Overview
Bimekizumab is a humanized monoclonal antibody directed towards IL-17, which was approved for use in the EU on August 20, 2021, for the treatment of plaque psoriasis. It is the first IL-17 inhibitor to target both IL-17A and IL-17F. It has demonstrated superior efficacy as compared to another IL-17 inhibitor, secukinumab, as well as ustekinumab (an IL-12/23 inhibitor) and adalimumab (a TNF inhibitor) in the treatment of moderate-to-severe psoriasis, likely owing to its dual inhibition of both IL-17A and IL-17F. Bimekizumab was also granted FDA approval on October 18, 2023.
Indication
Bimekizumab is indicated for the treatment of moderate-to-severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy.
Associated Conditions
- Severe Plaque psoriasis
- Moderate Plaque psoriasis
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2025/08/24 | Not Applicable | Not yet recruiting | |||
2025/04/10 | Phase 3 | Recruiting | |||
2025/03/21 | Phase 1 | Recruiting | |||
2025/01/22 | N/A | Recruiting | |||
2024/12/19 | Phase 2 | Recruiting | |||
2024/10/31 | Phase 3 | Recruiting | |||
2024/10/02 | Phase 3 | Recruiting | |||
2024/07/18 | Phase III and phase IV (Integrated) | Recruiting | |||
2024/05/22 | Phase 3 | Recruiting | |||
2024/03/28 | Phase 4 | Recruiting |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
Authorised | 8/20/2021 |
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 |
|---|---|---|---|---|---|
| BIMZELX SOLUTION FOR INJECTION IN PRE-FILLED PEN 160MG/ML | N/A | N/A | N/A | 2/19/2025 | |
| BIMZELX SOLUTION FOR INJECTION IN PRE-FILLED PEN 160MG/ML | N/A | N/A | N/A | 2/19/2025 |
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| BIMZELX bimekizumab 160 mg/1 mL solution for injection auto-injector | 353268 | Medicine | A | 3/24/2022 | |
| BIMZELX bimekizumab 320 mg/2 mL solution for injection auto-injector | 443490 | Medicine | A | 4/8/2025 | |
| BIMZELX bimekizumab 160 mg/1 mL solution for injection safety syringe | 353269 | Medicine | A | 3/24/2022 | |
| BIMZELX bimekizumab 320 mg/2 mL solution for injection safety syringe | 443491 | Medicine | A | 4/8/2025 |
Health Canada Drug Approvals
Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
|---|---|---|---|---|---|
| BIMZELX | UCB Canada Inc | 02553619 | Solution - Subcutaneous | 320 MG / 2 ML | 4/7/2025 |
| BIMZELX | UCB Canada Inc | 02553627 | Solution - Subcutaneous | 320 MG / 2 ML | 4/7/2025 |
| BIMZELX | UCB Canada Inc | 02525267 | Solution - Subcutaneous | 160 MG / ML | 3/30/2022 |
| BIMZELX | UCB Canada Inc | 02525275 | Solution - Subcutaneous | 160 MG / ML | 3/30/2022 |
CIMA AEMPS Drug Approvals
Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
|---|---|---|---|---|---|
| BIMZELX 320 MG SOLUCION INYECTABLE EN PLUMA PRECARGADA | 1211575011 | SOLUCIÓN INYECTABLE EN PLUMA PRECARGADA | Diagnóstico Hospitalario | Commercialized | |
| BIMZELX 160 MG SOLUCION INYECTABLE EN PLUMA PRECARGADA | 1211575006 | SOLUCIÓN INYECTABLE EN PLUMA PRECARGADA | Diagnóstico Hospitalario | Commercialized | |
| BIMZELX 160 MG SOLUCION INYECTABLE EN JERINGA PRECARGADA | 1211575002 | SOLUCIÓN INYECTABLE EN JERINGA PRECARGADA | Diagnóstico 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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