Rimegepant

Inkcazelo emfutshane:

Igama le-API Isalathiso Umqalisi Umhla wokuphelelwa kwePatent(e-US)
Rimegepant Intloko yeMigraine I-Biohaven NgoFebruwari 22, 2031

 


Iinkcukacha zeMveliso

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IINKCUKACHA ZEMVELISO

I-Rimegepant yi-molecule encinci inhibitor yeicalcitonini-peptide ehlobene ne-gene (CGRP) i-receptor evimba isenzo se-CGRP, i-vasodilator enamandla ekholelwa ukuba idlala indima kwintloko ye-migraine. I-Rimegepant ivunyiwe kunyango lokuhlaselwa kwe-acute migraine. Kulingo lweklinikhi, i-rimegepant yayinyamezeleke ngokubanzi kunye neemeko ezinqabileyo kuphela zokunyuka kwe-serum aminotransferase okwethutyana ngexesha lonyango kwaye akukho ziganeko zichaziweyo zokwenzakala kwesibindi okubonakalayo.

I-Rimegepant ngumchasi womlomo we-CGRP receptor eyenziwe yi-Biohaven Pharmaceuticals. Ifumene imvume ye-FDA nge-27 kaFebruwari 2020 yonyango oluqatha lwentloko yentloko. Ngelixa abachasi abaninzi be-CGRP kunye ne-receptor yayo baye bavunywa kunyango lwe-migraine (umz. [erenumab], [fremanezumab], [galcanezumab]), i-rimegepant kunye [ubrogepant] ngamalungu kuphela osapho lwe "gepants" lwamayeza aseleyo kuphuhliso, kwaye kuphela ngabachasi beCGRP abanobukhona be-oral bioavailability. Umgangatho wangoku wonyango lwe-migraine ubandakanya unyango lokukhupha isisu kunye ne "triptans", ezifana [sumatriptan], kodwa la mayeza anqatshelwe kwizigulane ezine-cerebrovascular and cardiovascular disease esele zikhona ngenxa yeempawu zabo ze-vasoconstrictive. I-Antagonism ye-CGRP yendlela iye yaba yinto ekujoliswe kuyo ekhangayo yonyango lwe-migraine njengoko, ngokungafaniyo ne-triptans, abachasayo be-CGRP yomlomo ababoni iimpawu ze-vasoconstrictive kwaye ngoko ke zikhuselekile ukusetyenziswa kwizigulane ezine-contraindications kunyango oluqhelekileyo.

IRimegepant yiCalcitoninI-Gene-related Receptor Antagonist. Indlela yokwenza i-rimegepant ifana ne-aCalcitoninI-Gene-related Receptor Antagonist.

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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