Kcluximab (Ocluvance)
Product detail for Kcluximab, INN: kcluximab. Therapeutic area: Oncology. This record shows all linked substances, markets, applications, presentations, and labeling artefacts.
Product ID
PROD-001
INN
kcluximab
Therapeutic Area
Oncology
Status
Active
Owner
Tomoko Ikeda
Created
2022-10-03
Last Updated
2023-12-07
Markets
9
Presentations
| Form | Strength | Route |
|---|---|---|
| Film-coated tablet | 400 mg | Intravitreal |
| Film-coated tablet | 5 mg/mL | Oral |
| Concentrate for solution for infusion | 5 mg | Intravenous |
Active Substances
| ID | Name | INN | CAS | Type | Status |
|---|---|---|---|---|---|
| SUB-023 | Upadacitimab | upadacitimab | 75138-41-9 | small-molecule | Active |
| SUB-043 | Benzyl alcohol | benzyl alcohol | 29540-71-8 | combination | Active |
Applications (4)
| Application # | Market | Procedure Type | Status | Owner | Submitted |
|---|---|---|---|---|---|
| FDA-2024-0001 | United States | Type II Variation | Failed | Carlos Mendez | 2022-09-18 |
| TFDA-2024-0031 | United States | sBLA | Draft | Aisha Okonkwo | 2023-09-22 |
| FDA-2024-0061 | United States | NDA | Active | Nadia Petrova | 2022-05-19 |
| TFDA-2024-0091 | United States | BLA | Approved | Sarah Chen | 2023-02-11 |
Markets (9)