Clinical Trials

Numerous clinical trials evaluate 6-mercaptopurine across early phase 1 through phase 4 studies for conditions such as acute lymphoblastic leukemia, T-cell lymphoblastic lymphoma, Crohn's disease, ulcerative colitis, and glioblastoma. Sponsored by academic institutions, university hospitals, and biopharmaceutical organizations, these studies encompass active, recruiting, completed, terminated, and withdrawn statuses. Research across the portfolio investigates multi-agent chemotherapy regimens, targeted formulations, and combination therapies for hematological malignancies, inflammatory bowel disease, and solid tumors.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT07716735 NOT_YET_RECRUITING
Advanced Kidney Carcinoma; Advanced Renal Cell Carcinoma; Hereditary Leiomyomatosis and Renal Cell Carcinoma; Metastatic Kidney Carcinoma; Metastatic Renal Cell Carcinoma; Skin Leiomyoma; Stage III Renal Cell Cancer AJCC v8; Stage IV Renal Cell Cancer AJCC v8; Uterine Corpus Leiomyoma
Jonsson Comprehensive Cancer Center
 2026-12-01 PHASE1
NCT04043494 RECRUITING
Lymphoblastic Lymphoma, Childhood
University Hospital Muenster
 2019-08-23 PHASE3
NCT03643276 RECRUITING
Acute Lymphoblastic Leukemia, Pediatric
Martin Schrappe
 2018-07-15 PHASE3
NCT06533748 RECRUITING
Acute Lymphoblastic Leukemia; Lymphoblastic Lymphoma
St. Jude Children's Research Hospital
 2025-01-23 PHASE2
NCT03286634 ACTIVE_NOT_RECRUITING
Down Syndrome; Acute Lymphoblastic Leukemia; Childhood Cancer
National Hospital Organization Nagoya Medical Center
 2017-04-18 PHASE2
NCT04747912 RECRUITING
Lymphoblastic Leukemia; Acute Lymphoblastic Leukemia; ph+ Acute Lymphoblastic Leukemia
University of Chicago
 2021-03-02 PHASE2
NCT07462299 NOT_YET_RECRUITING
Childhood Acute Lymphoblastic Leukemia
The Children's Hospital of Zhejiang University School of Medicine
 2026-02-20
NCT05660473 RECRUITING
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Institute of Hematology & Blood Diseases Hospital, China
 2022-08-01 PHASE2
NCT06639958 SUSPENDED
Acute Lymphoblastic Leukemia; Childhood Acute Lymphoblastic Leukemia
Children's Oncology Group
 2024-12-04
NCT05681260 RECRUITING
T-cell Lymphoblastic Lymphoma
Children's Cancer Group, China
 2023-02-06 PHASE3
NCT06387121 RECRUITING
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Institute of Hematology & Blood Diseases Hospital, China
 2024-04-02 PHASE2
NCT01920737 ACTIVE_NOT_RECRUITING
Leukemia
Memorial Sloan Kettering Cancer Center
 2013-08-07 PHASE2
NCT06199557 RECRUITING
Acute Myeloid Leukemia, Adult; Myelodysplastic Syndromes, Adult
Haukeland University Hospital
 2024-05-23 PHASE1; PHASE2
NCT06279767 UNKNOWN
Glioblastoma; Cancer; Temozolomide
The First Affiliated Hospital with Nanjing Medical University
 2022-07-01 PHASE1; PHASE2
NCT05276284 COMPLETED
Solid Tumor, Adult; Metastatic Cancer
Kristoffer Rohrberg
 2022-09-01 PHASE1; PHASE2
NCT05506332 RECRUITING
Acute Myeloid Leukemia, in Relapse; Acute Myeloid Leukemia Refractory
University Hospital, Antwerp
 2022-07-15 PHASE1
NCT02303821 COMPLETED
Acute Lymphoblastic Leukemia (ALL)
Amgen
 2015-02-16 PHASE1
NCT02845882 ACTIVE_NOT_RECRUITING
Lymphoblastic Lymphoma
Children's Cancer Group, China
 2016-01 PHASE3
NCT04228393 UNKNOWN
Acute Lymphoblastic Leukemia, Pediatric
Wei Zhao
 2020-02-01 PHASE2; PHASE3
NCT03384654 COMPLETED
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Janssen Research & Development, LLC
 2018-05-14 PHASE2
NCT02143414 ACTIVE_NOT_RECRUITING
Acute Lymphoblastic Leukemia; B Acute Lymphoblastic Leukemia; B Acute Lymphoblastic Leukemia With t(9;22)(q34.1;q11.2); BCR-ABL1; Recurrent Acute Lymphoblastic Leukemia; Refractory Acute Lymphoblastic Leukemia
National Cancer Institute (NCI)
 2015-06-30 PHASE2
NCT02200978 COMPLETED
Childhood Acute Promyelocytic Leukemia
South China Children's Leukemia Group
 2011-09 PHASE4
NCT02852694 COMPLETED
Crohn's Disease
PIBD-Net
