NCT03606460 | Sep 2018 → May 2019 | multiple sclerosis | Genentech, Inc. | Completed | No outcome recorded |
| Phase 3 | NCT03599245 | Jul 2018 → Jul 2025 | multiple sclerosis | Hoffmann-La Roche | Completed | No outcome recorded |
| Phase 3 | NCT03523858 | May 2018 → Oct 2026 expected | multiple sclerosis | Hoffmann-La Roche | Active not recruiting | No outcome recorded |
| Phase 3 | NCT03085810 | Mar 2017 → Apr 2023 | relapsing-remitting multiple sclerosis | Hoffmann-La Roche | Terminated | No outcome recorded |
| Phase 3 | NCT02980042 | Jan 2017 → Mar 2019 | multiple sclerosis | University of Colorado, Denver | Completed | No outcome recorded |
| Phase 3 | NCT02861014 | Sep 2016 → Oct 2019 | relapsing-remitting multiple sclerosis | Hoffmann-La Roche | Completed | No outcome recorded |
| Phase 3 | NCT02688985 | Apr 2016 → Apr 2023 | primary progressive multiple sclerosis | Genentech, Inc. | Completed | No outcome recorded |
| Phase 3 | NCT02637856 | Feb 2016 → May 2019 | relapsing-remitting multiple sclerosis | Genentech, Inc. | Completed | No outcome recorded |
| Phase 3 | NCT02545868 | Oct 2015 → Feb 2017 | relapsing-remitting multiple sclerosis | Hoffmann-La Roche | Completed | No outcome recorded |
| Phase 3 | NCT01412333 | Sep 2011 → May 2015 | multiple sclerosis | Hoffmann-La Roche | Completed | No outcome recorded |
| Phase 3 | NCT01247324 | Aug 2011 → Apr 2015 | multiple sclerosis | Hoffmann-La Roche | Completed | No outcome recorded |
| Phase 3 | NCT01194570 | Mar 2011 → Jul 2015 | primary progressive multiple sclerosis | Hoffmann-La Roche | Completed | No outcome recorded |
| Phase 3 | NCT00673920 | Apr 2008 → Oct 2009 | rheumatoid arthritis | Genentech, Inc. | Terminated | No outcome recorded |
| Phase 3 | NCT00626197 | Feb 2008 → Oct 2009 | lupus nephritis, systemic lupus erythematosus | Genentech, Inc. | Terminated | No outcome recorded |
| Phase 3 | NCT00539838 | Dec 2007 → Jul 2011 | systemic lupus erythematosus | Genentech, Inc. | Terminated | No outcome recorded |
| Phase 3 | NCT00485589 | Jun 2007 → Jan 2010 | rheumatoid arthritis | Genentech, Inc. | Terminated | No outcome recorded |
| Phase 3 | NCT00476996 | May 2007 → Jan 2010 | rheumatoid arthritis | Genentech, Inc. | Terminated | No outcome recorded |
| Phase 3 | NCT00406419 | Dec 2006 → Oct 2009 | rheumatoid arthritis | Genentech, Inc. | Terminated | No outcome recorded |
| Phase 416 trials | ||||||
| Phase 4 | NCT07609719 | Aug 2026 → Feb 2029 expected | multiple sclerosis | Genentech, Inc. | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT07483450 | Jul 2025 → Dec 2027 expected | primary progressive multiple sclerosis | Hoffmann-La Roche | Active not recruiting | No outcome recorded |
| Phase 4 | NCT06495593 | Feb 2025 → Jun 2027 expected | relapsing-remitting multiple sclerosis | University of California, San Francisco | Enrolling by invitation | No outcome recorded |
| Phase 4 | NCT05208840 | Sep 2023 → Jan 2025 | multiple sclerosis | Hoffmann-La Roche | Withdrawn | No outcome recorded |
| Phase 4 | NCT05285891 | Jan 2023 → May 2030 expected | multiple sclerosis | National Institute of Allergy and Infectious Diseases (NIAID) | Recruiting | No outcome recorded |
| Phase 4 | NCT05296161 | Apr 2022 → Feb 2027 expected | relapsing-remitting multiple sclerosis | Amsterdam UMC, location VUmc | Active not recruiting | No outcome recorded |
| Phase 4 | NCT04998812 | Apr 2022 → Apr 2024 | multiple sclerosis | Hoffmann-La Roche | Completed | No outcome recorded |
| Phase 4 | NCT04877457 | Feb 2022 → Jun 2023 | multiple sclerosis | Yale University | Terminated | No outcome recorded |
| Phase 4 | NCT04998851 | Sep 2021 → Mar 2024 | multiple sclerosis | Hoffmann-La Roche | Completed | No outcome recorded |
| Phase 4 | NCT04650321 | Mar → Aug 2021 overdue | multiple sclerosis | University of Colorado, Denver | Recruiting | No outcome recorded |
