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Details:
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.
Lead Product(s): Linzagolix
Therapeutic Area: Obstetrics/Gynecology (Women’s Health) Product Name: Yselty
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 28, 2022
Details:
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.
Lead Product(s): Linzagolix
Therapeutic Area: Obstetrics/Gynecology (Women’s Health) Product Name: Yselty
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Theramex
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 17, 2022
Details:
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.
Lead Product(s): Linzagolix
Therapeutic Area: Obstetrics/Gynecology (Women’s Health) Product Name: Yselty
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 24, 2022
Details:
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.
Lead Product(s): Linzagolix,Estradiol,Norethisterone Acetate
Therapeutic Area: Obstetrics/Gynecology (Women’s Health) Product Name: OBE-2109
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 09, 2022
Details:
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.
Lead Product(s): Linzagolix
Therapeutic Area: Obstetrics/Gynecology (Women’s Health) Product Name: OBE-2109
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Theramex
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Licensing Agreement April 25, 2022
Details:
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.
Lead Product(s): Linzagolix,Estradiol,Norethisterone Acetate
Therapeutic Area: Obstetrics/Gynecology (Women’s Health) Product Name: OBE-2109
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 22, 2022
Details:
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.
Lead Product(s): Linzagolix
Therapeutic Area: Obstetrics/Gynecology (Women’s Health) Product Name: Undisclosed
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: ObsEva
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Licensing Agreement February 10, 2022
Details:
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.
Lead Product(s): Linzagolix
Therapeutic Area: Obstetrics/Gynecology (Women’s Health) Product Name: Yselty
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 10, 2021
Details:
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.
Lead Product(s): Linzagolix
Therapeutic Area: Obstetrics/Gynecology (Women’s Health) Product Name: Undisclosed
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 22, 2021
Details:
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.
Lead Product(s): Linzagolix
Therapeutic Area: Obstetrics/Gynecology (Women’s Health) Product Name: Yselty
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 20, 2021
Details:
The data presented further substantiate the best-in-class potential of linzagolix for the treatment of heavy menstrual bleeding (HMB) due to uterine fibroids addressing both key efficacy and safety parameters from the PRIMROSE Phase 3 program.
Lead Product(s): Linzagolix
Therapeutic Area: Obstetrics/Gynecology (Women’s Health) Product Name: Yselty
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 30, 2021
Details:
Linzagolix is a novel, once daily, oral GnRH receptor antagonist with a best-in-class profile. Linzagolix is currently in late-stage clinical development for the treatment of heavy menstrual bleeding associated with uterine fibroids and pain associated with endometriosis.
Lead Product(s): Linzagolix,Hormonal add-back therapy
Therapeutic Area: Obstetrics/Gynecology (Women’s Health) Product Name: Yselty
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 22, 2020
Details:
PRIMROSE 1 achieved statistically significant and clinically meaningful results across primary and key secondary endpoints at week 24. Results confirm linzagolix as a potential best-in-class GnRH antagonist.
Lead Product(s): Linzagolix,Hormonal add-back therapy
Therapeutic Area: Obstetrics/Gynecology (Women’s Health) Product Name: Yselty
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 06, 2020
Details:
By week 12 of treatment with 200 mg linzagolix, the patient was amenorrheic (cessation of bleeding), her pelvic pain was substantially improved, anemia was resolved, and MRI showed marked shrinkage in uterine volume (to 290 cm3) with regression of adenomyotic lesions.
Lead Product(s): Linzagolix
Therapeutic Area: Obstetrics/Gynecology (Women’s Health) Product Name: Undisclosed
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 04, 2020
Details:
Trial assessed safety and tolerability of daily oral linzagolix doses in women with endometriosis-associated pain. linzagolix significantly improved in quality of life after 52 weeks of treatment.
Lead Product(s): Linzagolix
Therapeutic Area: Obstetrics/Gynecology (Women’s Health) Product Name: Undisclosed
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 22, 2020
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