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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FDA approval date
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Commercial
Therapeutic Areas
Trade Name
FDA
EMA
Omlyclo, Xolair
Drug Products
FDA
EMA
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| xolair | Biologic Licensing Application | 2018-05-30 |
| xolair xolair pfs | Biologic Licensing Application | 2024-11-20 |
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
246 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 | — | 3 | 10 | 13 | 6 | 31 |
| Chronic urticaria | D000080223 | — | L50.8 | — | 1 | 3 | 1 | — | 5 |
| Urticaria | D014581 | EFO_0005531 | L50 | — | 1 | — | 2 | — | 3 |
| Sinusitis | D012852 | EFO_0007486 | J32 | — | — | — | 1 | — | 1 |
| Healthy volunteers/patients | — | — | — | — | — | — | 1 | — | 1 |
| Bullous pemphigoid | D010391 | EFO_0007187 | L12 | — | — | — | 1 | — | 1 |
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Peanut hypersensitivity | D021183 | EFO_0007425 | — | 1 | 2 | 1 | — | — | 3 |
| Dyspnea | D004417 | — | R06.0 | — | — | 1 | — | — | 1 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Hypersensitivity | D006967 | EFO_0003785 | T78.40 | 1 | 6 | — | — | 2 | 8 |
| Nasal polyps | D009298 | — | J33 | 1 | 1 | — | — | — | 2 |
| Kidney diseases | D007674 | EFO_0003086 | N08 | — | 1 | — | — | — | 1 |
| Nephritis | D009393 | — | N05 | — | 1 | — | — | — | 1 |
| Interstitial nephritis | D009395 | — | N10-N16 | — | 1 | — | — | — | 1 |
| Food hypersensitivity | D005512 | EFO_1001890 | — | — | 1 | — | — | — | 1 |
| Chronic obstructive pulmonary disease | D029424 | EFO_0000341 | J44.9 | — | 1 | — | — | — | 1 |
| Lung diseases | D008171 | EFO_0003818 | J98.4 | — | 1 | — | — | — | 1 |
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Eosinophilic esophagitis | D057765 | EFO_0004232 | K20.0 | 1 | — | — | — | — | 1 |
| Esophagitis | D004941 | HP_0100633 | K20 | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Atopic dermatitis | D003876 | EFO_0000274 | L20 | — | — | — | — | 1 | 1 |
| Herpes simplex | D006561 | — | B00 | — | — | — | — | 1 | 1 |
| Kaposi varicelliform eruption | D007617 | — | B00.0 | — | — | — | — | 1 | 1 |
| Anaphylaxis | D000707 | — | T78.2 | — | — | — | — | 1 | 1 |
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
No data
Financial
Estimated US medical usage
Omalizumab
Total medical expenditures per year (USD, in millions)
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Number of persons purchased
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Number of purchases
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Refill frequency
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Tabular view
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 9,516 documents
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Safety
Black-box Warning
Black-box warning for: Xolair, Xolair xolair pfs
Adverse Events
Top Adverse Reactions
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403,488 adverse events reported
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