Figure 1. TAK-448 structure (A) and effect on the hypothalamic-pituitary-gonadal axis (B). At the normal physiological state, GnRH pulses in the hypothalamus.

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Figure 1. TAK-448 structure (A) and effect on the hypothalamic-pituitary-gonadal axis (B). At the normal physiological state, GnRH pulses in the hypothalamus lead to an elevation in T levels via stimulation of the pituitary. Continuous administration of TAK-448 suppresses GnRH pulses and T levels, primarily through the desensitization of the KISS1 receptor/GPR54. A low level of nonpulsatile GnRH leakage may be detected due to residual receptor activity (18). From: Sustained Exposure to the Investigational Kisspeptin Analog, TAK-448, Down-Regulates Testosterone into the Castration Range in Healthy Males and in Patients With Prostate Cancer: Results From Two Phase 1 Studies J Clin Endocrinol Metab. 2014;99(8):E1445-E1453. doi:10.1210/jc.2013-4236 J Clin Endocrinol Metab | Copyright © 2014 by the Endocrine Society

Figure 2. Part A: mean serum concentration-time profiles of total T (A), LH (B), and FSH (C) in healthy subjects receiving TAK-448 as a single-bolus dose (0.001–0.3 mg) or a 2-hour infusion (1–6 mg). From: Sustained Exposure to the Investigational Kisspeptin Analog, TAK-448, Down-Regulates Testosterone into the Castration Range in Healthy Males and in Patients With Prostate Cancer: Results From Two Phase 1 Studies J Clin Endocrinol Metab. 2014;99(8):E1445-E1453. doi:10.1210/jc.2013-4236 J Clin Endocrinol Metab | Copyright © 2014 by the Endocrine Society

Figure 3. Part B: mean serum concentrations of T (A), LH (B), and FSH (C) after TAK-448 administered as a single-bolus dose (d 1) and followed by a 13-day infusion (d 2–14) in healthy subjects. From: Sustained Exposure to the Investigational Kisspeptin Analog, TAK-448, Down-Regulates Testosterone into the Castration Range in Healthy Males and in Patients With Prostate Cancer: Results From Two Phase 1 Studies J Clin Endocrinol Metab. 2014;99(8):E1445-E1453. doi:10.1210/jc.2013-4236 J Clin Endocrinol Metab | Copyright © 2014 by the Endocrine Society

Figure 4. Patients with PC not receiving GnRH: aggregate individual serum T concentration-time curves after TAK-448 administration at 12 mg (A) and 24 mg (B). From: Sustained Exposure to the Investigational Kisspeptin Analog, TAK-448, Down-Regulates Testosterone into the Castration Range in Healthy Males and in Patients With Prostate Cancer: Results From Two Phase 1 Studies J Clin Endocrinol Metab. 2014;99(8):E1445-E1453. doi:10.1210/jc.2013-4236 J Clin Endocrinol Metab | Copyright © 2014 by the Endocrine Society

Figure 5. Mean plasma concentrations of TAK-448 up to 72 hours after the administration of a single-bolus dose in healthy subjects (part A of study; inset shows concentrations after 4 h) (A); and in healthy subjects during a 13-day sc infusion of TAK-448 (d 2–14), by treatment group (part B of study) (B). From: Sustained Exposure to the Investigational Kisspeptin Analog, TAK-448, Down-Regulates Testosterone into the Castration Range in Healthy Males and in Patients With Prostate Cancer: Results From Two Phase 1 Studies J Clin Endocrinol Metab. 2014;99(8):E1445-E1453. doi:10.1210/jc.2013-4236 J Clin Endocrinol Metab | Copyright © 2014 by the Endocrine Society