|Product Candidate (Indication):||Status||Next Expected Milestone(s)|
|Uterine Fibroids||Phase 2||Initiate a Phase 2B (vaginal delivery) (Q4 2013)|
|Endometriosis||Phase 2||Complete Phase 2 study (oral delivery) (Q2 2014)|
Proellex® is a new chemical entity that acts as a selective blocker of the progesterone receptor and is being developed for the treatment of symptoms associated with uterine fibroids and endometriosis. There are currently no FDA-approved orally administered drug treatments for the long-term treatment of either uterine fibroids or endometriosis. Additionally, the FDA has accepted an Investigational New Drug Application for vaginally delivered Proellex®. The National Uterine Fibroids Foundation estimates that 80% of all women in the U.S. have uterine fibroids, and one in four of these women have symptoms severe enough to require treatment.
The current standards of care for uterine fibroids and endometriosis consist of surgery or short-term treatment with gonadotropin-releasing hormone (“GnRH”) agonists drugs. GnRH agonists induce a low estrogen, menopausal-like state and promote bone loss and are not recommended for use for more than six months.
|Ongoing Studies:||Currently Enrolling:|