CLINICAL TRIALS PROFILE FOR ALLOPURINOL SODIUM

All Clinical Trials for Allopurinol Sodium

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
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.
NCT00317629 ↗	Controlled Nitric Oxide Releasing Patch Versus Meglumine Antimoniate in the Treatment of Cutaneous Leishmaniasis	Terminated	Secretaria de Salud de Santander	Phase 3	2006-05-01	Cutaneous leishmaniasis is a worldwide disease, endemic in 88 countries, that has shown an increasing incidence over the last two decades. So far, pentavalent antimony compounds have been considered the treatment of choice, with a percentage of cure of about 85%. However, the high efficacy of these drugs is counteracted by their many disadvantages and adverse events. Previous studies have shown nitric oxide to be a potential alternative treatment when administered topically with no serious adverse events. However, due to the unstable nitric oxide release, the topical donors needed to be applied frequently, making the adherence to the treatment difficult. The electrospinning technique has allowed the production of a multilayer transdermal patch that produces a continuous and stable nitric oxide release. The main objective of this study is to evaluate this novel nitric oxide topical donor for the treatment of cutaneous leishmaniasis. A double-blind, randomized, double-masked, placebo-controlled clinical trial, including 620 patients from endemic areas for leishmaniasis in Colombia was designed to investigate whether this patch is as effective as meglumine antimoniate for the treatment of cutaneous leishmaniasis but with less adverse events. Subjects with ulcers characteristic of cutaneous leishmaniasis will be medically evaluated and laboratory tests and parasitological confirmation performed. After checking the inclusion/exclusion criteria, the patients will be randomly assigned to one of two groups. During 20 days Group 1 will receive simultaneously meglumine antimoniate and placebo of nitric oxide patches while Group 2 will receive placebo of meglumine antimoniate and active nitric oxide patches. During the treatment visits, the medications will be administered daily and the presence of adverse events assessed. During the follow-up, the research group will visit the patients at days 21, 45, 90 and 180. The healing process of the ulcer, the health of the participants, recidivisms and/or reinfection will also be assessed. The evolution of the ulcers will be photographically registered. In the case that the effectiveness of the patches is demonstrated, a novel and safe therapeutic alternative for one of the most important public health problems in many countries will be available to patients.
NCT00317629 ↗	Controlled Nitric Oxide Releasing Patch Versus Meglumine Antimoniate in the Treatment of Cutaneous Leishmaniasis	Terminated	Secretaria de Salud de Tolima	Phase 3	2006-05-01	Cutaneous leishmaniasis is a worldwide disease, endemic in 88 countries, that has shown an increasing incidence over the last two decades. So far, pentavalent antimony compounds have been considered the treatment of choice, with a percentage of cure of about 85%. However, the high efficacy of these drugs is counteracted by their many disadvantages and adverse events. Previous studies have shown nitric oxide to be a potential alternative treatment when administered topically with no serious adverse events. However, due to the unstable nitric oxide release, the topical donors needed to be applied frequently, making the adherence to the treatment difficult. The electrospinning technique has allowed the production of a multilayer transdermal patch that produces a continuous and stable nitric oxide release. The main objective of this study is to evaluate this novel nitric oxide topical donor for the treatment of cutaneous leishmaniasis. A double-blind, randomized, double-masked, placebo-controlled clinical trial, including 620 patients from endemic areas for leishmaniasis in Colombia was designed to investigate whether this patch is as effective as meglumine antimoniate for the treatment of cutaneous leishmaniasis but with less adverse events. Subjects with ulcers characteristic of cutaneous leishmaniasis will be medically evaluated and laboratory tests and parasitological confirmation performed. After checking the inclusion/exclusion criteria, the patients will be randomly assigned to one of two groups. During 20 days Group 1 will receive simultaneously meglumine antimoniate and placebo of nitric oxide patches while Group 2 will receive placebo of meglumine antimoniate and active nitric oxide patches. During the treatment visits, the medications will be administered daily and the presence of adverse events assessed. During the follow-up, the research group will visit the patients at days 21, 45, 90 and 180. The healing process of the ulcer, the health of the participants, recidivisms and/or reinfection will also be assessed. The evolution of the ulcers will be photographically registered. In the case that the effectiveness of the patches is demonstrated, a novel and safe therapeutic alternative for one of the most important public health problems in many countries will be available to patients.
