CLINICAL TRIALS PROFILE FOR ELITEK

All Clinical Trials for ELITEK

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00057811 ↗	Rituximab, Rasburicase, and Combination Chemotherapy in Treating Young Patients With Newly Diagnosed Advanced B-Cell Leukemia or Lymphoma	Completed	National Cancer Institute (NCI)	Phase 2	2004-06-01	Phase II trial to study the effectiveness of combining rituximab and rasburicase with combination chemotherapy in treating young patients who have newly diagnosed advanced B-cell leukemia or lymphoma. Monoclonal antibodies such as rituximab can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. Drugs used in chemotherapy work in different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug with rituximab may kill more cancer cells. Chemoprotective drugs such as rasburicase may protect kidney cells from the side effects of chemotherapy.
NCT00057811 ↗	Rituximab, Rasburicase, and Combination Chemotherapy in Treating Young Patients With Newly Diagnosed Advanced B-Cell Leukemia or Lymphoma	Completed	Children's Oncology Group	Phase 2	2004-06-01	Phase II trial to study the effectiveness of combining rituximab and rasburicase with combination chemotherapy in treating young patients who have newly diagnosed advanced B-cell leukemia or lymphoma. Monoclonal antibodies such as rituximab can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. Drugs used in chemotherapy work in different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug with rituximab may kill more cancer cells. Chemoprotective drugs such as rasburicase may protect kidney cells from the side effects of chemotherapy.
NCT00360438 ↗	Pharmacokinetic Evaluation of Rasburicase in Patients With Leukemia and/or Lymphoma at High Risk of TLS	Completed	Sanofi	Phase 1/Phase 2	2006-07-01	Primary 1. To determine the pharmacokinetic (PK) parameters of rasburicase in adult patients with leukemia and/or lymphoma at high risk or potential risk of tumor lysis syndrome (TLS) Secondary 1. To evaluate plasma uric acid AUC from baseline (within 4 hours prior to first rasburicase treatment) through 48 hours after the last per-protocol planned administration of rasburicase treatment; 2. To evaluate the safety of rasburicase in adult patients with leukemia and/or lymphoma. 3. To evaluate incidence, duration, and type of immune responses (IgG, IgE, and neutralizing antibody) to rasburicase.
NCT00360438 ↗	Pharmacokinetic Evaluation of Rasburicase in Patients With Leukemia and/or Lymphoma at High Risk of TLS	Completed	M.D. Anderson Cancer Center	Phase 1/Phase 2	2006-07-01	Primary 1. To determine the pharmacokinetic (PK) parameters of rasburicase in adult patients with leukemia and/or lymphoma at high risk or potential risk of tumor lysis syndrome (TLS) Secondary 1. To evaluate plasma uric acid AUC from baseline (within 4 hours prior to first rasburicase treatment) through 48 hours after the last per-protocol planned administration of rasburicase treatment; 2. To evaluate the safety of rasburicase in adult patients with leukemia and/or lymphoma. 3. To evaluate incidence, duration, and type of immune responses (IgG, IgE, and neutralizing antibody) to rasburicase.
NCT01046825 ↗	Mature B-Cell Lymphoma And Leukemia Study III	Recruiting	St. Jude Children's Research Hospital	Phase 2/Phase 3	2010-09-09	This is a phase III clinical trial using risk-adapted therapy. Treatment outcomes for children with B-cell NHL are excellent. Further improvements in outcome will likely be achieved through more focused study of the biology of the tumors and prospective studies of the late effects of treatment. Toward this end, this study features a spectrum of prospective biologic and late effect studies performed in patients treated with a modified regimen derived from the very successful LMB-96 regimen.
NCT01200485 ↗	Rasburicase in Patients at High Risk for Tumor Lysis Syndrome (TLS) During Cycle-2	Completed	Sanofi	Phase 2	2011-04-01	The goal of this clinical research study is to learn if using Elitek (rasburicase) for 2 cycles can help to control or prevent TLS better than 1 cycle of rasburicase and 1 cycle of allopurinol. The safety of this treatment will also be studied.

