Overview
A potent inhibitor of adenosine deaminase. The drug is effective in the treatment of many lymphoproliferative malignancies, particularly hairy-cell leukemia. It is also synergistic with some other antineoplastic agents and has immunosuppressive activity.
Background
A potent inhibitor of adenosine deaminase. The drug is effective in the treatment of many lymphoproliferative malignancies, particularly hairy-cell leukemia. It is also synergistic with some other antineoplastic agents and has immunosuppressive activity.
Indication
For the treatment of hairy cell leukaemia refractory to alpha interferon.
Associated Conditions
- Acute Graft-Versus-Host Disease (GVHD)
- B-Lymphocytic, prolymphocytic leukemia (Kiel Classification) refractory
- Chronic Lymphocytic Leukemia
- Hairy Cell Leukemia (HCL)
- Mycosis Fungoides (MF)
- Sezary Syndrome
- Steroid refractory Chronic graft versus host disease
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2023/03/07 | Phase 1 | Recruiting | City of Hope Medical Center | ||
2017/08/15 | Phase 1 | Active, not recruiting | City of Hope Medical Center | ||
2017/04/13 | Phase 3 | Completed | |||
2017/03/13 | Phase 1 | Active, not recruiting | |||
2014/04/07 | Phase 2 | Active, not recruiting | |||
2012/09/10 | Phase 2 | Completed | |||
2011/05/30 | Phase 1 | Completed | |||
2011/05/11 | Phase 1 | Terminated | |||
2010/08/25 | Phase 3 | Completed | |||
2010/02/01 | Phase 2 | Active, not recruiting |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Hospira, Inc. | 0409-0801 | INTRAVENOUS | 2 mg in 1 mL | 12/20/2023 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
| No EMA approvals found for this drug. | |||
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No HSA approvals found for this drug. | |||||
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 |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| Hospira Nipent (pentostatin for injection) 10 mg US | 171027 | Medicine | A | 5/4/2010 | |
| Hospira Nipent (Pentostatin for Injection) 10 mg | 171028 | Medicine | A | 5/4/2010 |