Arimoclomol Ban Lifted

December 2, 2009 

FDA Lifts Ban on Development of Arimoclomol

The Food and Drug Administration (FDA) has lifted a nearly two-year suspension on development of arimoclomol as a treatment for ALS, or Lou Gehrig's disease, according to a report in Associated Press and the company developing the drug, CytRx Corp.

The FDA previously approved a revised clinical trial design for the drug candidate.

In January 2008, the FDA halted arimoclomol studies, citing the need for additional analysis from previously completed animal studies with arimoclomol. In June 2008, CytRx said it would have to conduct more animal toxicology studies on arimoclomol.

Results from the new trial could be available 18 months after the study starts, according to CytRx.

For additional information on arimoclomol, please visit http://www.alsa.org/patient/drug.cfm?id=1414.