Clinical Studies

FOUR CLINICAL STUDIES to determine the efficacy of VORAXAZE®1,2

Efficacy of Voraxaze® has been evaluated in 4 multi-centre, compassionate use, single-arm, open label studies in patients with delayed MTX elimination. There was no head to head study conducted between these trials - each study was separate and conducted independent of each other.

Patients' characteristics & data available:

 Abbreviations: CrCl, creatinine clearance; MTX, methotrexate; sCr, serum creatinine; SD, standard deviation; ULN, upper limit of normal.
Plasma MTX concentration >2 SD of the mean MTX excretion curve specific for the dose of MTX administered.
†† Patients with at least 1 post-Voraxaze® MTX concentration measured by high-performnance liguid chromatography (HPLC) 
ΔPatients with safety data available for analysis in the 4 studies. ΔΔPatients with central MTX date.

VORAXAZE® allows a CLINICALLY IMPORTANT REDUCTION IN PLASMA MTX CONCENTRATION sustained for up to 8 DAYS1

Efficacy of Voraxaze® has been evaluated in 4 multi-centre, compassionate use, single-arm, open label studies in patients with delayed MTX elimination.

Primary endpoint

Clinically important reduction (CIR) in MTX concentration based on central MTX HPLC data.

  • A patient was considered to have achieved a CIR if all central MTX HPLC plasma concentrations after the first dose of Voraxaze® were ≤1 μmol/L

Abbreviations: CIR, clinically important reductions; HPLC, high-performance liquid chromatography; MTX, methotrexate.


VORAXAZE® lowers plasma MTX concentration BY >98% IN 15 MINUTES1,2


Efficacy of Voraxaze® has been evaluated in 4 multi-centre, compassionate use, single-arm, open label studies in patients with delayed MTX elimination.

What is the effect of earlier intervention with Voraxaze® in grade 4 toxicities?3

Prospective study to assess the role of Voraxaze®, leucovorin, and thymidine in the management and outcome of patients with HDMTX-induced nephrotoxicity.


Primary endpoint

Development of grade ≥4 toxicity after Voraxaze® administration.