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.

Clinical Trial Conditions for allopurinol sodium

Condition Name

Condition Name for allopurinol sodium
Intervention	Trials
Hypertension	2
Type 1 Diabetes	1
Heart Diseases	1
Hyperuricemia or Gout	1

Condition MeSH

Condition MeSH for allopurinol sodium
Intervention	Trials
Leishmaniasis, Cutaneous	2
Leishmaniasis	2
Hypertension	2
Kidney Diseases	2

Clinical Trial Locations for allopurinol sodium

Trials by Country

Trials by Country for allopurinol sodium
Location	Trials
United States	3
China	2
Korea, Republic of	1
Netherlands	1
Pakistan	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
University of Bari	1
Universidad de Santander	1
Fondazione Schena	1

Sponsor Type

Sponsor Type for allopurinol sodium
Sponsor	Trials
Other	20

Allopurinol Sodium Clinical Trials Update, Market Analysis, and Forecast (2024–2035)

Last updated: July 27, 2026

Allopurinol sodium is the soluble salt form of allopurinol, used to achieve rapid xanthine-oxidase inhibition in settings where oral administration is not feasible. Public clinical-trials activity is limited compared with the longstanding allopurinol tablet franchise; commercial dynamics track the underlying allopurinol market, with supply availability and hospital formulary adoption driving near-term demand. Market projections through 2035 are best modeled as a low-growth to modest-growth segment within the broader urate-lowering therapy market, with upside tied to institutional use, oncology tumor lysis syndrome (TLS) protocols, and breakthrough payer or formulary expansions.

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What clinical trials are ongoing for allopurinol sodium (IV) and what are the key endpoints?

Are there active interventional studies for allopurinol sodium specifically?

Publicly indexed interventional trial activity for “allopurinol sodium” is sparse and often fragmented across:

• salt naming variations (allopurinol sodium, allopurinol sodium injection, soluble allopurinol)
• comparators (rasburicase, hydration protocols, standard of care)
• patient settings (TLS prophylaxis, TLS treatment, advanced malignancies, renal impairment)

The practical implication for investors and partners is that the clinical evidence base for the salt form largely reinforces established allopurinol pharmacology and differs mainly by administration route and formulation-controlled PK/PD and safety observations.

What endpoints are typically reported in allopurinol TLS and xanthine-oxidase inhibitor studies?

Trials that include allopurinol (including sodium salt formulations) commonly report:

• serum uric acid change from baseline and time to target urate reduction
• incidence of TLS (biochemical and clinical TLS)
• time to achieve urate normalization
• renal safety (creatinine change, AKI rates)
• adverse events including hepatic enzymes and hypersensitivity
• need for rescue therapy (often rasburicase)

Clinical-trial monitoring focus for allopurinol sodium is route-specific: readiness to demonstrate comparable urate-lowering performance and tolerability when given intravenously versus oral allopurinol.

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When do major clinical trials for allopurinol sodium read out, and how do timelines affect market entry or expansion?

Why “trial readout timing” matters less for allopurinol sodium than for new chemical entities

Allopurinol is not new; allopurinol sodium is mainly a formulation/route product. As a result:

• trial timelines rarely create a clean “new entrant” step-change
• adoption is tied to hospital procurement cycles, guideline embedding, and supply continuity
• regulatory pathways for reformulations can compress development time versus brand-new active ingredients

For commercialization planning, the highest value is not prospective phase progression but:

• stability of supply and pharmacovigilance
• competitive availability versus rasburicase in TLS protocols
• institutional confidence in dosing, infusion compatibility, and handling procedures

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How does the allopurinol sodium evidence compare with rasburicase for tumor lysis syndrome?

Clinical comparison drivers in TLS protocols

Even where allopurinol sodium is used in TLS prophylaxis or treatment, rasburicase has different clinical positioning:

• rasburicase provides immediate urate degradation through uricolysis
• allopurinol inhibits xanthine oxidase, slowing production of uric acid and requiring time for urate reduction
• practice patterns often favor rasburicase for established TLS or high-risk cases where rapid urate control is required

How IV allopurinol sodium fits in real-world TLS workflows

Allopurinol sodium is generally evaluated as:

• prophylaxis or early intervention where rapid urate reduction is less critical than in fulminant TLS
• alternative when rasburicase is not available, not covered, or contraindicated
• solution when oral intake is delayed or unsafe

The competitive market impact is therefore incremental rather than substitutional at the class level, unless guideline changes materially broaden IV allopurinol sodium use.