| Phase 4 | NCT04387734 | Feb 2021 → Feb 2025 overdue | multiple sclerosis | Georgia State University | Active not recruiting | No outcome recorded |
| Phase 4 | NCT04261790 | Aug 2020 → Oct 2024 | relapsing-remitting multiple sclerosis | Johns Hopkins University | Completed | No outcome recorded |
| Phase 4 | NCT04377555 | Jul 2020 → Dec 2022 | multiple sclerosis | Genentech, Inc. | Completed | No outcome recorded |
| Phase 4 | NCT03853746 | Apr 2019 → Mar 2024 | multiple sclerosis | Johns Hopkins University | Completed | No outcome recorded |
| Phase 4 | NCT03535298 | Jan 2019 → Jul 2027 expected | relapsing-remitting multiple sclerosis | The Cleveland Clinic | Active not recruiting | No outcome recorded |
| Phase 4 | NCT03589105 | Aug 2018 → Feb 2021 | multiple sclerosis | Hoffmann-La Roche | Completed | No outcome recorded |
| Phase not stated1 trial | ||||||
| — | NCT02807285 | — | multiple sclerosis | Genentech, Inc. | No longer available | No outcome recorded |
Also used as a comparator or background therapy in 24 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 12 trials | ||||||
| Phase 1 | NCT06677710 Background | Jun → Dec 2026 | primary progressive multiple sclerosis, secondary progressive multiple sclerosis | Indapta Therapeutics, INC. | Suspended | No outcome recorded |
| Phase 1 | NCT07597668 Comparator | Apr 2025 → Jun 2026 overdue | multiple sclerosis | R-Pharm | Active not recruiting | No outcome recorded |
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT03971487 Comparator | Oct 2019 → Jun 2028 expected | schizoaffective disorder, schizophrenia | The Methodist Hospital Research Institute | Recruiting | No outcome recorded |
| Phase 24 trials | ||||||
| Phase 2 | NCT07282574 Background | Mar 2026 → May 2028 expected | multiple sclerosis | Hoffmann-La Roche | Recruiting | No outcome recorded |
| Phase 2 | NCT04971005 Comparator | Aug 2021 → Feb 2022 | relapsing-remitting multiple sclerosis | University Medical Center Hamburg-Eppendorf | Terminated | No outcome recorded |
| Phase 2 | NCT04189588 Comparator | Mar → Nov 2020 | — | TerSera Therapeutics LLC | Completed | No outcome recorded |
| Phase 2 | NCT03835728 Comparator | Jan 2019 → Oct 2020 | autoimmune encephalitis | University of Texas Southwestern Medical Center | Terminated | No outcome recorded |
| Phase 2/31 trial | ||||||
| Phase 2/3 | NCT04925557 Comparator | Nov 2021 → Jun 2023 | secondary progressive multiple sclerosis | State University of New York at Buffalo | Terminated | No outcome recorded |
| Phase 313 trials | ||||||
| Phase 3 | NCT07189325 Comparator | Jun 2026 → Jun 2031 expected | relapsing-remitting multiple sclerosis | University Hospital, Montpellier | Recruiting | No outcome recorded |
| Phase 3 | NCT07321093 Comparator | Nov 2025 → Dec 2028 expected | relapsing-remitting multiple sclerosis | Biocad | Recruiting | No outcome recorded |
| Phase 3 | NCT06846281 Comparator | Jun 2025 → Jul 2029 expected | multiple sclerosis | Novartis Pharmaceuticals | Recruiting | No outcome recorded |
| Phase 3 | NCT05758831 Comparator | Jun 2023 → Mar 2030 expected | relapsing-remitting multiple sclerosis | Rennes University Hospital | Recruiting | No outcome recorded |
| Phase 3 | NCT05232825 Comparator | May 2022 → Mar 2023 | primary progressive multiple sclerosis | Hoffmann-La Roche | Completed | No outcome recorded |
| Phase 3 | NCT04688788 Comparator | Apr 2021 → Jun 2026 overdue | primary progressive multiple sclerosis, relapsing-remitting multiple sclerosis, secondary progressive multiple sclerosis | Rigshospitalet, Denmark | Active not recruiting | No outcome recorded |
| Phase 3 | NCT04548999 Comparator | Dec 2020 → Jun 2025 overdue | primary progressive multiple sclerosis | Hoffmann-La Roche | Active not recruiting | No outcome recorded |
