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Find Clinical Drug Pipeline Developments & Deals for Linzagolix
Yselty® (linzagolix) is the first and only approved GnRH antagonist to provide flexible dosing options with and without hormonal add-back therapy, for the Treatment of Uterine Fibroids.
Yselty (Linzagolix) is the only approved oral GnRH antagonist to offer flexible dosing options, with and without additional hormonal therapy, for women suffering from UF.
Summary of data and key takeaway: At 12 weeks, once-daily treatment with Yselty (linzagolix 200 mg) with hormonal ABT significantly improved dysmenorrhea, non-menstrual pelvic pain, and other symptoms of endometriosis, including dyschezia and ability to do daily activities.
Results demonstrated that OBE-2109 (linzagolix) has potential to balance safety, efficacy, and address wide-ranging symptoms of uterine fibroids also showed promise in delivering sustained clinical benefit.
ObsEva has entered into a licensing agreement with Theramex to support the commercialization and market introduction of linzagolix in Europe. Theramex’s extensive women’s health commercial infrastructure includes a dedicated sales force of more than 180 representatives.
Both DYS and NMPP showed rapid reductions compared to placebo (after 1 and 2 months of treatment), with continued reduction up to 6 months of treatment and with higher reductions with linzagolix, an oral GnRH antagonist, 200 mg + ABT compared to linzagolix 75 mg.
Linzagolix is a GnRH receptor antagonist for the treatment of uterine fibroids. Linzagolix is also in development as a potential treatment for endometriosis-associated pain. Linzagolix is not currently approved for any indication anywhere in the world.
The data from the Phase 3 PRIMROSE studies of Yselty (linzagolix) for the treatment of uterine fibroids demonstrating sustained safety and efficacy results at 52 weeks.
Study on trial of Linzagolix investigated that efficacy and safety of two dosing regimens, 100mg once daily and 200mg once daily, alone or in combination with hormonal ABT for the treatment of heavy menstrual bleeding associated with uterine fibroids.
Linzagolix is the only GnRH antagonist to provide flexible dosing options to better address the individual needs of patients, and the results further underscore its differentiated profile and potential clinical utility.
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