We are focused on developing and delivering innovative therapies that provide hope and healing for patients living with cancer. The company is conducting a pivotal clinical trial of its lead drug candidate, galeterone, in patients with metastatic castration resistant prostate cancer (mCRPC) whose tumors express the AR-V7 splice variant, which is a truncated form of the androgen receptor that has been associated with non-responsiveness to commonly-used oral therapies for mCRPC.

This trial is the first precision medicine-based pivotal clinical trial in prostate cancer, and top-line data from the study are expected by the first half of 2017.

Tokai Pharmaceuticals is focused on developing novel, proprietary therapies for prostate cancer and other hormonally-driven diseases. The company’s lead drug candidate, galeterone, is currently being evaluated in an ongoing Phase 2 study, called ARMOR2, in patients with castration resistant prostate cancer (CRPC). The company plans to initiate a pivotal clinical trial of galeterone in the first half of 2015.

Galeterone is a highly selective, multi-targeted, oral small molecule drug candidate that is currently being developed for the treatment of prostate cancer. Galeterone disrupts androgen receptor (AR) signaling, the key driver of prostate cancer growth, via multiple mechanisms of action.


ARMOR (Androgen Receptor Modulation Optimized for Response) is Tokai’s clinical development program for the evaluation of galeterone in patients with prostate cancer.