NCT00317629 ↗	Controlled Nitric Oxide Releasing Patch Versus Meglumine Antimoniate in the Treatment of Cutaneous Leishmaniasis	Terminated	The University of Akron	Phase 3	2006-05-01	Cutaneous leishmaniasis is a worldwide disease, endemic in 88 countries, that has shown an increasing incidence over the last two decades. So far, pentavalent antimony compounds have been considered the treatment of choice, with a percentage of cure of about 85%. However, the high efficacy of these drugs is counteracted by their many disadvantages and adverse events. Previous studies have shown nitric oxide to be a potential alternative treatment when administered topically with no serious adverse events. However, due to the unstable nitric oxide release, the topical donors needed to be applied frequently, making the adherence to the treatment difficult. The electrospinning technique has allowed the production of a multilayer transdermal patch that produces a continuous and stable nitric oxide release. The main objective of this study is to evaluate this novel nitric oxide topical donor for the treatment of cutaneous leishmaniasis. A double-blind, randomized, double-masked, placebo-controlled clinical trial, including 620 patients from endemic areas for leishmaniasis in Colombia was designed to investigate whether this patch is as effective as meglumine antimoniate for the treatment of cutaneous leishmaniasis but with less adverse events. Subjects with ulcers characteristic of cutaneous leishmaniasis will be medically evaluated and laboratory tests and parasitological confirmation performed. After checking the inclusion/exclusion criteria, the patients will be randomly assigned to one of two groups. During 20 days Group 1 will receive simultaneously meglumine antimoniate and placebo of nitric oxide patches while Group 2 will receive placebo of meglumine antimoniate and active nitric oxide patches. During the treatment visits, the medications will be administered daily and the presence of adverse events assessed. During the follow-up, the research group will visit the patients at days 21, 45, 90 and 180. The healing process of the ulcer, the health of the participants, recidivisms and/or reinfection will also be assessed. The evolution of the ulcers will be photographically registered. In the case that the effectiveness of the patches is demonstrated, a novel and safe therapeutic alternative for one of the most important public health problems in many countries will be available to patients.
NCT00317629 ↗	Controlled Nitric Oxide Releasing Patch Versus Meglumine Antimoniate in the Treatment of Cutaneous Leishmaniasis	Terminated	Universidad de Antioquia	Phase 3	2006-05-01	Cutaneous leishmaniasis is a worldwide disease, endemic in 88 countries, that has shown an increasing incidence over the last two decades. So far, pentavalent antimony compounds have been considered the treatment of choice, with a percentage of cure of about 85%. However, the high efficacy of these drugs is counteracted by their many disadvantages and adverse events. Previous studies have shown nitric oxide to be a potential alternative treatment when administered topically with no serious adverse events. However, due to the unstable nitric oxide release, the topical donors needed to be applied frequently, making the adherence to the treatment difficult. The electrospinning technique has allowed the production of a multilayer transdermal patch that produces a continuous and stable nitric oxide release. The main objective of this study is to evaluate this novel nitric oxide topical donor for the treatment of cutaneous leishmaniasis. A double-blind, randomized, double-masked, placebo-controlled clinical trial, including 620 patients from endemic areas for leishmaniasis in Colombia was designed to investigate whether this patch is as effective as meglumine antimoniate for the treatment of cutaneous leishmaniasis but with less adverse events. Subjects with ulcers characteristic of cutaneous leishmaniasis will be medically evaluated and laboratory tests and parasitological confirmation performed. After checking the inclusion/exclusion criteria, the patients will be randomly assigned to one of two groups. During 20 days Group 1 will receive simultaneously meglumine antimoniate and placebo of nitric oxide patches while Group 2 will receive placebo of meglumine antimoniate and active nitric oxide patches. During the treatment visits, the medications will be administered daily and the presence of adverse events assessed. During the follow-up, the research group will visit the patients at days 21, 45, 90 and 180. The healing process of the ulcer, the health of the participants, recidivisms and/or reinfection will also be assessed. The evolution of the ulcers will be photographically registered. In the case that the effectiveness of the patches is demonstrated, a novel and safe therapeutic alternative for one of the most important public health problems in many countries will be available to patients.

