Year
DEALS // DEV.
Country
Therapeutic Area
Study Phase
Deal Type
Product Type
Dosage Form
Lead Product
Target
Lead Product(s) : Linzagolix
Therapeutic Area : Obstetrics/Gynecology (Women’s Health)
Study Phase : Approved
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
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.
Brand Name : Yselty
Molecule Type : Small molecule
Upfront Cash : Not Applicable
June 28, 2022
Lead Product(s) : Linzagolix
Therapeutic Area : Obstetrics/Gynecology (Women’s Health)
Highest Development Status : Approved
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Lead Product(s) : Linzagolix
Therapeutic Area : Obstetrics/Gynecology (Women’s Health)
Study Phase : Approved
Sponsor : Theramex
Deal Size : Not Applicable
Deal Type : Not Applicable
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.
Brand Name : Yselty
Molecule Type : Small molecule
Upfront Cash : Not Applicable
June 17, 2022
Lead Product(s) : Linzagolix
Therapeutic Area : Obstetrics/Gynecology (Women’s Health)
Highest Development Status : Approved
Sponsor : Theramex
Deal Size : Not Applicable
Deal Type : Not Applicable
Lead Product(s) : Linzagolix
Therapeutic Area : Obstetrics/Gynecology (Women’s Health)
Study Phase : Phase III
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
ObsEva Presents Clinical Data on Oral GnRH Antagonist Linzagolix at Multiple Congresses
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 ...
Brand Name : Yselty
Molecule Type : Small molecule
Upfront Cash : Not Applicable
May 24, 2022
Lead Product(s) : Linzagolix
Therapeutic Area : Obstetrics/Gynecology (Women’s Health)
Highest Development Status : Phase III
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Lead Product(s) : Linzagolix,Estradiol,Norethisterone Acetate
Therapeutic Area : Obstetrics/Gynecology (Women’s Health)
Study Phase : Phase III
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
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.
Brand Name : OBE-2109
Molecule Type : Small molecule
Upfront Cash : Not Applicable
May 09, 2022
Lead Product(s) : Linzagolix,Estradiol,Norethisterone Acetate
Therapeutic Area : Obstetrics/Gynecology (Women’s Health)
Highest Development Status : Phase III
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Lead Product(s) : Linzagolix
Therapeutic Area : Obstetrics/Gynecology (Women’s Health)
Study Phase : Phase III
Sponsor : Theramex
Deal Size : Undisclosed
Deal Type : Licensing Agreement
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 ...
Brand Name : OBE-2109
Molecule Type : Small molecule
Upfront Cash : Undisclosed
April 25, 2022
Lead Product(s) : Linzagolix
Therapeutic Area : Obstetrics/Gynecology (Women’s Health)
Highest Development Status : Phase III
Sponsor : Theramex
Deal Size : Undisclosed
Deal Type : Licensing Agreement
Lead Product(s) : Linzagolix,Estradiol,Norethisterone Acetate
Therapeutic Area : Obstetrics/Gynecology (Women’s Health)
Study Phase : Phase III
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
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 linzago...
Brand Name : OBE-2109
Molecule Type : Small molecule
Upfront Cash : Not Applicable
March 22, 2022
Lead Product(s) : Linzagolix,Estradiol,Norethisterone Acetate
Therapeutic Area : Obstetrics/Gynecology (Women’s Health)
Highest Development Status : Phase III
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Lead Product(s) : Linzagolix
Therapeutic Area : Obstetrics/Gynecology (Women’s Health)
Study Phase : Phase III
Sponsor : ObsEva
Deal Size : Undisclosed
Deal Type : Licensing Agreement
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.
Brand Name : Undisclosed
Molecule Type : Small molecule
Upfront Cash : Undisclosed
February 10, 2022
Lead Product(s) : Linzagolix
Therapeutic Area : Obstetrics/Gynecology (Women’s Health)
Highest Development Status : Phase III
Sponsor : ObsEva
Deal Size : Undisclosed
Deal Type : Licensing Agreement
Lead Product(s) : Linzagolix
Therapeutic Area : Obstetrics/Gynecology (Women’s Health)
Study Phase : Phase III
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
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.
Brand Name : Yselty
Molecule Type : Small molecule
Upfront Cash : Not Applicable
December 10, 2021
Lead Product(s) : Linzagolix
Therapeutic Area : Obstetrics/Gynecology (Women’s Health)
Highest Development Status : Phase III
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Lead Product(s) : Linzagolix
Therapeutic Area : Obstetrics/Gynecology (Women’s Health)
Study Phase : Phase III
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Obseva Announces U.S. FDA Acceptance of New Drug Application for Linzagolix
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.
Brand Name : Undisclosed
Molecule Type : Small molecule
Upfront Cash : Not Applicable
November 22, 2021
Lead Product(s) : Linzagolix
Therapeutic Area : Obstetrics/Gynecology (Women’s Health)
Highest Development Status : Phase III
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Lead Product(s) : Linzagolix
Therapeutic Area : Obstetrics/Gynecology (Women’s Health)
Study Phase : Phase III
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
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.
Brand Name : Yselty
Molecule Type : Small molecule
Upfront Cash : Not Applicable
October 20, 2021
Lead Product(s) : Linzagolix
Therapeutic Area : Obstetrics/Gynecology (Women’s Health)
Highest Development Status : Phase III
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
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