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Elafibranor (GFT505) Powder-ʻO Ke ʻAle Paʻa Hou No ka ʻĀina Hoʻomaʻomaʻo NASH

He aha ka Elafibranor (GFT505)?

ʻO Elafibranor (GFT505) ka pauma (923978-27-2), he lāʻau lapaʻau i hana ʻia e hoʻomau ʻia ana noiʻi. Mālama, ka noiʻi ʻana a me ka hoʻomohala ʻia e Genfit e pili ana i ka hopena o ka Elafibranor (GFT505) ka lehu (923978-27-2) i ka hakakā ʻana i nā maʻi e like me ka maʻi leka ʻona ʻole o ka maʻi wai, ka dyslipidemia, ke kūʻē o ka insulin, a me ka maʻi diabetes.

ʻO Elafibranor (GFT505) ka hana o ka hana

ʻO Elafibranor (GFT505) ka pauma he hana hōʻeha e hana ana ma nā subtypes PPAR ʻekolu. Hoʻokomo lākou iā PPARa, PPARd, a me PPARg. Eia nō naʻe, ua hana nui ia ma PPARa.

ʻO ka hana o ka Elafibranor o ka hana he paʻakikī i ka hoʻokaʻawale ʻana i nā cofactors i ka mea hoʻokele nukle. A ʻo kahi hopena, alakaʻi kēia i ka hoʻoponopono kaʻawale ʻana o nā ʻano o nā ʻano a me ka hopena ʻōlohelohe.

Hiki i ka paukū Elafibranor (GFT505) ke hoʻomaopopo a ka hoʻopōmaikaʻi ʻana i ka hana nīkini mea neʻe i nā mea hoʻonani nuklea (SNuRMs). A ʻo ke hopena, hāʻawi ia i ka holomua ʻoi aku me ka hopena o ka hopena.

Ua hōʻike ʻia nā molekila multimodal a me ka pluripotent e kū pono i ka hakakā ʻana i nā ʻano like ʻole. Hoʻopili lākou i ka kū'ē o ka insulin a me ka maʻi diabetes, ka uihue, nā momona, a me ka lipid triad, ka mea i hōʻike ʻia e ka hoʻonui ʻana o ka kolamu HDL a me ka hoʻohaʻahaʻa i ka kolamu LDL a me ka triglycerides.

ʻO ka ʻokoʻa ma waena o ka hana a ka Elafibranor a me nā mea hoʻohui ʻē aʻe e kuhikuhi ana i nā PPAR ma NASH (nonalcoholic steatohepatitis) ʻo ia ka mea ʻaʻole ia e hōʻike i kekahi ʻano lāʻau lapaʻau PPARy.

Ma ka hopena, Elafibranor ʻaʻoleʻike nā mea hoʻohana i nā hopena i makemake ʻole ʻia e pili pū ana me ka hoʻolaʻa PPARy. Loaʻa nā hopena maikaʻi; ka paʻa o ke kahe, edema, a me ke kaupaona loaʻa nā mea a pau e hoʻonui i ka pilikia i ka ʻehaʻeha o ka puʻuwai.

ʻO Elafibranor (GFT505) no ke aʻo ʻana no Nash

NASH (nonaloholic steatohepatitis) he maʻi ia e pili ana i ka maʻi a me ka hoʻoneʻe ʻana i nā hepatocytes me ka hōʻiliʻili ʻana i ka momona kahi i ʻike ʻia ka poʻe lipid. ʻO ka maʻamau, ʻo kekahi mau kūlana olakino e like me ka metabolic syndrome, type type 2, a me ka momona he helu kumu hoʻokahi o ka nonato alaka steatohepatitis (NASH), a me nā maʻi momona momona kūlohelohe (NAFLD).

Elafibranor (GFT505) Powder-ʻO Ke ʻAle Paʻa Hou No ka ʻĀina Hoʻomaʻomaʻo NASH

I kēia mau lā, nui ka poʻe e ʻeha nei i kēia maʻi make. ʻO ka ʻōlelo hopohopo e pili ana i ia mea hiki iā ia ke alakaʻi i ka cirrhosis, kahi kūlana e hiki ai i ka ʻōpū ke hana. Hiki nō hoʻi iā ia ke holomua i ka maʻi paleka kōpaʻa a ma kekahi mau mea, kahi e make ai.

