Overview
Brolucizumab, also known as RTH258 or ESBA1008, is a monoclonal antibody indicated to treat neovascular age related macular degeneration. Brolucizumab was granted FDA approval in October 2019.
Indication
Brolucizumab is a monoclonal antibody indicated to treat neovascular age related macular degeneration.
Associated Conditions
- Neovascular Age-Related Macular Degeneration (nAMD)
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2024/07/12 | Phase 4 | Active, not recruiting | |||
2023/02/02 | Phase 4 | Completed | |||
2023/01/05 | Phase 3 | Not yet recruiting | |||
2022/12/28 | Phase 3 | Active, not recruiting | |||
2022/03/08 | Phase 4 | Completed | |||
2022/02/02 | N/A | UNKNOWN | |||
2021/11/08 | N/A | Completed | |||
2021/10/19 | N/A | Completed | |||
2021/09/08 | N/A | Completed | |||
2021/07/08 | Phase 3 | UNKNOWN |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| No FDA approvals found for this drug. | |||||
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
Authorised | 2/13/2020 |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No HSA approvals found for this drug. | |||||
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 |
|---|---|---|---|---|---|
| BEOVU SOLUTION FOR INJECTION 6MG/0.05ML | N/A | N/A | N/A | 3/1/2021 |
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| BEOVU brolucizumab (rbe) 120 mg/mL solution for injection in vial | 313680 | Medicine | A | 1/16/2020 | |
| BEOVU brolucizumab (rbe) 120 mg/mL solution for injection in pre-filled syringe | 313681 | Medicine | A | 1/16/2020 | |
| VSIQQ brolucizumab (rbe) 120 mg/mL solution for injection in vial | 349910 | Medicine | A | 1/28/2021 |
CIMA AEMPS Drug Approvals
Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
|---|---|---|---|---|---|
| BEOVU 120 MG/ML SOLUCION INYECTABLE EN JERINGA PRECARGADA | 1191417 | SOLUCIÓN INYECTABLE EN JERINGA PRECARGADA | Uso Hospitalario | 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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