Clinical Trial Conditions for Allopurinol Sodium

Condition Name

Condition Name for Allopurinol Sodium
Intervention	Trials
Hypertension	2
Hyperuricemia or Gout	1
Immunoglobulin A Nephropathy	1
Atrial Fibrillation	1

Condition MeSH

Condition MeSH for Allopurinol Sodium
Intervention	Trials
Kidney Diseases	2
Leishmaniasis, Cutaneous	2
Leishmaniasis	2
Hypertension	2

Clinical Trial Locations for Allopurinol Sodium

Trials by Country

Trials by Country for Allopurinol Sodium
Location	Trials
United States	3
China	2
Colombia	1
Brazil	1
Korea, Republic of	1

Trials by US State

Trials by US State for Allopurinol Sodium
Location	Trials
Colorado	1
Utah	1
Florida	1

Clinical Trial Progress for Allopurinol Sodium

Clinical Trial Phase

Clinical Trial Phase for Allopurinol Sodium
Clinical Trial Phase	Trials
PHASE4	1
Phase 4	4
Phase 3	4

Clinical Trial Status

Clinical Trial Status for Allopurinol Sodium
Clinical Trial Phase	Trials
Completed	6
Unknown status	2
Terminated	1

Clinical Trial Sponsors for Allopurinol Sodium

Sponsor Name

Sponsor Name for Allopurinol Sodium
Sponsor	Trials
UMC Utrecht	1
Fundação de Amparo à Pesquisa do Estado de São Paulo	1
University of Florida	1

Sponsor Type

Sponsor Type for Allopurinol Sodium
Sponsor	Trials
Other	20

Allopurinol Sodium Market Analysis and Financial Projection

Last updated: April 27, 2026

Allopurinol Sodium: Clinical-Stage Update, Market Read and Demand Outlook

Allopurinol sodium is the commercially established urate-lowering therapy (ULT) in gout and a core option for hyperuricemia management. It is a legacy generic drug with broad manufacturing coverage, so market outcomes are dominated by patent-free competition, pricing pressure, tender dynamics, and guideline-based utilization rather than late-stage clinical entrants.

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What does the clinical-trials landscape look like for allopurinol sodium?

Trial density: mostly formulation, dosing, and real-world evidence

For an established, off-patent medicine, the global clinical literature and registries tend to concentrate on:

• Bioequivalence and formulation changes (tablet strength variants, excipient shifts, regional manufacturing)
• Comparative effectiveness and real-world outcomes using allopurinol versus other ULTs (febuxostat, pegloticase in refractory disease)
• Safety and dosing strategies, including titration protocols and adherence interventions

Phase distribution (practical read-through)

Across typical registries for mature ULTs, the pattern for allopurinol is:

• Late-stage “new mechanism” development: uncommon
• Phase 2 to Phase 3: sparse relative to novel urate-lowering candidates
• Phase 1/BA and pragmatic trials: more common

Given allopurinol’s position as standard-of-care in urate reduction and longstanding use, most “clinical trial updates” relevant to investors are incremental: local regulatory submissions, bioequivalence batches, and evidence-generation around dosing tolerance and treat-to-target implementation.

Key clinical evidence drivers used by payers and guidelines

The utilization of allopurinol is reinforced by treat-to-target urate control and safety profile evidence that supports its role as first-line ULT. Major guideline bodies align on:

• ULT use for gout with urate-lowering targets
• Allopurinol as first-line for most patients
• Dose titration based on serum urate

Clinical decision context: if urate control programs expand or payers enforce treat-to-target pathways, volumes for allopurinol tend to stabilize even as competitors gain share.

Sources: ACR guidance is repeatedly cited in payer and clinician workflows. (See citations [1], [2].)

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Where does allopurinol sodium sit in the competitive market?

Market structure: generic-heavy, multi-manufacturer, tender-led

Allopurinol sodium is widely distributed and available as generic products under multiple brand and label configurations. The competitive set typically includes:

• Other generic allopurinol brands (price competition and supply assurance)
• Alternative ULTs: febuxostat (often used when allopurinol is not tolerated)
• Biologic or specialty options for refractory gout (e.g., pegloticase), with different patient funnels

What wins demand in this segment

For allopurinol, commercial outcomes correlate more with:

• Access and reimbursement (formulary placement)
• Acquisition cost and tender pricing
• Supply reliability (national and regional manufacturing capacity)
• Clinical pathway adoption (treat-to-target, adherence programs)

Novel-therapy marketing has limited displacement power unless it changes guideline positioning or payer coverage rules at scale.

Adverse event and tolerability economics

Allopurinol is used widely, with monitoring around hypersensitivity risk and kidney function considerations. This affects:

• Starting doses in CKD
• Need for patient education and follow-up
• Switching rates to febuxostat in intolerance cases

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How big is the total addressable demand for allopurinol-based ULT?

Core demand pool: gout prevalence and hyperuricemia treatment

The market demand for allopurinol is driven by:

• Gout incidence and prevalence
• ULT initiation rates after diagnosis
• Persistence/adherence to chronic urate lowering
• Intensity of treat-to-target implementation

Global gout epidemiology provides the macro ceiling. Updated population-based analyses show rising gout burden in many regions, with a mix of underdiagnosis and undertreatment that creates long-run expansion potential for ULT adoption.

Sources for gout epidemiology and burden: [3], [4].

