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IDR 14,249,993
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Elafibranor received accelerated approval in the United States in June 2024.
Stok 10000
Indicated for adults with primary biliary cholangitis who have an inadequate response to ursodeoxycholic acid or cannot tolerate it.
Elafibranor Mekanisme Kerja Mekanisme Kerja ，
2 ， ， / (2.1) 80 mg， (2.2) 2.1 IQIRVO IQIRVO [ Peringatan (5.1)] IQIRVO ， [ Peringatan (5.3)， (8.1, 8.3)] 2.2 IQIRVO 80 mg， [ (12.3)] 2.3 IQIRVO 4 4 ， [ (7.2)]
5 Peringatan IQIRVO ， (CPK) ， IQIRVO 5.1 IQIRVO ， 5.2
11 GFT1007 PPAR pH 1.2 6.8 ， pH 7.5 ， DMSO ， C₂₂H₂₄O₄S， 384.49 g/mol， 2-(2,6- -4-{3-[4-( ) ]-3- -1- -1- } )-2- ， IQIRVO 80 mg ，
Indicated for adults with primary biliary cholangitis who have an inadequate response to ursodeoxycholic acid or cannot tolerate it.
2 ， ， / (2.1) 80 mg， (2.2) 2.1 IQIRVO IQIRVO [ Peringatan (5.1)] IQIRVO ， [ Peringatan (5.3)， (8.1, 8.3)] 2.2 IQIRVO 80 mg， [ (12.3)] 2.3 IQIRVO 4 4 ， [ (7.2)]
5 Peringatan IQIRVO ， (CPK) ， IQIRVO 5.1 IQIRVO ， 5.2
8.1 ， IQIRVO ， elafibranor ， / ， IQIRVO ，
12 12.1 Mekanisme Kerja GFT1007 PPAR ， PPAR-α PPAR-γ PPAR-δ ， PBC PPAR-α PPAR-δ ，PPAR-δ 21 FGF21 CYP7A1 ，CYP7A1 PPAR ，elafibranor GFT1007 PPAR-α EC50 46 nM 14 nM，Em 0.05 0.05
13 13.1 2 CD-1 ， elafibranor 1 3 10 30 mg/kg/ ， elafibranor GFT1007 AUC， 0.007 0.14 0.003 0.16 Sprague-Dawley ， elafibranor 10 mg/kg/ elafibranor GFT1007 AUC 0.36 ， 30 mg/kg/ elafibranor GFT1007 AUC 2.1 ，elafibranor
14 1 (NCT04526665) IQIRVO 161 (UDCA) (PBC) IQIRVO 80 mg (n=108) (n=53)， ， 52 ， UDCA (ALP) ≥ (ULN) 1.67 ， (TB) ≤ 2
Indikasi
Indicated for adults with primary biliary cholangitis who have an inadequate response to ursodeoxycholic acid or cannot tolerate it.
Mekanisme Kerja
Elafibranor Mekanisme Kerja Mekanisme Kerja ，
Dosis dan Penggunaan
2 ， ， / (2.1) 80 mg， (2.2) 2.1 IQIRVO IQIRVO [ Peringatan (5.1)] IQIRVO ， [ Peringatan (5.3)， (8.1, 8.3)] 2.2 IQIRVO 80 mg， [ (12.3)] 2.3 IQIRVO 4 4 ， [ (7.2)]
Peringatan
5 Peringatan IQIRVO ， (CPK) ， IQIRVO 5.1 IQIRVO ， 5.2
