Filgotinib

also known as GLPG0634 · GS-6034 · FIL · FILGOTINIB (GLPG0634) · FILGOTINIB HYDROCHLORIDE · Filgotinib hydrochloride trihydrate · Filgotinib Maleate · FILGOTINIB??GLPG0643) · +4 more

Small molecule targets JAK1, JAK2, JAK3, TYK2 via inhibition

Developed for: rheumatoid arthritis · psoriatic arthritis · ulcerative colitis · ankylosing spondylitis · Crohn disease · juvenile idiopathic arthritis · spondyloarthropathy · Behcet disease
+9 more
· cutaneous lupus erythematosus · idiopathic inflammatory myopathy · immunoglobulin G4-related sclerosing disease · inflammatory bowel disease · lupus nephritis · polyarticular juvenile idiopathic arthritis · Sjogren syndrome · small bowel Crohn disease · uveitis
Investigated by: Lakefront Biotherapeutics NV · Gilead Sciences · Alfasigma S.p.A. · Eisai Co., Ltd. · Atsushi Kawakami · Autoimmune Research and Collaboration Hub
+10 more
· Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives · Leiden University Medical Center · Ono Pharmaceutical Co., Ltd. · ReumaNederland · Sint Maartenskliniek · UMC Utrecht · University Hospital, Clermont-Ferrand · University Hospital, Strasbourg, France · University of Verona · ZonMw: The Netherlands Organisation for Health Research and Development

Regulatory milestones approvals, filings & regulatory actions · 6 recorded

Milestone	Jurisdiction	Brand	Indication	Date	Sentence it was read from
Filed rheumatoid arthritis 4 milestones
Rejected (CRL)	US (FDA)	—	rheumatoid arthritis	2020-08-18	“the U.S. Food and Drug Administration (FDA) has issued a complete response letter (CRL) for the New Drug Application (NDA) for filgotinib” gilead.com ↗ “Complete Response Letter (CRL) related to the New Drug Application (NDA) for filgotinib in the treatment of RA.” gilead.com ↗ “the U.S. Food and Drug Administration (FDA) to discuss the points raised in the Complete Response Letter (CRL)” gilead.com ↗
Filed	US (FDA)	—	rheumatoid arthritis	2019-12-19	“it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration ( FDA ) for filgotinib, an investigational, oral, selective JAK1 inhibitor for the...” gilead.com ↗
Filed	EU (EMA)	—	rheumatoid arthritis	2019-10-24	“A Marketing Authorization Application (MAA) for filgotinib for the treatment of adults with rheumatoid arthritis is now under evaluation by the European Medicines Agency (EMA)” gilead.com ↗ “European Medicines Agency’s (EMA) validation of the marketing authorization application for filgotinib for the treatment of adults with RA” gilead.com ↗
Filed	Japan (PMDA)	—	rheumatoid arthritis	2019-10-10	“Submission of the new drug application for filgotinib for the treatment of adults with RA to the Japanese Ministry of Health, Labor and Welfare (MHLW).” gilead.com ↗ “and a New Drug Application (NDA) for filgotinib has been submitted to the Japanese Ministry of Health, Labor and Welfare (MHLW).” gilead.com ↗
Filed ulcerative colitis 1 milestone
Filed	EU (EMA)	—	ulcerative colitis	2020-11-02	“Filgotinib was submitted to the European Commission for an extended indication for the treatment of adults with moderately to severely active ulcerative colitis” gilead.com ↗ “EMA validated and is reviewing the application of Gilead and Galapagos for a new indication to the approved license for filgotinib 200mg.” gilead.com ↗ “validated and is now under evaluation by the European Medicines Agency (EMA)” gilead.com ↗
Approved Indication not stated 1 milestone
Approved	EU (EMA)	Jyseleca	—	2020-09-24	europa.eu ↗

Trials 55

today

EU approved 2020

NCT07576452 · Ph 4 NCT07554495 · Ph 3 NCT07553182 · Ph 3 NCT06865417 · Ph 3 NCT07160231 · Ph 4 NCT06964113 · Ph 4 NCT06625242 · Ph 4 NCT06527534 · Ph 4 NCT06222034 · Ph 1 NCT06285539 · Ph 2 NCT06043739 · Ph 1 NCT05785611 · Ph 3 NCT05502731 · Ph 4 NCT05479058 · Ph 3 NCT05090410 · Ph 3 NCT04483687 · Ph 3 NCT04483700 · Ph 3 NCT04608344 · Ph 1 NCT04115748 · Ph 3 NCT04115839 · Ph 3 NCT03926195 · Ph 2 NCT03417778 · Ph 1 NCT03285711 · Ph 2 NCT03207815 · Ph 2 NCT03320876 · Ph 2 NCT03201445 · Ph 2 NCT03134222 · Ph 2 NCT03100942 · Ph 2 NCT03046056 · Ph 2 NCT03077412 · Ph 2 NCT02914600 · Ph 3 NCT03101670 · Ph 2 NCT03117270 · Ph 2 NCT03025308 · Ph 3 NCT02914535 · Ph 3 NCT02914522 · Ph 3 NCT02914561 · Ph 3 NCT02885181 · Ph 2 NCT02889796 · Ph 3 NCT02886728 · Ph 3 NCT02873936 · Ph 3 NCT02714634 · Ph 4 NCT02162355 · Ph 1 NCT02084199 · Ph 1 NCT02065700 · Ph 2 NCT02048618 · Ph 2 NCT01894516 · Ph 2 NCT01888874 · Ph 2 NCT01820806 · Ph 1 NCT01798979 · Ph 1 NCT01665924 · Ph 1 NCT01668641 · Ph 2 NCT01419990 · Ph 1 NCT01384422 · Ph 2 NCT01179581 · Ph 1

