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Data updated: May 26, 2026

ALOPRIM (allopurinol sodium)

Oncology Approved 1996-05-17

Aloprim helps adult and pediatric cancer patients manage high levels of uric acid in their blood and urine caused by certain cancer therapies. It is used for individuals with leukemia, lymphoma, or solid tumors who are unable to take oral medications. By controlling these uric acid levels, the drug helps prevent complications that can arise during intensive cancer treatment.

Source: FDA Label • Viatris

How ALOPRIM Works

Aloprim works by blocking xanthine oxidase, the specific enzyme responsible for converting purine bases into uric acid. By inhibiting this process, the medication reduces the overall production of uric acid in both the blood and urine. This approach avoids the risks associated with drugs that lower uric acid by forcing the kidneys to excrete more of it.

1
Indication
--
Phase 3 Trials
1
Priority Reviews
30
Years on Market

Details

Status
Prescription
First Approved
1996-05-17
Routes
INJECTION
Dosage Forms
INJECTABLE

Companies

Active Ingredient: ALLOPURINOL SODIUM

ALOPRIM Approval History

1997
1998
1999
2000
2001
2002
2003
2004
2005
2006
2007
2008
2009
2010
2011
2012
2013
2014
2015
2016
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2020
2021
2022
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2024
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2026
Original
New Indication
New Form
Label Update
8 FDA actions from 1996 to 2022
Feb 2022 SUPPL
Label · Labeling
Dec 2020 SUPPL
Label · Labeling
Aug 2020 SUPPL
Label · Labeling

What ALOPRIM Treats

3 indications

ALOPRIM is approved for 3 conditions since its original approval in 1996. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Leukemia
  • Lymphoma
  • Solid Tumor Malignancies
Source: FDA Label

ALOPRIM Competitive Set

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

Direct competitors

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MoA expansion candidates

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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.

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

Drugs Similar to ALOPRIM

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Shared indications:
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Shared indications:
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Active Pipeline

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Key Completed 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.

ALOPRIM FDA Label Details

Indications & Usage

FDA Label (PDF)

ALOPRIM is indicated for the treatment of Leukemia; Lymphoma; Solid Tumor Malignancies.

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Data Sources

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