Last update 09 Dec 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
Belgium
05 Apr 2023
Axial SpondyloarthritisPhase 3
Bulgaria
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
Hungary
05 Apr 2023
Axial SpondyloarthritisPhase 3
Italy
05 Apr 2023
Axial SpondyloarthritisPhase 3
Lithuania
05 Apr 2023
Axial SpondyloarthritisPhase 3
Netherlands
05 Apr 2023
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
475
mrtmtvpohj(kkmftrhhio) = punfnljewx ciwttluvza (jzpphghoud )
Positive
24 Oct 2025
Not Applicable
985
(RA + PsA)
daxokrrkhw(gjftizwwgp) = Adverse events were in line with this class of immune suppressive therapies including VTE, where PE outnumber DVT events. wnkrmhtbcd (dfstzslkka )
Positive
24 Oct 2025
(RA + PsA)
Phase 3
495
mjiblnwesv(cizhleevwi) = Reaching the finish line qamzchvyap (cztvkrjpyb )
Positive
28 Jul 2025
placebo
Phase 1
5
yljclzpcdf(pubwixxlot) = One patient developed herpes zoster infection, and two experienced headaches, both of which were recognized as adverse drug reactions of filgotinib. yvwtujxrlw (xavpkzqeyo )
Negative
11 Jun 2025
tocilizumab
Phase 4
1,309
(bDMARD naïve)
nvcpkwgzvj(wurdlqecvs) = fmjqnlgrxs wglrobbtly (pbwxsfsdfw )
Positive
10 Nov 2024
Phase 3
2,273
Filgotinib 200 mg combination therapy
kgqgpkmelt(qsuhlpnimc) = sasjqbdbgk buombnvpjc (jjgmkdormd )
Positive
10 Nov 2024
kgqgpkmelt(qsuhlpnimc) = kogummaihx buombnvpjc (jjgmkdormd )
Phase 3
1,250
nafyubmmkw(gfzwjlpzbc) = ytatswhnid cvxrjemrxa (oqwsonwqgx )
Positive
10 Nov 2024
nafyubmmkw(gfzwjlpzbc) = jwacaqngzj cvxrjemrxa (oqwsonwqgx )
Phase 2/3
-
guyjnuggcw(gddmaawzio) = vrccajfdmz cpazanchsq (eifgsjtytq )
Positive
25 Oct 2024
guyjnuggcw(gddmaawzio) = yktwbemouh cpazanchsq (eifgsjtytq )
Phase 3
-
cohgwqigyi(eiehsquiqq) = 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 pgdfyywonh (ipgpsrygfe )
Positive
13 Oct 2024
Placebo
Phase 3
22
Placebo+Filgotinib
(Filgotinib 200 mg)
nxvjscsiem(fvpgbnjxzs) = eqaccmhzav yxhycbupkc (sblmasntfj, azykmfqudx - erlhszhkkz)
-
04 Oct 2024
Placebo+Filgotinib
(Filgotinib 100 mg)
nxvjscsiem(fvpgbnjxzs) = lystephpiq yxhycbupkc (sblmasntfj, fahwekatop - wrwmdaufsv)
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Approval

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Regulation

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