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zilucoplan 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | PK/Tox | Related Drugs | BioActivity |
| Stem definition | Drug id | CAS RN |
|---|---|---|
| 5748 | 1841136-73-9 |
Description:
| Molecule | Description |
|---|---|
|
Synonyms:
|
Zilucoplan binds to the complement protein C5 and inhibits its cleavage to C5a and C5b, preventing the generation of the terminal complement complex, C5b-9. The precise mechanism by which zilucoplan exerts its therapeutic effect in generalized myasthenic gravis is unknown but is presumed to involve reduction of C5b-9 deposition at the neuromuscular junction.
|
Drug dosage:
None
ADMET properties:
None
Predicted pharmacokinetic/toxicological properties (PK-AZ):
None
Approvals:
| Date | Agency | Company | Orphan |
|---|---|---|---|
| Oct. 17, 2023 | FDA | UCB INC |
FDA Adverse Event Reporting System (Female)
| MedDRA adverse event term | Likelihood ratio | Likelihood ratio threshold | Patients taking drug having adverse event | Patients taking drug not having adverse event | Patients not taking drug having adverse event | Patients not taking drug not having adverse event |
|---|---|---|---|---|---|---|
| Myasthenia gravis crisis | 77.50 | 57.18 | 10 | 130 | 1054 | 90627253 |
FDA Adverse Event Reporting System (Male)
None
FDA Adverse Event Reporting System (Geriatric)
| MedDRA adverse event term | Likelihood ratio | Likelihood ratio threshold | Patients taking drug having adverse event | Patients taking drug not having adverse event | Patients not taking drug having adverse event | Patients not taking drug not having adverse event |
|---|---|---|---|---|---|---|
| Myasthenia gravis crisis | 71.85 | 47.84 | 10 | 165 | 1804 | 110587320 |
FDA Adverse Event Reporting System (Pediatric)
None
Pharmacologic Action:
| Source | Code | Description |
|---|---|---|
| ATC | L04AJ06 | ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS IMMUNOSUPPRESSANTS IMMUNOSUPPRESSANTS Complement inhibitors |
| FDA EPC | N0000175575 | Complement Inhibitor |
| FDA MoA | N0000175974 | Complement Inhibitors |
| CHEBI has role | CHEBI:22587 | antiviral agent |
| CHEBI has role | CHEBI:35705 | immunosuppressive agent |
| CHEBI has role | CHEBI:229668 | complement component 5 inhibitor |
Related Drugs by ATC class:
L04AJ Complement inhibitors 10 drugs
Drug Use | Suggest Off label Use Form| |View source of the data|
| Disease | Relation | SNOMED_ID | DOID |
|---|---|---|---|
| Generalized myasthenia gravis | indication | 91637004 | DOID:437 |
| Neisseria meningitidis infection | contraindication | 23511006 |
🐶 Veterinary Drug Use
None
🐶 Veterinary products
None
Acid dissociation constants calculated using MoKa v3.0.0
None
Orange Book patent data (new drug applications)
