Product Description
Omalizumab (Xolair(®)) is a subcutaneously administered monoclonal antibody that targets circulating free IgE and prevents its interaction with the high-affinity IgE receptor (FCepsilonRI), thereby interrupting the allergic cascade. (Sourced from: https://pubmed.ncbi.nlm.nih.gov/23812924/)
Mechanisms of Action: IgE Inhibitor
Novel Mechanism: No
Modality: Antibody
Route of Administration: Subcutaneous
FDA Designation: Priority Review - Food Hypersensitivity *
Approval Status: Approved
Approved Countries: Algeria | Argentina | Australia | Austria | Belgium | Bosnia | Brazil | Canada | Chile | Colombia | Croatia | Cyprus | Czech | Denmark | Dominican Republic | Ecuador | Egypt | Estonia | European Medicines Agency | Finland | France | Germany | Greece | Hong Kong | Hungary | Iceland | India | Indonesia | Ireland | Israel | Italy | Japan | Jordan | Korea | Latvia | Lebanon | Lithuania | Luxembourg | Malaysia | Mexico | Netherlands | New Zealand | Norway | Pakistan | Peru | Philippines | Poland | Portugal | Romania | Russia | Saudi Arabia | Serbia | Singapore | Slovakia | Slovenia | South Africa | Spain | Sri Lanka | Sweden | Switzerland | Taiwan | Thailand | Tunisia | Turkey | Ukraine | United Arab Emirates | United Kingdom | United States | Uruguay | Venezuela | Vietnam
Approved Indications: None
Known Adverse Events: None
Company: Novartis
Company Location: BASEL V8 CH 4056
Company CEO: Vasant Narasimhan
Additional Commercial Interests: None
Clinical Description
Countries in Clinic: Bulgaria, Canada, China, Denmark, Hungary, India, Iran, Jordan, Latvia, Lithuania, Poland, Russia, Slovakia, United States
Active Clinical Trial Count: 25
Highest Development Phases
Phase 3: Asthma, Allergic|Chronic Spontaneous Urticaria|Environmental Hypersensitivity|Food Hypersensitivity|Peanut Hypersensitivity|Urticaria
Phase 2: Asthma|Infertility, Female|Infertility, Male
Phase 1: Healthy Volunteers|Nasal Polyposis|Sinusitis
Trial |
Phase |
Trial Status |
Disease |
Primary Completion Date |
Probability of Success |
|---|---|---|---|---|---|
| IRB00467873 | P2 |
Not yet recruiting |
Food Hypersensitivity |
2027-04-15 |
|
| CMAB007-003 | P3 |
Recruiting |
Chronic Spontaneous Urticaria |
2025-11-01 |
|
| BP11-301 | P3 |
Unknown Status |
Urticaria |
2025-09-04 |
|
| ADL-018 Autoinjector | P1 |
Recruiting |
Urticaria |
2025-06-15 |