I-Rimegepant

Incazelo emfushane:

Igama le-API Inkomba Umsunguli Idethi yokuphelelwa yisikhathi kwelungelo lobunikazi(e-US)
I-Rimegepant Ikhanda le-Migraine I-Biohaven Februwari 22, 2031

 


Imininingwane Yomkhiqizo

Omaka bomkhiqizo

IMINININGWANE YOMKHIQIZO

I-Rimegepant iyi-inhibitor encane ye-moleculei-calcitonini-peptide ehlobene nezakhi zofuzo (CGRP) receptor evimbela isenzo se-CGRP, i-vasodilator enamandla okukholelwa ukuthi idlala indima ekuphathweni kwekhanda elibuhlungu. I-Rimegepant igunyazwe ukwelapha ukuhlasela kwe-acute migraine. Ezivivinyweni zomtholampilo, i-rimegepant ngokuvamile yabekezelelwa kahle ngezimo ezingavamile kuphela zokuphakama kwesikhashana kwe-serum aminotransferase phakathi nokwelashwa futhi ngaphandle kwezimo ezibikiwe zokulimala kwesibindi okubonakala ngokomtholampilo.

U-Rimegepant ungumphikisi womlomo we-CGRP receptor eyakhiwe yi-Biohaven Pharmaceuticals. Ithole imvume ye-FDA ngoFebhuwari 27, 2020 yokwelashwa okubuhlungu kwekhanda lekhanda elibuhlungu. Nakuba abaphikisi abambalwa be-CGRP kanye ne-receptor yayo bavunyelwe ukwelashwa kwe-migraine (isb. [erenumab], [fremanezumab], [galcanezumab]), i-rimegepant kanye [i-ubrogepant] ukuphela kwamalungu omndeni we-"gepants" wemithi esele isakhula, futhi okuwukuphela kwabaphikisi be-CGRP abanokutholakala kwe-oral bioavailability. Izinga lamanje lokwelashwa kwe-migraine lihilela ukwelashwa kokukhipha isisu ngama-"triptans", afana [i-sumatriptan], kodwa le mithi iphikisana neziguli ezine-cerebrovascular kanye nesifo senhliziyo esivele zikhona ngenxa yezakhiwo zazo ze-vasoconstrictive. I-Antagonism ye-CGRP indlela isiphenduke into ekhangayo yokwelashwa kwe-migraine njengoba, ngokungafani nama-triptans, abaphikisi be-CGRP bomlomo abanazo izici ze-vasoconstrictive eziphawuliwe ngakho-ke ziphephile ukuthi zisetshenziswe ezigulini ezinokuphikisana nokwelashwa okujwayelekile.

I-Rimegepant aI-CalcitoninI-Peptide Receptor Antagonist ehlobene neGene. Indlela yokusebenza ye-rimegepant ifana ne-aI-CalcitoninI-Peptide Receptor Antagonist ehlobene neGene.

ISItifiketi

2018 GMP-2
原料药GMP证书201811 (captopril,thalidomide njll)
I-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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