Toremifene citrate is an oral selective estrogen receptor modulator

Selective estrogen receptor modulator

Selective Estrogen Receptor Modulators are a class of compounds that act on the estrogen receptor. A characteristic that distinguishes these substances from pure receptor agonists and antagonists is that their action is different in various tissues, thereby granting the possibility to selectively...

 (SERM) which helps oppose the actions of estrogen

Estrogen

Estrogens , oestrogens , or œstrogens, are a group of compounds named for their importance in the estrous cycle of humans and other animals. They are the primary female sex hormones. Natural estrogens are steroid hormones, while some synthetic ones are non-steroidal...

 in the body. Licensed in the United States under the brand name Fareston, toremifene citrate is FDA

Food and Drug Administration

The Food and Drug Administration is an agency of the United States Department of Health and Human Services, one of the United States federal executive departments...

-approved for use in advanced (metastatic) breast cancer

Breast cancer

Breast cancer is cancer originating from breast tissue, most commonly from the inner lining of milk ducts or the lobules that supply the ducts with milk. Cancers originating from ducts are known as ductal carcinomas; those originating from lobules are known as lobular carcinomas...

. It is also being evaluated for prevention of prostate cancer

Prostate cancer

Prostate cancer is a form of cancer that develops in the prostate, a gland in the male reproductive system. Most prostate cancers are slow growing; however, there are cases of aggressive prostate cancers. The cancer cells may metastasize from the prostate to other parts of the body, particularly...

 under the brand name Acapodene.

In 2007 the pharmaceutical company GTx, Inc was conducting two different phase 3 clinical trial

Clinical trial

Clinical trials are a set of procedures in medical research and drug development that are conducted to allow safety and efficacy data to be collected for health interventions...

s; First, a pivotal Phase clinical trial for the treatment of serious side effects of androgen deprivation therapy

Androgen deprivation therapy

Androgen deprivation therapy , a treatment for prostate cancer that reduces the production or effect of androgen hormones, eg. testosterone, which many prostate cancers depend on. The side-effects make it controversial in some cases. There is an increased risk of osteoporosis, and possibly...

 (ADT) (especially vertebral/spine fractures and hot flashes, lipid profile, and gynecomastia

Gynecomastia

Gynecomastia or Gynaecomastia, , is the abnormal development of large mammary glands in males resulting in breast enlargement. The term comes from the Greek γυνή gyné meaning "woman" and μαστός mastós meaning "breast"...

) for advanced prostate cancer, and second, a pivotal Phase III clinical trial for the prevention of prostate cancer in high risk men with high grade prostatic intraepithelial neoplasia, or PIN. Results of these trials are expected by first quarter of 2008

An NDA for the first application (relief of prostate cancer ADT side effects) was submitted in Feb 2009, and in Oct 2009 the FDA said they would need more clinical data, eg. another phase III trial.