Mercaptopurine

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
Testing the Addition of Daratumumab to Chemotherapy for Treating Patients With Newly-Diagnosed T-Cell Lymphoblastic Leukemia (T-ALL) and T-Cell Lymphoblastic Lymphoma (T-LL)	2025/07/18	NCT07072585	Not Applicable	Not yet recruiting	Children's Oncology Group
Asparaginase Erwinia Chrysanthemi With Chemotherapy for the Treatment of High-Risk Adults With Newly Diagnosed Acute Lymphoblastic Leukemia or Lymphoblastic Lymphoma	2025/04/09	NCT06918431	Phase 2	Not yet recruiting	City of Hope Medical Center
A Study of Different Programs to Help ALL Patients With Taking Maintenance Medicine at Home	2024/10/15	NCT06639958	Not Applicable	Active, not recruiting	Children's Oncology Group
Therapy for Newly Diagnosed Patients With B-Cell Precursor Acute Lymphoblastic Leukemia and Lymphoma	2024/08/01	NCT06533748	Phase 2	Recruiting	St. Jude Children's Research Hospital
Adding Dasatinib Or Venetoclax To Improve Responses In Children With Newly Diagnosed T-Cell Acute Lymphoblastic Leukemia (ALL) Or Lymphoma (T-LLY) Or Mixed Phenotype Acute Leukemia (MPAL)	2024/04/30	NCT06390319	Phase 2	Recruiting	St. Jude Children's Research Hospital
Efficacy and Safety of Low-dose Chemotherapy Plus Immuno-targeted Drugs in Newly Diagnosed Elderly/Unfit Ph- B-ALL	2024/04/26	NCT06387121	Phase 2	Recruiting	Institute of Hematology & Blood Diseases Hospital, China
Ma-Spore ALL 2020 Study	2024/03/28	NCT06336395	Phase 2	Recruiting	National University Hospital, Singapore
Testing the Addition of the Anti-cancer Drug Venetoclax and/or the Anti-cancer Immunotherapy Blinatumomab to the Usual Chemotherapy Treatment for Infants With Newly Diagnosed KMT2A-rearranged or KMT2A-non-rearranged Leukemia	2024/03/19	NCT06317662	Phase 2	Recruiting	National Cancer Institute (NCI)
Efficacy and Safety of TMZ Plus 6-MP in the Patients With Recurrent Glioblastoma	2024/02/28	NCT06279767	Phase 1	Recruiting	The First Affiliated Hospital with Nanjing Medical University
Adding Targeted Drugs to Usual Chemotherapy for Adults With Newly Diagnosed T-Cell Acute Lymphoblastic Leukemia (T-ALL) and T-Cell Lymphoblastic Lymphoma (T-LBL)	2024/01/18	NCT06210750	Phase 2	Withdrawn	National Cancer Institute (NCI)

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
mercaptopurine	Physicians Total Care, Inc.	54868-5282	ORAL	50 mg in 1 1	10/1/2012
Mercaptopurine	Mylan Pharmaceuticals Inc.	0378-3547	ORAL	50 mg in 1 1	3/11/2022
Mercaptopurine	Quinn Pharmaceuticals	69076-913	ORAL	50 mg in 1 1	1/3/2024
Mercaptopurine	Hikma Pharmaceuticals USA Inc.	0054-4581	ORAL	50 mg in 1 1	11/6/2018
mercaptopurine	Par Pharmaceutical Inc.	49884-922	ORAL	50 mg in 1 1	1/7/2015
PURINETHOL	Stason Pharmaceuticals, Inc.	60763-601	ORAL	50 mg in 1 1	1/3/2024
PURIXAN	Nova Laboratories, Ltd	62484-0020	ORAL	20 mg in 1 mL	8/20/2025

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	KOREA UNITED PHARMACEUTICAL INC	SIN10810P	TABLET	50 mg	3/17/1999

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
PURI-NETHOL mercaptopurine monohydrate 50mg tablet bottle	10993	Aspen Pharmacare Australia Pty Ltd	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

Health Canada Drug Approvals

Approved Product	Company	DIN	Dosage Form	Strength	Market Date
MERCAPTOPURINE TABLETS USP	Sterimax Inc	02415275	Tablet - Oral	50 MG	11/27/2013
PURINETHOL	teva canada limited	00004723	Tablet - Oral	50 MG	12/31/1954

CIMA AEMPS Drug Approvals

Approved Product	Company	Registration Number	Pharmaceutical Form	Prescription Type	Status
MERCAPTOPURINA ASPEN 50 MG COMPRIMIDOS	Aspen Pharma Trading Limited	34565	COMPRIMIDO	Medicamento Sujeto A Prescripción Médica	Commercialized
XALUPRINE 20 mg/ml SUSPENSION ORAL	Nova Laboratories Limited	11727001	SOLUCIÓN ORAL	Uso Hospitalario	Not Commercialized
MERCAPTOPURINA ZENTIVA 50 MG COMPRIMIDOS EFG	Zentiva K.S.	85931	COMPRIMIDO	Medicamento Sujeto A Prescripción Médica	Commercialized
MERCAPTOPURINA SILVER PHARMA 50 MG COMPRIMIDOS EFG	Silver Pharma S.L.	84602	COMPRIMIDO	Medicamento Sujeto A Prescripción Médica	Not 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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