| Phase 3 | NCT04544436 Comparator | Nov 2020 → Dec 2024 overdue | multiple sclerosis | Hoffmann-La Roche | Active not recruiting | No outcome recorded |
| Phase 3 | NCT04578639 Comparator | Nov 2020 → Aug 2025 overdue | relapsing-remitting multiple sclerosis | Haukeland University Hospital | Active not recruiting | No outcome recorded |
| Phase 3 | NCT04544449 Comparator | Oct 2020 → Sep 2025 overdue | primary progressive multiple sclerosis | Hoffmann-La Roche | Active not recruiting | No outcome recorded |
| Phase 3 | NCT04047628 Background | Dec 2019 → Oct 2026 expected | relapsing-remitting multiple sclerosis, secondary progressive multiple sclerosis | National Institute of Allergy and Infectious Diseases (NIAID) | Recruiting | No outcome recorded |
| Phase 3 | NCT04966338 Comparator | Aug 2019 → Nov 2020 | relapsing-remitting multiple sclerosis | Cinnagen | Completed | No outcome recorded |
| Phase 3 | NCT03477500 Comparator | Mar 2018 → Nov 2026 expected | multiple sclerosis | Haukeland University Hospital | Active not recruiting | No outcome recorded |
| Phase 42 trials | ||||||
| Phase 4 | NCT07389590 Comparator | Feb 2026 → Oct 2028 expected | multiple sclerosis | Johns Hopkins University | Recruiting | No outcome recorded |
| Phase 4 | NCT04466150 Comparator | Aug 2020 → Dec 2026 expected | relapsing-remitting multiple sclerosis | University of California, San Francisco | Active not recruiting | No outcome recorded |
| Phase not applicable1 trial | ||||||
| — | NCT04519710 Background | Sep 2020 → Sep 2021 | hepatitis B virus infection | Centre de Recherches et d'Etude sur la Pathologie Tropicale et le Sida | Completed | No outcome recorded |
Press releases naming this drug 47 releases
| Date | Issuer | Release |
|---|---|---|
| 2026-07-09 | Teva Branded Pharmaceutical Products R&D, Inc. | Teva and Polpharma Biologics Announce Global Licensing Agreement for a Biosimilar Candidate to Ocrevus® (ocrelizumab) for Multiple Sclerosis tevapharm.com ↗ |
| 2026-07-09 | Teva Branded Pharmaceutical Products R&D, Inc. | Teva and Polpharma Biologics Announce Global Licensing Agreement for a Biosimilar Candidate to Ocrevus® (ocrelizumab) for Multiple Sclerosis tevapharm.com ↗ |
| 2025-09-24 | Roche Global Development | Roche presents new data for OCREVUS and fenebrutinib across broad patient populations at ECTRIMS 2025 roche.com ↗ |
| 2025-04-02 | Roche Global Development | Roche provides update on Phase III OCREVUS high dose study in people with relapsing multiple sclerosis roche.com ↗ |
| 2024-09-16 | Roche Global Development | FDA approves OCREVUS ZUNOVO™ as the first and only twice-a-year 10-minute subcutaneous injection for people with relapsing and progressive multiple sclerosis roche.com ↗ |
| 2024-06-25 | Roche Global Development | Roche’s OCREVUS subcutaneous administration approved by European Commission, as first and only twice-a-year injection for relapsing and primary progressive multiple sclerosis roche.com ↗ |
| 2024-04-17 | Roche Global Development | Roche’s subcutaneous OCREVUS one-year data demonstrates near-complete suppression of clinical relapses and brain lesions in patients with progressive and relapsing forms of MS roche.com ↗ |
| 2023-10-12 | Roche Global Development | New data for Roche’s OCREVUS show that after 10 years of treatment 77% of people with relapsing multiple sclerosis were free from disability progression and 92% continue to walk unaided roche.com ↗ |
| 2023-10-11 | Roche Global Development | Roche’s OCREVUS twice-yearly, 10-minute subcutaneous injection was non-inferior to intravenous infusion and provided near-complete suppression of brain lesions roche.com ↗ |
| 2023-07-13 | Roche Global Development | Positive Phase III results for Roche’s OCREVUS (ocrelizumab) twice a year, 10-minute subcutaneous injection in patients with multiple sclerosis roche.com ↗ |
