Overview
Danicopan is under investigation in clinical trial NCT03459443 (A Proof of Concept Study for a 12 Month Treatment in Patients With C3 Glomerulopathy (C3G) or Immune-Complex Membranoproliferative Glomerulonephritis (IC-MPGN)).
Indication
No indication information available.
Associated Conditions
No associated conditions information available.
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2024/06/07 | Phase 3 | Recruiting | |||
2023/08/09 | N/A | AVAILABLE | |||
2023/02/01 | Phase 1 | Completed | |||
2022/05/25 | Phase 3 | Active, not recruiting | |||
2021/11/05 | Phase 1 | Completed | |||
2021/08/25 | Phase 2 | Completed | |||
2021/08/23 | Phase 1 | Completed | |||
2021/08/03 | Phase 2 | Completed | |||
2021/06/25 | Phase 1 | Completed | |||
2021/06/23 | Phase 1 | Completed |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Alexion Pharmaceuticals Inc. | 25682-043 | ORAL | 100 mg in 1 1 | 3/1/2024 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
Authorised | 4/19/2024 | ||
Authorised | 4/19/2024 |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| VOYDEYA FILM-COATED TABLET 100 MG + 50 MG | SIN17152P | TABLET, FILM COATED | 100mg | 12/26/2024 | |
| VOYDEYA FILM-COATED TABLET 100 MG + 100 MG | SIN17151P | TABLET, FILM COATED | 100mg | 12/26/2024 | |
| VOYDEYA FILM-COATED TABLET 100 MG + 50 MG | SIN17152P | TABLET, FILM COATED | 50mg | 12/26/2024 |
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 |
|---|---|---|---|---|---|
| VOYDEYA TABLETS 100MG + 100MG | N/A | N/A | N/A | 12/16/2024 | |
| VOYDEYA TABLETS 50MG + 100MG | N/A | N/A | N/A | 12/16/2024 |
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| VOYDEYA 50 + 100 mg film-coated tablets, composite blister pack | 416092 | Medicine | A | 11/25/2024 | |
| VOYDEYA danicopan 100 mg film-coated tablets, blister pack | 416093 | Medicine | A | 11/25/2024 | |
| VOYDEYA danicopan 100 mg film-coated tablets, bottle | 416090 | Medicine | A | 11/25/2024 | |
| VOYDEYA 50 + 100 mg film-coated tablets, composite bottle pack | 416091 | Medicine | A | 11/25/2024 |
CIMA AEMPS Drug Approvals
Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
|---|---|---|---|---|---|
| VOYDEYA 50 MG + 100 MG COMPRIMIDOS RECUBIERTOS CON PELICULA | 1241792001 | COMPRIMIDO RECUBIERTO CON PELÍCULA | Diagnóstico Hospitalario | Commercialized | |
| VOYDEYA 100 MG COMPRIMIDOS RECUBIERTOS CON PELICULA | 1241792003 | COMPRIMIDO RECUBIERTO CON PELÍCULA | 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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