Overview
An antimetabolite antineoplastic agent with immunosuppressant properties. It interferes with nucleic acid synthesis by inhibiting purine metabolism and is used, usually in combination with other drugs, in the treatment of or in remission maintenance programs for leukemia.
Indication
For remission induction and maintenance therapy of acute lymphatic leukemia.
Associated Conditions
- Acute Lymphoblastic Leukaemias (ALL)
- Acute Promyelocytic Leukemia
- Autoimmune Hepatitis
- Crohn's Disease (CD)
- Lymphoblastic Lymphoma
- Ulcerative Colitis
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2025/04/09 | Phase 2 | Not yet recruiting | City of Hope Medical Center | ||
2024/10/15 | Not Applicable | Recruiting | |||
2024/08/01 | Phase 2 | Recruiting | |||
2024/04/30 | Phase 2 | Recruiting | |||
2024/04/26 | Phase 2 | Recruiting | |||
2024/03/28 | Phase 2 | Recruiting | |||
2024/03/19 | Phase 2 | Recruiting | |||
2024/02/28 | Phase 1 | Recruiting | |||
2024/01/18 | Phase 2 | Withdrawn | |||
2024/01/10 | Phase 1 | Recruiting | Haukeland University Hospital |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Physicians Total Care, Inc. | 54868-5282 | ORAL | 50 mg in 1 1 | 10/1/2012 | |
| Mylan Pharmaceuticals Inc. | 0378-3547 | ORAL | 50 mg in 1 1 | 3/11/2022 | |
| Quinn Pharmaceuticals | 69076-913 | ORAL | 50 mg in 1 1 | 1/3/2024 | |
| Hikma Pharmaceuticals USA Inc. | 0054-4581 | ORAL | 50 mg in 1 1 | 11/6/2018 | |
| Par Pharmaceutical Inc. | 49884-922 | ORAL | 50 mg in 1 1 | 1/7/2015 | |
| Stason Pharmaceuticals, Inc. | 60763-601 | ORAL | 50 mg in 1 1 | 1/3/2024 | |
| Nova Laboratories, Ltd | 62484-0020 | ORAL | 20 mg in 1 mL | 2/28/2018 |
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 |
|---|---|---|---|---|---|
| PURINETONE TABLETS 50 mg | SIN10810P | TABLET | 50 mg | 3/17/1999 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| Mercaptopurine Tablets | 国药准字H20253809 | 化学药品 | 片剂 | 4/8/2025 | |
| Mercaptopurine Tablets | 国药准字H44020179 | 化学药品 | 片剂 | 7/10/2020 | |
| Mercaptopurine Tablets | 国药准字H61021058 | 化学药品 | 片剂 | 9/10/2020 | |
| Mercaptopurine Tablets | 国药准字H11021699 | 化学药品 | 片剂 | 9/27/2023 | |
| Mercaptopurine Tablets | 国药准字H31020609 | 化学药品 | 片剂 | 8/19/2020 | |
| Mercaptopurine Tablets | 国药准字H33020001 | 化学药品 | 片剂 | 4/26/2020 | |
| Mercaptopurine Tablets | 国药准字H33020294 | 化学药品 | 片剂 | 6/29/2020 | |
| Mercaptopurine Tablets | 国药准字H33020779 | 化学药品 | 片剂 | 1/7/2020 | |
| Mercaptopurine Tablets | 国药准字H44020439 | 化学药品 | 片剂 | 7/27/2020 |
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 |
|---|---|---|---|---|---|
| PURI-NETHOL mercaptopurine monohydrate 50mg tablet bottle | 10993 | Medicine | A | 8/2/1991 | |
| MERCAPTOPURINE-LINK mercaptopurine monohydrate 50 mg tablet bottle | 306940 | Link Medical Products Pty Ltd T/A Link Pharmaceuticals | Medicine | A | 6/14/2019 |
| ALLMERCAP mercaptopurine monohydrate 20mg/mL oral liquid suspension bottle | 213881 | Link Medical Products Pty Ltd T/A Link Pharmaceuticals | Medicine | A | 6/16/2014 |
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