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What is the market size of allopurinol sodium (IV) and how fast is it growing?

Market definition issue that drives forecast selection

Public market data is typically reported for:

• the active ingredient allopurinol (tablets) across geographies
• urate-lowering therapy class aggregates
• TLS-supportive care markets (including rasburicase and urate-lowering agents)

Allopurinol sodium as a distinct “market” category is less consistently reported, meaning forecasting must treat it as a segment within the allopurinol supply chain:

• conversion of institutional consumption from oral allopurinol to IV sodium salt for specific care settings
• total institutional TLS and oncology infusion volumes
• formulary and procurement constraints

Segment growth outlook (directional)

A defensible segmentation for 2024–2035:

• base demand: continued hospital use in TLS protocols and inpatient bridging
• substitution pressure: rasburicase adoption in high-risk TLS pathways
• modest growth tail: expanded inpatient chemotherapy throughput, aging oncology populations, and tighter TLS prophylaxis checklists

Overall expectation is low single-digit growth for the IV-salt segment, assuming no major payer/guideline shift that materially increases IV urate-lowering penetration.

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How do pricing, tendering, and hospital procurement dynamics affect allopurinol sodium revenue?

What drives economic outcomes

Unlike branded chronic use products, IV allopurinol sodium competes on:

• tender pricing and unit cost per patient episode
• supply reliability and lead times
• pack size, concentration, storage stability, and administration burden
• inclusion in hospital formularies and chemotherapy pathway order sets

Key pricing lever

Volume concentration in large purchasing organizations determines realized pricing more than wholesale list pricing. Allopurinol sodium revenue sensitivity typically tracks:

• TLS hospitalization and infusion center volumes
• formulary updates and stewardship decisions
• competitive inventory cycles among generics

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What is the competitive landscape for allopurinol sodium (injection) and who are the major suppliers?

How competition typically manifests

Competition in IV allopurinol usually comes from:

• generic injectables with differing concentrations, pack sizes, and submission histories
• branded and generic allopurinol oral products that may shift use away from IV when oral intake is safe
• TLS alternatives such as rasburicase and other supportive agents

What to assess for commercial risk

• number of ANDA/abbreviated pathways and market exits
• quality/compliance signals (manufacturing interruptions)
• regional tender winners and secondary supplier arrangements

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What patents protect allopurinol sodium (IV) and how strong is the patent estate?

Allopurinol as an API has a long-standing patent and generic era. For the sodium salt injectable, practical IP risk is usually concentrated in:

• formulation-specific patents (stability, concentration, excipient systems)
• manufacturing process patents (sterility assurance, particle control, residual impurities)
• device and administration system claims (less common for simple injections)
• method-of-use claims tied to TLS prophylaxis or oncology regimens

If a salt-form or formulation patent exists in a given jurisdiction, it often has limited lifespan and will have already expired or be close to expiration for most markets, leaving the competitive field to generics and supply chains.

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What generic entry risks exist for allopurinol sodium and how does FDA exclusivity affect launch timing?

Exclusivity and entry risk: the practical view

For established APIs with long patent history:

• the main barrier tends to be formulation-specific patents and any remaining patents on the specific injectable product
• FDA exclusivities are less likely to be the binding constraint unless there is a still-active listed drug-specific pediatric, data, or reference exclusivity

As a result, generic entry timing is more often constrained by:

• patent litigation status (if any active listed patents)
• manufacturing capacity and inspection outcomes
• product-specific formulation and labeling acceptance

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What is the Orange Book status of allopurinol sodium (injection) and how does it map to litigation risk?

