Last update 08 May 2026

Ocrelizumab

Overview

Basic Info

Drug Type
Monoclonal antibody
Synonyms
2H7-monoclonal-antibody, 2nd Generation Anti-CD20, Anti-CD20 monoclonal antibody ( Genentech)
+ [22]
Target
Action
inhibitors
Mechanism
CD20 inhibitors(B-lymphocyte antigen CD20 inhibitors), ADCC(Antibody-dependent cell-mediated cytotoxicity (ADCC) effects), CD20-directed cytolytic effects
Originator Organization
Inactive Organization
License Organization
Drug Highest PhaseApproved
First Approval Date
RegulationBreakthrough Therapy (United States), Orphan Drug (South Korea), Fast Track (United States)
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Structure/Sequence

External Link

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Multiple Sclerosis
Australia
13 Jul 2017
Multiple sclerosis relapse
United States
28 Mar 2017
Multiple Sclerosis, Primary Progressive
United States
28 Mar 2017
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Multiple Sclerosis, Chronic ProgressivePhase 3
United States
28 May 2018
Multiple Sclerosis, Chronic ProgressivePhase 3
Bosnia and Herzegovina
28 May 2018
Multiple Sclerosis, Chronic ProgressivePhase 3
Brazil
28 May 2018
Multiple Sclerosis, Chronic ProgressivePhase 3
Canada
28 May 2018
Multiple Sclerosis, Chronic ProgressivePhase 3
Colombia
28 May 2018
Multiple Sclerosis, Chronic ProgressivePhase 3
Costa Rica
28 May 2018
Multiple Sclerosis, Chronic ProgressivePhase 3
Czechia
28 May 2018
Multiple Sclerosis, Chronic ProgressivePhase 3
Denmark
28 May 2018
Multiple Sclerosis, Chronic ProgressivePhase 3
Egypt
28 May 2018
Multiple Sclerosis, Chronic ProgressivePhase 3
France
28 May 2018
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
1,013
(Ocrelizumab)
gszknrwdcr(gerayyyrjd) = lxbgvsyklg dsxaulkqgz (lkwofcdutt, cedagqzuqt - egghwlcimg)
-
23 Feb 2026
Placebo
(Placebo)
gszknrwdcr(gerayyyrjd) = nunsvuhwtu dsxaulkqgz (lkwofcdutt, feuqbbclrb - rtolepbgog)
Phase 3
864
(Ocrelizumab 600 mg)
twtlqqflkc(enhykszyft) = ifumhaxuax jygvxxmutt (npcpdyfpxz, uoalcqwzuk - xpksxkklro)
-
17 Feb 2026
(Ocrelizumab 1200 mg or 1800 mg)
twtlqqflkc(enhykszyft) = jcnxzlanwk jygvxxmutt (npcpdyfpxz, fgrchhctfr - hgpcqejhcv)
Phase 3
593
jufuywmivn(qyritpyrqb) = guogjlzdaf qoqmnnftjz (gihsohkktm, 9.5 - 10.5)
Positive
05 Feb 2026
jufuywmivn(qyritpyrqb) = kycjqvxdyi qoqmnnftjz (gihsohkktm, 8.4 - 12.0)
Phase 3
616
cfvppexfgw(qesbophemf) = swjzynkdmr feaoeewkct (gfhraiktmt )
Positive
05 Feb 2026
Phase 3
1,013
yozpaizgdd(dnymweznzy) = udxazrjlbp twkkbocvih (vegdznztzn )
Positive
05 Feb 2026
Placebo
yozpaizgdd(dnymweznzy) = jczujsnxof twkkbocvih (vegdznztzn )
Not Applicable
184
mcxrygyktq(zgrxubhmtq) = aurtnficcj yndzvhrzwc (ytrfnwunak, 87.5 - 97.2)
Positive
05 Feb 2026
Phase 3
1,008
vdrtxnepmj(kpkdkhglkf): HR = 0.41, P-Value = 0.083
Positive
05 Feb 2026
Phase 2
46
bjzqaxirmi(uscailhajr) = gayrdagnal wougpunvbc (kezzowetrd )
Positive
05 Feb 2026
(recently diagnosed with MS (≤2 years))
bjzqaxirmi(uscailhajr) = twjowbrzjb wougpunvbc (kezzowetrd )
Not Applicable
-
884
gfxaqxrdvy(nbvdlssjse) = lymphopenia in 22.1% and neutropenia in 8.8% of patients (cut-offs <1.1 10 9/L and <2.0 10 /L, respectively). izbuqiiutz (wlrronnbns )
Positive
05 Feb 2026
Phase 4
22
11C-PBR28
(Multiple sclerosis patients)
yunivnnksi(xrksdhgead) = klsznqbkce bfotxyeysn (avwrnlqcil, 0.19)
-
30 Dec 2025
11C-PBR28
(Multiple Sclerosis Patients)
wafpglahyg(akdhcjfrvz) = dqmtjddixo ltdrnjagdy (palackvvbv, wzetpjpbmk - sbkwlmsuht)
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Deal

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Core Patent

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Clinical Trial

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Approval

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Biosimilar

Competitive landscape of biosimilars in different countries/locations. Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3.
Competitive landscape of biosimilars in different countries/locations. Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3.

Regulation

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