Relugolix in combination with estradiol/norethindrone acetate for moderate to severe symtpoms of uterine fibroids


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Interventions: Relugolix (TAK-385)
Therapeutic Areas: Gynaecology and Obstetrics
Year: 2020

Relugolix in combination with estradiol/norethindrone acetate is in clinical development for the treatment of moderate to severe symptoms associated with uterine fibroids. Uterine fibroids are non-cancerous growths that develop in or around the womb. Many women with fibroids do not develop symptoms, however, symptoms can include heavy and/or painful periods, abdominal pain, lower back pain, a frequent need to urinate, constipation and pain or discomfort during sex. Current treatment options aim to reduce heavy periods, for example using contraception, however, treatments for fibroids remain limited.

Relugolix is a small molecule that binds to the gonadotropin-releasing hormone receptor in the pituitary gland, decreasing the release of hormones which control oestrogen and progesterone production by the ovaries. Results from clinical trials demonstrated that relugolix in combination with estradiol and norethisterone acetate reduced menstrual bleeding in women with uterine fibroids. Relugolix is administered orally, and if licensed would offer an additional treatment option for women moderate to severe symptoms associated with uterine fibroids.