ʻO ka lono kaumaha e pili ana iā NASH (nonalcoholic steatohepatitis) ke kī ʻole ia i ka makahiki a hoʻomau ka hopena i kēlā me kēia. ʻOi aku ka ʻino, hiki i nā hōʻailona maʻi ke like asymptomatic, a ʻike paha kekahi ʻaʻole lākou e ʻeha nei lākou mai ka maʻi a hiki i ka pae hope ʻana.

ʻO ka ʻili a me ka mumū i lawe ʻia e NASH (steatohepatitis hauole ʻole) hiki ke alakaʻi i nā hoʻopiʻi maʻi a me nā puʻuwai. Me nā poʻe he nui e ʻeha nei i kēia ʻano e hoʻomaka ana mai ka maʻi momona ngona ʻona ʻole, ke noiʻi nei nā mea noiʻi i nā koho maʻi ʻē aʻe ma mua o kahi hoʻololi hāpū.

ʻO kekahi o nā lāʻau lapaʻau e noiʻi nei no ka mālama ʻana iā NASH ʻo ia ʻo Elafibranor (GFT505) pauma (923978-27-2). I kēia manawa, hōʻike ia i nā hopena kūpono i nā hiʻohiʻona koʻikoʻi ʻelua o ka maʻi, ʻo ia hoʻi, ballooning a me ka ʻūhā. ʻO ka nani me ia e hiki ke ahonui a ʻaʻole iki e hana i kekahi e hoʻopiʻi i kekahi hopena ʻaoʻao. ʻO ia ke kumu i hāʻawi ai ka US Food and Drug Administration i kahi ʻano wikiwiki i kēia lāʻau lapaʻau no ka Hoʻohana ʻia NASH.

I kēia manawa, ʻo Elafibranor (GFT505) pauka i loko o Phase 3 hoʻokolohua hoʻokolohua, i kapa ʻia ʻo RESOLVE IT.

OLELO HOOLAHA -

ʻO ia kahi noiʻi honua i hoʻomaka ma ka hapa mua o 2016, ʻo ia ka randomized, placebo-control in ratio 2: 1 and double-blind. ʻO nā mea maʻi e pili pū ana i kēia noiʻi nā mea i loaʻa i ka maʻi NASH (NAS> = 4) a me nā fibrosis (F2 a i F3 paha i ʻike ʻia ka pōʻino o ka ate ma loko o nā noi holoʻokoʻa, e lawelawe ʻia nā mea maʻi me Elafibranor (GFT505) 120mg a placebo paha i kēlā me kēia lā.

E kōkua ka mea hoʻokahi i ka maʻi kauahi hoʻokahi kaukaʻi e hōʻike inā mālama ʻia ʻo NASH me Elafibranor (GFT505) me ka hoʻopiʻi ʻana o ka fibrosis e like me ka poʻe i mālama ʻia me ka pletebo.

ʻO ka cohort mua i kau inoa ʻia ma ʻApelila 2018, a e hōʻike ʻia ka loiloi o nā hopena i ka hopena o ka makahiki 2019. E hōʻike ka ʻikepili i ka ʻōlelo a loaʻa ʻo Elafibranor e ʻae ʻia e ka US Food and Drug Administration ma ke ʻano he ʻae ʻia me ka hoʻokele ʻia e ka European Medicines Agency, maikaʻi. kaulana ia Ea e 2020.

Ua hele i mua ka ʻike ma ka mahina ʻo Dekemaba 2018 i ka manawa o ka Data Safety Monitoring Board (DSMB) i kākoʻo ai i ka hoʻomau ʻana o ka hoʻokolokolo me ka ʻole o kahi hoʻololi. ʻO ia ma hope o ka loiloi mua i hoʻolālā ʻia e pili ana i ka ʻike palekana ma hope o kanakolu mau mahina.

