Data updated: May 26, 2026
MERCAPTOPURINE
Oncology
Approved 2004-02-11
MERCAPTOPURINE is indicated for the treatment of Acute Lymphoblastic Leukemia.
Source: FDA Label • Viatris
How MERCAPTOPURINE Works
Mercaptopurine is a purine analog that undergoes intracellular transport and activation to form thioguanine nucleotides (TGNs). These metabolites are incorporated into DNA and RNA, leading to cell-cycle arrest and apoptosis. Additionally, mercaptopurine and its metabolites inhibit de novo purine synthesis and purine nucleotide interconversions.
Source: FDA Label
4
Indications
--
Phase 3 Trials
22
Years on Market
Details
- Status
- Prescription
- First Approved
- 2004-02-11
- Routes
- ORAL
- Dosage Forms
- TABLET, SUSPENSION
MERCAPTOPURINE Approval History
2005
2006
2007
2008
2009
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
18 FDA actions from 2004 to 2025
Jun 2025 SUPPL
Label · Labeling
Feb 2025 SUPPL
Label · Labeling
Jan 2022 SUPPL
Label
Nov 2021 SUPPL
Label
Jan 2021 SUPPL
Label
Jan 2021 SUPPL
Label
Dec 2018 SUPPL
Label
May 2013 SUPPL
Label
Mar 2013 SUPPL
Label
Aug 2012 SUPPL
Label
Nov 2007 SUPPL
Label
Jul 2005 ORIGINAL
Update
May 2005 SUPPL
Label
Jan 2005 SUPPL
Label
Feb 2004 ORIGINAL
Update
What MERCAPTOPURINE Treats
1 indicationsMERCAPTOPURINE is approved for 1 conditions since its original approval in 2004. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Acute Lymphoblastic Leukemia
Source: FDA Label
MERCAPTOPURINE Competitive Set
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Indication competitors
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What's emerging in MERCAPTOPURINE's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications MERCAPTOPURINE treats. First-in-class if their pivotal trials read out positive.
Drugs Similar to MERCAPTOPURINE
3 of 19FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
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Clinical Trial Registry
59 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT06124157 | NCI-2023-09214 NCI-2023-09214, AALL2131 | Ph 2 | recruiting | A Study Testing the Combination of Dasatinib or Imatinib to Chemotherapy Treatment With Blinatumomab for Children, Adolescents, and Young Adults With Philadelphia Chromosome Positive (Ph+) or ABL-Class Philadelphia Chromosome-Like (Ph-Like) B-cell Acute Lymphoblastic Leukemia (B-ALL) |
| NCT06317662 | NCI-2024-01994 NCI-2024-01994, AALL2321 | Ph 2 | recruiting | 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 |
| NCT03150693 | A041501 NCI-2016-01981, U10CA180821 | Ph 3 | recruiting | Inotuzumab Ozogamicin and Frontline Chemotherapy in Treating Young Adults With Newly Diagnosed B Acute Lymphoblastic Leukemia |
| NCT03959085 | AALL1732 NCI-2019-02845, AALL1732 | Ph 3 | recruiting | Inotuzumab Ozogamicin and Post-Induction Chemotherapy in Treating Patients With High-Risk B-ALL, Mixed Phenotype Acute Leukemia, and B-LLy |
| NCT02112916 results posted | NCI-2014-00712 NCI-2014-00712, s14-01925 | Ph 3 | active not recruiting | Combination Chemotherapy With or Without Bortezomib in Treating Younger Patients With Newly Diagnosed T-Cell Acute Lymphoblastic Leukemia or Stage II-IV T-Cell Lymphoblastic Lymphoma |
| NCT02101853 results posted | NCI-2014-00631 NCI-2014-00631, s15-00970 | Ph 3 | active not recruiting | Blinatumomab in Treating Younger Patients With Relapsed B-cell Acute Lymphoblastic Leukemia |
| NCT03914625 | NCI-2019-02187 NCI-2019-02187, AALL1731 | Ph 3 | active not recruiting | A Study to Investigate Blinatumomab in Combination With Chemotherapy in Patients With Newly Diagnosed B-Lymphoblastic Leukemia |
| NCT02883049 results posted | NCI-2011-03797 NCI-2011-03797, S12-01254 | Ph 3 | active not recruiting | Combination Chemotherapy in Treating Young Patients With Newly Diagnosed High-Risk B Acute Lymphoblastic Leukemia and Ph-Like TKI Sensitive Mutations |
| NCT03007147 | AALL1631 NCI-2016-01588, AALL1631 | Ph 3 | active not recruiting | Imatinib Mesylate and Combination Chemotherapy in Treating Patients With Newly Diagnosed Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia |
