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Abstract：
UNASSIGNED: Uterine myomas and endometriosis are benign hormone-dependent diseases affecting women of reproductive age. Substantial efforts have been made to develop innovative medical options for treating these gynecologic diseases. Elagolix and relugolix have been approved in some countries for treating endometriosis and myomas, respectively; however, linzagolix (OBE 2109, KLH 2109) is a new oral gonadotropin-releasing hormone (GnRH) antagonist in phase II-III trials. Treatment options for women with contraindications for hormonal therapies or who refuse particular options, are the driving force behind the development of new drugs in this area.
UNASSIGNED: This drug evaluation highlights definitive and preliminary results from previous and ongoing studies of linzagolix for the treatment of endometriosis and myomas.
UNASSIGNED: Linzagolix showed a dose-dependent and rapidly reversible action on the pituitary-gonadal axis. In a recent phase II trial (EDELWEISS), linzagolix significantly reduced pain related to endometriosis and improved quality of life at single daily doses of 75-200 mg. The preliminary results of international, double-blind phase III trials (PRIMROSE 1 and 2) reported its efficacy in treating heavy menstrual bleeding related to myomas with a good safety profile. Further studies will determine the necessity of add-back therapy during long-term use of linzagolix.
UNASSIGNED: This drug evaluation highlights definitive and preliminary results from previous and ongoing studies of linzagolix for the treatment of endometriosis and myomas.
UNASSIGNED: Linzagolix showed a dose-dependent and rapidly reversible action on the pituitary-gonadal axis. In a recent phase II trial (EDELWEISS), linzagolix significantly reduced pain related to endometriosis and improved quality of life at single daily doses of 75-200 mg. The preliminary results of international, double-blind phase III trials (PRIMROSE 1 and 2) reported its efficacy in treating heavy menstrual bleeding related to myomas with a good safety profile. Further studies will determine the necessity of add-back therapy during long-term use of linzagolix.
摘要：
■子宫肌瘤和子宫内膜异位症是影响育龄妇女的良性激素依赖性疾病。已经做出了大量努力来开发用于治疗这些妇科疾病的创新医疗选择。Elagolix和relugolix已在一些国家被批准用于治疗子宫内膜异位症和肌瘤。分别；然而，linzagolix（OBE2109，KLH2109）是II-III期试验中的一种新型口服促性腺激素释放激素（GnRH）拮抗剂。有激素治疗禁忌症或拒绝特定选择的女性的治疗选择，是该领域新药开发的推动力。
■该药物评估强调了linzagolix治疗子宫内膜异位症和肌瘤的先前和正在进行的研究的明确和初步结果。
■Linzagolix对垂体-性腺轴显示出剂量依赖性且快速可逆的作用。在最近的第二阶段试验(EDELWEISS)中，linzagolix可显著减轻与子宫内膜异位症相关的疼痛，提高每日剂量75-200mg的生活质量。国际的初步结果,双盲III期试验(PRIMROSE1和2)报道了其在治疗与肌瘤相关的重度月经出血方面的疗效,安全性良好.进一步的研究将确定长期使用linzagolix期间补充治疗的必要性。
■该药物评估强调了linzagolix治疗子宫内膜异位症和肌瘤的先前和正在进行的研究的明确和初步结果。
■Linzagolix对垂体-性腺轴显示出剂量依赖性且快速可逆的作用。在最近的第二阶段试验(EDELWEISS)中，linzagolix可显著减轻与子宫内膜异位症相关的疼痛，提高每日剂量75-200mg的生活质量。国际的初步结果,双盲III期试验(PRIMROSE1和2)报道了其在治疗与肌瘤相关的重度月经出血方面的疗效,安全性良好.进一步的研究将确定长期使用linzagolix期间补充治疗的必要性。