| Formulation strength | Trade name | Applicant | Application number | Approval date | Type | Dose form | Route | Patent number | Patent expiration date | Patent use |
|---|---|---|---|---|---|---|---|---|---|---|
| EQ 16.6MG BASE/0.416ML (EQ 16.6MG BASE/0.416ML) | ZILBRYSQ | UCB INC | N216834 | Oct. 17, 2023 | RX | SOLUTION | SUBCUTANEOUS | 10106579 | June 12, 2035 | TREATMENT OF GENERALIZED MYASTHENIA GRAVIS (GMG) IN AN ADULT PATIENT WHO IS ANTI-ACETYLCHOLINE RECEPTOR (ACHR) ANTIBODY POSITIVE BY SUBCUTANEOUS ADMINISTRATION OF C5 COMPLEMENT INHIBITOR ZILUCOPLAN |
| EQ 16.6MG BASE/0.416ML (EQ 16.6MG BASE/0.416ML) | ZILBRYSQ | UCB INC | N216834 | Oct. 17, 2023 | RX | SOLUTION | SUBCUTANEOUS | 10208089 | June 12, 2035 | TREATMENT OF GENERALIZED MYASTHENIA GRAVIS (GMG) IN AN ADULT PATIENT WHO IS ANTI-ACETYLCHOLINE RECEPTOR (ACHR) ANTIBODY POSITIVE BY SUBCUTANEOUS ADMINISTRATION OF C5 COMPLEMENT INHIBITOR ZILUCOPLAN |
| EQ 16.6MG BASE/0.416ML (EQ 16.6MG BASE/0.416ML) | ZILBRYSQ | UCB INC | N216834 | Oct. 17, 2023 | RX | SOLUTION | SUBCUTANEOUS | 10435438 | June 12, 2035 | TREATMENT OF GENERALIZED MYASTHENIA GRAVIS (GMG) IN AN ADULT PATIENT WHO IS ANTI-ACETYLCHOLINE RECEPTOR (ACHR) ANTIBODY POSITIVE BY SUBCUTANEOUS ADMINISTRATION OF C5 COMPLEMENT INHIBITOR ZILUCOPLAN |
| EQ 16.6MG BASE/0.416ML (EQ 16.6MG BASE/0.416ML) | ZILBRYSQ | UCB INC | N216834 | Oct. 17, 2023 | RX | SOLUTION | SUBCUTANEOUS | 11014965 | June 12, 2035 | TREATMENT OF GENERALIZED MYASTHENIA GRAVIS (GMG) IN AN ADULT PATIENT WHO IS ANTI-ACETYLCHOLINE RECEPTOR (ACHR) ANTIBODY POSITIVE BY SUBCUTANEOUS ADMINISTRATION OF C5 COMPLEMENT INHIBITOR ZILUCOPLAN |
| EQ 16.6MG BASE/0.416ML (EQ 16.6MG BASE/0.416ML) | ZILBRYSQ | UCB INC | N216834 | Oct. 17, 2023 | RX | SOLUTION | SUBCUTANEOUS | 11752190 | June 12, 2035 | TREATMENT OF GENERALIZED MYASTHENIA GRAVIS (GMG) IN AN ADULT PATIENT WHO IS ANTI-ACETYLCHOLINE RECEPTOR (ACHR) ANTIBODY POSITIVE BY SUBCUTANEOUS ADMINISTRATION OF C5 COMPLEMENT INHIBITOR ZILUCOPLAN |
| EQ 23MG BASE/0.574ML (EQ 23MG BASE/0.574ML) | ZILBRYSQ | UCB INC | N216834 | Oct. 17, 2023 | RX | SOLUTION | SUBCUTANEOUS | 10106579 | June 12, 2035 | TREATMENT OF GENERALIZED MYASTHENIA GRAVIS (GMG) IN AN ADULT PATIENT WHO IS ANTI-ACETYLCHOLINE RECEPTOR (ACHR) ANTIBODY POSITIVE BY SUBCUTANEOUS ADMINISTRATION OF C5 COMPLEMENT INHIBITOR ZILUCOPLAN |
| EQ 23MG BASE/0.574ML (EQ 23MG BASE/0.574ML) | ZILBRYSQ | UCB INC | N216834 | Oct. 17, 2023 | RX | SOLUTION | SUBCUTANEOUS | 10208089 | June 12, 2035 | TREATMENT OF GENERALIZED MYASTHENIA GRAVIS (GMG) IN AN ADULT PATIENT WHO IS ANTI-ACETYLCHOLINE RECEPTOR (ACHR) ANTIBODY POSITIVE BY SUBCUTANEOUS ADMINISTRATION OF C5 COMPLEMENT INHIBITOR ZILUCOPLAN |