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What is the projected market trajectory for allopurinol sodium (2019-2030)?

Projection logic (high-level)

Allopurinol sodium’s projection rests on four levers:

1. Unit volume: driven by gout burden and ULT uptake
2. Real pricing: typically pressured in generics; margins compress unless differentiated via supply or tender wins
3. Share shifts: small churn to febuxostat for intolerance, but no structural replacement
4. Policy effect: treat-to-target and guideline-driven programs raise continuation and titration, lifting total consumption

Base-case projection (qualitative)

• Volumes: steady to modest growth, tied to broader gout recognition and ULT penetration.
• Value: flatter than volume because pricing in generic categories declines or remains constrained.
• Market share: stable for allopurinol as first-line; incremental share loss to febuxostat occurs where clinicians and payers favor it due to formulary rules or intolerance.

Upside scenario

• Acceleration in guideline implementation and tighter payer enforcement of treat-to-target
• Expansion of chronic disease management programs that increase long-term persistence

Downside scenario

• Stronger formulary preferences for febuxostat in “uncomplicated” pathways
• Additional generic price erosion in key tender markets faster than demand growth

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What is the patent and exclusivity risk profile for this molecule?

Allopurinol is not protected by meaningful active patent exclusivity for most jurisdictions. As a result:

• Launch barriers are low
• Differentiation is mostly manufacturing, bioequivalence, and distribution
• The market is characterized by ongoing generic supply and periodic pricing resets

This lowers R&D upside for new entrants unless they develop differentiated formulations or delivery systems, or they target specific subpopulations with new evidence.

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What regulatory and quality factors matter most for allopurinol sodium suppliers?

Bioequivalence is the central clearance pathway

For off-patent drugs, commercial entries typically depend on:

• Bioequivalence demonstrations
• Compliance with cGMP standards
• Stability and manufacturing process controls for consistent product performance

Formulation and packaging

Commercial continuity depends on:

• Batch-to-batch impurity controls
• Shelf-life and storage performance
• Strength-specific demand planning (common tablet strengths have different procurement patterns by country)

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So what should decision-makers do: investment and R&D positioning

Investment posture

• Treat allopurinol sodium as a cashflow and supply-chain business rather than a clinical innovation platform.
• Underwrite returns around tender competitiveness and manufacturing reliability, not clinical differentiation.

R&D posture

If building a development pipeline around allopurinol:

• Focus on formulation differentiation where it can change access or adherence (dose titration usability, tolerability management support)
• Target evidence-generation around treat-to-target implementation and persistence outcomes (real-world and pragmatic endpoints)

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Key Takeaways

• Allopurinol sodium is established standard ULT with clinical activity dominated by incremental trials (bioequivalence, pragmatic evidence, dosing strategies), not late-stage innovation.
• Market dynamics are generic and tender-led; demand is driven by gout burden, ULT initiation, and persistence under treat-to-target pathways.
• Projection supports stable to modest volume growth and flatter-to-soft value growth due to price competition.
• Competitive differentiation is less about new clinical claims and more about supply reliability, access, and execution in formularies and tenders.

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FAQs

1) Is allopurinol sodium still used as first-line therapy for gout?

Yes. Major rheumatology guidance positions allopurinol as first-line ULT for most patients, using treat-to-target serum urate and titration.

2) Do new clinical trials materially change the role of allopurinol?

Most new trials are incremental (bioequivalence, dosing strategies, implementation studies). They reinforce utilization patterns more than they change the therapeutic hierarchy at population scale.

3) How does febuxostat affect allopurinol demand?

Febuxostat can capture share when patients cannot tolerate allopurinol or when formulary preferences shift. However, it does not structurally replace first-line positioning in guideline-based practice.

4) What drives long-term unit volume for allopurinol?

Gout incidence and prevalence, plus ULT initiation rates and persistence under treat-to-target care pathways.

5) What should matter most to suppliers competing for contracts?

Tender pricing, supply continuity, and product quality consistency, with regulatory clearance typically depending on bioequivalence rather than novel clinical endpoints.

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References (APA)

[1] American College of Rheumatology. (2020). 2020 American College of Rheumatology guideline for the management of gout. Arthritis Care & Research.
[2] European Alliance of Associations for Rheumatology (EULAR). (2016). EULAR evidence-based recommendations for the management of gout. Annals of the Rheumatic Diseases.
[3] Neogi, T., & Jansen, T. L. (2017). Epidemiology of gout. Rheumatic Disease Clinics of North America.
[4] Dalbeth, N., & Merriman, T. R. (2015). Epidemiology and genetics of gout. Nature Reviews Rheumatology.