| NCT02003222 results posted | NCI-2013-02229 NCI-2013-02229, ECOG-E1910 | Ph 3 | active not recruiting | Combination Chemotherapy With or Without Blinatumomab in Treating Patients With Newly Diagnosed BCR-ABL-Negative B Lineage Acute Lymphoblastic Leukemia |
| NCT06390319 | SJALL23T NCI-2024-03015 | Ph 2 | recruiting | 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) |
| NCT00558519 results posted | CALGB-10403 CALGB-10403, ECOG C10403 | Ph 2 | completed | Combination Chemotherapy in Treating Young Patients With Newly Diagnosed Acute Lymphoblastic Leukemia |
| NCT05645718 | 2022-0312 NCI-2022-10168 | Ph 2 | recruiting | Study of Pedi-cRIB: Mini-Hyper-CVD With Condensed Rituximab, Inotuzumab Ozogamicin and Blinatumomab (cRIB) for Relapsed Therapy for Pediatric With B-Cell Lineage Acute Lymphocytic Leukemia |
| NCT05848687 | IRB-68271 PEDSHEMALL0015, NCI-2023-04129 | Ph 1, Ph 2 | recruiting | TINI 2: Total Therapy for Infants With Acute Lymphoblastic Leukemia II |
| NCT04216524 | 2019-0587 NCI-2019-08358, 2019-0587 | Ph 2 | recruiting | Venetoclax, SL-401, and Chemotherapy for the Treatment of Blastic Plasmacytoid Dendritic Cell Neoplasm |
| NCT02143414 results posted | NCI-2014-01047 NCI-2014-01047, SWOG-S1318 | Ph 2 | active not recruiting | Blinatumomab and Combination Chemotherapy or Dasatinib, Prednisone, and Blinatumomab in Treating Older Patients With Acute Lymphoblastic Leukemia |
| NCT02205762 | 13-428 2011-001699-20, 042011 | Ph 2, Ph 3 | active not recruiting | LCH-IV, International Collaborative Treatment Protocol for Children and Adolescents With Langerhans Cell Histiocytosis |
| NCT01503632 | ACCL1033 NCI-2012-00105, S12-01789 | Ph 3 | completed | Assessing Compliance With Mercaptopurine Treatment in Younger Patients With Acute Lymphoblastic Leukemia in First Remission |
| NCT05303792 | A042001 NCI-2022-01735, U10CA180821 | Ph 2 | active not recruiting | Testing the Combination of Inotuzumab Ozogamicin and Lower Dose Chemotherapy Compared to Usual Chemotherapy for Adults With B-Cell Acute Lymphoblastic Leukemia or B-Cell Lymphoblastic Lymphoma |
| NCT01190930 results posted | AALL0932 NCI-2011-02599, CDR0000683227 | Ph 3 | active not recruiting | Risk-Adapted Chemotherapy in Treating Younger Patients With Newly Diagnosed Standard-Risk Acute Lymphoblastic Leukemia or Localized B-Lineage Lymphoblastic Lymphoma |
| NCT06918431 | 24442 NCI-2025-02184, 24442 | Ph 2 | recruiting | Asparaginase Erwinia Chrysanthemi With Chemotherapy for the Treatment of High-Risk Adults With Newly Diagnosed Acute Lymphoblastic Leukemia or Lymphoblastic Lymphoma |
| NCT02723994 | INCB 18424-269 AALL1521 | Ph 2 | completed | A Phase 2 Study of Ruxolitinib With Chemotherapy in Children With Acute Lymphoblastic Leukemia |
| NCT05157971 | 21134 NCI-2021-09185, 21134 | Ph 1 | recruiting | Venetoclax and a Pediatric-Inspired Regimen for the Treatment of Newly Diagnosed B Cell Acute Lymphoblastic Leukemia |
| NCT02523976 | IIT2015001 | Ph 2 | completed | Dasatinib Combined With Chemotherapy in Philadelphia Chromosome-positive Acute Lymphoblastic Leukemia |
| NCT03020030 | 16-001 | Ph 3 | active not recruiting | Treatment of Newly Diagnosed Acute Lymphoblastic Leukemia in Children and Adolescents |
| NCT03571321 | IRB17-1110 | Ph 1 | recruiting | Ruxolitinib and Chemotherapy in Adolescents and Young Adults With Ph-like Acute Lymphoblastic Leukemia |
| NCT01371630 | 2010-0991 NCI-2011-01123, 2010-0991 | Ph 1, Ph 2 | recruiting | Inotuzumab Ozogamicin and Combination Chemotherapy in Treating Patients With Acute Lymphoblastic Leukemia |
| NCT02881086 | GMALL08_2013 | Ph 3 | completed | Optimization of Therapy in Adult Patients With Newly Diagnosed Acute Lymphoblastic Leukemia or Lymphoblastic Lymphoma by Individualised, Targeted and Intensified Treatment |
| NCT02553460 results posted | TINI NCI-2015-01493 | Ph 1, Ph 2 | active not recruiting | Total Therapy for Infants With Acute Lymphoblastic Leukemia (ALL) I |
| NCT03117751 | TOT17 NCI-2017-00582 | Ph 2, Ph 3 | active not recruiting | Total Therapy XVII for Newly Diagnosed Patients With Acute Lymphoblastic Leukemia and Lymphoma |
| NCT07227584 | 25-533 | Ph 2 | not yet recruiting | ALL Backbone in AYAs |