| EQ 23MG BASE/0.574ML (EQ 23MG BASE/0.574ML) | ZILBRYSQ | UCB INC | N216834 | Oct. 17, 2023 | RX | SOLUTION | SUBCUTANEOUS | 10435438 | June 12, 2035 | TREATMENT OF GENERALIZED MYASTHENIA GRAVIS (GMG) IN AN ADULT PATIENT WHO IS ANTI-ACETYLCHOLINE RECEPTOR (ACHR) ANTIBODY POSITIVE BY SUBCUTANEOUS ADMINISTRATION OF C5 COMPLEMENT INHIBITOR ZILUCOPLAN |
| EQ 23MG BASE/0.574ML (EQ 23MG BASE/0.574ML) | ZILBRYSQ | UCB INC | N216834 | Oct. 17, 2023 | RX | SOLUTION | SUBCUTANEOUS | 11014965 | June 12, 2035 | TREATMENT OF GENERALIZED MYASTHENIA GRAVIS (GMG) IN AN ADULT PATIENT WHO IS ANTI-ACETYLCHOLINE RECEPTOR (ACHR) ANTIBODY POSITIVE BY SUBCUTANEOUS ADMINISTRATION OF C5 COMPLEMENT INHIBITOR ZILUCOPLAN |
| EQ 23MG BASE/0.574ML (EQ 23MG BASE/0.574ML) | ZILBRYSQ | UCB INC | N216834 | Oct. 17, 2023 | RX | SOLUTION | SUBCUTANEOUS | 11752190 | June 12, 2035 | TREATMENT OF GENERALIZED MYASTHENIA GRAVIS (GMG) IN AN ADULT PATIENT WHO IS ANTI-ACETYLCHOLINE RECEPTOR (ACHR) ANTIBODY POSITIVE BY SUBCUTANEOUS ADMINISTRATION OF C5 COMPLEMENT INHIBITOR ZILUCOPLAN |
| EQ 32.4MG BASE/0.81ML (EQ 32.4 BASE/0.81ML) | ZILBRYSQ | UCB INC | N216834 | Oct. 17, 2023 | RX | SOLUTION | SUBCUTANEOUS | 10106579 | June 12, 2035 | TREATMENT OF GENERALIZED MYASTHENIA GRAVIS (GMG) IN AN ADULT PATIENT WHO IS ANTI-ACETYLCHOLINE RECEPTOR (ACHR) ANTIBODY POSITIVE BY SUBCUTANEOUS ADMINISTRATION OF C5 COMPLEMENT INHIBITOR ZILUCOPLAN |
| EQ 32.4MG BASE/0.81ML (EQ 32.4 BASE/0.81ML) | ZILBRYSQ | UCB INC | N216834 | Oct. 17, 2023 | RX | SOLUTION | SUBCUTANEOUS | 10208089 | June 12, 2035 | TREATMENT OF GENERALIZED MYASTHENIA GRAVIS (GMG) IN AN ADULT PATIENT WHO IS ANTI-ACETYLCHOLINE RECEPTOR (ACHR) ANTIBODY POSITIVE BY SUBCUTANEOUS ADMINISTRATION OF C5 COMPLEMENT INHIBITOR ZILUCOPLAN |
| EQ 32.4MG BASE/0.81ML (EQ 32.4 BASE/0.81ML) | ZILBRYSQ | UCB INC | N216834 | Oct. 17, 2023 | RX | SOLUTION | SUBCUTANEOUS | 10435438 | June 12, 2035 | TREATMENT OF GENERALIZED MYASTHENIA GRAVIS (GMG) IN AN ADULT PATIENT WHO IS ANTI-ACETYLCHOLINE RECEPTOR (ACHR) ANTIBODY POSITIVE BY SUBCUTANEOUS ADMINISTRATION OF C5 COMPLEMENT INHIBITOR ZILUCOPLAN |
| EQ 32.4MG BASE/0.81ML (EQ 32.4 BASE/0.81ML) | ZILBRYSQ | UCB INC | N216834 | Oct. 17, 2023 | RX | SOLUTION | SUBCUTANEOUS | 11014965 | June 12, 2035 | TREATMENT OF GENERALIZED MYASTHENIA GRAVIS (GMG) IN AN ADULT PATIENT WHO IS ANTI-ACETYLCHOLINE RECEPTOR (ACHR) ANTIBODY POSITIVE BY SUBCUTANEOUS ADMINISTRATION OF C5 COMPLEMENT INHIBITOR ZILUCOPLAN |
| EQ 32.4MG BASE/0.81ML (EQ 32.4 BASE/0.81ML) | ZILBRYSQ | UCB INC | N216834 | Oct. 17, 2023 | RX | SOLUTION | SUBCUTANEOUS | 11752190 | June 12, 2035 | TREATMENT OF GENERALIZED MYASTHENIA GRAVIS (GMG) IN AN ADULT PATIENT WHO IS ANTI-ACETYLCHOLINE RECEPTOR (ACHR) ANTIBODY POSITIVE BY SUBCUTANEOUS ADMINISTRATION OF C5 COMPLEMENT INHIBITOR ZILUCOPLAN |
Orange Book exclusivity data (new drug applications)
