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Drug ReportsOmalizumab
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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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
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
respiratory tract diseasesD012140
skin and connective tissue diseasesD017437
immune system diseasesD007154
Trade Name
FDA
EMA
Omlyclo, 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
XolairomalizumabGenentechN-103976 RX2003-06-20
7 products
Labels
FDA
EMA
Brand Name
Status
Last Update
xolairBiologic Licensing Application2018-05-30
xolair xolair pfsBiologic Licensing Application2025-12-02
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
asthmaEFO_0000270D001249J45
Agency Specific
FDA
EMA
No data
Patent Expiration
No data
ATC Codes
R: Respiratory system drugs
— R03: Drugs for obstructive airway diseases
— R03D: Other systemic drugs for obstructive airway diseases in atc
— R03DX: Other systemic drugs for obstructive airway diseases in atc
— R03DX05: Omalizumab
HCPCS
Code
Description
J2357
Injection, omalizumab, 5 mg
Clinical
Clinical Trials
246 clinical trials
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Indications Phases 4
No data
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Chronic urticariaD000080223—L50.8——1——1
Indications Phases 2
No data
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Healthy volunteers/patients———1————1
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameOmalizumab
INNomalizumab
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 classmonoclonal antibodies
Image (chem structure or protein)Loading
Structure (InChI/SMILES or Protein Sequence)
>2XA8:H|OMALIZUMAB HEAVY CHAIN EVQLVESGGGLVQPGGSLRLSCAVSGYSITSGYSWNWIRQAPGKGLEWVASITYDGSTNYNPSVKGRITISRDDSKNTFY LQMNSLRAEDTAVYYCARGSHYFGHWHFAVWGQGTLVTVSSASTKGPSVFPLAPSSKSTSGGTAALGCLVKDYFPEPVTV SWNSGALTSGVHTFPAVLQSSGLYSLSSVVTVPSSSLGTQTYICNVNHKPSNTKVDKKV >2XA8:L|OMALIZUMAB LIGHT CHAIN DIQLTQSPSSLSASVGDRVTITCRASQSVDYDGDSYMNWYQQKPGKAPKLLIYAASYLESGVPSRFSGSGSGTDFTLTIS SLQPEDFATYYCQQSHEDPYTFGQGTKVEIKRTVAAPSVFIFPPSDEQLKSGTASVVCLLNNFYPREAKVQWKVDNALQS GNSQESVTEQDSKDSTYSLSSTLTLSKADYEKHKVYACEVTHQGLSSPVTKSFNRGEC
Identifiers
PDB2XA8, 4X7S, 4X7T, 5HYS, 6TCM, 6TCN, 6TCO, 6TCP, 6TCQ, 6TCR, 6TCS, 7SHT, 7SHU, 7SHY
CAS-ID—
RxCUI—
ChEMBL IDCHEMBL1201589
ChEBI ID—
PubChem CID—
DrugBankDB00043
UNII ID2P471X1Z11 (ChemIDplus, GSRS)
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
P01854
Mouse ortholog
—
—
Alternate
No data
Variants
No data
Financial
Revenue by drug
$
€
£
â‚£
Xolair – Novartis
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Xolair – Roche
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Tabular view
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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Price per prescription (USD)
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Tabular view
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 9,605 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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