Elagolix 834153-87-6

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Igama le-API Inkomba Ukucaciswa I-US DMF I-EU DMF CEP
ElagolixI-CAS:834153-87-6 I-Endometriosis Endlini      


Imininingwane Yomkhiqizo

Omaka bomkhiqizo

IMINININGWANE YOMKHIQIZO

Lo muthi usetshenziswa ngabesifazane ukusiza ekudambiseni ubuhlungu obumaphakathi kuya kobunzima ngenxa yesimo esibizwa nge-endometriosis.
Ingase Yelaphe: Endometriosis
Amagama Brand: Orilissa
Isigaba Sezidakamizwa: Abaphikisi be-LHRH (GnRH).
Ukutholakala: Incwadi kadokotela iyadingeka
Ukukhulelwa: Gwema ukusetshenziswa ngesikhathi sokukhulelwa
Ukuncelisa: Bonana nodokotela ngaphambi kokusebenzisa

I-Elagolix iyi-oral bioavailable, isizukulwane sesibili, isekelwe ku-non-peptide, i-molecule encane kanye ne-gonadotropin-releasing hormone (GnRH; LHRH) ekhethiwe yomphikisi, enomsebenzi ovimbela ukukhiqizwa kwamahomoni.Lapho iphathwa ngomlomo, i-elagolix incintisana ne-GnRH ngokubopha ama-receptor futhi ivimbele ukusayinda kwesamukeli se-GnRH kundlala yepituitary yangaphambili.Lokhu kuvimbela ukukhiqizwa kwehomoni ye-luteinizing (LH) kanye ne-follicle stimulating hormone (FSH).Kwabesilisa, ukuvinjelwa kwe-LH secretion kuvimbela ukukhululwa kwe-testosterone.Kwabesifazane, ukuvinjelwa kwe-FSH ne-LH kuvimbela ukukhiqizwa kwe-estrogen ngama-ovari.Ukuvinjelwa kokusayina kwe-GnRH kungase kwelaphe noma kuvimbele izimpawu zezifunda zezifo ezincike kuma-hormone ocansi.

I-Elagolix iyi-oral, nonsteroidal gonadotropin releasing hormone (GnRH) enciphisa ukukhiqizwa kwe-estrogen futhi isetshenziselwa ukwelapha izinhlobo ezibuhlungu ze-endometriosis kwabesifazane.Ukwelashwa kwe-Elagolix kuhlotshaniswa nezinga eliphansi lokuphakama kwe-serum enzyme ngesikhathi sokwelashwa futhi kusazoxhunyaniswa nezimo zokulimala kwesibindi okubonakala ngokomtholampilo.

I-Elagolix isetshenziswe ezivivinyweni zokutadisha isayensi eyisisekelo kanye nokwelashwa kwe-Endometriosis, i-Folliculogenesis, i-Uterine Fibroids, ukopha okunamandla kwesibeletho, kanye nokopha kakhulu kokuya esikhathini.Kusukela ngomhla zingama-24 kuJulayi 2018, nokho, i-US Food and Drug Administration (FDA) igunyaze i-elagolix ka-AbbVie ngaphansi kwegama lomkhiqizo i-Orilissa njengomphikisi wokuqala futhi okuwukuphela kwawo okhishwa ngomlomo we-gonadotropin-release hormone (GnRH) esungulwe ngokukhethekile abesifazane abanobuhlungu obumaphakathi kuya kobunzima be-endometriosis.Kutholakale ukuthi i-endometriosis ingenye yezifo ezivame kakhulu ze-gynecologic e-United States.Ikakhulukazi, izilinganiso zisikisela ukuthi oyedwa kwabesifazane abayishumi abaneminyaka yobudala yokuzala uthintwa i-endometriosis futhi uhlangabezana nezimpawu zobuhlungu obuqeda amandla.Ngaphezu kwalokho, abesifazane abathintekayo yilesi simo bangahlupheka iminyaka engaba yisithupha kuya kweyishumi futhi bavakashele odokotela abaningi ngaphambi kokuthola ukuxilongwa okufanele.Ngokulandelayo, njengoba u-Orilissa (elagolix) agunyazwa yi-FDA ngaphansi kokubuyekezwa okubalulekile, lokhu kugunyazwa okusha okusheshayo kunikeza ochwepheshe bezokunakekelwa kwezempilo enye inketho ebalulekile yokwelapha izidingo okungenzeka azihlangatshezwa zabesifazane abathintwa i-endometriosis, kuya ngohlobo lwabo oluthile kanye nobukhulu bobuhlungu be-endometriosis. .

Isakhiwo samakhemikhali

dsfs

ISItifiketi

2018 GMP-2
原料药GMP证书201811(captopril ,thalidomide etc)
GMP-of-PMDA-in-Chanyoo-平成28年08月03日 Nantong-Chanyoo-Pharmatech-Co
FDA-EIR-Letter-201901

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