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Last Updated: March 17, 2025

CLINICAL TRIALS PROFILE FOR ALLOPURINOL SODIUM


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All Clinical Trials for ALLOPURINOL SODIUM

Trial IDTitleStatusSponsorPhaseStart DateSummary
NCT00189007 ↗ Antenatal Allopurinol During Fetal Hypoxia Unknown status ZonMw: The Netherlands Organisation for Health Research and Development Phase 3 2009-10-01 A former study (submitted) in 32 severely asphyxiated infants participating in a randomized double blind study, in which early postnatal allopurinol or a placebo (within 4 hours after birth) was administered to reduce free radical formation and consequently reperfusion/reoxygenation injury to the newborn brain, showed an unaltered high mortality and no clinically relevant improvement in morbidity in infants treated with allopurinol. It was hypothesized that postnatal allopurinol treatment started too late to reduce reperfusion-induced free radical surge and that initiating allopurinol treatment of the fetus with (imminent) hypoxia already via the mother during labor will be more effective to reduce free radical-induced post-asphyxial brain damage.
NCT00189007 ↗ Antenatal Allopurinol During Fetal Hypoxia Unknown status UMC Utrecht Phase 3 2009-10-01 A former study (submitted) in 32 severely asphyxiated infants participating in a randomized double blind study, in which early postnatal allopurinol or a placebo (within 4 hours after birth) was administered to reduce free radical formation and consequently reperfusion/reoxygenation injury to the newborn brain, showed an unaltered high mortality and no clinically relevant improvement in morbidity in infants treated with allopurinol. It was hypothesized that postnatal allopurinol treatment started too late to reduce reperfusion-induced free radical surge and that initiating allopurinol treatment of the fetus with (imminent) hypoxia already via the mother during labor will be more effective to reduce free radical-induced post-asphyxial brain damage.
NCT00241839 ↗ Uric Acid and Hypertension in African Americans Completed University of Florida Phase 3 2005-08-01 This study will test the hypothesis that the administration of a xanthine oxidase inhibitor (allopurinol) will prevent thiazide-induced hyperuricemia, which will result in better blood pressure (BP) control in African Americans.
>Trial ID>Title>Status>Phase>Start Date>Summary
Showing 1 to 3 of 3 entries

Clinical Trial Conditions for ALLOPURINOL SODIUM

Condition Name

2110-0.200.20.40.60.811.21.41.61.822.2HypertensionAtrial FibrillationLeukemia[disabled in preview]
Condition Name for ALLOPURINOL SODIUM
Intervention Trials
Hypertension 2
Atrial Fibrillation 1
Leukemia 1
[disabled in preview] 0
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Condition MeSH

2220-0.200.20.40.60.811.21.41.61.822.2Leishmaniasis, CutaneousLeishmaniasisHypertension[disabled in preview]
Condition MeSH for ALLOPURINOL SODIUM
Intervention Trials
Leishmaniasis, Cutaneous 2
Leishmaniasis 2
Hypertension 2
[disabled in preview] 0
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Clinical Trial Locations for ALLOPURINOL SODIUM

Trials by Country

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Trials by Country for ALLOPURINOL SODIUM
Location Trials
United States 3
Korea, Republic of 1
Netherlands 1
Pakistan 1
China 1
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Trials by US State

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Trials by US State for ALLOPURINOL SODIUM
Location Trials
Colorado 1
Utah 1
Florida 1
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Clinical Trial Progress for ALLOPURINOL SODIUM

Clinical Trial Phase

44.4%44.4%11.1%000.511.522.533.54Phase 4Phase 3Phase 2[disabled in preview]
Clinical Trial Phase for ALLOPURINOL SODIUM
Clinical Trial Phase Trials
Phase 4 4
Phase 3 4
Phase 2 1
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Clinical Trial Status

66.7%22.2%11.1%00123456CompletedUnknown statusNot yet recruiting[disabled in preview]
Clinical Trial Status for ALLOPURINOL SODIUM
Clinical Trial Phase Trials
Completed 6
Unknown status 2
Not yet recruiting 1
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Clinical Trial Sponsors for ALLOPURINOL SODIUM

Sponsor Name

trials000001111111Universidad de AntioquiaUniversity of BariUniversidad de Santander[disabled in preview]
Sponsor Name for ALLOPURINOL SODIUM
Sponsor Trials
Universidad de Antioquia 1
University of Bari 1
Universidad de Santander 1
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Sponsor Type

100.0%002468101214161820Other[disabled in preview]
Sponsor Type for ALLOPURINOL SODIUM
Sponsor Trials
Other 19
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Allopurinol Sodium: Clinical Trials, Market Analysis, and Projections

Introduction

Allopurinol, a well-established medication for managing gout and hyperuricemia, continues to be a focal point in both clinical research and market analysis. This article delves into the current clinical trials, market trends, and future projections for allopurinol sodium.

Clinical Trials Update

Ongoing and Recent Trials

Several clinical trials are currently underway or have recently concluded, providing valuable insights into the efficacy and safety of allopurinol and its combinations.

