Elagolix 834153-87-6

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ElagolixI-CAS:834153-87-6 Endometriosis Endlwini      


Iinkcukacha zeMveliso

Iithegi zeMveliso

IINKCUKACHA ZEMVELISO

Eli yeza lisetyenziswa ngabasetyhini ukunceda ukuthomalalisa okuphakathi ukuya kwiintlungu ezinzima ngenxa yemeko ebizwa ngokuba yi-endometriosis.
Ngamana Ukunyanga: Endometriosis
Amagama eBrand: Orilissa
Udidi lweziyobisi: LHRH (GnRH) Abachasi
Ukufumaneka: Umyalelo ofunekayo
Ukukhulelwa: Kuphephe ukusebenzisa ngexesha lokukhulelwa
Ukuncancisa: Dibana nogqirha phambi kokuba usebenzise

I-Elagolix yi-bioavailable yomlomo, isizukulwana sesibini, i-non-peptide esekelwe, i-molecule encinci ye-molecule kunye ne-hormone ekhethiweyo ye-gonadotropin-releasing (GnRH; LHRH) ye-receptor antagonist, kunye nomsebenzi onokuthi unqande ukuveliswa kwehomoni. Ekulawuleni komlomo, i-elagolix ikhuphisana ne-GnRH yokubopha i-receptor kwaye inqanda ukubonakaliswa kwe-GnRH ye-receptor kwi-pituitary gland yangaphambili. Oku kuthintela ukukhutshwa kwehomoni ye-luteinizing (LH) kunye ne-follicle stimulating hormone (FSH). Kwamadoda, ukuvinjelwa kwe-LH secretion kuthintela ukukhululwa kwe testosterone. Kwabasetyhini, ukuvinjelwa kwe-FSH kunye ne-LH kuthintela ukuveliswa kwe-estrogen ngama-ovari. Ukuvinjwa kokubonakaliswa kwe-GnRH kunokunyanga okanye kuthintele iimpawu zesifo esixhomekeke kwihomoni yesini.

I-Elagolix sisichasi somlomo, esingekho steroidal se-gonadotropin esikhupha ihomoni (GnRH) eyehlisa imveliso ye-estrogen kwaye isetyenziselwa ukunyanga iintlobo ezibuhlungu ze-endometriosis kwabasetyhini. Unyango lwe-Elagolix lunxulunyaniswa nezinga eliphantsi lokunyuka kwe-serum enzyme ngexesha lonyango kwaye kusafuneka inxulunyaniswe neemeko zokwenzakala kwesibindi okubonakalayo.

I-Elagolix isetyenzisiwe kulingo lokufunda isayensi esisiseko kunye nonyango lwe-Endometriosis, i-Folliculogenesis, i-Uterine Fibroids, ukopha kakhulu kwesibeleko, kunye nokopha kakhulu exesheni. Ukusukela nge-24 kaJulayi ka-2018, nangona kunjalo, i-US Food and Drug Administration (FDA) yavuma i-elagolix ye-AbbVie phantsi kwegama lebrand i-Orilissa njengeyokuqala kunye nekuphela kwehomoni yomlomo ekhupha i-gonadotropin (GnRH) ephuhliswe ngokukodwa kubasetyhini abaneentlungu eziphakathi ukuya kwi-endometriosis eqatha. Kuye kwafunyaniswa ukuba i-endometriosis yenye yezona zifo zixhaphakileyo ze-gynecologic e-United States. Ngokukodwa, uqikelelo lucebisa ukuba omnye kwabasetyhini abalishumi abakwiminyaka yokuzala uchatshazelwa yi-endometriosis kwaye abe namava eentlungu ezidambisayo. Ngaphezu koko, abasetyhini abachatshazelwa yile meko banokubandezeleka ukuya kutsho kwiminyaka emithandathu ukuya kwelishumi kwaye batyelele oogqirha abaninzi ngaphambi kokuba bafumane ukuxilongwa ngokufanelekileyo. Emva koko, njengoko u-Orilissa (elagolix) wamkelwa yi-FDA phantsi kophononongo oluphambili, le mvume ikhawulezileyo entsha inika abaqeqeshi bezempilo olunye ukhetho oluxabisekileyo lokunyanga iimfuno ezinokuthi zingafezekiswa zabasetyhini abachatshazelwe yi-endometriosis, ngokuxhomekeke kuhlobo lwabo oluthile kunye nobukhulu bentlungu ye-endometriosis. .

Ubume beMichiza

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ISIQINISEKISO

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
I-FDA-EIR-Letter-201901

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