201120122013201420152016201720182019202020212022202320242025202620272028202920302031

Phase	Registry id	Dates	Indication	Sponsor	Status	Outcome
Phase 111 trials
Phase 1	NCT06222034	May 2024 → Jun 2026	juvenile idiopathic arthritis	Alfasigma S.p.A.	Terminated	No outcome recorded Stop: Enrollment
Phase 1	NCT06043739	Sep → Oct 2023	—	Lakefront Biotherapeutics NV	Completed	No outcome recorded
Phase 1	NCT04608344	Nov 2020 → Jan 2021	rheumatoid arthritis	Gilead Sciences	Completed	No outcome recorded
Phase 1	NCT03417778	Apr → Aug 2018	rheumatoid arthritis	Gilead Sciences	Completed	No outcome recorded
Phase 1	NCT02162355	Jun → Sep 2014	—	Lakefront Biotherapeutics NV	Completed	No outcome recorded
Phase 1	NCT02084199	Mar → Jul 2014	impaired renal function disease	Lakefront Biotherapeutics NV	Completed	No outcome recorded
Phase 1	NCT01820806	Mar → Apr 2013	—	Lakefront Biotherapeutics NV	Completed	No outcome recorded
Phase 1	NCT01798979	Feb → Apr 2013	—	Lakefront Biotherapeutics NV	Completed	No outcome recorded
Phase 1	NCT01665924	Jul → Sep 2012	—	Lakefront Biotherapeutics NV	Completed	No outcome recorded
Phase 1	NCT01419990	Aug → Oct 2011	—	Lakefront Biotherapeutics NV	Completed	No outcome recorded
Phase 1	NCT01179581	Aug 2010 → Mar 2011	—	Lakefront Biotherapeutics NV	Completed	No outcome recorded

Phase 219 trials · 8 met primary · 5 missed
Phase 2	NCT06285539	Mar 2024 → Dec 2026 expected	Behcet disease, idiopathic inflammatory myopathy, immunoglobulin G4-related sclerosing disease	UMC Utrecht	Recruiting	No outcome recorded
Phase 2	NCT03926195	May 2019 → Aug 2020	ankylosing spondylitis, psoriatic arthritis	Lakefront Biotherapeutics NV	Completed	No outcome recorded
Phase 2	NCT03285711	Oct 2017 → May 2019	lupus nephritis	Gilead Sciences	Completed	No outcome recorded
Phase 2	NCT03207815	Jul 2017 → Dec 2020	uveitis	Gilead Sciences	Terminated	Met primary
Phase 2	NCT03320876	Jul 2017 → Jun 2021	psoriatic arthritis	Lakefront Biotherapeutics NV	Terminated	No outcome recorded
Phase 2	NCT03201445	Jul 2017 → Nov 2020	inflammatory bowel disease	Lakefront Biotherapeutics NV	Terminated	No outcome recorded
Phase 2	NCT03134222	May 2017 → Mar 2019	cutaneous lupus erythematosus	Gilead Sciences	Completed	Missed primary
Phase 2	NCT03100942	May 2017 → Jan 2019	Sjogren syndrome	Gilead Sciences	Completed	Missed primary
Phase 2	NCT03046056	Apr 2017 → Jul 2020	small bowel Crohn disease	Gilead Sciences	Completed	Missed primary
Phase 2	NCT03077412	Apr 2017 → Jan 2021	Crohn disease	Gilead Sciences	Completed	Missed primary
Phase 2	NCT03101670	Mar 2017 → Mar 2018	psoriatic arthritis	Lakefront Biotherapeutics NV	Completed	Met primary
Phase 2	NCT03117270	Mar 2017 → Jul 2018	ankylosing spondylitis	Lakefront Biotherapeutics NV	Completed	Met primary
Phase 2	NCT02885181	Sep 2016 → Aug 2017	rheumatoid arthritis	Gilead Sciences	Completed	Missed primary
Phase 2	NCT02065700	Feb 2014 → Jan 2023	rheumatoid arthritis	Lakefront Biotherapeutics NV	Completed	No outcome recorded
Phase 2	NCT02048618	Feb 2014 → Nov 2015	Crohn disease	Lakefront Biotherapeutics NV	Completed	Met primary
Phase 2	NCT01894516	Oct 2013 → Mar 2015	rheumatoid arthritis	Lakefront Biotherapeutics NV	Completed	Met primary
Phase 2	NCT01888874	Jul 2013 → Feb 2015	rheumatoid arthritis	Lakefront Biotherapeutics NV	Completed	Met primary
Phase 2	NCT01668641	May → Sep 2012	rheumatoid arthritis	Lakefront Biotherapeutics NV	Completed	Met primary
Phase 2	NCT01384422	Jun → Nov 2011	rheumatoid arthritis	Lakefront Biotherapeutics NV	Completed	Met primary

