Ocrelizumab
Highest phase reached
Approved
Drug type
Antibody
First approval year
2017
- First approval year
- 2017
- Listing at source
- Listed
- Highest phase reached
- Approved
- Drug type
- Antibody
- Drug name
- Ocrelizumab
- ocrelizumab component of ocrevus zunovo
- Ocrelizumab component of ocrevus zunovo
- ocrevus
- Ocrevus
- 2h7
- 2H7
- immunoglobulin g1 anti human cd20 antigen human mouse monoclonal 2h7 gamma 1 chain disulfide with human mouse monoclonal 2h7 kappa chain dimer
- immunoglobulin g1 anti human cd20 antigen human mouse monoclonal 2h7 gamma 1 chain disulphide with human mouse monoclonal 2h7 kappa chain dimer
- IMMUNOGLOBULIN G1, ANTI-(HUMAN CD20 (ANTIGEN)) (HUMAN-MOUSE MONOCLONAL 2H7 .GAMMA.1-CHAIN), DISULFIDE WITH HUMAN-MOUSE MONOCLONAL 2H7 .KAPPA.-CHAIN, DIMER
- IMMUNOGLOBULIN G1, ANTI-(HUMAN CD20 (ANTIGEN)) (HUMAN-MOUSE MONOCLONAL 2H7 .GAMMA.1-CHAIN), DISULPHIDE WITH HUMAN-MOUSE MONOCLONAL 2H7 .KAPPA.-CHAIN, DIMER
- ocrelizumab
- Ocrelizumab
- Ocrelizumab (EU)
- Ocrelizumab (US)
- ocrelizumab [INN]
- OCRELIZUMAB [JAN]
- OCRELIZUMAB [MI]
- OCRELIZUMAB [PURPLE BOOK CDER]
- OCRELIZUMAB [USAN]
- Ocrelizumab [WHO-DD]
- Ocrelizumab 300 mg
- ocrelizumab 500mg
- Ocrelizumab 600 mg
- Ocrelizumab infusion
- ocrelizumab inn
- Ocrelizumab IV
- ocrelizumab jan
- ocrelizumab mi
- ocrelizumab ocsq
And 16 more, listed on the interactive page.
- ATC classification codes
- L04AG08
Sources for recorded values
- CAS registry numbers
- 637334-45-3
- ChEMBL ID
- CHEMBL2108041
- FDA ingredient codes (UNII)
- A10SJL62JY
- 1876366
- 2693449
- Applicant
- GENENTECH INC
- Approval date
- 28 Mar 2017
- Application number
- BLA761053
- Status
- Authorised
- Status date
- 8 Jan 2018
- Authorisation date
- 8 Jan 2018
- Approved indications
- Treatment of adult patients with relapsing forms of multiple sclerosis (RMS) with active disease defined by clinical or imaging features. Treatment of adult patients with early primary progressive multiple sclerosis (PPMS) in terms of disease duration and level of disability, and with imaging features characteristic of inflammatory activity.
- Product number
- EMEA/H/C/004043
- Authorisation holder
- Roche Registration GmbH
- Priority medicines scheme
- No
- Generic
- No
- Biosimilar
- No
- Generic medicines
- 0
- Biosimilar medicines
- 0
- Advanced therapy
- No
- Conditional approval
- No
- Additional monitoring
- No
- Accelerated assessment
- No
- Exceptional circumstances
- No
Therapeutic areas
- Multiple Sclerosis
European medicines record
- Patents
- 0
- Designations
- 5
- First in class
- Yes
- Fast track
- Yes
- Breakthrough designation
- Yes
- Orphan designation
- No
- Priority review
- Yes
- Orphan exclusivity
- No
- Accelerated approval
- No
- Availability
- Prescription only
- Pharmacology name
- ocrelizumab
- Type
- Antibody
- Drug name stem
- -mab; -mab
- Approval recorded by Guide to Pharmacology
- Yes
Administration routes
- Parenteral
- Mechanism
- B-lymphocyte antigen CD20 binding agent
- Action type
- BINDING_AGENT
- Target
- B-lymphocyte antigen CD20
- Protein identifier
- P11836
- Action
- Binding
- Action type
- Binding
- Target
- CD20 (membrane-spanning 4-domains, subfamily A, member 1)
- Gene symbol
- MS4A1
- Protein identifier
- P11836
- Median affinity
- 9.08
- Affinity units
- pKd
- Primary target
- Yes
Open Targets mechanisms
- Mechanism
- B-lymphocyte antigen CD20 binding agent
- Action type
- BINDING AGENT
- Target
- B-lymphocyte antigen CD20
- Condition
- Arthritis, Rheumatoid
- Highest recorded phase
- 3
- Condition identifier
- EFO:0000685
- Subject identifier
- D001172
- Condition
- Multiple Sclerosis, Chronic Progressive
- Highest recorded phase
- 4
- Condition identifier
- EFO:0003840
- Subject identifier
- D020528
- Condition
- Multiple Sclerosis, Relapsing-Remitting
- Highest recorded phase
- 4
- Condition identifier
- EFO:0003929
- Subject identifier
- D020529
- Condition
- Psychotic Disorders
- Highest recorded phase
- 1
- Condition identifier
- EFO:0005407
- Subject identifier
- D011618
- Condition
- Lymphoma, Non-Hodgkin
