FDA Grants CytRx Orphan-Drug Status for Arimoclomol

The FDA has granted orphan-drug status to CytRx's lead small molecule drug candidate, arimoclomol.

The drug will be used to treat amyotrophic lateral sclerosis, commonly known as Lou Gehrig's disease. CytRx plans to file its investigational new drug application with the FDA for arimoclomol this month and anticipates beginning a Phase II clinical trial for the drug this quarter.

The FDA grants orphan-drug status to promote the development of products for the diagnosis or treatment of rare diseases or conditions that affect fewer than 200,000 individuals in the U.S.