Orange Book mapping framework

For any injectable of allopurinol sodium, Orange Book analysis should be structured around:

• listed drug(s) and their marketing status
• each listed patent’s expiration date
• which patent numbers are asserted in any Paragraph IV filings (if present)
• whether settlement agreements exist and whether there are authorized generics

Without a product-specific Orange Book table, the most actionable approach is to treat litigation risk as likely low in mature allopurinol landscapes, unless a current formulation patent or newly listed patent blocks an abbreviated filing.

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What formulations are protected by patents for allopurinol sodium, and what dosage forms matter?

Dose form segmentation

Clinically relevant segmentation for allopurinol sodium includes:

• injection concentration and fill size
• buffering and excipient system controlling solubility and pH
• stability under common infusion setups
• compatibility with IV lines and co-administered oncology regimens

Market impact comes from whether competing products can match:

• storage conditions
• dosing flexibility
• shelf-life performance in hospital storage

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What FDA regulatory pathway applies to allopurinol sodium and what data requirements usually govern changes?

Route and change classification

For established active ingredients, regulatory submissions for the injectable sodium salt generally require:

• product-specific chemistry manufacturing and controls (CMC) alignment
• sterility, endotoxin, and stability showing for the final formulation
• bioequivalence is often route- and formulation-specific; IV products frequently rely on PK comparability and clinical relevance of urate-lowering markers

The practical entry speed depends more on CMC execution and inspection readiness than on novel clinical endpoints.

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Market projection 2024–2035: base case, upside, and downside scenarios for allopurinol sodium (IV)

Model structure

A segment-level forecast for allopurinol sodium typically ties to:

• TLS incidence and oncology infusion volumes (demand driver)
• penetration of IV over oral in hospitalized settings (share driver)
• average selling price (realization driver)
• competitive intensity and supply continuity (risk driver)

Base case

Assumes:

• stable IV TLS protocol use
• ongoing generic supply without major shortages
• pricing pressure from tender dynamics stabilizing at low single-digit declines or flat-to-modest increases

Outcome: low single-digit CAGR for IV allopurinol sodium segment through 2035, with growth driven mainly by hospital volume rather than label expansion.

Upside

Occurs if:

• guideline updates or payer policies increase IV prophylaxis or early-treatment reliance
• rasburicase access constraints (coverage, shortage, or budget impact) push more patients toward allopurinol sodium
• expanded oncology centers increase supportive infusion utilization

Outcome: higher single-digit growth with better realization from volume concentration.

Downside

Occurs if:

• TLS pathways further shift toward rasburicase for broader risk tiers
• shortages or quality actions limit supply and force switching
• additional generic competition drives sustained pricing compression

Outcome: flat to low growth with episodic volatility.

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Key regional commercialization outlook: where allopurinol sodium demand is likely concentrated

Drivers by geography

• North America: hospital formulary adoption and oncology center concentration
• Europe: national procurement structures and MS/therapeutic guideline adherence
• Emerging markets: variable TLS protocol penetration and supply stability as the primary constraints

Because allopurinol is generic widely, the limiting factor for the IV sodium salt segment is not API availability alone but injectable formulation supply and tender access.

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Key Takeaways

• Allopurinol sodium demand tracks IV supportive care needs tied to TLS and hospitalized oncology workflows, not chronic urate-lowering markets alone.
• Clinical-trials activity specific to the salt form is limited in public visibility; commercialization relies more on formulation evidence, CMC stability, and hospital protocol adoption than on new phase readouts.
• Competitive dynamics are supply- and tender-driven; pricing is compressed by generic competition and hospital procurement cycles.
• Forecast outlook for 2024–2035 is best modeled as low-growth to modest-growth, with upside tied to TLS protocol shifts that broaden IV allopurinol sodium use.

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FAQs

1. Is IV allopurinol sodium interchangeable with oral allopurinol for tumor lysis syndrome prophylaxis?
2. How does allopurinol sodium dosing differ across renal impairment populations in TLS protocols?
3. What formulation attributes most influence hospital acceptance of allopurinol sodium injection (stability, pH, infusion compatibility)?
4. Do supply shortages of rasburicase increase utilization of allopurinol sodium injection?
5. What are the main FDA CMC hurdles for biosimilar-like competition is not relevant, so what hurdles matter for injectable sodium salt generics?

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References

1. APA: Not provided.