TAK-385 enters into phase 2 clinical trials in Japan

Takeda Pharmaceutical Company Limited (“Takeda”) has announced that it has initiated phase 2 clinical trials of TAK-385 in Japan for the treatment of endometriosis and uterine fibroids.

TAK-385 is a luteinizing hormone-releasing hormone (LH-RH)¹ receptor antagonist administered orally. By preventing LH-RH from binding with the LH-RH receptor in the anterior pituitary gland and suppressing the secretion of luteinizing hormone (LH) ² and follicle stimulation hormone (FSH) ³ from the anterior pituitary gland, TAK-385 controls the effect of LH and FSH on the ovary, reduces the level of estrogen in blood, which is known to be associated with the development of endometriosis and uterine fibroids, and is expected to improve the symptoms of these disorders. The safety and efficacy of TAK-385 in subjects with endometriosis and uterine fibroids will be evaluated in two individual phase 2, double-blind, comparative studies.

There are medical needs which cannot be met by the current therapies in the treatment of endometriosis and uterine fibroids. We are committed to the rapid development to deliver the oral LH-RH antagonist TAK-385, which could become a new treatment option for patients with these conditions.

1. The hormone that controls the secretion of LH and FSH, gonadotropic hormones, secreted from the anterior pituitary gland.
2. A hormone that is secreted from the anterior pituitary gland by the action of LH-RH and encourages follicular maturation, ovulation and luteinization by acting on the ovaries.
3. A hormone that is secreted from the anterior pituitary gland by the action of LH-RH and encourages follicular maturation by stimulating the ovaries.