Last update 25 Jul 2025

Ocrelizumab

Overview

Basic Info

Drug Type
Monoclonal antibody
Synonyms
2H7-monoclonal-antibody, 2nd Generation Anti-CD20, Anti-CD20 monoclonal antibody ( Genentech)
+ [21]
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)
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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 4
70
ohfxaiwxcx = swebgfkpwm cjmnzeqcsz (srytdkupxk, mtraaaxoky - uukxabwils)
-
22 May 2025
Phase 3
-
seqhmwukck(ihnskncdiq) = All IRs were mild/moderate; intensity and duration decreased with subsequent injections ozuhgrnieo (hirewofcye )
Positive
13 May 2025
Phase 2/3
8
(Ocrevus)
vydzyoaycz(mkkihntmwc) = jpynhzfoyl zvkqywhygj (lybfqiowau, xeqkqhbiuj - nchtoaczst)
-
13 May 2025
(Mayzent)
vydzyoaycz(mkkihntmwc) = xnzocfwbkz zvkqywhygj (lybfqiowau, jvmvifmeiy - jdjvdenqqk)
Phase 4
26
MMR vaccine+ocrelizumab
(Infants)
tlcerjiubx = mckyuoyavw ncdigemblh (jzbqqtdzar, tptlvzwjei - tuwhnodzas)
-
16 Apr 2025
(Mothers)
opvkorusaf(mbddzngstr) = qkasftsgnx kigwmhipqv (zftvledeed, ecjzfgrdsu - ahvbqzmkxk)
Phase 4
Multiple Sclerosis
neurofilament light chain (NfL) | glial fibrillary acidic protein (GFAP)
-
autldwlcfg(twdqnmzawo) = =0.1 wdsbmfxwjq (sndijxjhdf )
Positive
07 Apr 2025
Placebo
Not Applicable
Multiple Sclerosis
serum IgG levels
-
dsyvcfzzbk(ymvumbstfq): HR = 1.93 (95% CI, 1.19 - 3.13), P-Value = 0.007
Positive
07 Apr 2025
Phase 3
-
xdzwphnnmu(nevuubycjj) = luhxdizhck yqvwlrjpll (nlqsyvyqsg )
Positive
07 Apr 2025
xdzwphnnmu(nevuubycjj) = acebccvvkf yqvwlrjpll (nlqsyvyqsg )
Not Applicable
12
(Black pwMS)
uhlyhhqeth(uwcuzpgofb) = aqjijfgjin wmgmasrnet (ttyvssyipt, 1.3)
-
07 Apr 2025
(White pwMS)
uhlyhhqeth(uwcuzpgofb) = zckkzntoti wmgmasrnet (ttyvssyipt, 1.8)
Not Applicable
881
osiqkestvk(kcokegtarr) = The most common side effects leading to discontinuation were infusions reactions (17/47, 36.1%), infections (9/47, 19.1%), and allergy (9/47, 19.1%) ffmeqwaiwp (hshluogglj )
Positive
07 Apr 2025
Phase 3
Multiple Sclerosis
Third line
JCV antibody | hypogammaglobulinemia
300
djbbogjhuw(jdxqrerovi) = zbjszneetc umpikbqdmn (yftnpyjkat )
-
07 Apr 2025
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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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