Gazyva, Gazyvaro(obinutuzumab)
Gazyva, Gazyvaro (obinutuzumab) is an antibody pharmaceutical. Obinutuzumab was first approved as Gazyva on 2013-11-01. It is used to treat follicular lymphoma and lymphoid leukemia in the USA. It has been approved in Europe to treat b-cell chronic lymphocytic leukemia. The pharmaceutical is active against B-lymphocyte antigen CD20.
Download report
Favorite
Events Timeline
Commercial
Clinical
Drug
Target
Variants
Financial
Trends
Safety
Events Timeline
5D
1M
3M
6M
YTD
1Y
2Y
5Y
Max
Events
FDA approval date
EMA approval date
Patent expiration date
Study first post date
Last update post date
Start date
Primary completion date
Completion date
Results first post date
Mock data
Subscribe for the real data
Subscribe for the real data
Commercial
Therapeutic Areas
Trade Name
FDA
EMA
Gazyva
Drug Products
FDA
EMA
Labels
FDA
EMA
No data
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| follicular lymphoma | — | D008224 | C82 |
| lymphoid leukemia | — | D007945 | C91 |
Agency Specific
FDA
EMA
Expiration | Code | ||
|---|---|---|---|
obinutuzumab, Gazyva, Genentech, Inc. | |||
| 2024-11-16 | Orphan excl. | ||
Patent Expiration
No data
HCPCS
Code | Description |
|---|---|
| J9301 | Injection, obinutuzumab, 10 mg |
Clinical
Clinical Trials
266 clinical trials
View more details
Mock data
Subscribe for the real data
Subscribe for the real data
Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Follicular lymphoma | D008224 | — | C82 | 14 | 26 | 4 | 1 | 6 | 42 |
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| B-cell chronic lymphocytic leukemia | D015451 | — | C91.1 | 21 | 41 | 20 | — | 7 | 83 |
| Non-hodgkin lymphoma | D008228 | — | C85.9 | 22 | 18 | 2 | — | — | 34 |
| Large b-cell lymphoma diffuse | D016403 | — | C83.3 | 7 | 10 | 2 | — | — | 16 |
| Lymphoma | D008223 | — | C85.9 | 11 | 6 | 1 | — | — | 12 |
| Lupus nephritis | D008181 | EFO_0005761 | — | — | 2 | 2 | — | — | 4 |
| Systemic lupus erythematosus | D008180 | HP_0002725 | M32 | — | — | 2 | — | — | 2 |
| Membranous glomerulonephritis | D015433 | EFO_0004254 | N03.2 | — | 1 | 1 | — | — | 2 |
| Nephrotic syndrome | D009404 | EFO_0004255 | N04 | — | — | 1 | — | — | 1 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Mantle-cell lymphoma | D020522 | — | C83.1 | 5 | 10 | — | — | 1 | 13 |
| B-cell lymphoma | D016393 | — | — | 6 | 3 | — | — | — | 9 |
| Waldenstrom macroglobulinemia | D008258 | HP_0005508 | C88.0 | 2 | 4 | — | — | 1 | 6 |
| Reactive arthritis | D016918 | EFO_0007460 | M02.3 | 2 | 4 | — | — | — | 5 |
| Burkitt lymphoma | D002051 | — | C83.7 | 3 | 2 | — | — | — | 4 |
| Colorectal neoplasms | D015179 | — | — | 3 | 1 | — | — | — | 3 |
| B-cell lymphoma marginal zone | D018442 | — | C88.4 | 1 | 2 | — | — | — | 3 |
| Hairy cell leukemia | D007943 | — | C91.4 | 2 | 2 | — | — | — | 3 |
| Non-small-cell lung carcinoma | D002289 | — | — | 2 | 2 | — | — | — | 3 |
| Leukemia | D007938 | — | C95 | 1 | 2 | — | — | — | 3 |
Show 21 more