| Formulation strength | Trade name | Applicant | Application number | Approval date | Type | Dose form | Route | Exclusivity date | Description |
|---|---|---|---|---|---|---|---|---|---|
| EQ 16.6MG BASE/0.416ML (EQ 16.6MG BASE/0.416ML) | ZILBRYSQ | UCB INC | N216834 | Oct. 17, 2023 | RX | SOLUTION | SUBCUTANEOUS | Oct. 17, 2028 | NEW CHEMICAL ENTITY |
| EQ 23MG BASE/0.574ML (EQ 23MG BASE/0.574ML) | ZILBRYSQ | UCB INC | N216834 | Oct. 17, 2023 | RX | SOLUTION | SUBCUTANEOUS | Oct. 17, 2028 | NEW CHEMICAL ENTITY |
| EQ 32.4MG BASE/0.81ML (EQ 32.4 BASE/0.81ML) | ZILBRYSQ | UCB INC | N216834 | Oct. 17, 2023 | RX | SOLUTION | SUBCUTANEOUS | Oct. 17, 2028 | NEW CHEMICAL ENTITY |
| EQ 16.6MG BASE/0.416ML (EQ 16.6MG BASE/0.416ML) | ZILBRYSQ | UCB INC | N216834 | Oct. 17, 2023 | RX | SOLUTION | SUBCUTANEOUS | Oct. 17, 2030 | TREATMENT OF GENERALIZED MYASTHENIA GRAVIS (GMG) IN ADULT PATIENTS WHO ARE ANTI-ACETYLCHOLINE RECEPTOR (ACHR) ANTIBODY POSITIVE |
| EQ 23MG BASE/0.574ML (EQ 23MG BASE/0.574ML) | ZILBRYSQ | UCB INC | N216834 | Oct. 17, 2023 | RX | SOLUTION | SUBCUTANEOUS | Oct. 17, 2030 | TREATMENT OF GENERALIZED MYASTHENIA GRAVIS (GMG) IN ADULT PATIENTS WHO ARE ANTI-ACETYLCHOLINE RECEPTOR (ACHR) ANTIBODY POSITIVE |
| EQ 32.4MG BASE/0.81ML (EQ 32.4 BASE/0.81ML) | ZILBRYSQ | UCB INC | N216834 | Oct. 17, 2023 | RX | SOLUTION | SUBCUTANEOUS | Oct. 17, 2030 | TREATMENT OF GENERALIZED MYASTHENIA GRAVIS (GMG) IN ADULT PATIENTS WHO ARE ANTI-ACETYLCHOLINE RECEPTOR (ACHR) ANTIBODY POSITIVE |
Bioactivity Summary:
| Target | Class | Pharos | UniProt | Action | Type | Activity value (-log[M]) | Mechanism action | Bioact source | MoA source |
|---|---|---|---|---|---|---|---|---|---|
| Complement C5 | Secreted | INHIBITOR | Kd | 9.37 | SCIENTIFIC LITERATURE |
External reference:
| ID | Source |
|---|---|
| CHEBI:229659 | CHEBI |
| CHEMBL4298207 | ChEMBL_ID |
| C000719268 | MESH_SUPPLEMENTAL_RECORD_UI |
| 10404 | IUPHAR_LIGAND_ID |
| DB15636 | DRUGBANK_ID |
| 1351624003 | SNOMEDCT_US |
| 42627011000001102 | SNOMEDCT_US |
| 4042879 | VANDF |
| C5203810 | UMLSCUI |
| CHEMBL5315048 | ChEMBL_ID |
| 10602 | INN_ID |
| 133083018 | PUBCHEM_CID |
| 372272 | MMSL |
| 42076 | MMSL |
| d10120 | MMSL |
| 019584 | NDDF |
| 019585 | NDDF |
| YG391PK0CC | UNII |
| 2672489 | RXNORM |
| D12357 | KEGG_DRUG |
Pharmaceutical products:
| Product | Category | Ingredients | NDC | Form | Quantity | Route | Marketing | Label |
|---|---|---|---|---|---|---|---|---|
| ZILBRYSQ | HUMAN PRESCRIPTION DRUG LABEL | 1 | 50474-990 | INJECTION, SOLUTION | 40 mg | SUBCUTANEOUS | NDA | 31 sections |
| ZILBRYSQ | HUMAN PRESCRIPTION DRUG LABEL | 1 | 50474-991 | INJECTION, SOLUTION | 40 mg | SUBCUTANEOUS | NDA | 31 sections |
| ZILBRYSQ | HUMAN PRESCRIPTION DRUG LABEL | 1 | 50474-992 | INJECTION, SOLUTION | 40 mg | SUBCUTANEOUS | NDA | 31 sections |