- Highest recorded phase
- 1
- Condition identifier
- EFO:0005952
- Subject identifier
- D008228
- Condition
- Multiple Sclerosis, Chronic Progressive
- Highest recorded phase
- 4
- Condition identifier
- EFO:0008520
- Subject identifier
- D020528
- Condition
- Multiple Sclerosis, Chronic Progressive
- Highest recorded phase
- 4
- Condition identifier
- EFO:0008522
- Subject identifier
- D020528
- Condition
- Schizophrenia
- Highest recorded phase
- 1
- Condition identifier
- MONDO:0005090
- Subject identifier
- D012559
- Condition
- Multiple Sclerosis
- Highest recorded phase
- 4
- Condition identifier
- MONDO:0005301
- Subject identifier
- D009103
- Condition
- Lupus Erythematosus, Systemic
- Highest recorded phase
- 3
- Condition identifier
- MONDO:0007915
- Subject identifier
- D008180
- Condition
- Autoimmune Diseases of the Nervous System
- Highest recorded phase
- 2
- Condition identifier
- MONDO:0020640
- Subject identifier
- D020274
- Condition identifier
- EFO_0000403
- Condition identifier
- EFO_0000685
- Highest recorded phase
- 3
- Condition identifier
- EFO_0003840
- Condition identifier
- EFO_0003929
- Condition identifier
- EFO_0005407
- Condition identifier
- EFO_0005952
- Condition identifier
- HP_0004313
- Condition identifier
- MONDO_0000450
- Highest recorded phase
- 1
- Condition identifier
- MONDO_0000451
- Highest recorded phase
- 1
- Condition identifier
- MONDO_0001166
- Highest recorded phase
- 3
- Condition identifier
- MONDO_0002211
- Condition identifier
- MONDO_0004985
- Highest recorded phase
- 1
- Condition identifier
- MONDO_0005090
- Condition identifier
- MONDO_0005090
- Highest recorded phase
- 1
- Condition identifier
- MONDO_0005284
- Highest recorded phase
- 4
- Condition identifier
- MONDO_0005301
- Condition identifier
- MONDO_0005301
- Highest recorded phase
- 4
- Condition identifier
- MONDO_0005314
- Highest recorded phase
- 4
- Condition identifier
- MONDO_0007915
- Highest recorded phase
- 3
- Condition identifier
- MONDO_0008383
- Highest recorded phase
- 3
- Condition identifier
- MONDO_0015977
- Condition identifier
- MONDO_0018905
- Highest recorded phase
- 4
- Condition identifier
- MONDO_0018906
- Highest recorded phase
- 1
- Condition identifier
- MONDO_0020640
- Highest recorded phase
- 2
- Event
- b-lymphocyte count decreased
- Reports
- 68
- Reporting signal score
- 218.042
- Event
- covid-19
- Reports
- 1,300
- Reporting signal score
- 3,235.32
- Event
- covid-19 pneumonia
- Reports
- 135
- Reporting signal score
- 326.941
- Event
- ear pruritus
- Reports
- 78
- Reporting signal score
- 215.616
- Event
- herpes zoster
- Reports
- 371
- Reporting signal score
- 404.666
- Event
- influenza
- Reports
- 257
- Reporting signal score
- 159.708
- Event
- infusion related reaction
- Reports
- 602
- Reporting signal score
- 855.237
- Event
- injection site pain
- Reports
- 4
- Reporting signal score
- 161.795
- Event
- jc polyomavirus test positive
- Reports
- 85
- Reporting signal score
- 332.975
- Event
- multiple sclerosis
- Reports
- 373
- Reporting signal score
- 699.468
- Event
- multiple sclerosis relapse
- Reports
- 440
- Reporting signal score
- 649.616
- Event
- nasopharyngitis
- Reports
- 373
- Reporting signal score
- 198.601
- Event
- oral herpes
- Reports
- 180
- Reporting signal score
- 343.526
- Event
- suspected covid-19
- Reports
- 74
- Reporting signal score
- 221.506
- Event
- throat irritation
- Reports
- 382
- Reporting signal score
- 697.686
- Event
- urinary tract infection
- Reports
- 797
- Reporting signal score
- 791.751
- NCT00077870
- NCT00406419
- NCT00476996
- NCT00485589
- NCT00673920
- NCT00779220
- NCT00808210
- NCT02720120
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- NCT00676715
- NCT02637856
- NCT02861014
- NCT03085810
- NCT04261790
- NCT04578639
- NCT04971005
- NCT05123703
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- NCT05906992
- NCT01194570
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- NCT04035005
- NCT04544449
- NCT01247324
And 31 more, listed on the interactive page.
