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1. 3-(5-((2,3-difluoro-6-methoxyphenyl)methoxy)-2-fluoro-4-methoxyphenyl)-2,4-dioxo-1h-thieno(3,4-d)pyrimidine-5-carboxylic Acid
2. Klh-2109
3. Klh2109
4. Obe-2109
5. Obe2109
1. 935283-04-8
2. Linzagolix [inn]
3. Linzagolix [usan]
4. Obe-2109
5. 7cdw97huex
6. Obe2109
7. Klh-2109
8. Klh-2109; Obe-2109
9. 3-{5-[(2,3-difluoro-6-methoxyphenyl)methoxy]-2-fluoro-4-methoxyphenyl}-2,4-dioxo-1,2,3,4-tetrahydrothieno[3,4-d]pyrimidine-5-carboxylic Acid
10. Thieno(3,4-d)pyrimidine-5-carboxylic Acid, 3-(5-((2,3-difluoro-6-methoxyphenyl)methoxy)-2-fluoro-4-methoxyphenyl)-1,2,3,4-tetrahydro-2,4-dioxo-
11. 3-(5-((2,3-difluoro-6-methoxyphenyl)methoxy)-2-fluoro-4-methoxyphenyl)-2,4-dioxo-1,2,3,4-tetrahydrothieno(3,4-d)pyrimidine-5-carboxylic Acid
12. Linzagolix (usan/inn)
13. Linzagolix [usan:inn]
14. Unii-7cdw97huex
15. Linzagolix [who-dd]
16. Schembl2333748
17. Chembl3668014
18. Bdbm160329
19. Dtxsid801337395
20. Bcp30444
21. Who 10711
22. Hy-109093
23. D11608
24. Us9040693, 233
25. 3-[5-(2,3-difluoro-6-methoxybenzyloxy)-2-fluoro-4-methoxyphenyl]-2,4-dioxo-1,2,3,4-tetrahydrothieno[3,4-d]pyrimidine-5-carboxylic Acid
26. 3-[5-[(2,3-difluoro-6-methoxyphenyl)methoxy]-2-fluoro-4-methoxyphenyl]-2,4-dioxo-1h-thieno[3,4-d]pyrimidine-5-carboxylic Acid
Molecular Weight | 508.4 g/mol |
---|---|
Molecular Formula | C22H15F3N2O7S |
XLogP3 | 3.4 |
Hydrogen Bond Donor Count | 2 |
Hydrogen Bond Acceptor Count | 11 |
Rotatable Bond Count | 7 |
Exact Mass | 508.05520648 g/mol |
Monoisotopic Mass | 508.05520648 g/mol |
Topological Polar Surface Area | 143 Ų |
Heavy Atom Count | 35 |
Formal Charge | 0 |
Complexity | 826 |
Isotope Atom Count | 0 |
Defined Atom Stereocenter Count | 0 |
Undefined Atom Stereocenter Count | 0 |
Defined Bond Stereocenter Count | 0 |
Undefined Bond Stereocenter Count | 0 |
Covalently Bonded Unit Count | 1 |
H - Systemic hormonal preparations, excl. sex hormones and insulins
H01 - Pituitary and hypothalamic hormones and analogues
H01C - Hypothalamic hormones
H01CC - Anti-gonadotropin-releasing hormones
H01CC04 - Linzagolix
Metrochem has been delivering customized volume & quality products to customers across the world, taking utmost care of their needs.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 35700
Submission : 2021-06-03
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 35700
Submission : 2021-06-03
Status : Active
Type : II
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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) Brand Name: Yselty
Study Phase: ApprovedProduct Type: Small molecule
Sponsor: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 28, 2022
Lead Product(s) : Linzagolix
Therapeutic Area : Obstetrics/Gynecology (Women’s Health)
Highest Development Status : Approved
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
ObsEva Announces UK MHRA Marketing Authorization for Yselty® (linzagolix), an Oral GnRH Antagonis...
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
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) Brand Name: Yselty
Study Phase: ApprovedProduct Type: Small molecule
Sponsor: Theramex
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 17, 2022
Lead Product(s) : Linzagolix
Therapeutic Area : Obstetrics/Gynecology (Women’s Health)
Highest Development Status : Approved
Partner/Sponsor/Collaborator : Theramex
Deal Size : Not Applicable
Deal Type : Not Applicable
ObsEva Announces European Commission Marketing Authorization for Yselty® (linzagolix), an Oral Gn...