Phase 318 trials · 6 met primary
Phase 3	NCT07554495	May 2026 → Jun 2027 expected	polyarticular juvenile idiopathic arthritis	Alfasigma S.p.A.	Recruiting	No outcome recorded
Phase 3	NCT07553182	Apr 2026 → Dec 2027 expected	juvenile idiopathic arthritis	Alfasigma S.p.A.	Recruiting	No outcome recorded
Phase 3	NCT06865417	Sep 2025 → Jun 2028 expected	ulcerative colitis	Alfasigma S.p.A.	Recruiting	No outcome recorded
Phase 3	NCT05785611	Apr 2023 → Sep 2024 overdue	spondyloarthropathy	Alfasigma S.p.A.	Active not recruiting	Met primary
Phase 3	NCT05479058	Jul 2022 → Oct 2023	ulcerative colitis	Lakefront Biotherapeutics NV	Terminated	No outcome recorded
Phase 3	NCT05090410	Mar 2021 → Feb 2023	rheumatoid arthritis	Atsushi Kawakami	Unknown	No outcome recorded
Phase 3	NCT04483687	Dec 2020 → Jan 2023	ankylosing spondylitis	Gilead Sciences	Withdrawn	No outcome recorded
Phase 3	NCT04483700	Dec 2020 → Oct 2022	ankylosing spondylitis	Gilead Sciences	Withdrawn	No outcome recorded
Phase 3	NCT04115748	Dec 2019 → Jan 2021	psoriatic arthritis	Gilead Sciences	Terminated	Met primary
Phase 3	NCT04115839	Nov 2019 → Jan 2021	psoriatic arthritis	Gilead Sciences	Terminated	Met primary
Phase 3	NCT02914600	Mar 2017 → Aug 2023	Crohn disease	Lakefront Biotherapeutics NV	Terminated	No outcome recorded
Phase 3	NCT03025308	Feb 2017 → May 2025	rheumatoid arthritis	Alfasigma S.p.A.	Completed	No outcome recorded
Phase 3	NCT02914535	Feb 2017 → Sep 2026	ulcerative colitis	Alfasigma S.p.A.	Completed	No outcome recorded
Phase 3	NCT02914522	Nov 2016 → Mar 2020	ulcerative colitis	Gilead Sciences	Completed	No outcome recorded
Phase 3	NCT02914561	Oct 2016 → Nov 2022	Crohn disease	Lakefront Biotherapeutics NV	Completed	Mixed
Phase 3	NCT02889796	Aug 2016 → Jul 2018	rheumatoid arthritis	Gilead Sciences	Completed	Met primary
Phase 3	NCT02886728	Aug 2016 → Oct 2018	rheumatoid arthritis	Gilead Sciences	Completed	Met primary
Phase 3	NCT02873936	Jul 2016 → Mar 2018	rheumatoid arthritis	Gilead Sciences	Completed	Met primary

Phase 47 trials
Phase 4	NCT07576452	Dec 2026 → Jun 2030 expected	ulcerative colitis	University Hospital, Clermont-Ferrand	Not yet recruiting	No outcome recorded
Phase 4	NCT07160231	Sep 2025 → May 2028 expected	psoriatic arthritis, spondyloarthropathy	Sint Maartenskliniek	Recruiting	No outcome recorded
Phase 4	NCT06964113	Jun 2025 → Nov 2027 expected	ulcerative colitis	Eisai Co., Ltd.	Active not recruiting	No outcome recorded
Phase 4	NCT06625242	Oct 2024 → Jan 2026	rheumatoid arthritis	Eisai Co., Ltd.	Completed	No outcome recorded
Phase 4	NCT06527534	Jul 2024 → Jul 2025 overdue	rheumatoid arthritis	University of Verona	Recruiting	No outcome recorded
Phase 4	NCT05502731	Oct 2022 → Mar 2025	rheumatoid arthritis	Leiden University Medical Center	Unknown	No outcome recorded
Phase 4	NCT02714634	Mar 2016 → Mar 2029 expected	rheumatoid arthritis	University Hospital, Strasbourg, France	Recruiting	No outcome recorded
Comparator or background therapy3 trials
Phase 1	NCT01915667 Comparator	Jul → Sep 2013	—	Lakefront Biotherapeutics NV	Completed	No outcome recorded
Phase 4	NCT06687551 Comparator	Jan 2025 → Apr 2029 expected	rheumatoid arthritis	University Hospital, Toulouse	Not yet recruiting	No outcome recorded
Phase 4	NCT04985435 Comparator	May 2021 → Sep 2025 overdue	rheumatoid arthritis	R.Bos	Recruiting	No outcome recorded

