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Market Opportunities

photoVasomotor Symptoms (VMS)

In the United States, there are 40 million post-menopausal women and this number is increasing at the rate of 4000 per day due to the aging “baby boomer” population. Approximately 70% of these women seek treatment for their VMS. The major products for VMS are estrogen products with US sales of approximately $1.8 billion. Although antidepressants and nutraceuticals are also used to treat hot flashes, they are much less effective than estrogens. The results of the Women’s Health Initiative (WHI) showing the long-term effects of estrogen-progestin therapy on the increased risk of breast cancer, cardiovascular events, stroke, and venous thrombosis have dramatically changed the market conditions for the treatment of VMS. Women do not want to risk their health by consuming estrogens and are demanding a more safe and effective medicine. AUS-131 may answer that call.

Benign Prostatic Hyperplasia (BPH)

The incidence of BPH increases with age and occurs in > 50% of men over the age of 65. It is estimated that there are 20 million men in this age group. The total US market for drugs for BPH is approximately $2.5 billion. Most marketed drugs fall into two main classes: 5α-reductase inhibitors that reduce the size of the prostate, and fast-acting adrenergic receptor α blockers to reduce the symptoms of an enlarged prostate. Men taking these drugs experience major side effects including a decrease in quality of life, reduced libido, dizziness, dry mouth, and hot flashes. As an ERβ agonist, AUS-131 downregulates the androgen receptor, and unlike marketed drugs, may actually lead to a rapid alteration of disease progression.


Osteoporosis and low bone mass are major public health threats for both women and men aged 50 and older. The National Osteoporosis Foundation estimates that in the United States 61 million people will be affected by osteoporosis in 2020. The global sales of drugs for the prevention and treatment of osteoporosis exceeds $10 billion. The market is dominated by hormone replacement therapy, bisphosphonates, and selective estrogen receptor modulators. AUS-131 has shown bone sparing activity in preclinical models of osteoporosis.


There is evidence that suggests that selective estrogen receptor β-agonists may also provide benefit for patients with castration-resistant prostate cancer and neurodegenerative disease.


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