 2017-02-28 PHASE4
NCT03564704 UNKNOWN
Leukemia; Leukemia, Acute; Adult Lymphoblastic Lymphoma; Leukemia, Lymphoblastic; Leukemia, T Cell; Adult Acute Lymphoblastic Leukemia; Lymphoblastic Lymphoma; Lymphoblastic Leukemia
Nanfang Hospital, Southern Medical University
 2016-02-14 PHASE2; PHASE3
NCT03760003 COMPLETED
Ulcerative Colitis
Abivax S.A.
 2019-08-13 PHASE2
NCT02611492 UNKNOWN
Philadelphia Chromosome Positive Adult Acute Lymphoblastic Leukemia
Assistance Publique - Hôpitaux de Paris
 2016-04 PHASE3
NCT03553238 UNKNOWN
Leukemia, Acute; Leukemia, T Cell; Leukemia, Lymphoblastic
Nanfang Hospital, Southern Medical University
 2016-02-14 PHASE2; PHASE3
NCT02046694 COMPLETED
Acute Lymphoblastic Leukemia (ALL)
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
 2014-01-06 EARLY_PHASE1
NCT02912676 COMPLETED
Acute Lymphoblastic Leukemia; Lymphoblastic Lymphoma
Kjeld Schmiegelow
 2016-10 PHASE1; PHASE2
NCT02660762 UNKNOWN
Leukaemia,Lymphoblastic
Sun Yat-sen University
 2016-01 PHASE2
NCT03022747 UNKNOWN
Lymphoblastic Leukemia, Acute, Childhood
Vastra Gotaland Region
 2017-01 PHASE2
NCT02894645 UNKNOWN
Acute Lymphoblastic Leukemia (ALL)
National University Hospital, Singapore
 2008-10 PHASE4
NCT01906671 UNKNOWN
Acute Lymphoblastic Leukemia; 6-mercaptopurine Therapy
Kjeld Schmiegelow
 2013-06 PHASE4
NCT02518750 TERMINATED
Acute Lymphoblastic Leukemia; Lymphoma, Non-Hodgkin's; Leukemia, T-Cell; Leukemia, B-Cell
St. Jude Children's Research Hospital
 2016-11-23 PHASE2
NCT02578511 WITHDRAWN
Acute Lymphoblastic Leukemia in Complete Remission; Lymphoblastic Lymphoma in Complete Remission; Mixed Phenotype Acute Leukemia in Complete Remission
Ehab L Atallah
 2017-06-29 PHASE1
NCT02413047 TERMINATED
Inflammatory Bowel Disease; Ulcerative Colitis; Crohn's Disease
Indiana University
 2015-05
NCT02141100 WITHDRAWN
Non-Hodgkin Lymphoma
Kjeld Schmiegelow
 2014-07 PHASE1; PHASE2
NCT01629628 UNKNOWN
Crohn Disease
Tel-Aviv Sourasky Medical Center
 2012-07 PHASE3
NCT00816049 COMPLETED
Acute Lymphoblastic Leukemia
Rigshospitalet, Denmark
 2009-01 PHASE3
NCT00973752 COMPLETED
Acute Lymphoblastic Leukemia
Massachusetts General Hospital
 2009-08 PHASE2
NCT01432145 COMPLETED
Breast Cancer; Ovarian Cancer
University of Oxford
 2011-05 PHASE2
NCT00846703 UNKNOWN
Acute Lymphoblastic Leukemia
Sun Yat-sen University
 2008-07 PHASE4
NCT00476190 COMPLETED
Acute Lymphoblastic Leukemia
Dana-Farber Cancer Institute
 2007-04 PHASE2
NCT01094613 TERMINATED
Crohn's Disease
Teva GTC
 2010-11 PHASE1; PHASE2
NCT01358253 COMPLETED
Acute Lymphoblastic Leukemia
Ruijin Hospital
 2010-12 PHASE4
NCT01433432 WITHDRAWN
Crohn's Disease
Teva GTC
 2011-10 PHASE2
NCT00521950 COMPLETED
Inflammatory Bowel Diseases; Crohn Disease; Ulcerative Colitis
ZonMw: The Netherlands Organisation for Health Research and Development
 2007-09
NCT00184041 COMPLETED
Acute Lymphoblastic Leukemia
University of Southern California
 2004-07 PHASE2
NCT00514982 WITHDRAWN
Hermanski-Pudlak Syndrome; Colitis; Cytokines; Lymphocytes; Drug Evaluation
National Institute of Allergy and Infectious Diseases (NIAID)
 2007-08-07 PHASE2
NCT00774982 COMPLETED
Crohns Disease
Teva GTC
 2008-12 PHASE1
NCT00548431 COMPLETED
Leukemia, Lymphocytic, Acute
Rigshospitalet, Denmark
 2007-12 PHASE2
NCT00136435 COMPLETED
Acute Lymphoblastic Leukemia
Dana-Farber Cancer Institute
 2002-06 PHASE2
NCT00176462 COMPLETED
Acute Lymphocytic Leukemia
Rutgers, The State University of New Jersey
 2001-02 PHASE2
NCT00962767 COMPLETED
Leukemia, Myelocytic, Acute
Wyeth is now a wholly owned subsidiary of Pfizer
 2002-05 PHASE3
NCT00199056 COMPLETED
Adult Acute Lymphocytic Leukemia
Goethe University
 1999-10 PHASE4
NCT00602134 COMPLETED
Acute Lymphoblastic Leukemia
Roxane Laboratories
 2002-11
NCT00199069 COMPLETED
Adult Acute Lymphocytic Leukemia
Goethe University
 1993-04 PHASE4
NCT00287170 COMPLETED
Crohn's Disease
Teva GTC
 2006-07 PHASE1; PHASE2

