Rimegepant

Apejuwe kukuru:

Orukọ API Itọkasi Innovator Ọjọ Itọsi Itọsi (AMẸRIKA)
Rimegepant Orififo orififo Biohaven Oṣu kejila ọjọ 22, Ọdun 2031

 


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Rimegepant ni a kekere moleku onidalẹkun ti awọncalcitoninpeptide ti o ni ibatan pẹlu jiini (CGRP) olugba ti o ṣe idiwọ iṣẹ ti CGRP, vasodilator ti o lagbara ti a gbagbọ lati ṣe ipa ninu awọn efori migraine.Rimegepant jẹ ifọwọsi fun itọju awọn ikọlu migraine nla.Ninu awọn idanwo ile-iwosan, rimegepant ni gbogbogbo farada daradara pẹlu awọn iṣẹlẹ to ṣọwọn nikan ti awọn ipele giga ti omi ara aminotransferase lakoko itọju ailera ati laisi awọn iṣẹlẹ ti o royin ti ipalara ẹdọ ti o han gbangba ni ile-iwosan.

Rimegepant jẹ antagonist oral ti olugba CGRP ti o dagbasoke nipasẹ Biohaven Pharmaceuticals.O gba ifọwọsi FDA ni Oṣu Kẹta ọjọ 27, Ọdun 2020 fun orififo migraine itọju nla.Lakoko ti ọpọlọpọ awọn antagonists parenteral ti CGRP ati olugba rẹ ti fọwọsi fun itọju ailera migraine (fun apẹẹrẹ [erenumab], [fremanezumab], [galcanezumab]), rimegepant ati [ubrogepant] jẹ awọn ọmọ ẹgbẹ nikan ti idile “gepants” ti awọn oogun ti o ku ni idagbasoke, ati pe awọn antagonists CGRP nikan ti o ni bioavailability roba.Idiwọn lọwọlọwọ ti itọju ailera migraine pẹlu itọju aboyun pẹlu awọn “triptans”, gẹgẹbi [sumatriptan], ṣugbọn awọn oogun wọnyi jẹ contraindicated ni awọn alaisan pẹlu cerebrovascular ati arun inu ọkan ati ẹjẹ ti o ti wa tẹlẹ nitori awọn ohun-ini vasoconstrictive wọn.Antagonism ti ọna CGRP ti di ibi-afẹde ti o wuyi fun itọju ailera migraine bi, ko dabi awọn triptans, awọn antagonists CGRP oral ko ni akiyesi awọn ohun-ini vasoconstrictive ati nitorinaa jẹ ailewu fun lilo ninu awọn alaisan pẹlu awọn ilodisi si itọju ailera.

Rimegepant jẹ aCalcitoninGene-jẹmọ Peptide Olugba Olugba.Awọn siseto igbese ti rimegepant jẹ bi aCalcitoninGene-jẹmọ Peptide Olugba Olugba.

Ijẹrisi

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

Ìṣàkóso didara

Quality management1

Igbero18Awọn iṣẹ akanṣe Igbelewọn Iṣeduro Didara eyiti o ti fọwọsi4, ati6ise agbese ni o wa labẹ alakosile.

Quality management2

Eto iṣakoso didara agbaye ti ilọsiwaju ti fi ipilẹ to lagbara fun tita.

Quality management3

Abojuto didara n ṣiṣẹ nipasẹ gbogbo igbesi aye ọja lati rii daju didara ati ipa itọju ailera.

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Ẹgbẹ Aṣoju Iṣeduro Ọjọgbọn ṣe atilẹyin awọn ibeere didara lakoko ohun elo ati iforukọsilẹ.

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