News releases announcing trial results or a regulatory action · 38

Date	Issuer	Release
2026-09-18	Alfasigma S.p.A.	Regulatory CHMP recommends EU approval of new indication for Alfasigma’s filgotinib, treatment of adults with axial spondyloarthritis alfasigma.com ↗ Following this positive opinion, the application is now referred to the European Commission (EC) for final action.
2025-07-28	Alfasigma S.p.A.	Results Filgotinib Shows Positive Topline Results Across Full Spectrum of Axial Spondyloarthritis in OLINGUITO Phase 3 Study alfasigma.com ↗ Filgotinib, an oral, once-daily JAK1 preferential inhibitor, met the primary endpoint in the OLINGUITO Phase 3 clinical trial in active axSpA.
2020-11-02	Gilead Sciences	Regulatory European Medicines Agency Validates Marketing Application for Filgotinib for the Treatment of Ulcerative Colitis gilead.com ↗
2020-10-12	Gilead Sciences	Results Phase 2b/3 Trial Shows Efficacy of Filgotinib for the Induction and Maintenance of Remission in Moderately and Severely Active Ulcerative Colitis gilead.com ↗ The data from the randomized, double-blind, placebo-controlled, Phase 2b/3 SELECTION trial showed that a significantly higher proportion of patients treated with filgotinib 200 mg, versus placebo, achieved clinical remission at Week 10 and maintained remission through Week 58.
2020-09-25	Gilead Sciences	Regulatory Jyseleca® (Filgotinib) Approved in Japan for Rheumatoid Arthritis gilead.com ↗ the Japanese Ministry of Health, Labour and Welfare (MHLW) has granted Gilead K.K. (Tokyo, Japan) regulatory approval of Jyseleca ® (filgotinib 200 mg and 100 mg tablets)
2020-09-25	Gilead Sciences	Regulatory European Commission Grants Marketing Authorization for Jyseleca® ▼ (Filgotinib) for the Treatment of Adults With Moderate to Severe Active Rheumatoid Arthritis gilead.com ↗
2020-08-18	Gilead Sciences	Regulatory Gilead Receives Complete Response Letter for Filgotinib for the Treatment of Moderately to Severely Active Rheumatoid Arthritis gilead.com ↗ Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the U.S. Food and Drug Administration (FDA) has issued a complete response letter (CRL) for the New Drug Application (NDA) for filgotinib, an investigational treatment for moderately to severely active rheumatoid arthritis (RA).
2020-07-24	Gilead Sciences	Regulatory Gilead and Galapagos Announce Positive European CHMP Opinion for Jyseleca® (Filgotinib) for the Treatment of Adults With Moderate to Severe Rheumatoid Arthritis gilead.com ↗ The CHMP positive opinion is a scientific recommendation to the European Commission to grant marketing authorization in Europe.
2020-06-05	Gilead Sciences	Results New Analyses of Phase 2 EQUATOR Clinical Program Support Durable Efficacy of Filgotinib in Psoriatic Arthritis gilead.com ↗ Gilead Sciences, Inc. (Nasdaq: GILD) and Galapagos NV (Euronext & Nasdaq: GLPG) today announced new analyses from two clinical trials evaluating filgotinib, an investigational, oral, selective JAK1 inhibitor, in adults with psoriatic arthritis (PsA).
2020-06-04	Gilead Sciences	Results Filgotinib Demonstrates Durable Efficacy and Consistent Safety Profile at 52 Weeks in FINCH 1 and 3 Studies in Rheumatoid Arthritis gilead.com ↗ Gilead Sciences, Inc. (Nasdaq: GILD) and Galapagos NV (Euronext & Nasdaq: GLPG) today announced Week 52 results from the Phase 3 FINCH 1 and FINCH 3 studies of filgotinib, an investigational, oral, selective JAK1 inhibitor, in adults with moderately to severely active rheumatoid arthritis (RA).
2020-05-20	Gilead Sciences	Results Gilead and Galapagos Announce Positive Topline Results of Phase 2b/3 Trial of Filgotinib in Moderately to Severely Active Ulcerative Colitis gilead.com ↗ Filgotinib 200 mg achieved all primary endpoints in the study, inducing clinical remission at Week 10 and maintaining clinical remission at Week 58 in a significantly higher proportion of patients compared with placebo.
2019-12-19	Gilead Sciences	Regulatory Gilead Submits Filgotinib New Drug Application to U.S. Food and Drug Administration Under Priority Review for Rheumatoid Arthritis Treatment gilead.com ↗
2019-11-09	Gilead Sciences	Results New Data on Filgotinib in Rheumatoid Arthritis (RA) Demonstrate Durable Efficacy and Safety Profile gilead.com ↗ The data demonstrate durable efficacy and safety results with filgotinib across multiple RA patient populations, from MTX-naïve patients to those who have had an inadequate response to two or more biologic disease-modifying antirheumatic drugs (bDMARDs).