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Breast neoplasms | D001943 | EFO_0003869 | C50 | 2 | — | — | — | — | 2 |
| Hodgkin disease | D006689 | — | C81 | 1 | — | — | — | — | 1 |
| Mycosis fungoides | D009182 | — | C84.0 | 1 | — | — | — | — | 1 |
| Prostatic neoplasms | D011471 | — | C61 | 1 | — | — | — | — | 1 |
| Ovarian neoplasms | D010051 | EFO_0003893 | C56 | 1 | — | — | — | — | 1 |
| Pancreatic neoplasms | D010190 | EFO_0003860 | C25 | 1 | — | — | — | — | 1 |
| Endometrial neoplasms | D016889 | EFO_0004230 | — | 1 | — | — | — | — | 1 |
| Hepatocellular carcinoma | D006528 | — | C22.0 | 1 | — | — | — | — | 1 |
| Urinary bladder neoplasms | D001749 | — | C67 | 1 | — | — | — | — | 1 |
| Liver neoplasms | D008113 | EFO_1001513 | C22.0 | 1 | — | — | — | — | 1 |
Show 6 more
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Liver diseases | D008107 | HP_0002910 | K70-K77 | — | — | — | — | 1 | 1 |
| Hepatitis b | D006509 | — | — | — | — | — | — | 1 | 1 |
| Immunosuppression therapy | D007165 | — | — | — | — | — | — | 1 | 1 |
Epidemiology
Epidemiological information for investigational and approved indications
View more details
Drug
General
| Drug common name | Obinutuzumab |
| INN | obinutuzumab |
| Description | Obinutuzumab (humanized mab) |
| Classification | Antibody |
| Drug class | monoclonal antibodies |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | >6Y9A:H|Obinutuzumab Fab heavy chain
VQLVQSGAEVKKPGSSVKVSCKASGYAFSYSWINWVRQAPGQGLEWMGRIFPGDGDTDYNGKFKGRVTITADKSTSTAYM
ELSSLRSEDTAVYYCARNVFDGYWLVYWGQGTLVTVSSASTKGPSVFPLAPSSKSTSGGTAALGCLVKDYFPEPVTVSWN
SGALTSGVHTFPAVLQSSGLYSLSSVVTVPSSSLGTQTYICNVNHKPSNTKVDKKVEPK
>6Y9A:L|Obinutuzumab Fab Light chain
DIVMTQTPLSLPVTPGEPASISCRSSKSLLHSNGITYLYWYLQKPGQSPQLLIYQMSNLVSGVPDRFSGSGSGTDFTLKI
SRVEAEDVGVYYCAQNLELPYTFGGGTKVEIKRTVAAPSVFIFPPSDEQLKSGTASVVCLLNNFYPREAKVQWKVDNALQ
SGNSQESVTEQDSKDSTYSLSSTLTLSKADYEKHKVYACEVTHQGLSSPVTKSFNRGEC |
Identifiers
| PDB | 6Y97, 6Y9A |
| CAS-ID | — |
| RxCUI | — |
| ChEMBL ID | CHEMBL1743048 |
| ChEBI ID | — |
| PubChem CID | — |
| DrugBank | DB08935 |
| UNII ID | O43472U9X8 (ChemIDplus, GSRS) |
Target
Agency Approved
MS4A1
MS4A1
Organism
Homo sapiens
Gene name
MS4A1
Gene synonyms
CD20
NCBI Gene ID
Protein name
B-lymphocyte antigen CD20
Protein synonyms
B-lymphocyte cell-surface antigen B1, B-lymphocyte surface antigen B1, Bp35, CD20, CD20 antigen, CD20 receptor, Leukocyte surface antigen Leu-16, Membrane-spanning 4-domains subfamily A member 1, membrane-spanning 4-domains, subfamily A, member 1
Uniprot ID
Mouse ortholog
Ms4a1 (12482)
B-lymphocyte antigen CD20 (P19437)
Alternate
No data
Variants
No data
Financial
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
Mock data
Subscribe for the real data
Subscribe for the real data
Additional graphs summarizing 4,621 documents
View more details
Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
Mock data
Subscribe for the real data
Subscribe for the real data
6,912 adverse events reported
View more details
© 2020-2023 Collaborative Drug Discovery Inc. (CDD) | Terms of Use