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 |
|---|---|---|---|---|---|
2025/07/18 | N/A | Not yet recruiting | Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud | ||
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 | ||
2024/05/31 | Phase 4 | Active, not recruiting | AAADRS Clinical Research Center |
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 | ||
Authorised | 5/16/2024 | ||
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 |
|---|---|---|---|---|---|
| No NMPA approvals found for this drug. | |||||
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
Health Canada Drug Approvals
Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
|---|---|---|---|---|---|
| XOLAIR | novartis pharmaceuticals canada inc | 02545144 | Solution - Subcutaneous | 150 MG / 1 ML | 9/25/2024 |
| XOLAIR | novartis pharmaceuticals canada inc | 02545136 | Solution - Subcutaneous | 75 MG / 0.5 ML | 9/25/2024 |
| OMLYCLO | 02553813 | Solution - Subcutaneous | 150 MG / 1 ML | 3/4/2025 | |
| XOLAIR | novartis pharmaceuticals canada inc | 02545160 | Solution - Subcutaneous | 300 MG / 2 ML | N/A |
| XOLAIR | novartis pharmaceuticals canada inc | 02459787 | Solution - Subcutaneous | 75 MG / 0.5 ML | 6/28/2017 |
| XOLAIR | novartis pharmaceuticals canada inc | 02459795 | Solution - Subcutaneous | 150 MG / 1 ML | 7/6/2017 |
| XOLAIR | novartis pharmaceuticals canada inc | 02545152 | Solution - Subcutaneous | 300 MG / 2 ML | N/A |
| XOLAIR | novartis pharmaceuticals canada inc | 02260565 | Powder For Solution - Subcutaneous | 150 MG / VIAL | 2/3/2005 |
| OMLYCLO | 02553805 | Solution - Subcutaneous | 75 MG / 0.5 ML | 3/4/2025 |
CIMA AEMPS Drug Approvals
Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
|---|---|---|---|---|---|
| OMLYCLO 75 MG SOLUCION INYECTABLE EN PLUMA PRECARGADA | 1241817005 | SOLUCIÓN INYECTABLE EN PLUMA PRECARGADA | Diagnóstico Hospitalario | Not Commercialized | |
| XOLAIR 75 MG SOLUCION INYECTABLE | 05319005 | SOLUCIÓN INYECTABLE EN JERINGA PRECARGADA | Diagnóstico Hospitalario | Commercialized | |
| XOLAIR 150 mg POLVO Y DISOLVENTE PARA SOLUCION INYECTABLE | 05319002 | POLVO Y DISOLVENTE PARA SOLUCIÓN INYECTABLE | Diagnóstico Hospitalario | Not Commercialized | |
| OMLYCLO 75 MG SOLUCION INYECTABLE EN JERINGA PRECARGADA | 1241817001 | SOLUCIÓN INYECTABLE EN JERINGA PRECARGADA | Diagnóstico Hospitalario | Not Commercialized | |
| XOLAIR 150 MG SOLUCION INYECTABLE | 05319008 | SOLUCIÓN INYECTABLE EN JERINGA PRECARGADA | Diagnóstico Hospitalario | Commercialized | |
| OMLYCLO 150 MG SOLUCION INYECTABLE EN PLUMA PRECARGADA | 1241817006 | SOLUCIÓN INYECTABLE EN PLUMA PRECARGADA | Diagnóstico Hospitalario | Not Commercialized | |
| OMLYCLO 150 MG SOLUCION INYECTABLE EN JERINGA PRECARGADA | 1241817002 | SOLUCIÓN INYECTABLE EN JERINGA PRECARGADA | Diagnóstico Hospitalario | Not Commercialized |
Philippines FDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Philippines FDA approvals found for this drug. | |||||
Saudi SFDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Saudi SFDA approvals found for this drug. | |||||
Malaysia NPRA Drug Approvals
Approved Product | Company | Registration Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Malaysia NPRA approvals found for this drug. | |||||
UK EMC Drug Information
Medicine Name | MA Holder | MA Number | Pharmaceutical Form | Active Ingredient | Authorization Date |
|---|---|---|---|---|---|
| No UK EMC drug information found for this drug. | |||||
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