2019-10-10	Gilead Sciences	Results Gilead and Galapagos Announce Efficacy and Safety Results of Filgotinib Through 52 Weeks in FINCH 1 and FINCH 3 Studies in Rheumatoid Arthritis gilead.com ↗ In the second half of the FINCH 1 and FINCH 3 trials, filgotinib exhibited the same favorable safety profile seen in the first 24 weeks, including similar rates of thrombotic events as previously observed, as well as persistent efficacy,
2019-10-08	Gilead Sciences	Regulatory Gilead Sciences Submits New Drug Application for Filgotinib for the Treatment of Adults With Rheumatoid Arthritis in Japan gilead.com ↗
2019-08-15	Gilead Sciences	Regulatory European Medicines Agency Validates Marketing Application for Filgotinib for the Treatment of Rheumatoid Arthritis gilead.com ↗ “We are excited about the validation of this application which is an important milestone in our ongoing work to improve the lives of people living with rheumatoid arthritis and other inflammatory conditions,”
2019-05-29	Gilead Sciences	Results Gilead and Galapagos to Present Latest Data on Filgotinib at the Annual European Congress of Rheumatology (EULAR 2019) gilead.com ↗ The study achieved its primary endpoint at both 100 mg and 200 mg doses of filgotinib, in the proportion of patients achieving an American College of Rheumatology (ACR) 20 percent response (ACR20) compared with placebo at Week 12.
2019-05-02	Gilead Sciences	Results Gilead Sciences Announces First Quarter 2019 Financial Results gilead.com ↗ The study achieved its primary endpoint for both doses of filgotinib in the proportion of patients achieving an American College of Rheumatology 20% response (ACR20) compared to placebo at week 12.
2019-03-28	Gilead Sciences	Results Gilead and Galapagos Report Updated Safety Information for Filgotinib in Rheumatoid Arthritis (RA) gilead.com ↗ The data include 24 week results of the ongoing Phase 3 FINCH 1, 2, and 3 trials, and updated Week 156 safety data from the Phase 2b DARWIN 3 long term extension study in patients with RA.
2019-03-28	Gilead Sciences	Results Gilead and Galapagos Announce Filgotinib Meets Primary Endpoint in the Phase 3 FINCH 3 Study in Methotrexate-Naïve Rheumatoid Arthritis Patients gilead.com ↗ The study achieved its primary endpoint in the proportion of patients achieving an American College of Rheumatology 20 percent response (ACR20) at Week 24.
2019-03-28	Gilead Sciences	Results Gilead and Galapagos Announce Filgotinib Meets Primary and Key Secondary Endpoints in the Phase 3 FINCH 1 Rheumatoid Arthritis Study gilead.com ↗ The study achieved its primary endpoint for both doses of filgotinib in the proportion of patients achieving an American College of Rheumatology 20 percent response (ACR20) compared to placebo at Week 12.
2018-10-22	Gilead Sciences	Results Positive Trial Results with Filgotinib in Psoriatic Arthritis and Ankylosing Spondylitis Both Published in The Lancet gilead.com ↗
2018-10-20	Gilead Sciences	Results Phase 3 Data on Filgotinib in Biologic-Experienced Rheumatoid Arthritis to Be Presented at 2018 ACR/ARHP Annual Meeting gilead.com ↗ Gilead Sciences, Inc. (Nasdaq: GILD) and Galapagos NV (Euronext & NASDAQ: GLPG) today announced detailed results from the Phase 3 FINCH 2 clinical trial of filgotinib, an investigational, selective JAK1 inhibitor, in adults with moderately-to-severely active rheumatoid arthritis and prior inadequate response or intolerance to biologic agents.
2018-09-11	Gilead Sciences	Results Gilead and Galapagos Announce Filgotinib Meets Primary and All Key Secondary Endpoints in First Phase 3 Study in Rheumatoid Arthritis gilead.com ↗
2018-09-11	Lakefront Biotherapeutics NV	Results GILEAD AND GALAPAGOS ANNOUNCE FILGOTINIB MEETS PRIMARY AND ALL KEY SECONDARY ENDPOINTS IN FIRST PHASE 3 STUDY IN RHEUMATOID ARTHRITIS lakefrontbio.com ↗ Both Filgotinib Doses also Achieved All Key Secondary Efficacy Endpoints, including Low Disease Activity and Clinical Remission
2018-09-06	Gilead Sciences	Results Gilead and Galapagos Announce TORTUGA Phase 2 Study of Filgotinib in Ankylosing Spondylitis Achieves Primary Endpoint gilead.com ↗ Gilead Sciences, Inc. (NASDAQ:GILD) and Galapagos NV (Euronext & NASDAQ:GLPG) today announced that the randomized, placebo-controlled Phase 2 TORTUGA study of filgotinib, an investigational, selective JAK1 inhibitor, achieved its primary efficacy endpoint in adults with moderately to severely active ankylosing spondylitis (AS).
