VORAXAZE

(Glucarpidase)

Phase 1Protein / enzyme

BBTG International Inc.

VORAXAZE is one of 34 small molecule programs targeting Central Nervous System Lymphoma. It is currently in Phase 1.

Indications

Total Trials

Active Trials

Competitors

FDA Application

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[3][1]

Indication

Central Nervous System LymphomaActive, not recruiting

OverdoseActive, not recruiting

Central Nervous System LymphomaPhase 1

Active, not recruiting

OverdosePreclinical

Active, not recruiting

Competition

Competitive Landscape

34 competitors in Central Nervous System Lymphoma

#DrugCompanyPhaseTrials

Rituxan

Roche

Approved

17 2

Idamycin

Tepadina

Brukinsa

1 5

Temodar

CCidara Therapeutics Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)

Phase 3

6 6

Trexall

Jazz Pharmaceuticals

Phase 2

19 7

Nublexa

BBeijing InnoCare Pharma Tech Co., Ltd.

Phase 3

4 8

Cytosar

Teva

Phase 2

6 9

Fludara

Sanofi

Phase 2

1 10

Gazyva

Roche

Phase 2

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q4 2027

Phase 1Active, not recruiting

Central Nervous System Lymphoma

NCT03684980

Clinical

Trials by Indication[1]

Central Nervous System Lymphoma3 trials

Dose Dense Re-challenge of High Dose Methotrexate With Glucarpidase for Relapsed Primary Central Nervous System Lymphoma

Unknown status·AAssistance Publique - Hôpitaux de Paris·Phase 1·NCT05135858·18 enrolled

LTA Pilot Study of Glucarpidase in Patients With Central Nervous System Lymphoma

Active, not recruiting·MMemorial Sloan Kettering Cancer Center·Phase 1·NCT03684980·58 enrolled

Methotrexate, Glucarpidase, and Leucovorin in Treating Patients With Newly Diagnosed Primary Central Nervous System Lymphoma

Completed·UUniversity College, London·Phase 1/2·NCT00727831·4 enrolled

Osteosarcoma2 trials

High Dose Methotrexate With Leucovorin Rescue With or Without Glucarpidase in Osteosarcoma

Terminated·BBTG International Inc.·Phase 2·NCT00634322·7 enrolled

An Open-Label, Multi-Institutional Pilot Study to Assess the Use of Glucarpidase in Adult Patients With Osteosarcoma Receiving High-Dose Methotrexate

Completed·OOHSU Knight Cancer Institute·Phase 1·NCT03960177·11 enrolled

Methotrexate2 trials

Retrospective Registry Study of Patients With Cancer Treated With High-dose Methotrexate

Unknown status·PProtherics Medicines Development Limited··NCT05899751·1,000 enrolled

Study of Glucarpidase (CPG2) for the Management of Patients With Delayed Methotrexate Clearance

Completed·BBTG International Inc.·Phase 2·NCT00219791

Bone Sarcoma1 trial

Will Glucarpidase After Methotrexate Treatment for Bone Sarcoma Lead to Fewer Side Effects and Reduce Chemotherapy Delays?

Terminated·UUniversity College, London·Phase 2·NCT02022358·34 enrolled

Overdose1 trial

Carboxypeptidase-G2 in Treating Nervous System Toxic Effects in Patients Given an Overdose of Intrathecal Methotrexate

Completed·NNational Cancer Institute (NCI)·N/A·NCT00018967·10 enrolled

2 more indications

Lymphoma1 trial

HM-178: Assessing Methods for Improvement in Methotrexate Toxicity Management and Detection of Central Nervous System Involvement of Aggressive Lymphoma

Suspended·FFox Chase Cancer Center·Phase 2·NCT04668768·3 enrolled

Children1 trial

Glucarpidase Effect on Severe Delayed HDM-clearance in Children Treated With High-dose Mtx in ALL

Completed·NNordic Society for Pediatric Hematology and Oncology·Phase 3·NCT01305655·47 enrolled

Regulatory

FDA Approval Timeline[4]

Jan 17, 2012

VORAXAZE

BLA BLA125327

Sources

References

[1]
ClinicalTrials.gov — 11 trial records for Glucarpidase. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Glucarpidase compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Glucarpidase. EMBL-EBI & Wellcome Sanger Institute.
[4]
OpenFDA — FDA approval records (BLA BLA125327). U.S. Food & Drug Administration.
[5]
SEC EDGAR — BTG International Inc. company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Protein / enzyme[2]
Highest Phase: Phase 1[1]
Company: BBTG International Inc.

VORAXAZE

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q4 2027

Trials by Indication[1]

Central Nervous System Lymphoma3 trials

Osteosarcoma2 trials

Methotrexate2 trials

Bone Sarcoma1 trial

Overdose1 trial

Lymphoma1 trial

Children1 trial

FDA Approval Timeline[4]

References

Drug Info

Quick Facts

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