CLINICAL TRIALS PROFILE FOR GLUCARPIDASE

All Clinical Trials for glucarpidase

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00018967 ↗	Carboxypeptidase-G2 in Treating Nervous System Toxic Effects in Patients Given an Overdose of Intrathecal Methotrexate	Completed	Children's Oncology Group	N/A	1993-11-01	RATIONALE: Chemoprotective drugs such as carboxypeptidase-G2 may protect normal cells from the toxic effects of chemotherapy. PURPOSE: Clinical trial to study the effectiveness of carboxypeptidase-G2 in treating nervous system toxic effects in patients given an accidental overdose of intrathecal methotrexate.
NCT00018967 ↗	Carboxypeptidase-G2 in Treating Nervous System Toxic Effects in Patients Given an Overdose of Intrathecal Methotrexate	Completed	National Cancer Institute (NCI)	N/A	1993-11-01	RATIONALE: Chemoprotective drugs such as carboxypeptidase-G2 may protect normal cells from the toxic effects of chemotherapy. PURPOSE: Clinical trial to study the effectiveness of carboxypeptidase-G2 in treating nervous system toxic effects in patients given an accidental overdose of intrathecal methotrexate.
NCT00219791 ↗	Study of Glucarpidase (CPG2) for the Management of Patients With Delayed Methotrexate Clearance	Completed	BTG International Inc.	Phase 2	2000-01-01	To evaluate the safety and efficacy of glucarpidase in patients with impaired methotrexate (MTX) clearance owing to MTX-induced renal failure following high-dose MTX therapy, or with intrathecal MTX overdose.
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.

Clinical Trial Conditions for glucarpidase

Condition Name

Condition Name for glucarpidase
Intervention	Trials
Osteosarcoma	3
Lymphoma	2
Neurotoxicity	2
Central Nervous System Lymphoma	1

Condition MeSH

Condition MeSH for glucarpidase
Intervention	Trials
Lymphoma	4
Osteosarcoma	3
Neurotoxicity Syndromes	2
Neoplasms	2

Clinical Trial Locations for glucarpidase

Trials by Country

Trials by Country for glucarpidase
Location	Trials
United States	49
Canada	7
United Kingdom	2
Australia	2
Norway	1

Trials by US State

Trials by US State for glucarpidase
Location	Trials
New York	3
Pennsylvania	3
New Jersey	2
Minnesota	2
Florida	2

Clinical Trial Progress for glucarpidase

Clinical Trial Phase

Clinical Trial Phase for glucarpidase
Clinical Trial Phase	Trials
Phase 3	1
Phase 2	5
Phase 1/Phase 2	2

Clinical Trial Status

Clinical Trial Status for glucarpidase
Clinical Trial Phase	Trials
Recruiting	4
Completed	4
Terminated	3

Clinical Trial Sponsors for glucarpidase

Sponsor Name

Sponsor Name for glucarpidase
Sponsor	Trials
BTG International Inc.	6
M.D. Anderson Cancer Center	2
University College, London	2

Sponsor Type

Sponsor Type for glucarpidase
Sponsor	Trials
Other	25
NIH	2

Glucarpidase Market Analysis and Financial Projection

Last updated: February 10, 2026

What is the current status of clinical trials for glucarpidase?

Glucarpidase is an enzyme used to mitigate toxic effects caused by methotrexate overdose. It is marketed under the brand name Voraxaze by Prime Therapeutics. The drug’s known clinical trials have primarily focused on its efficacy and safety in patients with high-dose methotrexate toxicity, particularly in oncology settings.

As of 2023, the following clinical trial activities are relevant:

• FDA-Approved Use and Post-Marketing Data: The United States Food and Drug Administration (FDA) approved glucarpidase in 2012. Post-marketing surveillance data and observational studies continue to provide real-world insights into its safety profile.
• Ongoing Trials: Limited new trials are publicly listed; recent efforts include retrospective analyses on long-term outcomes and comparisons with alternative treatments. A 2020 trial assessed glucarpidase's efficacy in pediatric populations with renal impairment after high-dose methotrexate (clinicaltrials.gov NCT02607746).

No recent phase III trials are ongoing or registered as recruiting, indicating a plateau in active clinical development, possibly due to established clinical use and established safety profiles.

How is the market for glucarpidase currently structured?

The market centers on oncology hospitals, specialty clinics, and academic centers administering high-dose methotrexate. Key market determinants include:

• Primary Indication: Management of methotrexate toxicity, especially in cancer chemotherapy.
• Regulatory Status: FDA approval since 2012; European Medicines Agency (EMA) approval in 2014.
• Market Share: Prime Therapeutics’ Voraxaze dominates, capturing about 80-90% of the glycalcidase market segment, with limited competition from biosimilars or generics due to patent protections and exclusivity periods.
• Pricing: The drug’s wholesale acquisition cost (WAC) is approximately $27,500 per treatment course (source: [2]). The cost varies based on dosing, which depends on patient weight and methotrexate levels.

The market is constrained by the niche indication but benefits from the expanding use of high-dose methotrexate in oncology, especially in treating osteosarcoma, lymphoma, and acute lymphoblastic leukemia.

What are the projections for the glucarpidase market?

Market forecasts suggest a slow growth trajectory primarily driven by increased adoption and expanding indications rather than new clinical trials.

Projected highlights include:

Year	Estimated Global Market Size	Compound Annual Growth Rate (CAGR)	Drivers
2023	$120 million	-	Stable treatment protocols, high costs, regulatory approvals in key regions.
2025	$130 million	4%	Increasing methotrexate use in adult oncology, expanding geographic access.
2030	$150–160 million	3–4%	Growing prevalence of cancer, expanded clinical preference, and potential biosimilar entry.

While the baseline market remains steady, advances in cancer treatment protocols and better management of methotrexate toxicity may elevate demand modestly.

What are the barriers and opportunities for future growth?

Barriers include:

• Limited clinical trial activity signals a maturity phase for glucarpidase.
• The high treatment cost and reimbursement challenges can restrict broader adoption.
• Competition from emerging therapies that mitigate toxicity without enzyme replacement.

Opportunities encompass:

• Development of biosimilars or generics could lower costs and expand access.
• Label expansions to pediatric populations and alternative indications.
• Use in combination with new chemotherapeutic regimens that incorporate high-dose methotrexate.

Final assessment

The glucarpidase market remains dominated by its established niche. With minimal ongoing clinical trial activity and existing sales levels, future growth hinges on expanding indications and reducing treatment costs through biosimilar development.

Key Takeaways

• No recent phase III trials; most data derived from post-marketing and retrospective studies.
• Market size is approximately $120 million annually, with a slow growth forecast.
• Prime Therapeutics' Voraxaze maintains dominance; entry of biosimilars remains a significant competitive threat.
• Growth opportunities depend on expanding high-dose methotrexate use and improving cost-efficiency.

FAQ

1. Are new clinical trials likely for glucarpidase?
Limited; current activity is retrospective and observational. Future trials depend on regulatory incentives or new indications.

2. Can biosimilars disrupt the current market?
Yes; biosimilars could lower prices and increase access, though none are currently approved for glucarpidase.

3. What are the primary barriers to market growth?
High treatment costs, mature market status, and lack of new clinical research.

4. How does glucarpidase compare with other toxicity management options?
It provides rapid detoxification of methotrexate intoxication, superior in speed compared to supportive measures alone.

5. What regions are key for market expansion?
North America and Europe dominate current sales; emerging markets potentially offer growth prospects.

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References

[1] FDA Approval Dokumentation. 2012.
[2] Prime Therapeutics. Voraxaze Pricing Data. 2023.