- Dose
- 300 mg
- Route
- Intravenous
- How often
- Initial doses: 2 weeks apart; subsequent doses: every 6 months
- Administer under supervision with access to medical support
- Do not shake
- Do not use other diluents
- Must be diluted prior to administration
- Prepare by healthcare professional using aseptic technique
- Use infusion bag containing 0.9% Sodium Chloride Injection
- Visually inspect for particulate matter and discoloration prior to administration
- Withdraw 10 mL (300 mg) of OCREVUS for 300 mg dose in 250 mL
- Withdraw 20 mL (600 mg) of OCREVUS for 600 mg dose in 500 mL
- Prodrug
- No
- Chirality
- Single enantiomer
- Inorganic
- No
- Natural product
- No
- 50242-150
- 50242-554
Related records
Trials (96)
- A Biosimilar Trial to Investigate PK, PD, Safety With PB018 Versus US-licensed Ocrevus and EU-approved Ocrevus
- A Comparative Study of Pharmacokinetics, Pharmacodynamics, Safety, and Immunogenicity of RPH-035 and Ocrevus® in Patients With Relapsing-remitting or Secondary Progressive Multiple Sclerosis With Exacerbations
- A Phase III, Non-Inferiority, Randomized, Open-Label, Parallel Group, Multicenter Study To Investigate The Pharmacokinetics, Pharmacodynamics, Safety And Radiological And Clinical Effects Of Subcutaneous Ocrelizumab Versus Intravenous Ocrelizumab In Patients With Multiple Sclerosis
- A Prospective Randomized Non-inferiority Trial Comparing Anti-CD20 Maintenance Versus De-Escalation Strategy In Relapsing-Remitting Multiple Sclerosis
- A Rollover Study to Evaluate the Long-Term Safety and Efficacy of Ocrelizumab In Patients With Multiple Sclerosis
- A Study Evaluating B Cell Levels In Infants Of Lactating Women With CIS Or MS Receiving Ocrelizumab
- A Study Evaluating B Cell Levels In Infants Potentially Exposed To Ocrelizumab During Pregnancy
- A Study of Ocrelizumab Compared to Placebo in Patients With Active Rheumatoid Arthritis Continuing Methotrexate Treatment (STAGE)
- A Study of Ocrelizumab Compared to Placebo in Patients With Active Rheumatoid Arthritis Who Don't Have a Response to Anti-TNF-α Therapy (SCRIPT)
- A Study of Ocrelizumab in Children and Adolescents With Relapsing-Remitting Multiple Sclerosis
- A Study of Ocrelizumab in Combination With Methotrexate in Patients With Rheumatoid Arthritis Who Are Naive to Methotrexate (FILM)
- A Study of Ocrelizumab in Comparison With Interferon Beta-1a (Rebif) in Participants With Relapsing Multiple Sclerosis
- A Study of Ocrelizumab in Comparison With Interferon Beta-1a (Rebif) in Participants With Relapsing Multiple Sclerosis
- A Study of Ocrelizumab in Participants With Follicular Non-Hodgkin's Lymphoma (NHL)
- A Study of Ocrelizumab in Participants With Moderate to Severe Rheumatoid Arthritis (RA)
- A Study of Ocrelizumab in Participants With Primary Progressive Multiple Sclerosis
- A Study of Ocrelizumab in Participants With Relapsing Remitting Multiple Sclerosis (RRMS) Who Have Had a Suboptimal Response to an Adequate Course of Disease-Modifying Treatment (DMT)
- A Study of Ocrelizumab in Participants With Relapsing Remitting Multiple Sclerosis (RRMS) Who Have Had a Suboptimal Response to an Adequate Course of Disease-Modifying Treatment (DMT)
- A Study of the Efficacy and Safety of BCD-281 in Patients With Relapsing-Remitting Multiple Sclerosis
- A Study of the Efficacy and Safety of Ocrelizumab in Patients With Relapsing-Remitting Multiple Sclerosis
Approved for (5)
- Chronic progressive multiple sclerosis
- Multiple sclerosis
- Primary progressive multiple sclerosis
- Relapsing-remitting multiple sclerosis
- Secondary progressive multiple sclerosis
In development for (6)
- Autoimmune encephalitis Phase 2
- Non-Hodgkin lymphoma Phase 1
- Psychotic disorder Phase 1
- Rheumatoid arthritis Phase 3
- Schizophrenia Phase 1
- Systemic lupus erythematosus Phase 3
Other linked conditions (1)
Targets (1)
- MS4A1 B-lymphocyte antigen CD20 binding agent