Omalizumab

Anti-IgE — RESPIRATORY SYSTEM

Key facts

Omalizumab is a drug in the Anti-IgE class catalogued in DrugCentral. It was first approved by the FDA in 2003. Its mechanism of action is classified as IgE-directed Antibody Interactions. DrugCentral lists 1 molecular target, including IGHE. Recorded indications include Asthma, Chronic idiopathic urticaria and Seasonal allergic rhinitis.

• Drug class: Anti-IgE.
• Mechanism of action: IgE-directed Antibody Interactions.
• Molecular targets: IGHE (1 listed in DrugCentral).
• Indications: Asthma, Chronic idiopathic urticaria and Seasonal allergic rhinitis.
• ATC code: R03DX05 (Other systemic drugs for obstructive airway diseases).

Indications & contraindications

Drug–disease relationships curated by DrugCentral (OMOP / SNOMED concepts).

Indications (3)

• Asthma
• Chronic idiopathic urticaria
• Seasonal allergic rhinitis

Mechanism & targets

• Mechanism of action (MoA): IgE-directed Antibody Interactions
• Established pharmacologic class: Anti-IgE

Molecular targets (1)

Target	Gene	Action	Activity
Ig epsilon chain C region	IGHE	other	Kd 8.16

Regulatory approvals (3)

Date	Agency	Marketed as	Applicant	Orphan
2009-01-21	PMDA	—	Novartis Pharma K.K.
2005-10-25	EMA	—	Novartis Europharm Ltd
2003-06-20	FDA	—	GENENTECH

ATC classification

ATC code	Therapeutic hierarchy
R03DX05	RESPIRATORY SYSTEM › DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES › OTHER SYSTEMIC DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES › Other systemic drugs for obstructive airway diseases

Reported adverse-event signals

Strongest FDA FAERS disproportionality signals (log-likelihood ratio). A signal is a statistical association in spontaneous reports, not proof that the drug causes the event.

MedDRA term	LLR
No adverse event	13123.5
Urticaria	4781.7
Wheezing	3449.4
Anaphylactic reaction	3172.3
Forced expiratory volume decreased	3013.0
Cough	2642.0
Sputum discoloured	1971.0
Dyspnoea	1945.8
Obstructive airways disorder	1841.3
Productive cough	1543.4
Asthma	1530.6
Middle insomnia	1368.7

Chemical structure

• Molecular formula: —
• Molecular weight: —
• CAS number: 242138-07-4
• InChIKey: —
• PubChem CID: —

Frequently asked questions

Answers are generated from the structured data on this page, not written by hand.

What is Omalizumab used for?

DrugCentral lists the following indications for Omalizumab: Asthma, Chronic idiopathic urticaria and Seasonal allergic rhinitis.

How does Omalizumab work?

Omalizumab is classified as IgE-directed Antibody Interactions; its molecular targets in DrugCentral include IGHE.

When was Omalizumab first approved?

Omalizumab was first approved by the FDA in 2003.

What drug class does Omalizumab belong to?

Omalizumab is in the Anti-IgE class.

Sources

• DrugCentral drug card 4972 — structure, indications, targets, approvals, pharmacologic classes (CC BY-SA 4.0)
• ChEMBL CHEMBL1201589 — compound record and bioactivity
• DrugBank DB00043 — drug record
• FDA UNII 2P471X1Z11 — substance identity
• DailyMed: FDA labels for Omalizumab — current prescribing information (label search)
• UniProt P01854 (IGHE) — target protein
• FDA Adverse Event Reporting System (openFDA FAERS) — adverse-event signals, as aggregated by DrugCentral

How this page is built: methodology · editorial policy & corrections.