Cloretazine^®

 

Cloretazine^®, 1,2-bis(methylsulfonyl)-1-(2-chloroethyl)-2-[(methylamino)carbonyl]hydrazine), is a novel sulfonylhydrazine prodrug with broad-spectrum antitumor activity at well-tolerated doses in preclinical models. Alkylating agents damage DNA, which results in cell death and are generally known to be among the most highly effective agents in the treatment of cancer.

 

Cloretazine^®shows promise as a treatment for relapsed acute myeloid leukemia (AML). In March 2004, FDA granted fast track designation for Cloretazine^®, in relapsed or refractory AML and in October 2004, FDA granted orphan drug designation for Cloretazine^® in AML. After a Phase 2 and Phase 3 development program, an NDA was filed in 2009. The FDA has requested further clinical studies to be performed and this is currently being planned.