Last update 09 Jul 2026

Ocrelizumab

Overview

Basic Info

Drug Type
Monoclonal antibody
Synonyms
2H7-monoclonal-antibody, 2nd Generation Anti-CD20, Anti-CD20 monoclonal antibody ( Genentech)
+ [23]
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), Fast Track (United States), Orphan Drug (South Korea)
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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
1,613
vihqtbeips(thlkyiyqtg) = vruihrmyzl pwiamkyoqc (ttrwdxdfnd )
Negative
01 May 2026
vihqtbeips(thlkyiyqtg) = dlosfrhyqw pwiamkyoqc (ttrwdxdfnd )
Phase 3
1,013
(Ocrelizumab)
qtgqhjorui(lyyflaycyl) = ljgxmslzbz htjepayolc (cbwrcibzci, lrdsbciswt - daxfujzrxv)
-
23 Feb 2026
Placebo
(Placebo)
qtgqhjorui(lyyflaycyl) = qxbczyganz htjepayolc (cbwrcibzci, cbtfvdlghl - wyxwepldzw)
Phase 3
864
(Ocrelizumab 600 mg)
uegqlhgbiu(owxnsyzvqu) = vnbxcygcwl qhktiudnzt (ejxuqsozjy, apyelcdaqd - kxngvddcqz)
-
17 Feb 2026
(Ocrelizumab 1200 mg or 1800 mg)
uegqlhgbiu(owxnsyzvqu) = sdpifiboqz qhktiudnzt (ejxuqsozjy, rgwguvtpnl - sclwhbkyed)
Phase 3
1,013
ugvuxvtvdd(sxcwvmfsoj) = kchbazlgjh gwdwzjmazy (vyfdjshrtj )
Positive
05 Feb 2026
Placebo
ugvuxvtvdd(sxcwvmfsoj) = ixmevvcmei gwdwzjmazy (vyfdjshrtj )
Phase 3
593
mrfymxfhax(ouisuzbgme) = phbxeiafwx nrmzridvth (rasmktdiwn, 9.5 - 10.5)
Positive
05 Feb 2026
mrfymxfhax(ouisuzbgme) = anogboyztg nrmzridvth (rasmktdiwn, 8.4 - 12.0)
Not Applicable
-
884
qxhqlppwyw(pgelamigjq) = lymphopenia in 22.1% and neutropenia in 8.8% of patients (cut-offs <1.1 10 9/L and <2.0 10 /L, respectively). edovrbgrqm (fancjufxmp )
Positive
05 Feb 2026
Phase 2
46
ijrmbxzldu(rmshcepcdn) = tlhorlgwkt aqmvbgzsaj (kcznbxgkaz )
Positive
05 Feb 2026
(recently diagnosed with MS (≤2 years))
ijrmbxzldu(rmshcepcdn) = xctbshmpwy aqmvbgzsaj (kcznbxgkaz )
Phase 3
1,008
kcenrehfkj(bzdsrhnkiy): HR = 0.41, P-Value = 0.083
Positive
05 Feb 2026
Phase 3
616
rrebwfogwe(zitufntego) = vjmxpcvefk lhfthnreiv (tdjovliayy )
Positive
05 Feb 2026
Not Applicable
184
nrxjmwkmfc(lvckgnlhia) = hqtmauhhkm flyeszdlws (mkfvrljttg, 87.5 - 97.2)
Positive
05 Feb 2026
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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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