Overview
Omalizumab, manufactured by Genentech, was first FDA approved in 2003 to treat adults and children 12 years of age and older with moderate to severe persistent allergic asthma which is not controlled by inhaled steroids . Since its U.S. approval, more than 200,000 patients older than 12 with allergic asthma have been treated . In September 2018, a new prefilled syringe formulation of this drug was approved by the FDA .
Indication
This drug is an anti-IgE antibody indicated for:
Associated Conditions
- Chronic Idiopathic Urticaria
- Moderate Asthma
- Severe Asthma
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
---|---|---|---|---|---|
2025/07/10 | Not Applicable | Not yet recruiting | |||
2025/04/18 | Phase 2 | Recruiting | |||
2025/02/04 | Phase 4 | Completed | Yuzuncu Yıl University | ||
2025/01/13 | N/A | Active, not recruiting | Qianfoshan Hospital | ||
2024/11/11 | N/A | Recruiting | |||
2024/10/01 | Phase 4 | Recruiting | |||
2024/07/19 | Phase 2 | Recruiting | Jemincare | ||
2024/06/03 | Phase 2 | Active, not recruiting | Jemincare | ||
2024/04/15 | Phase 3 | Recruiting | |||
2023/10/27 | Phase 2 | Completed |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
---|---|---|---|---|---|
Genentech, Inc. | 50242-215 | SUBCUTANEOUS | 150 mg in 1 mL | 2/22/2024 | |
Genentech, Inc. | 50242-227 | SUBCUTANEOUS | 300 mg in 2 mL | 2/22/2024 | |
Genentech, Inc. | 50242-214 | SUBCUTANEOUS | 75 mg in 0.5 mL | 2/22/2024 | |
Genentech, Inc. | 50242-040 | SUBCUTANEOUS | 150 mg in 1.2 mL | 2/22/2024 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
---|---|---|---|
Authorised | 10/25/2005 | ||
Authorised | 5/16/2024 |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
---|---|---|---|---|---|
XOLAIR SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE 150MG/1.0ML | SIN16116P | INJECTION, SOLUTION | 150 mg/1.0 mL | 3/4/2021 | |
Xolair 150mg Powder and Solvent for Solution for Injection | SIN13212P | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION | 150mg | 7/7/2006 | |
XOLAIR SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE 75MG/0.5ML | SIN16115P | INJECTION, SOLUTION | 75mg/0.5ml | 3/4/2021 | |
Xolair 75mg Powder and Solvent for Solution for Injection | SIN13213P | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION | 75mg | 7/7/2006 | |
XOLAIR SOLUTION FOR INJECTION IN PRE-FILLED PEN 75MG/0.5ML | SIN17030P | INJECTION, SOLUTION | 75.00 mg/0.5 mL | 6/21/2024 | |
XOLAIR SOLUTION FOR INJECTION IN PRE-FILLED PEN 300MG/2.0ML | SIN17032P | INJECTION, SOLUTION | 300.00 mg / 2.0 mL | 6/21/2024 | |
XOLAIR SOLUTION FOR INJECTION IN PRE-FILLED PEN 150MG/1.0ML | SIN17031P | INJECTION, SOLUTION | 150.00 mg/1.0 mL | 6/21/2024 | |
XOLAIR SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE 300MG/2.0ML | SIN17029P | INJECTION, SOLUTION | 300.00 mg/2.0 mL | 6/21/2024 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
---|---|---|---|---|---|
Omalizumab Injection | 国药准字SJ20220016 | 生物制品 | 注射剂 | 8/30/2022 | |
Omalizumab alfa for Injection | 国药准字S20230030 | 生物制品 | 注射剂 | 5/19/2023 | |
Omalizumab alfa for Injection | 国药准字S20230031 | 生物制品 | 注射剂 | 5/19/2023 | |
Omalizumab for Injection | 国药准字SJ20170042 | 生物制品 | 注射剂 | 1/27/2022 | |
Omalizumab for Injection | 国药准字S20240043 | 生物制品 | 注射剂 | 9/26/2024 |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
---|---|---|---|---|---|
XOLAIR SOLUTION FOR INJECTION IN PRE-FILLED PEN 150MG/ML | N/A | N/A | N/A | 5/9/2025 | |
XOLAIR SOLUTION FOR INJECTION IN PRE-FILLED PEN 300MG/2ML | N/A | N/A | N/A | 5/9/2025 | |
XOLAIR SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE 75MG/0.5ML | N/A | N/A | N/A | 5/9/2025 | |
XOLAIR SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE 300MG/2ML | N/A | N/A | N/A | 5/9/2025 | |
XOLAIR SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE 150MG/ML | N/A | N/A | N/A | 5/9/2025 | |
XOLAIR SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE 150MG/ML | N/A | N/A | N/A | 8/31/2017 |
TGA Drug Approvals
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