2018-09-06	Lakefront Biotherapeutics NV	Results GILEAD AND GALAPAGOS ANNOUNCE TORTUGA PHASE 2 STUDY OF FILGOTINIB IN ANKYLOSING SPONDYLITIS ACHIEVES PRIMARY ENDPOINT lakefrontbio.com ↗ In the study, patients treated with filgotinib achieved significantly greater improvements in AS Disease Activity Score (ASDAS), the primary endpoint, at Week 12, with a mean change from baseline of -1.5 versus -0.6 for those treated with placebo (p<0.0001).
2018-05-30	Gilead Sciences	Results Gilead and Galapagos Announce Results With Filgotinib in the Phase 2 Equator Study in Psoriatic Arthritis and Progression Into Phase 3 for the Selection Study in Ulcerative Colitis gilead.com ↗ EQUATOR Achieves Primary Endpoint of ACR20 Response at Week 16
2018-05-30	Lakefront Biotherapeutics NV	Results GILEAD AND GALAPAGOS ANNOUNCE RESULTS WITH FILGOTINIB IN THE PHASE 2 EQUATOR STUDY IN PSORIATIC ARTHRITIS AND PROGRESSION INTO PHASE 3 FOR THE SELECTION STUDY IN ULCERATIVE COLITIS lakefrontbio.com ↗ There was an ACR20 response of 80 percent for filgotinib versus 33 percent for placebo (p<0.001).
2017-11-05	Lakefront Biotherapeutics NV	Results Consistent safety findings and durable activity with filgotinib treatment of rheumatoid arthritis patients up to week 84 in DARWIN 3 study lakefrontbio.com ↗ In this 84-week analysis of 560 patients representing 1,708 patient years of exposure, adverse events and treatment emergent lab abnormalities were consistent with prior safety results and filgotinib was shown to have durable activity; data are summarized in the abstract .
2017-06-20	Lakefront Biotherapeutics NV	Results Galapagos’ R&D Update 2017: rapidly advancing our product candidates lakefrontbio.com ↗ A total of 559 patients completed week 60.
2017-05-07	Lakefront Biotherapeutics NV	Results Galapagos presents three posters on filgotinib in Crohn’s disease at DDW® 2017 lakefrontbio.com ↗ “Efficacy of filgotinib, a selective JAK1 inhibitor, is independent of prior anti-TNF exposure: subgroup analysis of the Phase 2 FITZROY study in moderate-to-severe Crohn’s disease” (Su1920) by Prof Geert D’Haens et al.
2016-12-15	Lakefront Biotherapeutics NV	Results The Lancet publishes FITZROY study results with filgotinib in Crohn’s disease lakefrontbio.com ↗ Mechelen, Belgium; 12 December 2016 – Galapagos NV (Euronext & NASDAQ: GLPG) reports publication of the Phase 2 study with filgotinib in Crohn’s disease in The Lancet.
2016-09-26	Lakefront Biotherapeutics NV	Results Endoscopic improvements with filgotinib are consistent with clinical remission rates in patients with Crohn’s disease lakefrontbio.com ↗ “The endoscopic improvement and the histopathological benefit are additional strong and relevant indicators contributing to the potential of filgotinib as an oral treatment for Crohn’s patients,” said Dr Severine Vermeire, principal investigator of the FITZROY study.
2016-09-26	Lakefront Biotherapeutics NV	Results Endoscopic improvements with filgotinib are consistent with clinical remission rates in patients with Crohn’s disease lakefrontbio.com ↗ “The endoscopic improvement and the histopathological benefit are additional strong and relevant indicators contributing to the potential of filgotinib as an oral treatment for Crohn’s patients,” said Dr Severine Vermeire, principal investigator of the FITZROY study.
2016-05-25	Lakefront Biotherapeutics NV	Results FITZROY Phase 2 study with filgotinib in Crohn’s Disease presented as late breaker at DDW 2016 lakefrontbio.com ↗ Galapagos reported that the study achieved the primary endpoint of clinical remission: the percentage of patients achieving a Crohn’s Disease Activity Index (CDAI) score lower than 150 was statistically significantly higher in patients treated with filgotinib versus patients receiving placebo.
2016-04-21	Lakefront Biotherapeutics NV	Results Galapagos reports additional data with filgotinib from the Phase 2 FITZROY study lakefrontbio.com ↗ Mechelen, Belgium; 21 April 2016 – Galapagos NV (Euronext & NASDAQ: GLPG) reported 20-week results from its FITZROY study with the investigational, selective JAK1 inhibitor filgotinib in Crohn’s disease.
2016-03-18	Lakefront Biotherapeutics NV	Results Results from 10-week analysis of Phase 2 study with filgotinib in Crohn’s Disease presented at ECCO lakefrontbio.com ↗ Galapagos (Euronext & NASDAQ: GLPG) announces the presentation of detailed results from the Phase 2 FITZROY study of filgotinib in Crohn’s Disease, at the 11th Congress of ECCO in Amsterdam, the Netherlands, from March 16 – 19.

