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Data updated: Mar 10, 2026

MERCAPTOPURINE

MERCAPTOPURINE
Oncology Approved 2004-02-11
4
Indications
--
Phase 3 Trials
22
Years on Market

Details

Status
Prescription
First Approved
2004-02-11
Routes
ORAL
Dosage Forms
TABLET, SUSPENSION

Companies

Active Ingredient: MERCAPTOPURINE

MERCAPTOPURINE Approval History

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What MERCAPTOPURINE Treats

1 indications

MERCAPTOPURINE 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

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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

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

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Indications & Usage

Mercaptopurine is a nucleoside metabolic inhibitor indicated for the treatment of patients with acute lymphoblastic leukemia (ALL) as part of a combination chemotherapy maintenance regimen. 1.1 Acute Lymphoblastic Leukemia Mercaptopurine is indicated for the treatment of patients with acute lymphoblastic leukemia (ALL) as part of a combination chemotherapy maintenance regimen.

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Data Sources

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