Elafibranor (GFT505) Powder-ʻO Ke ʻAle Paʻa Hou No ka ʻĀina Hoʻomaʻomaʻo NASH

Nā hopena no nā haʻawina mua a me ke aʻo ʻana i ka mālama ʻana no NASH

ʻO ka ʻoihana a me ka palekana oElafibranor i loko o ka mālama ʻana i ka NASH ua loiloi i loko o ka mea i hala ma o nā kumu maʻi lehulehu. Ma ka pae 5a 2a, ua hoʻāʻo ʻia ka nui o nā hoʻokolohua ma nā maʻi like ʻole o nā mea maʻi e loaʻa ana i ka maʻi metabolic. Hoʻokomo ʻia i nā mea me ka diabetes type 2 a i ʻole pre-diabetes a me ka atherogenic dyslipidemia. I loko o ke aʻo ʻana, ua ʻike ʻia ua hāpai ʻo Elafibranor;

  • Hoʻemi ʻia ka pilikia o ka pilikia o nā pilikia cardiovascular
  • Hoʻemi ʻia nā hōʻailona ʻeha o ka hōʻeha o ka ate
  • Nā waiwai anti-inflammatory
  • Hoʻonui ka mahele o ka insulin
  • Huku hale home
  • ʻO ka ʻōlelo molika lipioprotective.

ʻO ka hōʻike 2b ʻoi i hoʻokumu ʻia ma ka makahiki 2012 ʻo ia ka hoʻokūkū interventional nui loa a me ka hoʻāʻo mua hoʻokele honua mua e hana ʻia ma NASH. Ma laila ua loaʻa iā Elafibranor i ka FDA e kuhikuhi i ka hopena o ka "Hoʻolālā NASH me ka ʻole o ka hoʻomakeke ʻana o Fibrosis." ʻO ia ka manaʻo nui no ka hoʻokolokolo honua 3 e hoʻomau nei.

Ua nānā ʻia nā mea maʻi e loaʻa ana ka hoʻomaikaʻi ʻana me NASH me Elafibranor i hoʻomaikaʻi ʻia i ka hoʻomaʻamaʻa ʻana i nā māka hana maʻi pokiʻai e like me ALP, GGT, a me ALT. Ma o ka loiloi ʻana o ka hopena o ka hope, aia kahi ʻike a Elafibranor (GFT505) dosage 120mg i hāʻawi i nā hopena therapeutic i nā hopena pilikia o ka cardiometabolic i pili me NASH, Ua komo lākou;

  • Nā hopena anti-inflammatory
  • ʻO kahi hoʻomaikaʻiʻana i ka sensitivity insulin a me ka metabolism glucose i nā maʻi maʻi i loaʻa i ka maʻi maʻi
  • Hoʻonui i nā pae o nā lipoproteins a me nā lipid plasma.
Ka hopena o Elafibranor ma ka mālamaʻana i ka NASH pediatric

Ua hoʻonui nui ʻia ka nui o nā keiki e loaʻa ana i ka obesity, me ka ulu ʻana ka hopohopo olakino. Ma kahi noiʻi i hana ʻia ma ka makahiki 2016, ua nānā 'ia NAFLD(nonaloholic fat fatty disease) pili i ka 10-20% o ka nui o ka lolo. Ua hōʻike ʻia aku ʻo NAFLD ka mea e alakaʻi ai i ka nui o ka palupalu o ka ate, ka pathology ate, a me ka implantation o ke ake ma nā keiki a me nā ʻōpio.

Ma Ianuali 2018 aia kahi hoʻolaha kūloko o ka papahana pediatric NASH e noʻonoʻo ana ʻo Elafibranor wale nō ka lāʻau lapaʻau i hōʻike ʻia e pili pono ana i ka mālama ʻana o NASH i nā pākeke a aia i ke kahua hoʻomohala hana i ka mālama ʻana i nā keiki.

Hiki ke hoʻohana pū iā Elafibranor me nā lāʻau lapaʻau ʻē aʻe i ka mālama ʻana i ka NASH?