All press releases naming this drug 65 releases

Date	Issuer	Release
2026-09-18	Alfasigma S.p.A.	CHMP recommends EU approval of new indication for Alfasigma’s filgotinib, treatment of adults with axial spondyloarthritis alfasigma.com ↗
2025-07-28	Alfasigma S.p.A.	Filgotinib Shows Positive Topline Results Across Full Spectrum of Axial Spondyloarthritis in OLINGUITO Phase 3 Study alfasigma.com ↗
2022-03-28	Eisai Inc.	Announcement about an approval for additional indication of Jyseleca®, JAK inhibitor, for the treatment of moderate to severe ulcerative colitis with inadequate response to conventional therapies Approval of additional indication based on Phase IIb/III SELECTION data for patients with active moderate-to-severe ulcerative colitis eisai.com ↗
2021-12-20	Eisai Inc.	EISAI ENTERS INTO COMMERCIALIZATION AND DISTRIBUTION AGREEMENT WITH GILEAD FOR JAK INHIBITOR FILGOTINIB IN ASIA eisai.com ↗
2021-04-23	Eisai Inc.	GILEAD SCIENCES SUBMITS NEW DRUG APPLICATION IN JAPAN FOR FILGOTINIB FOR THE TREATMENT OF ULCERATIVE COLITIS WITH AN INADEQUATE RESPONSE TO CONVENTIONAL THERAPIES Application is Based on Phase 2b/3 SELECTION Study Data with Patients with Moderately to Severely Active Ulcerative Colitis eisai.com ↗
2020-12-15	Gilead Sciences	Gilead and Galapagos Announce New Commercialization and Development Agreement for Jyseleca® (Filgotinib) gilead.com ↗
2020-11-18	Eisai Inc.	JYSELECA® (FILGOTINIB) FOR RHEUMATOID ARTHRITIS LAUNCHES IN JAPAN A once-daily, oral, JAK inhibitor for the treatment of rheumatoid arthritis in patients who have had an inadequate response to conventional therapies eisai.com ↗
2020-11-02	Gilead Sciences	European Medicines Agency Validates Marketing Application for Filgotinib for the Treatment of Ulcerative Colitis gilead.com ↗
2020-10-12	Gilead Sciences	Phase 2b/3 Trial Shows Efficacy of Filgotinib for the Induction and Maintenance of Remission in Moderately and Severely Active Ulcerative Colitis gilead.com ↗
2020-09-25	Gilead Sciences	Jyseleca® (Filgotinib) Approved in Japan for Rheumatoid Arthritis gilead.com ↗
2020-09-25	Gilead Sciences	European Commission Grants Marketing Authorization for Jyseleca® ▼ (Filgotinib) for the Treatment of Adults With Moderate to Severe Active Rheumatoid Arthritis gilead.com ↗
2020-09-25	Eisai Inc.	JYSELECA® (FILGOTINIB) APPROVED IN JAPAN FOR RHEUMATOID ARTHRITIS Filgotinib Demonstrates Durable Efficacy and Consistent Safety Profile Through 52 Weeks in Clinical Trials eisai.com ↗
2020-08-18	Gilead Sciences	Gilead Receives Complete Response Letter for Filgotinib for the Treatment of Moderately to Severely Active Rheumatoid Arthritis gilead.com ↗
2020-07-24	Gilead Sciences	Gilead and Galapagos Announce Positive European CHMP Opinion for Jyseleca® (Filgotinib) for the Treatment of Adults With Moderate to Severe Rheumatoid Arthritis gilead.com ↗
2020-06-05	Gilead Sciences	New Analyses of Phase 2 EQUATOR Clinical Program Support Durable Efficacy of Filgotinib in Psoriatic Arthritis gilead.com ↗
2020-06-04	Gilead Sciences	Filgotinib Demonstrates Durable Efficacy and Consistent Safety Profile at 52 Weeks in FINCH 1 and 3 Studies in Rheumatoid Arthritis gilead.com ↗
2020-05-20	Gilead Sciences	Gilead and Galapagos Announce Positive Topline Results of Phase 2b/3 Trial of Filgotinib in Moderately to Severely Active Ulcerative Colitis gilead.com ↗
2019-12-24	Gilead Sciences	Gilead and Eisai Enter Into Agreement in Japan for the Co-Promotion of the Investigational Rheumatoid Arthritis Therapy Filgotinib, Pending Regulatory Approval gilead.com ↗
2019-12-19	Gilead Sciences	Gilead Submits Filgotinib New Drug Application to U.S. Food and Drug Administration Under Priority Review for Rheumatoid Arthritis Treatment gilead.com ↗
2019-11-09	Gilead Sciences	New Data on Filgotinib in Rheumatoid Arthritis (RA) Demonstrate Durable Efficacy and Safety Profile gilead.com ↗
2019-10-31	Gilead Sciences	Gilead and Galapagos to Present New Data on Filgotinib at 2019 ACR/ARP Annual Meeting gilead.com ↗
2019-10-10	Gilead Sciences	Gilead and Galapagos Announce Efficacy and Safety Results of Filgotinib Through 52 Weeks in FINCH 1 and FINCH 3 Studies in Rheumatoid Arthritis gilead.com ↗
