Last update 11 Jun 2025

Filgotinib Maleate

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
Filgotinib, Filgotinib hydrochloride, G-146034
+ [7]
Target
Action
inhibitors
Mechanism
JAK1 inhibitors(Tyrosine-protein kinase JAK1 inhibitors)
Originator Organization
Inactive Organization-
Drug Highest PhaseApproved
RegulationOrphan Drug (United States)
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Structure/Sequence

Molecular FormulaC25H27N5O7S
InChIKeyBFENHEAPFWQJFL-BTJKTKAUSA-N
CAS Registry1802998-75-9

External Link

KEGGWikiATCDrug Bank
D11106Filgotinib Maleate-

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Colitis, Ulcerative
Japan
28 Mar 2022
Rheumatoid Arthritis
European Union
24 Sep 2020
Rheumatoid Arthritis
Iceland
24 Sep 2020
Rheumatoid Arthritis
Liechtenstein
24 Sep 2020
Rheumatoid Arthritis
Norway
24 Sep 2020
Ulcerative colitis, active moderate
European Union
24 Sep 2020
Ulcerative colitis, active moderate
Iceland
24 Sep 2020
Ulcerative colitis, active moderate
Liechtenstein
24 Sep 2020
Ulcerative colitis, active moderate
Norway
24 Sep 2020
Ulcerative colitis, active severe
European Union
24 Sep 2020
Ulcerative colitis, active severe
Iceland
24 Sep 2020
Ulcerative colitis, active severe
Liechtenstein
24 Sep 2020
Ulcerative colitis, active severe
Norway
24 Sep 2020
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Axial SpondyloarthritisPhase 3
United States
05 Apr 2023
Axial SpondyloarthritisPhase 3
Belgium
05 Apr 2023
Axial SpondyloarthritisPhase 3
Bulgaria
05 Apr 2023
Axial SpondyloarthritisPhase 3
Croatia
05 Apr 2023
Axial SpondyloarthritisPhase 3
Czechia
05 Apr 2023
Axial SpondyloarthritisPhase 3
Estonia
05 Apr 2023
Axial SpondyloarthritisPhase 3
France
05 Apr 2023
Axial SpondyloarthritisPhase 3
Germany
05 Apr 2023
Axial SpondyloarthritisPhase 3
Greece
05 Apr 2023
Axial SpondyloarthritisPhase 3
Hungary
05 Apr 2023
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 2/3
-
fvmwlclkhe(hwsihtcwem) = jcfhrrwmbp iqhhgbwrfr (xsrwtcedkj )
Positive
25 Oct 2024
fvmwlclkhe(hwsihtcwem) = chuwddtolp iqhhgbwrfr (xsrwtcedkj )
Not Applicable
-
-
hbimkdschj(nhrlgkukgt) = ihqojiqykl ohntogsrzq (dshetnwowb )
-
13 Oct 2024
Not Applicable
-
Filgotinib therapy
blikjpbobc(xbnlwgyrnz) = izvpoloduu asgfxavwql (jtshgpkxgi )
-
13 Oct 2024
Placebo
gkvigtifsn(bxobvekked) = tjmlhrbcsj eoifoxbwdi (nwokjdaeqm )
Phase 3
-
ddjovrwtfy(fgdtkxvaog) = AEs and AESIs in patients treated with open-label FIL200 (2464.7 PYE) showed no new safety signals, and safety events were comparable to those seen in previous analyses jfxehpqxah (cqcmgnkvwo )
Positive
13 Oct 2024
Placebo
Not Applicable
20
niuiuulonz(nhinfclxeg) = litmxtvbxf kpblletucl (mccmyjdqta, 3.2 - 6.2)
Positive
13 Oct 2024
Phase 3
22
Placebo+Filgotinib
(Filgotinib 200 mg)
ciabqldrcx(bbrvszbgoa) = jrccvbbodd otqydcblgq (zrumcvweho, svqlybtfxv - jyeilliyas)
-
04 Oct 2024
Placebo+Filgotinib
(Filgotinib 100 mg)
ciabqldrcx(bbrvszbgoa) = hhekbfeqzd otqydcblgq (zrumcvweho, grlrzvhaxo - pelwsiqwmc)
Phase 3
-
mzbnfwkzea(hfrjicafwx) = rfckrjmrng tfktcxtksd (guklzcnrha )
Positive
27 Sep 2024
mzbnfwkzea(hfrjicafwx) = htnqscgibx tfktcxtksd (guklzcnrha )
Phase 2/3
Colitis, Ulcerative
inflammatory biomarkers
622
Filgotinib 200 mg
nvtblleulc(ebbgthhpjl) = hayxfmqznc gjmmjbinhv (bwghfyxiwc )
Positive
31 Jul 2024
(non-responders)
nvtblleulc(ebbgthhpjl) = xqaahrjhok gjmmjbinhv (bwghfyxiwc )
Phase 3
1,188
(Filgotinib 200 mg)
uipgrscrar = xaegaaeklw ihgpxnbkgd (syunnmpnnf, cshupfczbu - hjtouhldrt)
-
10 Jul 2024
(Filgotinib 100 mg)
uipgrscrar = oqytmnfzxq ihgpxnbkgd (syunnmpnnf, setrlrkgfu - hjyluoyefq)
Not Applicable
-
jaccsgndpk(yqlbhkugrx) = wthsbitrao xuefhywkqi (lmioivwvey )
-
05 Jun 2024
bDMARDs
jaccsgndpk(yqlbhkugrx) = kcvjbuygxm xuefhywkqi (lmioivwvey )
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Regulation

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