| NCT02877303 | 2014-0845 NCI-2017-00596, 2014-0845 | Ph 2 | recruiting | Blinatumomab, Inotuzumab Ozogamicin, and Combination Chemotherapy as Frontline Therapy in Treating Patients With B Acute Lymphoblastic Leukemia |
| NCT05192889 results posted | RAVEN NCI-2022-00304 | Ph 1, Ph 2 | active not recruiting | Trial Treating Relapsed Acute Lymphoblastic Leukemia With Venetoclax and Navitoclax |
| NCT04546399 | NCI-2020-06813 NCI-2020-06813, AALL1821 | Ph 2 | recruiting | A Study to Compare Blinatumomab Alone to Blinatumomab With Nivolumab in Patients Diagnosed With First Relapse B-Cell Acute Lymphoblastic Leukemia (B-ALL) |
| NCT05032183 results posted | 2021-0545 NCI-2021-08859, 2021-0545 | Ph 1, Ph 2 | terminated | Tagraxofusp and Low-Intensity Chemotherapy for the Treatment of CD123 Positive Relapsed or Refractory Acute Lymphoblastic Leukemia or Lymphoblastic Lymphoma |
| NCT04440267 | IIT2020009 | Ph 2 | recruiting | Efficacy of Acute Lymphoblastic Leukemia-Based Therapy in Treating Patients With Acute Leukemia of Ambiguous Lineage |
| NCT02420717 results posted | 2014-0521 NCI-2015-00779, 2014-0521 | Ph 2 | terminated | Ruxolitinib Phosphate or Dasatinib With Chemotherapy in Treating Patients With Relapsed or Refractory Philadelphia Chromosome-Like Acute Lymphoblastic Leukemia |
| NCT02828358 results posted | NCI-2016-00973 NCI-2016-00973, s17-00488 | Ph 2 | completed | Azacitidine and Combination Chemotherapy in Treating Infants With Acute Lymphoblastic Leukemia and KMT2A Gene Rearrangement |
| NCT02688140 TUD-APOLLO-064 | TUD-APOLLO-064 | Ph 3 | completed | Study for Patients With Newly Diagnosed, High-risk Acute Promyelocytic Leukemia |
| NCT01228331 | CDR0000686545 2009-012758-18 | Ph 2, Ph 3 | completed | Clofarabine or High-Dose Cytarabine and Pegaspargase in Children with ALL |
| NCT03488225 results posted | 2015-0922 NCI-2018-00760, 2015-0922 | Ph 2 | terminated | Combination Chemotherapy and Inotuzumab Ozogamicin in Treating Patients With B Acute Lymphoblastic Leukemia |
| NCT00557193 results posted | AALL0631 NCI-2009-00313, CDR0000573996 | Ph 3 | completed | Combination Chemotherapy With or Without Lestaurtinib in Treating Younger Patients With Newly Diagnosed Acute Lymphoblastic Leukemia |
| NCT06210750 | NCI-2023-09521 NCI-2023-09521, S2306 | Ph 2 | withdrawn | 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) |
| NCT06336395 | 2019/00888 | Ph 2 | recruiting | Ma-Spore ALL 2020 Study |
| NCT01256398 results posted | NCI-2011-02621 NCI-2011-02621, CALGB 10701/CTSU C10701 | Ph 2 | completed | Dasatinib Followed by Stem Cell Transplant in Treating Older Patients With Newly Diagnosed Acute Lymphoblastic Leukemia |
| NCT03518112 results posted | 2017-0127 NCI-2018-00737, 2017-0127 | Ph 2 | terminated | Low-Intensity Chemotherapy and Blinatumomab in Treating Patients With Philadelphia Chromosome Negative Relapsed or Refractory Acute Lymphoblastic Leukemia |
| NCT00866918 results posted | AAML0631 NCI-2011-01904, CDR0000637184 | Ph 3 | completed | Combination Chemotherapy in Treating Young Patients With Newly Diagnosed Acute Promyelocytic Leukemia |
| NCT01700946 results posted | ALLR18 NCI-2012-00587 | Ph 2 | completed | Therapy for Pediatric Relapsed or Refractory Precursor B-Cell Acute Lymphoblastic Leukemia and Lymphoma |
| NCT02177071 SPARE | GETAID 2014-03 | Ph 4 | completed | A proSpective Randomized Controlled Trial comParing infliximAb-antimetabolites Combination Therapy to Anti-metabolites monotheRapy and Infliximab monothErapy in Crohn's Disease Patients in Sustained Steroid-free Remission on Combination Therapy |
| NCT01451515 results posted | NHL16 NCI-2012-00496 | Ph 2 | completed | NHL16: Study For Newly Diagnosed Patients With Acute Lymphoblastic Lymphoma |
Showing 50 of 59 trials
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Trial Timeline
Full development history with FDA approval milestones
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Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
MERCAPTOPURINE FDA Label Details
Indications & Usage
MERCAPTOPURINE is indicated for the treatment of Acute Lymphoblastic Leukemia.
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.