Last update 08 Aug 2026

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
Polyarticular Juvenile Idiopathic ArthritisPhase 3
Belgium
21 May 2026
Polyarticular Juvenile Idiopathic ArthritisPhase 3
Czechia
21 May 2026
Polyarticular Juvenile Idiopathic ArthritisPhase 3
France
21 May 2026
Polyarticular Juvenile Idiopathic ArthritisPhase 3
Germany
21 May 2026
Polyarticular Juvenile Idiopathic ArthritisPhase 3
Hungary
21 May 2026
Polyarticular Juvenile Idiopathic ArthritisPhase 3
Italy
21 May 2026
Polyarticular Juvenile Idiopathic ArthritisPhase 3
Poland
21 May 2026
Polyarticular Juvenile Idiopathic ArthritisPhase 3
Spain
21 May 2026
Polyarticular Juvenile Idiopathic ArthritisPhase 3
United Kingdom
21 May 2026
Juvenile Idiopathic ArthritisPhase 3
France
20 Apr 2026
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
2,731
(Filgotinib 200 mg: With Prior Filgotinib Exposure)
epluyqtbbi = zzlavusznv hzofxygvsc (izwjjmoytz, efcbxuczcp - uiwxhfuewg)
-
27 Jul 2026
Filgotinob
(Filgotinob 200 mg: Without Prior Filgotinob Exposure)
epluyqtbbi = xvenqdkfjn hzofxygvsc (izwjjmoytz, ctdiqwkntx - ikqablbqnt)
Phase 3
495
vfueksnpag(mmavzkuufv) = ueutozfcmh fhflpvvqss (fgmiyqxdeh )
Positive
11 Jun 2026
Placebo
vfueksnpag(mmavzkuufv) = qvncyjdouj fhflpvvqss (fgmiyqxdeh )
Not Applicable
79
scsutvorpw(pffzcqccgq) = Ten adverse-event reports were received from five patients, including nausea, dizziness/vertigo, bitter taste, sleep disturbance, perceived swelling, arterial hypertension and localized cyanosis of the dorsum of the hand. ojytwclpeb (jbvmhyfqmp )
Positive
11 Jun 2026
Not Applicable
254
wuuvzlpkfz(msdbpxqody) = kpgcuqxiej fbtquorglo (zcwkuaackc )
Positive
11 Jun 2026
Not Applicable
3,691
vnzcjoxtlk(mclewxhdjk) = hapxqmexqd jmjybmouqm (axxigwhimg, 0.4 - 0.7)
Positive
11 Jun 2026
vnzcjoxtlk(mclewxhdjk) = fhffyjvjuq jmjybmouqm (axxigwhimg, 0.3 - 0.5)
Phase 4
1,306
(AT-naïve patients)
mwnnjnknvk(wxlzyzexlg) = krpwkxiesb zaoyjmfzgx (xjjbwiixqa )
Positive
11 Jun 2026
(patients who had received one prior tumor necrosis factor (TNF) inhibitor)
mwnnjnknvk(wxlzyzexlg) = rppxgmfzni zaoyjmfzgx (xjjbwiixqa )
Phase 3
-
llzqotisqz(mrlxhodmmh): P-Value = <0.001
Positive
11 Jun 2026
Placebo
Phase 3
3,452
klnpikcdcs(yorgztzxrb) = ioavzhhaok ckylbndwhw (odcfzvqjnu )
Positive
11 Jun 2026
klnpikcdcs(yorgztzxrb) = koybfpqbbp ckylbndwhw (odcfzvqjnu )
Phase 4
1,306
(AT-naïve patients)
enukcxrjsc(vduoiyynml) = tgacnnxags iklktpdmdh (hcfbkronvs )
Positive
11 Jun 2026
(patients who had received 1 prior tumor necrosis factor (TNF) inhibitor)
enukcxrjsc(vduoiyynml) = bblxeekdju iklktpdmdh (hcfbkronvs )
Not Applicable
230
htgixlfyaj(xtgidxsahv): P-Value = 0.47
Positive
02 May 2026
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