In clinical studies, linzagolix fully suppressed estradiol levels (median <20pg/mL) in women at a dosage of 200mg/day, whereas partial suppression of estradiol levels (median 20–60pg/mL) occurred at a dosage 100mg/day.[6] Progesterone levels were also variably suppressed with these dosages.[6]
On 16 December 2021, and on 22 April 2022, theCommittee for Medicinal Products for Human Use (CHMP) of theEuropean Medicines Agency (EMA) adopted a positive opinion, recommending the granting of a marketing authorization for the medicinal product Yselty, intended for the treatment of symptoms of uterine fibroids.[12] The applicant for this medicinal product is ObsEva Ireland Ltd.[12] Linzagolix was approved for medical use in the European Union in June 2022.[1][5]
^abcdef"Yselty EPAR".European Medicines Agency (EMA). 14 December 2021. Retrieved19 August 2022. Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
^Kotlyar AM, Pal L, Taylor HS (December 2021). "Eliminating Hormones With Orally Active Gonadotropin-releasing Hormone Antagonists".Clinical Obstetrics and Gynecology.64 (4):837–849.doi:10.1097/GRF.0000000000000664.PMID34668887.S2CID239034628.
^ab"Yselty: Pending EC decision".European Medicines Agency. 16 December 2021. Archived fromthe original on 18 December 2021. Retrieved18 December 2021. Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
Dababou S, Garzon S, Laganà AS, Ferrero S, Evangelisti G, Noventa M, et al. (September 2021). "Linzagolix: a new GnRH-antagonist under investigation for the treatment of endometriosis and uterine myomas".Expert Opinion on Investigational Drugs.30 (9):903–911.doi:10.1080/13543784.2021.1957830.PMID34278887.S2CID236091261.
