Our Science

Unmet Medical Need

An orally active FSH agonist has been the futuristic goal of infertility treatments since the inception of injectable therapies. We are developing oral FSH agonists to improve the convenience of treatment for patients undergoing controlled ovarian hyperstimulation followed by in vitro fertilization, to provide a superior treatment option for mild ovarian stimulation followed by ovulation induction, and to develop the first prescription product for treatment of male factor infertility.

Reproductive endocrinologists, the experts in infertility treatments, have provided enthusiastic support for development of oral FSH agonists. Currently, women undergoing controlled ovarian hyperstimulation prior to in vitro fertilization receive 30-40 injections per cycle, and women undergoing milder ovarian stimulation prior to intrauterine insemination receive 10-14 injections. Women also undergo similar ovarian stimulation even if their male partner is the infertile patient because there is no approved therapy for men. Most women will require at least 2 cycles of ovarian stimulation in order to become pregnant and take home their baby.

Reproductive Biology

FSH, released from the pituitary of women and men:

Regulates growth and maturation of oocytes through its action on granulosa cells in the ovary
Regulates cell division and growth of sperm through its action on Sertoli cells in the testis

LH, released from the pituitary of women and men:

Causes final maturation and release of oocytes (ovulation) and sperm (spermiation)
Stimulates steroid production that amplifies the actions of both FSH and LH.

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