Data updated: May 26, 2026
THIOGUANINE
Trial Activity: Growth 18 active trials
Oncology
Approved 1966-01-18
THIOGUANINE is indicated for the treatment of Acute Nonlymphocytic Leukemia; Chronic Myelogenous Leukemia.
Source: FDA Label • WAYLIS THERAP
Development Insights
National Cancer Institute (NCI) conducting 8 trials (29%)
47 indications explored (Broad Platform)
→ b acute lymphoblastic leukemia (8 trials)
→ acute lymphoblastic leukemia (7 trials)
→ leukemia (5 trials)
1
Indication
--
Phase 3 Trials
1
Priority Reviews
60
Years on Market
Details
- Status
- Prescription
- First Approved
- 1966-01-18
- Routes
- ORAL
- Dosage Forms
- TABLET
THIOGUANINE Approval History
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Original
New Indication
New Form
Label Update
18 FDA actions from 1966 to 2024
Jul 2002 SUPPL Priority
Mfg
Jul 1991 SUPPL
Label
Apr 1990 SUPPL Priority
Mfg
Jul 1988 SUPPL Priority
Mfg
Apr 1987 SUPPL
Label
Sep 1986 SUPPL
Label
Nov 1985 SUPPL
Label
Aug 1985 SUPPL Priority
Mfg
Mar 1984 SUPPL
Label
Aug 1978 SUPPL
Label
Feb 1977 SUPPL Priority
Mfg
Jan 1966 ORIGINAL Priority
New Drug
What THIOGUANINE Treats
2 indicationsTHIOGUANINE is approved for 2 conditions since its original approval in 1966. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Acute Nonlymphocytic Leukemia
- Chronic Myelogenous Leukemia
Source: FDA Label
THIOGUANINE Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Indication competitors
10
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What's emerging in THIOGUANINE's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications THIOGUANINE treats. First-in-class if their pivotal trials read out positive.
Drugs Similar to THIOGUANINE
3 of 5FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
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Clinical Trial Registry
28 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 |
| NCT04043494 LBL 2018 | UKM17_0023 2017-001691-39 | Ph 3 | recruiting | International Cooperative Treatment Protocol for Children and Adolescents With Lymphoblastic Lymphoma |
| 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 |
| 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) |
| NCT06533748 | SJALL23H NCI-2024-06013 | Ph 2 | recruiting | Therapy for Newly Diagnosed Patients With B-Cell Precursor Acute Lymphoblastic Leukemia and Lymphoma |
| NCT00558519 results posted | CALGB-10403 CALGB-10403, ECOG C10403 | Ph 2 | completed | Combination Chemotherapy in Treating Young Patients With Newly Diagnosed Acute Lymphoblastic Leukemia |
| 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 |
| NCT02723994 | INCB 18424-269 AALL1521 | Ph 2 | completed | A Phase 2 Study of Ruxolitinib With Chemotherapy in Children With Acute Lymphoblastic Leukemia |
| NCT03571321 | IRB17-1110 | Ph 1 | recruiting | Ruxolitinib and Chemotherapy in Adolescents and Young Adults With Ph-like Acute Lymphoblastic Leukemia |
| NCT07072585 | AALL2331 NCI-2025-02230, AALL2331 | Ph 2, Ph 3 | not yet recruiting | 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) |
| 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 |
| NCT02521493 results posted | AAML1531 NCI-2015-00324, AAML1531 | Ph 3 | active not recruiting | Response-Based Chemotherapy in Treating Newly Diagnosed Acute Myeloid Leukemia or Myelodysplastic Syndrome in Younger Patients With Down Syndrome |
| 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 |
| NCT01228331 | CDR0000686545 2009-012758-18 | Ph 2, Ph 3 | completed | Clofarabine or High-Dose Cytarabine and Pegaspargase in Children with ALL |
| 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 |
| NCT01451515 results posted | NHL16 NCI-2012-00496 | Ph 2 | completed | NHL16: Study For Newly Diagnosed Patients With Acute Lymphoblastic Lymphoma |
| NCT01117441 | AIEOP-BFM ALL 2009 | Ph 3 | completed | International Collaborative Treatment Protocol For Children And Adolescents With Acute Lymphoblastic Leukemia |
| NCT00671034 results posted | AALL07P4 NCI-2009-00317, CDR0000594340 | Ph 3 | completed | Calaspargase Pegol or Pegaspargase and Combination Chemotherapy in Treating Younger Patients With Newly Diagnosed High-Risk Acute Lymphoblastic Leukemia |
| NCT00866307 results posted | AALL08P1 NCI-2009-01169, CDR0000636174 | Ph 1 | completed | Pegaspargase and Combination Chemotherapy in Treating Younger Patients With Newly Diagnosed High-Risk Acute Lymphoblastic Leukemia (Closed to Accrual 4-22-2011) |
| NCT02419469 results posted | 2014-0396 NCI-2015-00967 | Ph 2 | terminated | Augmented Berlin-Frankfurt-Munster Therapy Plus Ofatumumab for Young Adults With Acute Lymphoblastic Leukemia or Lymphoblastic Lymphoma |
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Pro Active Pipeline
Ongoing clinical trials by development phase
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Pro Key Completed Trials
Completed studies with published results, ranked by significance
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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.
THIOGUANINE FDA Label Details
Indications & Usage
FDA Label (PDF)THIOGUANINE is indicated for the treatment of Acute Nonlymphocytic Leukemia; Chronic Myelogenous Leukemia.
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Data Sources
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