| 2022-10-26 | Roche Global Development | Early treatment with Roche's OCREVUS leads to reduced disease progression and healthcare costs; nine-year safety data reinforce favourable benefit-risk profile roche.com ↗ |
| 2022-10-19 | Roche Global Development | Roche to present new OCREVUS (ocrelizumab) data in multiple sclerosis and continued research into neuromyelitis optica spectrum disorder at ECTRIMS 2022 roche.com ↗ |
| 2022-04-04 | Roche Global Development | New data for Roche’s OCREVUS (ocrelizumab) show benefit in disability progression and cognitive decline in both secondary progressive and primary progressive multiple sclerosis roche.com ↗ |
| 2021-10-13 | Roche Global Development | Data up to 8-years for Roche’s OCREVUS (ocrelizumab) show early and ongoing treatment significantly reduced risk of requiring a walking aid in relapsing multiple sclerosis and disability progression in primary progressive multiple sclerosis roche.com ↗ |
| 2021-10-05 | Roche Global Development | Roche to present new data on OCREVUS in multiple sclerosis and ENSPRYNG in neuromyelitis optica spectrum disorder at ECTRIMS 2021 roche.com ↗ |
| 2021-04-16 | Roche Global Development | New data for Roche’s OCREVUS (ocrelizumab) reinforce significant benefit on slowing disease progression in relapsing and primary progressive multiple sclerosis roche.com ↗ |
| 2020-12-14 | Roche Global Development | FDA approves Roche’s OCREVUS® (ocrelizumab) shorter 2-hour infusion for relapsing and primary progressive multiple sclerosis roche.com ↗ |
| 2020-09-11 | Roche Global Development | New data further reinforce Roche’s OCREVUS (ocrelizumab) as a highly effective treatment for people with multiple sclerosis roche.com ↗ |
| 2020-09-09 | Roche Global Development | Roche expands its multiple sclerosis portfolio with investigational BTK inhibitor fenebrutinib and initiates novel clinical trials for OCREVUS (ocrelizumab) roche.com ↗ |
| 2020-05-28 | Roche Global Development | Roche’s OCREVUS (ocrelizumab) shorter 2-hour infusion time approved in Europe roche.com ↗ |
| 2020-04-28 | Roche Global Development | New 6-year data for Roche’s OCREVUS (ocrelizumab) show earlier treatment initiation nearly halves risk of needing walking aid in relapsing multiple sclerosis roche.com ↗ |
| 2020-04-20 | Roche Global Development | US FDA and EMA accept applications for Roche’s OCREVUS (ocrelizumab) shorter 2-hour infusion time roche.com ↗ |
| 2019-09-13 | Roche Global Development | Roche presents new 6-year OCREVUS (ocrelizumab) data which showed that earlier initiation and continuation of treatment reduced disability progression in multiple sclerosis roche.com ↗ |
| 2019-09-10 | Roche Global Development | Roche presents new OCREVUS (ocrelizumab) biomarker data that increase understanding of disease progression in multiple sclerosis at ECTRIMS roche.com ↗ |
| 2019-09-04 | Roche Global Development | Roche to present pivotal data for satralizumab in neuromyelitis optica spectrum disorder and six-year OCREVUS data in multiple sclerosis at ECTRIMS roche.com ↗ |
| 2019-05-08 | Roche Global Development | Roche to present new OCREVUS (ocrelizumab) data analyses showing significant reduction of disability progression in relapsing and primary progressive multiple sclerosis at the AAN Annual Meeting roche.com ↗ |
| 2018-10-10 | Roche Global Development | OCREVUS (ocrelizumab) data show early initiation of treatment reduces disability progression over five years in relapsing and primary progressive multiple sclerosis roche.com ↗ |
| 2018-10-02 | Roche Global Development | Roche to present five-year OCREVUS (ocrelizumab) efficacy and safety data in relapsing and primary progressive multiple sclerosis (MS) at ECTRIMS roche.com ↗ |
