DT56a- Femarelle®

Menopause, although a natural phenomena in a woman’s life, is very often accompanied by disturbing side effects in the form of vasomotor symptoms, psychological and metabolic complaints, as well as significant health issues such as cardiovascular diseases and bone loss leading to osteopenia and osteoporosis. Menopause is traditionally characterized by the ovaries decreasing or ceasing production of estrogen and other hormones.

DT56a is a clinical-stage biochemical complex, derived from soy that uses a unique selective mechanism of action found safe and effective in alleviating menopausal symptoms and treating bone loss. Test-marketed as an OTC for over 10 years, accumulating to date over 3 million months of treatment, the DT56a complex was thoroughly evaluated and was found to provide a safe and effective therapeutic solution for the management of menopause.

  • DT56a is a SERM, planned to start its phase III track in 2011, towards an NDA under the FDA’s Botanical Drugs clearance track. 
  • DT56a was proven to be a safe and effective solution for menopausal symptoms relief and bone health.
  • DT56a was seen to have an Agonistic effect in target areas of the brain and the bone - providing symptom relief and bone build-up; 
  • DT56a was seen to have an Antagonistic (blocking) effect on the breast and uterine tissues, as well as having no effect on the clotting (coagulation) system thus, providing a safe therapeutic option.

Three DT56a-based drug candidates are in development, addressing the
unmet need for a safe & effective alternative to the current therapeutic options:

  • Treating Vasomotor Symptoms
  • Treating Vaginal Atrophy
  • Treating Bone Health - Osteoporosis 

Additional paths are under investigation.

For more information on Femarelle (DT56a) please visit the website: www.femarelle.com

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