CLINICAL TRIALS PROFILE FOR VORAXAZE

All Clinical Trials for VORAXAZE

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00424645 ↗	Voraxaze for Delayed Methotrexate Clearance	Terminated	BTG International Inc.	Phase 1/Phase 2	2007-01-01	Primary Objectives: 1. To evaluate the efficacy of Glucarpidase (Voraxaze) in increasing the rate of methotrexate (MTX) clearance following high dose MTX treatment in patients with a delayed MTX clearance. 2. To evaluate the pharmacokinetics (PK) of Glucarpidase following high dose MTX treatment in patients with a delayed MTX clearance. 3. To evaluate the safety profile of Glucarpidase following high dose MTX treatment in patients with a delayed MTX clearance. Secondary Objectives: 1. To evaluate the effect of Glucarpidase on the incidence of neutropenic fever and use of intravenous (IV) antibiotics. 2. To evaluate the effect of Glucarpidase on the length of hospitalization. 3. To evaluate the effect of Glucarpidase on renal function. 4. To evaluate the effect of Glucarpidase on Quality of Life (QOL). 5. To evaluate the anti-glucarpidase antibody response. 6. To evaluate the efficacy of Glucarpidase following its use in repeated cycles of high dose MTX treatment.
NCT00424645 ↗	Voraxaze for Delayed Methotrexate Clearance	Terminated	M.D. Anderson Cancer Center	Phase 1/Phase 2	2007-01-01	Primary Objectives: 1. To evaluate the efficacy of Glucarpidase (Voraxaze) in increasing the rate of methotrexate (MTX) clearance following high dose MTX treatment in patients with a delayed MTX clearance. 2. To evaluate the pharmacokinetics (PK) of Glucarpidase following high dose MTX treatment in patients with a delayed MTX clearance. 3. To evaluate the safety profile of Glucarpidase following high dose MTX treatment in patients with a delayed MTX clearance. Secondary Objectives: 1. To evaluate the effect of Glucarpidase on the incidence of neutropenic fever and use of intravenous (IV) antibiotics. 2. To evaluate the effect of Glucarpidase on the length of hospitalization. 3. To evaluate the effect of Glucarpidase on renal function. 4. To evaluate the effect of Glucarpidase on Quality of Life (QOL). 5. To evaluate the anti-glucarpidase antibody response. 6. To evaluate the efficacy of Glucarpidase following its use in repeated cycles of high dose MTX treatment.
NCT00481559 ↗	Treatment Protocol of Voraxaze for Patients Experiencing or at Risk of Methotrexate Toxicity	Approved for marketing	CTI Clinical Trial and Consulting Services		1969-12-31	This protocol is for the treatment of toxic plasma methotrexate concentrations (>1 micromole per liter) in patients with delayed methotrexate clearance due to impaired renal function
NCT00481559 ↗	Treatment Protocol of Voraxaze for Patients Experiencing or at Risk of Methotrexate Toxicity	Approved for marketing	BTG International Inc.		1969-12-31	This protocol is for the treatment of toxic plasma methotrexate concentrations (>1 micromole per liter) in patients with delayed methotrexate clearance due to impaired renal function
NCT00634504 ↗	Open-label Leucovorin Pharmacokinetic Study in Patients Receiving High Dose Methotrexate With or Without Voraxaze	Completed	BTG International Inc.	Phase 1	2008-05-01	The purpose of this study is to investigate whether the administration of Voraxaze reduces exposure to leucovorin and its active metabolite to below the level achieved in patients who have not received Voraxaze.

Clinical Trial Conditions for VORAXAZE

Condition Name

Condition Name for VORAXAZE
Intervention	Trials
Osteosarcoma	3
Neoplasms	1
Solid Tumor	1
Spindle Cell Sarcoma of Bone	1

Condition MeSH

Condition MeSH for VORAXAZE
Intervention	Trials
Osteosarcoma	3
Lymphoma	2
Hematologic Neoplasms	1
Sarcoma	1

Clinical Trial Locations for VORAXAZE

Trials by Country

Trials by Country for VORAXAZE
Location	Trials
United States	28
Germany	1
United Kingdom	1

Trials by US State

Trials by US State for VORAXAZE
Location	Trials
Texas	2
New York	2
Pennsylvania	2
New Jersey	2
Florida	2

Clinical Trial Progress for VORAXAZE

Clinical Trial Phase

Clinical Trial Phase for VORAXAZE
Clinical Trial Phase	Trials
Phase 2	1
Phase 1/Phase 2	2
Phase 1	1

Clinical Trial Status

Clinical Trial Status for VORAXAZE
Clinical Trial Phase	Trials
Recruiting	3
Terminated	2
Approved for marketing	1

Clinical Trial Sponsors for VORAXAZE

Sponsor Name

Sponsor Name for VORAXAZE
Sponsor	Trials
BTG International Inc.	4
Charite University, Berlin, Germany	1
M.D. Anderson Cancer Center	1

Sponsor Type

Sponsor Type for VORAXAZE
Sponsor	Trials
Other	13
NIH	1

VORAXAZE: Clinical Trials Update, Market Analysis, and 5-Year Projection

Last updated: May 5, 2026

What is VORAXAZE and what do existing records show?

No reliable, citable public record was provided in the prompt for a drug named VORAXAZE. Without verifiable identifiers (INN, manufacturer, active ingredient, or regulatory dossier linkage), a clinical-trials update, market sizing, and forecast cannot be produced with citation-grade accuracy.

What clinical trials are active for VORAXAZE?

No citable trial registry entries can be verified for “VORAXAZE” based on the information available in the prompt.

What is the market context for VORAXAZE?

No citable market inputs (indication, mechanism, formulation, approval status, pricing basis, geography, payer mix, comparator landscape) can be verified for “VORAXAZE” based on the information available in the prompt.

What is the 5-year projection for VORAXAZE?

A 5-year projection requires at minimum: (1) therapeutic category and indication, (2) clinical phase and expected filing/launch timing, (3) regulatory status and exclusivity posture, (4) pricing and reimbursement assumptions, and (5) adoption curve with comparator penetration. None of these can be verified for “VORAXAZE” from the prompt.

Key Takeaways

• A clinical-trials update, market analysis, and 5-year forecast cannot be generated for VORAXAZE without verifiable drug identity and citable registry and market sources.
• The prompt does not include the active ingredient, sponsor, or regulatory identifiers needed to anchor trial and market data to the correct product.

FAQs

1) What does “VORAXAZE” refer to (active ingredient)?
The active ingredient and regulatory identity are not provided in the prompt.

2) Is VORAXAZE approved in any market?
Approval status cannot be verified from the prompt.

3) Which clinical trial registries should be checked for VORAXAZE?
A complete update would require verification in registries such as ClinicalTrials.gov and EU CTR, but no identifiers are available in the prompt.

4) How is market size typically modeled for a new drug?
Models rely on indication-level incidence, treatable population, comparator sales, pricing, reimbursement coverage, and uptake curve, none of which can be anchored to VORAXAZE from the prompt.

5) Can a forecast be produced without knowing the indication and launch date?
No; forecasting requires indication and launch timing to set adoption and sales ramp assumptions.

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References

[1] No cited sources were provided or verifiable from the prompt.