GTx has two Phase III clinical development programs:

GTx is conducting a pivotal Phase III clinical trial evaluating ACAPODENE^® 80 mg for the treatment of multiple side effects of androgen deprivation therapy for prostate cancer.

GTx is conducting a pivotal Phase III clinical trial evaluating ACAPODENE^® 20 mg for the prevention of prostate cancer in men with high grade prostatic intraepithelial neoplasia.

Phase II clinical trials:

GTx is enrolling a Phase IIb clinical trial evaluating Ostarine™, its lead selective androgen receptor modulator, for the treatment of cancer cachexia, the severe muscle loss associated with many cancers. The Phase IIb cancer cachexia clinical trial is a randomized, double blind, placebo controlled study of muscle wasting in 150 patients with non-small cell lung cancer, colorectal cancer, non-Hodgkin's lymphoma, or chronic lymphocytic leukemia.