TheraRadar
Data updated: May 26, 2026

PURIXAN (mercaptopurine)

Trial Activity: Growth 32 active trials
Oncology Approved 2014-04-28

Purixan is a medication used for patients with acute lymphoblastic leukemia (ALL). It is typically prescribed as one component of a multi-drug chemotherapy plan during the maintenance phase of treatment. This drug helps manage the cancer by targeting proliferating cells to prevent the disease from returning or progressing.

Source: FDA Label • NOVA LABS LTD
Jump to: Indications Approvals Trials Competitors Similar Safety Patents

How PURIXAN Works

This drug works by acting as a purine analog that is converted inside cells into active metabolites. These metabolites incorporate themselves into the cell's DNA and RNA, which triggers cell-cycle arrest and leads to the death of cancer cells. Additionally, the drug and its metabolites interfere with the body's ability to create and convert new purine nucleotides.

Source: FDA Label

Development Insights

National Cancer Institute (NCI) conducting 13 trials (22%)
80 indications explored (Broad Platform)
→ acute lymphoblastic leukemia (17 trials)
→ b acute lymphoblastic leukemia (14 trials)
→ leukemia (8 trials)
1
Indication
--
Phase 3 Trials
12
Years on Market

Details

Status
Prescription
First Approved
2014-04-28
Routes
ORAL
Dosage Forms
SUSPENSION

Companies

NOVA LABS LTD
Active Ingredient: MERCAPTOPURINE

PURIXAN Approval History

2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
7 FDA actions from 2014 to 2024
Oct 2024 SUPPL
Label · Labeling
FDA Letter Label
Jul 2024 SUPPL
Label · Labeling
FDA Letter Label
Apr 2020 SUPPL
Label · Labeling
FDA Letter Label

What PURIXAN Treats

1 indications

PURIXAN is approved for 1 conditions since its original approval in 2014. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Acute Lymphoblastic Leukemia
Source: FDA Label

PURIXAN Competitive Set

Pro

Three rings of competition based on shared molecular targets and treated indications.

Indication competitors

10

Same indication, different mechanism — what else might this patient receive?

IMKELDI
SHORLA ONCOLOGY
2024 7 indic.
PHYRAGO
HANDA THERAP
2023 2 indic.
Unlock 8 more competitors across all three rings.
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Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.

What's emerging in PURIXAN's indications

See all emerging drugs →

Phase 3 candidates targeting molecules with no FDA-approved drug, in indications PURIXAN treats. First-in-class if their pivotal trials read out positive.

Ceralasertib AZD6738 ~ Mixed — Ph3 readout
AstraZeneca
ATR · small-molecule ATR kinase inhibitor · 2 Phase 3 trials

Drugs Similar to PURIXAN

3 of 19

FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.

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CALASPARGASE PEGOL-MKNL
1 shared
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Shared indications:
Acute Lymphoblastic Leukemia
BESPONSA
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1 shared
Pfizer
Shared indications:
Acute Lymphoblastic Leukemia
BLINCYTO
BLINATUMOMAB
1 shared
Amgen
Shared indications:
Acute Lymphoblastic Leukemia
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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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Active Pipeline

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Key Completed Trials

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Completed studies with published results, ranked by significance

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Trial Timeline

ClinicalTrials.gov ↗ Pro

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.

PURIXAN FDA Label Details

Indications & Usage

FDA Label (PDF)

PURIXAN is indicated for the treatment of Acute Lymphoblastic Leukemia.

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Data Sources

FDA Approval: NDA205919 → Label: DailyMed → Patents: FDA Orange Book → Trials: ClinicalTrials.gov →

Data sourced from official FDA and NIH databases. Click links to verify on original sources.

How We Calculate These Metrics

Trial Activity Stage

Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.

Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.

  • Growth: High proportion of early-phase trials (Phase 1/2), active development
  • Expansion: Significant Phase 3 activity, approaching or pursuing approvals
  • Mature: Substantial Phase 4 post-marketing studies
  • Stable: Mixed phase distribution, steady development
  • Declining: Low active trial ratio, reduced R&D investment