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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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
244 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 | 15 | 25 | 38 | 30 | 107 |
| Urticaria | D014581 | EFO_0005531 | L50 | 3 | 15 | 18 | 7 | 7 | 48 |
| Chronic urticaria | D000080223 | — | L50.8 | 3 | 11 | 18 | 6 | 6 | 42 |
| Hypersensitivity | D006967 | EFO_0003785 | T78.40 | 4 | 16 | 1 | 4 | 6 | 29 |
| Food hypersensitivity | D005512 | EFO_1001890 | — | 4 | 10 | 1 | 4 | 2 | 19 |
| Nasal polyps | D009298 | — | J33 | 1 | 2 | 3 | 3 | 4 | 13 |
| Rhinosinusitis | D000096825 | — | — | 1 | 1 | 4 | 2 | 4 | 12 |
| Rhinitis | D012220 | EFO_0008521 | J31 | 1 | 1 | 1 | 2 | 5 | 10 |
| Sinusitis | D012852 | EFO_0007486 | J32 | 1 | 1 | 3 | 3 | 2 | 10 |
| Allergic rhinitis | D065631 | — | J30.9 | 1 | — | 1 | 2 | 5 | 9 |
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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 | 8 | 1 | — | — | 9 |
| Allergic rhinitis seasonal | D006255 | EFO_0003956 | J30 | — | 1 | 1 | — | 2 | 4 |
| Syndrome | D013577 | — | — | 1 | — | 1 | — | — | 2 |
| Bronchitis | D001991 | — | J40 | — | 1 | 1 | — | — | 1 |
| Acute disease | D000208 | — | — | — | 1 | 1 | — | — | 1 |
| Mastocytosis | D008415 | — | D47.09 | — | 1 | 1 | — | — | 1 |
| Pain | D010146 | EFO_0003843 | R52 | — | — | 1 | — | — | 1 |
| Interstitial cystitis | D018856 | EFO_1000869 | N30.1 | — | — | 1 | — | — | 1 |
| Cystitis | D003556 | EFO_1000025 | N30 | — | — | 1 | — | — | 1 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Eosinophilic esophagitis | D057765 | EFO_0004232 | K20.0 | 1 | 2 | — | — | — | 3 |
| Cold urticaria | D000096703 | — | — | 1 | 1 | — | — | — | 2 |
| Esophagitis | D004941 | HP_0100633 | K20 | 1 | 1 | — | — | — | 2 |
| Chronic obstructive pulmonary disease | D029424 | EFO_0000341 | J44.9 | — | 2 | — | — | — | 2 |
| Immunotherapy | D007167 | — | — | — | 1 | — | — | 1 | 2 |
| Milk hypersensitivity | D016269 | EFO_0007369 | — | 1 | 1 | — | — | — | 2 |
| Shock | D012769 | — | R57.1 | — | 1 | — | — | 1 | 2 |
| Infertility | D007246 | EFO_0000545 | — | — | 1 | — | — | — | 1 |
| Female infertility | D007247 | EFO_0008560 | N97 | — | 1 | — | — | — | 1 |
| Solar urticaria | D000092130 | — | L56.3 | — | 1 | — | — | — | 1 |
Show 12 more
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| 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 |
| Job syndrome | D007589 | EFO_0003775 | D82.4 | 1 | — | — | — | — | 1 |
| Hypereosinophilic syndrome | D017681 | EFO_1001467 | D72.11 | 1 | — | — | — | — | 1 |
| Chronic inducible urticaria | D000094482 | — | L50.4 | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Emergencies | D004630 | — | — | — | — | — | — | 1 | 1 |
| Herpes simplex | D006561 | — | B00 | — | — | — | — | 1 | 1 |
| Kaposi varicelliform eruption | D007617 | — | B00.0 | — | — | — | — | 1 | 1 |
| Inflammation | D007249 | MP_0001845 | — | — | — | — | — | 1 | 1 |
| Mycoses | D009181 | — | B35-B49 | — | — | — | — | 1 | 1 |
| Psoriasis | D011565 | EFO_0000676 | L40 | — | — | — | — | 1 | 1 |
| Hidradenitis suppurativa | D017497 | — | L73.2 | — | — | — | — | 1 | 1 |
| Mycosis fungoides | D009182 | — | C84.0 | — | — | — | — | 1 | 1 |
| T-cell lymphoma cutaneous | D016410 | — | C84.A | — | — | — | — | 1 | 1 |
| Skin diseases | D012871 | — | L00-L99 | — | — | — | — | 1 | 1 |
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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
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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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368,660 adverse events reported
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