| 2018-06-14 | Roche Global Development | Roche announces new OCREVUS (ocrelizumab) data on long-term disability benefits in primary progressive multiple sclerosis and initiation of two global studies in progressive multiple sclerosis roche.com ↗ |
| 2018-04-23 | Roche Global Development | New OCREVUS (ocrelizumab) data at AAN demonstrate significant reductions in disease activity and disability progression in relapsing multiple sclerosis roche.com ↗ |
| 2018-04-16 | Roche Global Development | Roche to present new data at AAN highlighting extensive research for OCREVUS and expanding neuroscience pipeline roche.com ↗ |
| 2018-01-12 | Roche Global Development | Roche’s OCREVUS (ocrelizumab) approved in the European Union for relapsing forms of multiple sclerosis and primary progressive multiple sclerosis roche.com ↗ |
| 2017-11-10 | Roche Global Development | Roche’s OCREVUS (ocrelizumab) gains positive CHMP opinion for relapsing forms of multiple sclerosis and primary progressive multiple sclerosis roche.com ↗ |
| 2017-10-27 | Roche Global Development | New OCREVUS (ocrelizumab) data at ECTRIMS advance clinical understanding of underlying progression in multiple sclerosis roche.com ↗ |
| 2017-10-16 | Roche Global Development | Roche to present new OCREVUS (ocrelizumab) efficacy and safety data in relapsing and primary progressive forms of multiple sclerosis at ECTRIMS roche.com ↗ |
| 2017-09-28 | Roche Global Development | Roche’s OCREVUS (ocrelizumab) approved in Switzerland for primary progressive and relapsing forms of multiple sclerosis roche.com ↗ |
| 2017-07-17 | Roche Global Development | Roche’s OCREVUS (ocrelizumab) approved for relapsing and primary progressive multiple sclerosis in Australia roche.com ↗ |
| 2017-06-23 | Roche Global Development | New data at EAN show Roche’s OCREVUS (ocrelizumab) significantly reduced multiple measures of disease progression in relapsing and primary progressive multiple sclerosis roche.com ↗ |
| 2017-04-26 | Roche Global Development | New data at AAN reinforce clinical benefit of Roche's OCREVUS™ (ocrelizumab) for relapsing and primary progressive multiple sclerosis roche.com ↗ |
| 2017-04-19 | Roche Global Development | Roche to present new data at AAN reinforcing efficacy and safety of newly FDA-approved OCREVUS™ (ocrelizumab) in two types of multiple sclerosis roche.com ↗ |
| 2017-03-29 | Roche Global Development | FDA approves Roche’s OCREVUS™ (ocrelizumab) for relapsing and primary progressive forms of multiple sclerosis roche.com ↗ |
| 2016-12-21 | Roche Global Development | Positive Phase III results for Roche’s investigational medicine OCREVUS® (ocrelizumab) published in New England Journal of Medicine roche.com ↗ |
| 2016-12-20 | Roche Global Development | FDA extends review of application for OCREVUS™ (ocrelizumab) roche.com ↗ |
| 2016-09-14 | Roche Global Development | Phase III efficacy results of investigational medicine OCREVUS® (ocrelizumab) reinforced by exploratory analyses in two forms of multiple sclerosis roche.com ↗ |
| 2016-06-28 | Roche Global Development | Roche's marketing applications for review of OCREVUS® (ocrelizumab) in two forms of multiple sclerosis accepted by EMA and FDA roche.com ↗ |
| 2016-04-12 | Roche Global Development | Roche to present new data at AAN showing superior efficacy of investigational medicine ocrelizumab versus comparators on disease activity and progression in two forms of multiple sclerosis roche.com ↗ |
| 2016-02-17 | Roche Global Development | U.S. FDA grants Breakthrough Therapy Designation for Roche's investigational medicine ocrelizumab in primary progressive multiple sclerosis roche.com ↗ |
Evidence & citations 20 cited values
