Linzagolix
GnRH antagonist; Antigonadotropin | |
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Linzagolix, sold under the brand name Yselty, is a
In June 2022, it was approved for medical use in the European Union and in the United Kingdom.[1][4][8]
Medical uses
Linzagolix is
Available forms
Linzagolix is available as linzagolix choline, the
Pharmacology
Pharmacodynamics
Linzagolix acts as a
In clinical studies, linzagolix fully suppressed estradiol levels (median <20 pg/mL) in women at a dosage of 200 mg/day, whereas partial suppression of estradiol levels (median 20–60 pg/mL) occurred at a dosage 100 mg/day.[5] Progesterone levels were also variably suppressed with these dosages.[5]
Pharmacokinetics
The
Society and culture
Legal status
On 16 December 2021, and on 22 April 2022, the Committee for Medicinal Products for Human Use (CHMP) of the European 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.[10] The applicant for this medicinal product is ObsEva Ireland Ltd.[10] Linzagolix was approved for medical use in the European Union in June 2022.[1][4]
Brand names
Linzagolix is sold under the brand name Yselty.[5]
Availability
Linzagolix is available in the European Union and in the United Kingdom.[5][8]
References
- ^ a b c d e f "Yselty EPAR". European Medicines Agency (EMA). 14 December 2021. Retrieved 19 August 2022. Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
- ^ PMID 25581052.
- ^ "Linzagolix". Specialist Pharmacy Service. 8 August 2022. Retrieved 24 August 2022.
- ^ a b c "Yselty Product information". European Commission. EU/1/21/1606. Retrieved 24 June 2022.
- ^ a b c d e f g h i "Yselty film-coated tablets" (PDF). Theramex Ireland Limited. European Medicines Agency.
- ^ "Linzagolix - Kissei Pharmaceutical/ObsEva". AdisInsight. Springer Nature Switzerland AG.
- ISSN 2161-3303.
- ^ a b "ObsEva Announces UK MHRA Marketing Authorization for Yselty (linzagolix), an Oral GnRH Antagonist, for the Treatment of Uterine Fibroids" (Press release). ObsEva. 28 June 2022. Retrieved 24 August 2022 – via GlobeNewswire.
- S2CID 239034628.
- ^ a b "Yselty: Pending EC decision". European Medicines Agency. 16 December 2021. Retrieved 18 December 2021. Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
Further reading
- 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. S2CID 236091261.
External links
- "Linzagolix". Drug Information Portal. U.S. National Library of Medicine.
- "Linzagolix choline". Drug Information Portal. U.S. National Library of Medicine.