Overview
An antineoplastic agent used in the treatment of lymphoproliferative diseases including hairy-cell leukemia.
Indication
For the treatment of active hairy cell leukemia (leukemic reticuloendotheliosis) as defined by clinically significant anemia, neutropenia, thrombocytopenia, or disease-related symptoms. Also used as an alternative agent for the treatment of chronic lymphocytic leukemia (CLL), low-grade non-Hodgkin's lymphoma, and cutaneous T-cell lymphoma.
Associated Conditions
- Chronic Lymphocytic Leukemia
- Cutaneous T-Cell Lymphoma (CTCL)
- Hairy Cell Leukemia (HCL)
- Non-Hodgkin's Lymphomas
- Active confirmed by clinical features, confirmed by imaging features relapsing multiple sclerosis (MS)
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2025/06/24 | Phase 2 | Not yet recruiting | |||
2025/05/11 | Phase 1 | Not yet recruiting | |||
2025/03/25 | Phase 4 | Not yet recruiting | |||
2025/03/20 | N/A | Not yet recruiting | University Hospital, Strasbourg, France | ||
2024/08/20 | Phase 2 | Recruiting | |||
2024/08/19 | Phase 1 | Recruiting | |||
2024/07/16 | Phase 2 | Recruiting | |||
2024/06/26 | Phase 1 | Not yet recruiting | |||
2024/06/18 | Phase 3 | Recruiting | Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany | ||
2024/01/31 | Phase 2 | Recruiting |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| EMD Serono, Inc. | 44087-4000 | ORAL | 10 mg in 1 1 | 2/27/2024 | |
| Hikma Pharmaceuticals USA Inc. | 0143-9871 | INTRAVENOUS | 1 mg in 1 mL | 4/19/2023 | |
| Hisun Pharmaceuticals USA, Inc. | 42658-010 | INTRAVENOUS | 1 mg in 1 mL | 2/1/2023 | |
| Hisun Pharmaceuticals USA, Inc. | 42658-010 | INTRAVENOUS | 1 mg in 1 mL | 1/1/2024 | |
| Fresenius Kabi USA, LLC | 63323-140 | INTRAVENOUS | 1 mg in 1 mL | 12/31/2019 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
Authorised | 8/22/2017 | ||
Authorised | 4/14/2004 |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| MAVENCLAD TABLET 10MG | SIN15691P | TABLET | 10mg | 5/24/2019 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| Cladribine Injection | 国药准字H20243553 | 化学药品 | 注射剂 | 4/24/2024 | |
| Cladribine Injection | 国药准字H20052240 | 化学药品 | 注射剂 | 4/26/2020 |
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 |
|---|---|---|---|---|---|
| LITAK cladribine 10mg/5mL injection vial | 104283 | Medicine | A | 7/1/2004 | |
| MAVENCLAD cladribine 10mg tablet blister pack | 166483 | Medicine | A | 9/9/2010 | |
| LEUSTATIN 10mg/10mL injection | 48000 | Medicine | A | 2/17/1994 |
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