Xolair(omalizumab)
Xolair (omalizumab) is an antibody pharmaceutical. Omalizumab was first approved as Xolair on 2003-06-20. It is used to treat asthma in the USA. It has been approved in Europe to treat asthma and urticaria. The pharmaceutical is active against Immunoglobulin heavy constant epsilon.
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Novartis Pharmaceuticals
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Commercial
Trade Name
FDA
EMA
Xolair
Drug Products
FDA
EMA
Reference product - 351(a)
Reference product - 351(a)
Interchangeable product - 351(k)
Interchangeable product - 351(k)
Biosimilar product - 351(k)
Biosimilar product - 351(k)
Omalizumab
Tradename | Proper name | Company | Number | Date | Products |
|---|---|---|---|---|---|
| Xolair | omalizumab | Genentech | N-103976 RX | 2003-06-20 | 3 products |
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| xolair xolair pfs | Biologic Licensing Application | 2020-12-09 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| asthma | EFO_0000270 | D001249 | J45 |
Agency Specific
FDA
EMA
No data
Patent Expiration
No data
HCPCS
Code | Description |
|---|---|
| J2357 | Injection, omalizumab, 5 mg |
Clinical
Clinical Trials
184 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Asthma | D001249 | EFO_0000270 | J45 | 4 | 13 | 21 | 31 | 12 | 76 |
| Chronic urticaria | D000080223 | L50.8 | — | 7 | 13 | 4 | 1 | 24 | |
| Food hypersensitivity | D005512 | EFO_1001890 | 2 | 7 | — | 2 | — | 9 | |
| Nasal polyps | D009298 | HP_0100582 | J33 | 1 | 1 | 3 | 2 | 1 | 8 |
| Hypersensitivity | D006967 | EFO_0003785 | T78.40 | — | 4 | — | 1 | 2 | 7 |
| Atopic dermatitis | D003876 | EFO_0000274 | L20 | 2 | 1 | — | 3 | 1 | 7 |
| Allergic rhinitis | D065631 | J30.9 | 1 | — | — | 1 | 3 | 5 | |
| Urticaria | D014581 | EFO_0005531 | L50 | — | 1 | — | 2 | 1 | 4 |
| Bullous pemphigoid | D010391 | EFO_0007187 | L12 | — | — | 1 | 1 | — | 2 |
| Allergic bronchopulmonary aspergillosis | D001229 | EFO_0007140 | B44.81 | — | — | — | 1 | 1 | 2 |
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Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Peanut hypersensitivity | D021183 | EFO_0007425 | 3 | 7 | 1 | — | — | 8 | |
| Allergic rhinitis seasonal | D006255 | EFO_0003956 | J30 | — | 1 | 1 | — | 1 | 3 |
| Angioedema | D000799 | EFO_0005532 | T78.3 | — | 1 | 1 | — | — | 2 |
| Interstitial cystitis | D018856 | EFO_1000869 | N30.1 | — | — | 1 | — | — | 1 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Immunotherapy | D007167 | — | 1 | — | — | 1 | 2 | ||
| Milk hypersensitivity | D016269 | EFO_0007369 | 1 | 1 | — | — | — | 2 | |
| Female infertility | D007247 | EFO_0008560 | N97 | — | 1 | — | — | — | 1 |
| Esophagitis | D004941 | HP_0100633 | K20 | — | 1 | — | — | — | 1 |
| Chronic obstructive pulmonary disease | D029424 | EFO_0000341 | J44.9 | — | 1 | — | — | — | 1 |
| Covid-19 | D000086382 | U07.1 | — | 1 | — | — | — | 1 | |
| Interstitial nephritis | D009395 | N10-N16 | — | 1 | — | — | — | 1 | |
| Hypotension | D007022 | EFO_0005251 | I95 | — | 1 | — | — | — | 1 |
| Anaphylaxis | D000707 | T78.2 | — | 1 | — | — | — | 1 | |
| Bronchial spasm | D001986 | — | 1 | — | — | — | 1 |
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Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Healthy volunteers/patients | — | 6 | — | — | — | — | 6 | ||
| Autism spectrum disorder | D000067877 | F84.0 | 1 | — | — | — | — | 1 | |
| Drug hypersensitivity | D004342 | EFO_0009482 | T88.7 | 1 | — | — | — | — | 1 |
| Colonic neoplasms | D003110 | C18 | 1 | — | — | — | — | 1 | |
| Sjogren's syndrome | D012859 | EFO_0000699 | M35.0 | 1 | — | — | — | — | 1 |
| Systemic lupus erythematosus | D008180 | EFO_0002690 | M32 | 1 | — | — | — | — | 1 |
| Immune system diseases | D007154 | D89.9 | 1 | — | — | — | — | 1 | |
| Eosinophilic esophagitis | D057765 | EFO_0004232 | K20.0 | 1 | — | — | — | — | 1 |
| Job syndrome | D007589 | EFO_0003775 | D82.4 | 1 | — | — | — | — | 1 |
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | OMALIZUMAB |
| INN | omalizumab |
| Description | Immunoglobulin G, anti-(human immunoglobulin E Fc region) (human-mouse monoclonal E25 clone pSVIE26 y-chain), disulfide with human-mouse monoclonal E25 clone pSVIE26 x-chain, dimer |
| Classification | Antibody |
| Drug class | monoclonal antibodies |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | >2XA8:H|OMALIZUMAB HEAVY CHAIN
EVQLVESGGGLVQPGGSLRLSCAVSGYSITSGYSWNWIRQAPGKGLEWVASITYDGSTNYNPSVKGRITISRDDSKNTFY
LQMNSLRAEDTAVYYCARGSHYFGHWHFAVWGQGTLVTVSSASTKGPSVFPLAPSSKSTSGGTAALGCLVKDYFPEPVTV
SWNSGALTSGVHTFPAVLQSSGLYSLSSVVTVPSSSLGTQTYICNVNHKPSNTKVDKKV
>2XA8:L|OMALIZUMAB LIGHT CHAIN
DIQLTQSPSSLSASVGDRVTITCRASQSVDYDGDSYMNWYQQKPGKAPKLLIYAASYLESGVPSRFSGSGSGTDFTLTIS
SLQPEDFATYYCQQSHEDPYTFGQGTKVEIKRTVAAPSVFIFPPSDEQLKSGTASVVCLLNNFYPREAKVQWKVDNALQS
GNSQESVTEQDSKDSTYSLSSTLTLSKADYEKHKVYACEVTHQGLSSPVTKSFNRGEC |
Target
Agency Approved
IGHE
IGHE
Organism
Homo sapiens
Gene name
IGHE
Gene synonyms
NCBI Gene ID
—
Protein name
Immunoglobulin heavy constant epsilon
Protein synonyms
Ig epsilon chain C region, Ig epsilon chain C region ND
Uniprot ID
Mouse ortholog
—
—
Alternate
No data
Variants
Clinical Variant
No data
Financial
Xolair - Novartis
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Xolair - Roche
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Tabular view
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 6,561 documents
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Safety
Black-box Warning
Black-box warning for: Xolair xolair pfs
Adverse Events
Top Adverse Reactions
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7,433 adverse events reported
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