Overview
Zilucoplan is a 15 amino-acid, synthetic macrocyclic peptide. It is a complement inhibitor that works to prevent the activation of C5, which is a complement protein involved in the innate immune system to initiate inflammatory responses. In October 2023, zilucoplan gained its first FDA approval for the treatment of generalized myasthenia gravis.
Indication
Zilucoplan is indicated for the treatment of generalized myasthenia gravis (gMG) in adult patients who are anti-acetylcholine receptor (AChR) antibody-positive.
Associated Conditions
- Generalized Myasthenia Gravis
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2025/05/08 | Phase 1 | Recruiting | |||
2025/02/07 | N/A | Not yet recruiting | |||
2024/07/19 | Phase 1 | Completed | |||
2024/06/24 | Phase 3 | Completed | |||
2024/05/30 | Phase 3 | ENROLLING_BY_INVITATION | |||
2023/09/28 | Phase 2 | Recruiting | |||
2022/08/25 | Phase 3 | Completed | |||
2020/10/19 | Phase 3 | Completed | |||
2020/06/18 | Phase 2 | Completed | Merit E. Cudkowicz, MD | ||
2020/05/11 | Phase 2 | Completed |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
Authorised | 12/1/2023 |
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 |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| ZILBRYSQ zilucoplan (as tetrasodium) 32.4 mg/ 0.810 mL solution for injection pre-filled syringe | 414649 | Medicine | A | 8/20/2024 | |
| ZILBRYSQ zilucoplan (as tetrasodium) 23.0 mg/ 0.574 mL solution for injection pre-filled syringe | 414648 | Medicine | A | 8/20/2024 | |
| ZILBRYSQ zilucoplan (as tetrasodium) 16.6 mg/ 0.416 mL solution for injection pre-filled syringe | 410994 | Medicine | A | 8/20/2024 |
Health Canada Drug Approvals
Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
|---|---|---|---|---|---|
| No Health Canada approvals found for this drug. | |||||
CIMA AEMPS Drug Approvals
Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
|---|---|---|---|---|---|
| ZILBRYSQ 32,4 MG, SOLUCION INYECTABLE EN JERINGA PRECARGADA | 1231764005 | SOLUCIÓN INYECTABLE EN JERINGA PRECARGADA | Diagnóstico Hospitalario | Commercialized | |
| ZILBRYSQ 23 MG, SOLUCION INYECTABLE EN JERINGA PRECARGADA | 1231764003 | SOLUCIÓN INYECTABLE EN JERINGA PRECARGADA | Diagnóstico Hospitalario | Commercialized | |
| ZILBRYSQ 16,6 MG, SOLUCION INYECTABLE EN JERINGA PRECARGADA | 1231764001 | 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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