(data from https://clinicaltrials.gov, updated on 2026-08-06)

Check the 6-Mercaptopurine (6-MP) Monohydrate product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

6-Mercaptopurine is intracellularly converted into active thiopurine metabolites that incorporate into nucleic acids, thereby inhibiting de novo purine nucleotide synthesis and disrupting DNA and RNA metabolism in rapidly dividing cells. This metabolic blockade suppresses immune cell expansion and induces selective cytotoxicity, providing the rationale for its clinical utility in treating acute lymphoblastic leukemia, Crohn's disease, and ulcerative colitis.

Appendix RUO and cGMP Quality Standards

Quality Dimension RUO (Research Use Only) cGMP (Current Good Manufacturing Practice)
Clinical Applicability Prohibited in human clinical trials or medical diagnostics. Mandatory for human clinical trials (Phase I–III) and therapies.
Regulatory Status Non-regulated grade; exempt from drug manufacturing laws. Legally enforced by health authorities (e.g., FDA, EMA, NMPA).
Facility Environment Unclassified analytical or research laboratories. Validated Cleanrooms (ISO Class 5–8) with continuous monitoring.
Quality Control Basic purity and activity testing. Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma).
Process Validation Basic equipment calibration; no process validation required. Full qualification (IQ/OQ/PQ) and complete batch records.
Quality Assurance Vendor self-declared without required formal QMS. Mandatory QA/QC unit, Change Control, CAPA, and vendor audits.
Regulatory Impact High risk of IND rejection if used as a critical raw material. Required for IND/NDA filings, supported by Drug Master Files (DMF).

Footnotes

Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).

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Note: Technical data last updated: Sep 1, 2026.