Ua mākaʻikaʻi ʻia ua ola ʻo Elafibranor i ka mālama ʻana i ka NASH i kona wā pono ʻia. Eia naʻe, no ka paʻakikī o ka maʻi, hiki ke hoʻohana pū ʻia me nā lāʻau ʻē aʻe e pili ana i ka hoʻokele ʻana i nā fibrosis ngoʻi, NASH, a me kā lākou co-morbidities.

Hoʻohana ʻē aʻe ʻo Elafibranor (GFT505)

I ka hoʻomaʻamaʻa ʻana i nā maʻi maʻi cholstasis

ʻO Cholestasis kahi kumu i hoʻoiho ʻia e ka pōʻino i ka hoʻokumu ʻana o ka hua bile a me kona kahe ʻana ma o ka gallbladder a me duodenum. Hiki iā ia ke alakaʻi i ka ulu ʻana o ka maʻi ʻōnaehana a me ka maʻi o ka ate, ka oki ʻana o ka ate, a hiki i ka pono o ke hoʻololi ʻana i ke ate. Ua hōʻike ʻia kahi noiʻi haumanu e hōʻike ana ʻo Elafibranor (GFT505) pauku i ka hōʻailona o nā biochemical mark i ka plasma a laila e hōʻike nei i hiki ke lilo i ka mālama ʻana o ka maʻi cholestasis.

Diabetes

ʻO ka maʻi hakahaka he kūlana ia e loaʻa i ka nui o ke kō a me ke koko i loko o ke koko. Hoʻopilikia ʻia ia ma kahi o ʻehā mau miliona poʻe i ka honua. Hoʻokumu kekahi i ka maʻi diabetes type 2 inā ʻaʻole hiki i ko lākou kino ke hana a hoʻohana i ka insulin maʻamau.

ʻO nā noiʻi e pili ana i ka elafibranor e hōʻike ana e hōʻemi ana i ka holomua o ka maʻi diabetes type 2 i ʻelua mau ala. ʻO ka mea mua ma o ka hoʻomaikaʻi ʻana i ka metabolism glucose i loko o ke kino.

Hoʻonui pū ia i ka hoʻoliʻiliʻi ʻana o nā inanini ma nā uaua a me nā kiko peripheral.

Elafibranor (GFT505) Powder-ʻO Ke ʻAle Paʻa Hou No ka ʻĀina Hoʻomaʻomaʻo NASH

Panina

ʻO ka haʻawina ʻo Elafibranor e hele mai nei i nā lono maikaʻi i nā mea e ʻeha nei iā NASH. No ka hoʻokolohua ʻana i nā maʻi ʻoi aku ma mua o ʻewalu mau haneli i kēia manawa a hōʻike ʻia ua pono, aia ka manaʻa ʻaʻole pono ka poʻe e hōʻemi hou i kahi hoʻololi kino.

ʻAʻole Hoʻopili i nā lāʻau lapaʻau Elafibranor ua ʻike ʻia me ka sitagliptin, simvastatin, a i ʻole warfarin, kahi e hōʻike ana hiki ke hoʻohana pū ʻia me nā lāʻau ʻē aʻe me ka maluhia. Hoʻomaʻamaʻa maikaʻi ʻo Elafibranor i ke kino a ʻaʻole i hōʻike i nā hopena ʻelua.

E hoʻomaopopo '

  1. Nā Palapala ʻImi Hōʻailona ma ka Diabetes, Obesity, a me Nonalcoholic Fatty, hoʻoponopono ʻia e Andrew J. Krentz, Christian Weyer, Marcus Hompesch, Springer Nature, ʻaoʻao 261
  2. Nā PPAR i loko o ka cellular a - - Whole body Energy Metabolism i hoʻoponopono ʻia e Walter Wahli, Rachel Tee, 457-470
  3. Obesity and Gastroenterology, He Kino o nā Kila Kukulu ʻo Gastroenterology o North, Octavia Pickett-Blakely, Linda A. Lee, ʻaoʻao 1414-1420

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