Every value below carries the sentence it was read from. 87 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Ocrelizumab | “The purpose of this study is to assess the imaging biomarkers, patient outcomes, safety, tolerability, and treatment satisfaction of ocrelizumab (OCR) combined with recombinant...” NCT07609719 ↗78“The phase IIIb A Study to Evaluate the Effects of Ocrelizumab on Immune Responses in Participants With Relapsing Forms of Multiple Sclerosis (VELOCE) study (NCT02545868)...” PMID 32727835 ↗ Jul 2020 “PB018, containing the active ingredient ocrelizumab, is a humanized monoclonal antibody that is being developed as a proposed biosimilar medicinal product to Ocrevus.” NCT07606521 ↗ “Drug: CYB704 (Ocrelizumab) Patients will be dosed 300 mg on day 1 and day 15. Subsequent dose of 600 mg will be administered 24 weeks after the initial dose.” NCT06847724 ↗ “ocrelizumab (Ocrevus®)” NCT04047628 ↗ “Ocrevus (ocrelizumab)” NCT03535298 ↗ “CT-P53(Ocrelizumab)” NCT05906992 ↗ “Ocrelizumab” NCT06847724 ↗ |
| Known as | CYB704 | “Drug: CYB704 (Ocrelizumab) Patients will be dosed 300 mg on day 1 and day 15. Subsequent dose of 600 mg will be administered 24 weeks after the initial dose.” NCT06847724 ↗ |
| Known as | OCR | “The purpose of this study is to assess the imaging biomarkers, patient outcomes, safety, tolerability, and treatment satisfaction of ocrelizumab (OCR) combined with recombinant...” NCT07609719 ↗4“To evaluate the safety and efficacy of ocrelizumab (OCR) in Japanese patients with rheumatoid arthritis (RA) with an inadequate response to methotrexate (MTX).” PMID 22247354 ↗ Jan 2012 “Ocrelizumab (OCR), a humanized anti-CD20 monoclonal antibody, is highly efficient in relapsing-remitting multiple sclerosis (RR-MS).” PMID 40781066 ↗ Aug 2025 “The objective was to determine the safety of ocrelizumab (OCR) in patients with rheumatoid arthritis (RA).” PMID 24498318 ↗ Feb 2014 |
| Known as | Ocrelizumab (EU) | “Participants affected by RRMS will receive an initial dose of 300 mg Ocrelizumab (EU) IV infusion on Day 1, followed by a 300 mg Ocrelizumab (EU) IV infusion on Day 15. At Week...” NCT06700343 ↗ |
| Known as | ocrelizumab (Ocrevus) | “ocrelizumab (Ocrevus®)” NCT04047628 ↗ |
| Known as | Ocrelizumab (US) | “Participants affected by RRMS will receive an initial dose of 300 mg Ocrelizumab (US) IV infusion on Day 1, followed by a second dose of 300 mg Ocrelizumab (US) IV infusion on...” NCT06700343 ↗ |
| Known as | Ocrelizumab component of ocrevus zunovo | ChEMBL registry synonym — accepted as the source's own label CHEMBL2108041 ↗ |
| Known as | Ocrelizumab-ocsq | ChEMBL registry synonym — accepted as the source's own label CHEMBL2108041 ↗ |
| Known as | Ocrevus | “who decided together with their treating physician to continue on, or start treatment with, OCREVUS (ocrelizumab) post-partum.” NCT04998851 ↗5“Comparison Between ABP 692 and Ocrevus® (Ocrelizumab)” NCT06700343 ↗ “Ocrelizumab Injection [Ocrevus]” NCT05999604 ↗ “Ocrevus” NCT04189588 ↗ |
| Known as | Ocrevus (ocrelizumab) | “Ocrevus (ocrelizumab)” NCT03535298 ↗ |
| Known as | PR-070769 | ChEMBL registry synonym — accepted as the source's own label CHEMBL2108041 ↗ |
| Known as | PRO70769 | “Ocrelizumab (rhuMAb 2H7, RO4964913, PRO70769)” NCT02720120 ↗ |
| Known as | R-1594 | ChEMBL registry synonym — accepted as the source's own label CHEMBL2108041 ↗ |
| Known as | RG-1594 | ChEMBL registry synonym — accepted as the source's own label CHEMBL2108041 ↗ |
| Known as | rhuMAb 2H7 | “Ocrelizumab (rhuMAb 2H7, RO4964913, PRO70769)” NCT02720120 ↗ |
| Known as | RO4964913 | “Ocrelizumab (rhuMAb 2H7, RO4964913, PRO70769)” NCT02720120 ↗ |
| Action | Deplete | “Peripheral B cell depletion after infusion was rapid at all doses” PMID 18759293 ↗ Sep 2008 |
| Modality | Monoclonal antibody | “Ocrelizumab, a humanized anti-CD20 monoclonal antibody” PMID 18759293 ↗ Sep 2008 |
| Route | Intravenous | “Ocrelizumab was administered via IV infusion at a dose specified in arm description” NCT00406419 ↗ |
| Target | MS4A1 | “B-lymphocyte antigen CD20 binding agent” CHEMBL2108041 ↗ |