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danicopan 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | PK/Tox | Related Drugs | BioActivity |
| Stem definition | Drug id | CAS RN |
|---|---|---|
| complement receptor antagonists or complement inhibitors | 5816 | 1903768-17-1 |
Description:
| Molecule | Description |
|---|---|
|
Synonyms:
|
Danicopan binds reversibly to complement factor D (FD) and acts as a selective inhibitor of FD function. By inhibiting FD, danicopan selectively blocks the activation of complement alternative pathway (AP), leading to prevention of the production of multiple effectors, that include C3 fragments, after AP activation. The 2 other complement pathways (classical and lectin) remain active. It is used for the treatment of paroxysmal nocturnal hemoglobinuria.
Legend: OFP - off patent OFM - off market ONP - on patent |
Drug dosage:
None
ADMET properties:
None
Predicted pharmacokinetic/toxicological properties (PK-AZ):
None
Approvals:
| Date | Agency | Company | Orphan |
|---|---|---|---|
| March 30, 2024 | FDA | Alexion Pharmaceuticals Inc. | |
| April 19, 2024 | EMA | Alexion Europe SAS | |
| Jan. 8, 2024 | PMDA | Alexion Pharma GK |
FDA Adverse Event Reporting System (Female)
None
FDA Adverse Event Reporting System (Male)
None
FDA Adverse Event Reporting System (Geriatric)
None
FDA Adverse Event Reporting System (Pediatric)
None
Pharmacologic Action:
| Source | Code | Description |
|---|---|---|
| ATC | L04AJ09 | ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS IMMUNOSUPPRESSANTS IMMUNOSUPPRESSANTS Complement inhibitors |
| FDA MoA | N0000185503 | P-Glycoprotein Inhibitors |
| FDA MoA | N0000190113 | Breast Cancer Resistance Protein Inhibitors |
| FDA EPC | N0000194113 | Complement Factor D Inhibitor |
| FDA MoA | N0000194114 | Complement Factor D Inhibitors |
| CHEBI has role | CHEBI:22587 | antiviral agent |
| CHEBI has role | CHEBI:231911 | renoprotective agent |
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 |
|---|---|---|---|
| Paroxysmal nocturnal hemoglobinuria | indication | 1963002 | DOID:0060284 |
🐶 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 |
|---|---|---|---|---|---|---|---|---|---|---|
| 100MG | VOYDEYA | ALEXION PHARMS INC | N218037 | March 29, 2024 | RX | TABLET | ORAL | 9796741 | Feb. 25, 2035 | TREATMENT OF EXTRAVASCULAR HEMOLYSIS (EVH) IN ADULTS WITH PAROXYSMAL NOCTURNAL HEMOGLOBINURIA (PNH) AS ADD-ON THERAPY TO RAVULIZUMAB OR ECULIZUMAB |
| 50MG | VOYDEYA | ALEXION PHARMS INC | N218037 | March 29, 2024 | RX | TABLET | ORAL | 9796741 | Feb. 25, 2035 | TREATMENT OF EXTRAVASCULAR HEMOLYSIS (EVH) IN ADULTS WITH PAROXYSMAL NOCTURNAL HEMOGLOBINURIA (PNH) AS ADD-ON THERAPY TO RAVULIZUMAB OR ECULIZUMAB |
| 100MG | VOYDEYA | ALEXION PHARMS INC | N218037 | March 29, 2024 | RX | TABLET | ORAL | 12076319 | Aug. 2, 2038 | TREATMENT OF EXTRAVASCULAR HEMOLYSIS (EVH) IN ADULTS WITH PAROXYSMAL NOCTURNAL HEMOGLOBINURIA (PNH) AS ADD-ON THERAPY TO RAVULIZUMAB OR ECULIZUMAB |
| 50MG | VOYDEYA | ALEXION PHARMS INC | N218037 | March 29, 2024 | RX | TABLET | ORAL | 12076319 | Aug. 2, 2038 | TREATMENT OF EXTRAVASCULAR HEMOLYSIS (EVH) IN ADULTS WITH PAROXYSMAL NOCTURNAL HEMOGLOBINURIA (PNH) AS ADD-ON THERAPY TO RAVULIZUMAB OR ECULIZUMAB |
Orange Book exclusivity data (new drug applications)
| Formulation strength | Trade name | Applicant | Application number | Approval date | Type | Dose form | Route | Exclusivity date | Description |
|---|---|---|---|---|---|---|---|---|---|
| 100MG | VOYDEYA | ALEXION PHARMS INC | N218037 | March 29, 2024 | RX | TABLET | ORAL | March 29, 2029 | NEW CHEMICAL ENTITY |
| 50MG | VOYDEYA | ALEXION PHARMS INC | N218037 | March 29, 2024 | RX | TABLET | ORAL | March 29, 2029 | NEW CHEMICAL ENTITY |
| 100MG | VOYDEYA | ALEXION PHARMS INC | N218037 | March 29, 2024 | RX | TABLET | ORAL | March 29, 2031 | TREATMENT OF EXTRAVASCULAR HEMOLYSIS (EVH) IN ADULTS WITH PAROXYSMAL NOCTURNAL HEMOGLOBINURIA (PNH) |
| 50MG | VOYDEYA | ALEXION PHARMS INC | N218037 | March 29, 2024 | RX | TABLET | ORAL | March 29, 2031 | TREATMENT OF EXTRAVASCULAR HEMOLYSIS (EVH) IN ADULTS WITH PAROXYSMAL NOCTURNAL HEMOGLOBINURIA (PNH) |
Bioactivity Summary:
| Target | Class | Pharos | UniProt | Action | Type | Activity value (-log[M]) | Mechanism action | Bioact source | MoA source |
|---|---|---|---|---|---|---|---|---|---|
| Complement factor D | Secreted | COMPLEMENT INHIBITOR | Kd | 9.30 | DRUG LABEL | DRUG LABEL |
External reference:
| ID | Source |
|---|---|
| CHEMBL4250860 | ChEMBL_ID |
| C000718467 | MESH_SUPPLEMENTAL_RECORD_UI |
| DB15401 | DRUGBANK_ID |
| 4043055 | VANDF |
| C5139702 | UMLSCUI |
| CHEBI:231416 | CHEBI |
| 10610 | INN_ID |
| 118323590 | PUBCHEM_CID |
| 384305 | MMSL |
| 42756 | MMSL |
| d10181 | MMSL |
| 019716 | NDDF |
| 11988 | IUPHAR_LIGAND_ID |
| JM8C1SFX0U | UNII |
| 2678952 | RXNORM |
| 43726711000001101 | SNOMEDCT_US |
| D11641 | KEGG_DRUG |
Pharmaceutical products:
| Product | Category | Ingredients | NDC | Form | Quantity | Route | Marketing | Label |
|---|---|---|---|---|---|---|---|---|
| Voydeya | HUMAN PRESCRIPTION DRUG LABEL | 1 | 11014-0739 | TABLET, FILM COATED | 50 mg | ORAL | Export only | 1 sections |
| Voydeya | HUMAN PRESCRIPTION DRUG LABEL | 1 | 25682-043 | TABLET, FILM COATED | 100 mg | ORAL | NDA | 31 sections |