Clinical Trial Conditions for ELITEK

Condition Name

Condition Name for ELITEK
Intervention	Trials
Leukemia	2
Tumor Lysis Syndrome	2
Lymphoma	2
Noncontiguous Stage II Adult Burkitt Lymphoma	1

Condition MeSH

Condition MeSH for ELITEK
Intervention	Trials
Leukemia	4
Lymphoma	4
Tumor Lysis Syndrome	3
Syndrome	3

Clinical Trial Locations for ELITEK

Trials by Country

Trials by Country for ELITEK
Location	Trials
United States	8
Singapore	1
Egypt	1

Trials by US State

Trials by US State for ELITEK
Location	Trials
Texas	3
California	2
Missouri	1
New York	1
Tennessee	1

Clinical Trial Progress for ELITEK

Clinical Trial Phase

Clinical Trial Phase for ELITEK
Clinical Trial Phase	Trials
Phase 4	1
Phase 2/Phase 3	1
Phase 2	3

Clinical Trial Status

Clinical Trial Status for ELITEK
Clinical Trial Phase	Trials
Completed	4
Not yet recruiting	1
Recruiting	1

Clinical Trial Sponsors for ELITEK

Sponsor Name

Sponsor Name for ELITEK
Sponsor	Trials
M.D. Anderson Cancer Center	3
National Cancer Institute (NCI)	2
Sanofi	2

Sponsor Type

Sponsor Type for ELITEK
Sponsor	Trials
Other	7
NIH	2
Industry	2

Last updated: June 8, 2026

ELITEK (rasburicase) clinical trials update, market analysis and 2026–2035 projections

ELITEK (rasburicase) is an intravenous uric-acid–lowering enzyme approved for the treatment of hyperuricemia in patients with leukemia, lymphoma, or solid tumors who are at risk of tumor lysis syndrome (TLS). ELITEK’s core near-term business exposure is driven by TLS prophylaxis and treatment protocols in oncology centers and by formulary access versus competing rasburicase brands and alternative TLS regimens. A durable demand base exists where clinicians use rasburicase early for high-risk TLS, but utilization is sensitive to evolving TLS risk stratification, prophylaxis standards (including hydration and allopurinol versus rasburicase), and drug availability/pricing.

What is ELITEK (rasburicase) approved for and where is it used?

FDA-labeled indication (US)
ELITEK is indicated for the treatment of hyperuricemia in patients with leukemia, lymphoma, or solid tumors at risk of tumor lysis syndrome.

Clinical use case in practice

• High-risk TLS pathways favor rasburicase when rapid uric-acid reduction is needed.
• Hospitals typically position rasburicase as a time-critical intervention relative to xanthine oxidase inhibitors (allopurinol, febuxostat).

Which populations and dosing protocols drive utilization

Key utilization drivers are:

• Baseline uric acid and TLS risk category at oncology admission or treatment start
• Choice of prophylaxis regimen by institutional guidelines
• Timing and logistics of intravenous administration

How does ELITEK compare with competing TLS urate-lowering options?

Clinician selection typically depends on:

• Need for rapid urate clearance (rasburicase tends to be favored for acute high TLS risk)
• Toxicity profile and hypersensitivity risk
• Drug cost and formulary constraints
• Local availability and administration capacity

What clinical trials exist for ELITEK rasburicase, and what is the latest update?

ELITEK’s late-stage clinical development is historically anchored by rasburicase pivotal TLS trials from earlier eras; modern “ELITEK-only” updates are limited, and most incremental evidence in the market tends to be from:

• TLS management guideline updates
• Comparative practice studies (rasburicase versus allopurinol strategies)
• Retrospective safety and effectiveness studies across institutions
• Pharmacovigilance and product-specific manufacturing updates rather than new rasburicase development programs

Featured snippet answer: The most actionable “clinical trials update” for ELITEK today is less about new ELITEK registrations and more about how current TLS protocols use rasburicase early in high-risk patients, shaping real-world demand.

What TLS trial endpoints matter for ELITEK adoption

• Time to normalization/reduction of serum uric acid
• Incidence of TLS and clinical TLS components (renal injury, arrhythmias)
• Need for renal replacement therapy
• Safety: infusion reactions, hypersensitivity, methemoglobinemia, hemolysis risk in susceptible populations

What safety signals influence prescribing volume

• Hypersensitivity and infusion reactions affect willingness to use rasburicase in repeated exposures or in patients with prior reactions
• Patient selection protocols and premedication practices influence adoption rates

When does ELITEK lose exclusivity and what patents control generic entry risk?

This request requires an accurate, jurisdiction-specific patent and exclusivity map for ELITEK’s active ingredient and product-specific formulations (Orange Book listings, patent expiry dates, and any unexpired pediatric exclusivity or marketing exclusivity). Without those inputs, a complete and accurate exclusivity and patent-expiration table cannot be produced.

What is the Orange Book status of ELITEK rasburicase?

This requires the FDA Orange Book listing for the specific ELITEK NDA, including:

• Patent numbers listed for the drug substance and drug product
• Expiration dates
• Exclusivity codes tied to the NDA Without access to those listing details in the current context, a correct status summary cannot be generated.

How many patents cover ELITEK and what is the patent estate strength?

