Omalizumab
As of the edition of 20 October 2026, Omalizumab is an antibody: marketed, first approved in 2003 (US); acts on IGHE; US protection ended in 2015.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2009
- Kind
- Antibody
- Brand name
- Xolair
- First approved
- 20 June 2003 (US)
- Approvals on record
- 20 in 4 regions
- Holder of the most recent approval
- Novartis; 3 holders in all
- Registered trials
- 153, 18 stopped early
- Disease areas
- Immune system; Lungs and airways; Skin and connective tissue; Ear, nose and throat; Inherited and neonatal; Infections
US protection
US protection ended in 2015.
US protection ended in 2015, computed as 12 years from the first US licence because FDA publishes no date for this product. The application that gives this date is held by Roche. The date is computed, not published.
This is the US only, and it is not the date generics or biosimilars can enter.
The exact date and the listings behind it
In the product1 listing counts towards this date. The exact date and each listing are in the product.
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Companies that need a new molecule because of this drug
1 company on route B because of this drug.
Companies on route B for this drug
In the product1 company is on route B because of Omalizumab.
See the 1 company on route B for this drug, with the facts behind eachRequest access. Nothing is shown until you do.
Target
| Gene | Protein | UniProt |
|---|---|---|
| IGHE | Immunoglobulin heavy constant epsilon | P01854 |
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 24 | 12 | 4 | 2 |
| Phase 1 | 16 | 13 | 0 | 3 |
| Phase 2 | 28 | 20 | 3 | 3 |
| Phase 3 | 41 | 36 | 1 | 1 |
| Phase 4 | 44 | 29 | 1 | 9 |
| All trials | 153 |