Verinurad Plus Allopurinol

A randomized clinical trial investigated the combination of verinurad and allopurinol in patients with heart failure with preserved ejection fraction. Although the combination significantly lowered serum uric acid (SUA) levels more than allopurinol monotherapy or placebo, it did not result in significant improvements in peak oxygen uptake or symptom scores. The trial highlighted the safety profile of the combination, with no adverse safety signals observed[1].

Tigulixostat vs. Allopurinol

A Phase 3 study, sponsored by LG Chem, is comparing the efficacy and safety of tigulixostat with allopurinol in gout patients with hyperuricemia. This multi-regional, double-blind, double-dummy parallel-group study aims to assess the proportion of subjects achieving SUA levels below 6.0 mg/dL and 5.0 mg/dL, as well as the incidence of gout flares and tophus resolution. The study is ongoing, with anticipated completion in December 2025[5].

Market Analysis

Current Market Size and Growth

The global allopurinol market is experiencing significant growth driven by several factors.

  • Market Size: The allopurinol market was valued at USD 1.2 billion in 2023 and is projected to reach USD 2.5 billion by 2033, growing at a CAGR of 7.5% during the forecast period of 2024-2033[3].
  • Segmentation: The market is segmented by drug class, application, demographic, dosage form, end-users, and distribution channels. Key applications include gout, kidney stones, and hyperuricemia management[2][3].

Drivers of Market Growth

Several factors are driving the growth of the allopurinol market:

  • Increasing Incidence of Gout and Kidney Stones: The rise in gout and kidney stone cases globally is a major driver for the expansion of the allopurinol market[2].
  • Aging Population: The increasing geriatric population, which is more prone to gout and hyperuricemia, is another significant factor[2].
  • Healthcare Expenditure: Rising healthcare expenditure and increasing demand from various end-use industries are also contributing to market growth[2].

Regional Market Insights

  • North America: This region dominates the allopurinol market due to the presence of major key players, high disposable income, and well-developed healthcare infrastructure[2].
  • Asia-Pacific: This region is expected to grow significantly during the forecast period due to increasing research and development activities and growing government support[2].

Market Projections

Future Growth Prospects

The allopurinol market is expected to continue its upward trend due to several favorable factors:

  • Research and Development: Increasing research and development activities, particularly in emerging markets, will provide beneficial opportunities for the allopurinol market[2][3].
  • Rising Awareness: Growing awareness about the importance of managing uric acid levels and the availability of effective treatments will positively impact market growth[2].

Challenges and Limitations

Despite the positive outlook, there are challenges that could hamper market growth:

  • High Cost and Side Effects: The high cost of the drug and associated side effects, such as loss of appetite, dizziness, and skin rash, may deter some patients[2].
  • Lack of Awareness: Limited awareness in certain regions could also challenge the market growth[2].

Key Takeaways

  • Clinical Trials: Ongoing trials, such as the verinurad plus allopurinol study and the tigulixostat vs. allopurinol study, are providing valuable data on the efficacy and safety of allopurinol combinations.
  • Market Growth: The global allopurinol market is projected to grow significantly, driven by increasing incidence of gout and kidney stones, an aging population, and rising healthcare expenditure.
  • Regional Insights: North America currently dominates the market, while the Asia-Pacific region is expected to show substantial growth.
  • Challenges: High drug costs and side effects, along with limited awareness in some regions, are potential challenges to market growth.

FAQs

What are the primary applications of allopurinol?

Allopurinol is primarily used to treat gout, kidney stones, and to lower uric acid levels in patients undergoing cancer treatment[2].

What is the projected market size of allopurinol by 2033?

The global allopurinol market is forecasted to reach USD 2.5 billion by 2033, growing at a CAGR of 7.5% from 2024 to 2033[3].

What are the main drivers of the allopurinol market growth?

Key drivers include the increasing incidence of gout and kidney stones, an aging population, rising healthcare expenditure, and growing demand from various end-use industries[2].

What are the common side effects associated with allopurinol?

Common side effects include loss of appetite, dizziness, fever, chills, blood in urine, and skin rash[2].

Which regions are expected to show significant growth in the allopurinol market?

North America currently dominates the market, while the Asia-Pacific region is expected to show substantial growth during the forecast period[2].

Sources

  1. PubMed: Verinurad Plus Allopurinol for Heart Failure With Preserved Ejection Fraction: A Randomized Clinical Trial.
  2. Data Bridge Market Research: Global Allopurinol Market - Industry Trends and Forecast to 2029.
  3. Verified Industry Insights: Global Sodium Allopurinol Industry Insights: Market Size, Growth, and Forecast.
  4. FDA: 209203Orig1s000 - accessdata.fda.gov.
  5. ClinicalTrials.gov: A Randomized, Multi-regional, Double-blind, Double-dummy Parallel-group, Placebo and Allopurinol-controlled Phase 3 Study to Assess the Efficacy and Safety of Tigulixostat in Gout Patients With Hyperuricemia.

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