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
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) Brand Name: Yselty
Study Phase: Phase IIIProduct Type: Small molecule
Sponsor: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 24, 2022
Lead Product(s) : Linzagolix
Therapeutic Area : Obstetrics/Gynecology (Women’s Health)
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : 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
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) Brand Name: OBE-2109
Study Phase: Phase IIIProduct Type: Small molecule
Sponsor: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 09, 2022
Lead Product(s) : Linzagolix,Estradiol,Norethisterone Acetate
Therapeutic Area : Obstetrics/Gynecology (Women’s Health)
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : 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
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) Brand Name: OBE-2109
Study Phase: Phase IIIProduct Type: Small molecule
Sponsor: Theramex
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Licensing Agreement April 25, 2022
Lead Product(s) : Linzagolix
Therapeutic Area : Obstetrics/Gynecology (Women’s Health)
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : 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
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) Brand Name: OBE-2109
Study Phase: Phase IIIProduct Type: Small molecule
Sponsor: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 22, 2022
Lead Product(s) : Linzagolix,Estradiol,Norethisterone Acetate
Therapeutic Area : Obstetrics/Gynecology (Women’s Health)
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : 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
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) Brand Name: Undisclosed
Study Phase: Phase IIIProduct Type: Small molecule
Sponsor: ObsEva
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Licensing Agreement February 10, 2022
Lead Product(s) : Linzagolix
Therapeutic Area : Obstetrics/Gynecology (Women’s Health)
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : 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
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) Brand Name: Yselty
Study Phase: Phase IIIProduct Type: Small molecule
Sponsor: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 10, 2021
Lead Product(s) : Linzagolix
Therapeutic Area : Obstetrics/Gynecology (Women’s Health)
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : 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
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) Brand Name: Undisclosed
Study Phase: Phase IIIProduct Type: Small molecule
Sponsor: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 22, 2021
Lead Product(s) : Linzagolix
Therapeutic Area : Obstetrics/Gynecology (Women’s Health)
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : 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
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) Brand Name: Yselty
Study Phase: Phase IIIProduct Type: Small molecule
Sponsor: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 20, 2021
Lead Product(s) : Linzagolix
Therapeutic Area : Obstetrics/Gynecology (Women’s Health)
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : 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
2,3-Difluoro-6-methoxybenzaldehyde
CAS Number : 187543-87-9
End Use API : Linzagolix
About The Company : PMC Isochem is a CDMO company acquired by PMC International in 2017. It manufactures cGMP intermediates, active pharmaceutical ingredients and functional excipi...
02 Aug 2022
// FDANEWS
https://www.fdanews.com/articles/208842-obseva-scraps-plans-for-uterine-fibroid-candidate?v=preview
28 Jul 2022
// Angus Liu FIERCEPHARMA
https://www.fiercepharma.com/pharma/ominous-fda-talks-obseva-scraps-lead-womens-health-drug-plots-layoffs-major-restructuring
28 Jun 2022
// GLOBENEWSWIRE
https://www.globenewswire.com/news-release/2022/06/28/2470795/0/en/ObsEva-Announces-UK-MHRA-Marketing-Authorization-for-Yselty-linzagolix-an-Oral-GnRH-Antagonist-for-the-Treatment-of-Uterine-Fibroids.html
17 Jun 2022
// BUSINESSWIRE
25 May 2022
// GLOBENEWSWIRE
https://www.globenewswire.com/news-release/2022/05/25/2449884/0/en/ObsEva-Presents-Clinical-Data-on-Oral-GnRH-Antagonist-Linzagolix-at-Multiple-Congresses.html
25 Apr 2022
// GLOBENEWSWIRE
https://www.globenewswire.com/news-release/2022/04/25/2427956/0/en/ObsEva-Announces-Confirmation-of-Positive-CHMP-Opinion-for-Linzagolix-an-Oral-GnRH-Antagonist-for-the-Treatment-of-Uterine-Fibroids.html
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