A valid estimate of patent estate “strength” needs:

• A complete set of listed Orange Book patents (US)
• Litigation history and claim coverage for formulation, method-of-use, and manufacturing claims
• Status of any co-pending generics or biosimilar-like challengers (for biologic-enzyme products where relevant)

Without those case-specific identifiers, the patent count and strength assessment cannot be performed accurately.

What generic entry risks exist for ELITEK rasburicase?

Risk is determined by:

• Whether challengers can avoid patent claims (formulation or method-of-use)
• Whether product-specific manufacturing changes trigger non-infringement
• Regulatory pathway feasibility and data requirements
• Any resolved or pending Paragraph IV litigation

A credible generic entry risk analysis requires exact regulatory and litigation facts tied to the ELITEK NDA.

How does ELITEK’s market size and demand profile look by geography and setting?

Demand geography

• Uptake is concentrated in oncology centers and large hospital networks where TLS risk management is protocolized.
• US demand is most important for near-term volume and pricing because formularies and hospital procurement budgets govern rasburicase usage.

Demand setting

• Inpatient oncology and hematology wards
• Emergency admissions to oncology services at treatment initiation
• ICUs in TLS cases requiring rapid urate reduction

Key commercial KPIs that shape ELITEK projections

• TLS incidence proxy: number of high-risk oncology treatments
• Adoption rate of rasburicase as first-line urate-lowering therapy in high TLS risk
• Hospital utilization per 100 eligible patients
• Net price and rebates after formulary negotiations
• Inventory availability and drug supply reliability

ELITEK pricing, reimbursement, and payer pressure: what matters for projections?

ELITEK economics depend on:

• Wholesale acquisition cost (WAC) and net price realization
• Contracting behavior in group purchasing organizations (GPOs)
• Prior authorization or step therapy constraints at some institutions
• Comparative price erosion from competing rasburicase products, if present

Without verified price and reimbursement data tied to ELITEK’s current contracts, a numeric market projection would be speculative.

ELITEK competitive landscape: which products substitute in TLS protocols?

Likely competitive substitute classes

• Other rasburicase brands/products (same active enzyme)
• Xanthine oxidase inhibitors: allopurinol and febuxostat (for lower-risk TLS or prophylaxis)
• Supportive TLS care protocols that reduce urate peaks (hydration, monitoring intensity)

A quantified competitive substitution forecast requires current US hospital formulary data and competitor net pricing, which cannot be provided accurately in the present context.

Market projection for ELITEK 2026–2035: what is the scenario range?

Scenario logic (non-numeric)

• Base case: stable use among high-risk TLS protocols, modest volume growth tied to expanded oncology treatment intensity and better TLS detection
• Downside: tighter formulary restrictions, increased use of alternative prophylaxis in borderline-risk patients, and pricing pressure from competing products
• Upside: higher adoption of rasburicase in guideline-concordant pathways and improved drug availability

Numeric projections require baseline company/market revenue, unit volume, net price, and competitor pricing. Those figures are not available in the current context, so a table of forecasts cannot be produced.

Key takeaway risks that can change ELITEK demand quickly

1. Guideline shifts that move more patients toward allopurinol (or risk-adapted rasburicase use only for the highest TLS tier).
2. Product supply disruptions that reduce ability to administer at the required time window.
3. Hypersensitivity risk management tightening usage in select patient subgroups.
4. Pricing and contracting moves that change net realization across major hospital systems.

Key Takeaways

• ELITEK is an established TLS urate-lowering therapy with demand tied to oncology protocols for high-risk tumor lysis syndrome.
• Clinical “updates” affecting market outcomes are primarily protocol-driven (risk stratification and prophylaxis patterns) rather than brand-new ELITEK-specific late-stage registrations.
• A precise patent and Orange Book exclusivity picture is required to evaluate generic or competition timelines, but it cannot be produced accurately in this context.
• Numeric market size and 2026–2035 revenue projections depend on verifiable baseline unit and net price inputs, which are not available here.

FAQs

1. How is rasburicase dosing adjusted in high-risk tumor lysis syndrome patients?
2. What adverse events most affect rasburicase prescribing and monitoring protocols?
3. How do TLS risk stratification frameworks change rasburicase utilization rates?
4. What infusion reaction management strategies reduce discontinuation risk for rasburicase?
5. How do hospital formulary decisions shift between rasburicase and allopurinol in TLS prophylaxis?

References

1. FDA prescribing information for ELITEK (rasburicase).
2. FDA Orange Book database for the ELITEK NDA (rasburicase).
3. Clinical guideline publications on tumor lysis syndrome management (rasburicase vs xanthine oxidase inhibitors).