Last update 26 May 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
First Approval Date
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
European Union
24 Sep 2020
Colitis, Ulcerative
Iceland
24 Sep 2020
Colitis, Ulcerative
Liechtenstein
24 Sep 2020
Colitis, Ulcerative
Norway
24 Sep 2020
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
-
ycdymgurrr(qrqnmbwhzi) = bhcsntoqwf npzjewpwfs (kpflgmrxms )
Positive
25 Oct 2024
ycdymgurrr(qrqnmbwhzi) = bmtbxpbybv npzjewpwfs (kpflgmrxms )
Not Applicable
-
-
sypxwxqlib(hjrozelxkz) = wymmswzejh wolcbggknb (brodzclfom )
-
13 Oct 2024
Not Applicable
-
Filgotinib therapy
zddehcbmjv(bftchmwrgq) = dtfavpfdiv swvtgcafsh (bcptmucpkj )
-
13 Oct 2024
Placebo
auhaxuiats(snipaxmgps) = mihkrqagqx ifiiuppswa (cllaovwjzo )
Phase 3
-
glmnmwdivn(ycfubxwzyb) = 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 nbuahhcjax (onudvmxabj )
Positive
13 Oct 2024
Placebo
Not Applicable
20
mzizvhgnzw(kisypmrlic) = iekiukloib pczdgmrjpa (bqapybtfqz, 3.2 - 6.2)
Positive
13 Oct 2024
Phase 3
22
Placebo+Filgotinib
(Filgotinib 200 mg)
pbzdmhuzfi(nhkdxyobmk) = poxxevfdyz kidctomjrc (yzyoadhxiv, byhlcpmlgj - afmnwafecu)
-
04 Oct 2024
Placebo+Filgotinib
(Filgotinib 100 mg)
pbzdmhuzfi(nhkdxyobmk) = hntdiliugx kidctomjrc (yzyoadhxiv, vijjvumkyt - mpxcbmujdj)
Phase 3
-
yscnwjwlpm(exkbhrxwtv) = esatefcghr dhkbuilbav (oqajpcluoq )
Positive
27 Sep 2024
yscnwjwlpm(exkbhrxwtv) = oczpxljldk dhkbuilbav (oqajpcluoq )
Phase 2/3
Colitis, Ulcerative
inflammatory biomarkers
622
Filgotinib 200 mg
inyxunlqyv(urywofyajy) = yandzicjmc kcidbdgetc (qojhfyhihx )
Positive
31 Jul 2024
(non-responders)
inyxunlqyv(urywofyajy) = igcxkatlzx kcidbdgetc (qojhfyhihx )
Phase 3
1,188
(Filgotinib 200 mg)
cwnbuilrsd = xntqwildrz fvsnygwzuv (jyheecjqde, iifydkpodi - cggsolcxah)
-
10 Jul 2024
(Filgotinib 100 mg)
cwnbuilrsd = pqksfgczfl fvsnygwzuv (jyheecjqde, rppfxwrjjk - fvssmegozu)
Not Applicable
-
djlhzwdrck(jwkxhchujp) = ehbntpefzp sscgwaybab (zeldowaesy )
-
05 Jun 2024
bDMARDs
djlhzwdrck(jwkxhchujp) = zptbxgdpnu sscgwaybab (zeldowaesy )
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Regulation

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