2019-10-08	Gilead Sciences	Gilead Sciences Submits New Drug Application for Filgotinib for the Treatment of Adults With Rheumatoid Arthritis in Japan gilead.com ↗
2019-08-15	Gilead Sciences	European Medicines Agency Validates Marketing Application for Filgotinib for the Treatment of Rheumatoid Arthritis gilead.com ↗
2019-07-01	Gilead Sciences	Gilead Announces Intent to Submit New Drug Application for Filgotinib to U.S. Food and Drug Administration This Year gilead.com ↗
2019-05-29	Gilead Sciences	Gilead and Galapagos to Present Latest Data on Filgotinib at the Annual European Congress of Rheumatology (EULAR 2019) gilead.com ↗
2019-05-02	Gilead Sciences	Gilead Sciences Announces First Quarter 2019 Financial Results gilead.com ↗
2019-03-28	Gilead Sciences	Gilead and Galapagos Report Updated Safety Information for Filgotinib in Rheumatoid Arthritis (RA) gilead.com ↗
2019-03-28	Gilead Sciences	Gilead and Galapagos Announce Filgotinib Meets Primary Endpoint in the Phase 3 FINCH 3 Study in Methotrexate-Naïve Rheumatoid Arthritis Patients gilead.com ↗
2019-03-28	Gilead Sciences	Gilead and Galapagos Announce Filgotinib Meets Primary and Key Secondary Endpoints in the Phase 3 FINCH 1 Rheumatoid Arthritis Study gilead.com ↗
2018-10-22	Gilead Sciences	Positive Trial Results with Filgotinib in Psoriatic Arthritis and Ankylosing Spondylitis Both Published in The Lancet gilead.com ↗
2018-10-20	Gilead Sciences	Phase 3 Data on Filgotinib in Biologic-Experienced Rheumatoid Arthritis to Be Presented at 2018 ACR/ARHP Annual Meeting gilead.com ↗
2018-09-11	Gilead Sciences	Gilead and Galapagos Announce Filgotinib Meets Primary and All Key Secondary Endpoints in First Phase 3 Study in Rheumatoid Arthritis gilead.com ↗
2018-09-11	Lakefront Biotherapeutics NV	GILEAD AND GALAPAGOS ANNOUNCE FILGOTINIB MEETS PRIMARY AND ALL KEY SECONDARY ENDPOINTS IN FIRST PHASE 3 STUDY IN RHEUMATOID ARTHRITIS lakefrontbio.com ↗
2018-09-06	Gilead Sciences	Gilead and Galapagos Announce TORTUGA Phase 2 Study of Filgotinib in Ankylosing Spondylitis Achieves Primary Endpoint gilead.com ↗
2018-09-06	Lakefront Biotherapeutics NV	GILEAD AND GALAPAGOS ANNOUNCE TORTUGA PHASE 2 STUDY OF FILGOTINIB IN ANKYLOSING SPONDYLITIS ACHIEVES PRIMARY ENDPOINT lakefrontbio.com ↗
2018-05-30	Gilead Sciences	Gilead and Galapagos Announce Results With Filgotinib in the Phase 2 Equator Study in Psoriatic Arthritis and Progression Into Phase 3 for the Selection Study in Ulcerative Colitis gilead.com ↗
2018-05-30	Lakefront Biotherapeutics NV	GILEAD AND GALAPAGOS ANNOUNCE RESULTS WITH FILGOTINIB IN THE PHASE 2 EQUATOR STUDY IN PSORIATIC ARTHRITIS AND PROGRESSION INTO PHASE 3 FOR THE SELECTION STUDY IN ULCERATIVE COLITIS lakefrontbio.com ↗
2017-12-14	Lakefront Biotherapeutics NV	Galapagos exercises co-promotion option for filgotinib with collaboration partner Gilead Sciences in eight European countries lakefrontbio.com ↗
2017-11-05	Lakefront Biotherapeutics NV	Consistent safety findings and durable activity with filgotinib treatment of rheumatoid arthritis patients up to week 84 in DARWIN 3 study lakefrontbio.com ↗
2017-07-05	Lakefront Biotherapeutics NV	New Phase 2 study with filgotinib in non-infectious uveitis lakefrontbio.com ↗
2017-06-20	Lakefront Biotherapeutics NV	Galapagos’ R&D Update 2017: rapidly advancing our product candidates lakefrontbio.com ↗
2017-05-15	Lakefront Biotherapeutics NV	Seven abstracts on filgotinib accepted by EULAR 2017 lakefrontbio.com ↗
2017-05-07	Lakefront Biotherapeutics NV	Galapagos presents three posters on filgotinib in Crohn’s disease at DDW® 2017 lakefrontbio.com ↗
2017-04-25	Lakefront Biotherapeutics NV	Galapagos announces new Phase 2 Proof-of-Concept study with filgotinib in cutaneous lupus erythematosus lakefrontbio.com ↗
2017-04-05	Lakefront Biotherapeutics NV	Galapagos doses first psoriatic arthritis patient with filgotinib lakefrontbio.com ↗
2017-04-04	Lakefront Biotherapeutics NV	Galapagos announces three new Phase 2 Proof-of-Concept studies with filgotinib lakefrontbio.com ↗
2017-03-10	Lakefront Biotherapeutics NV	New Phase 2 studies with filgotinib in small bowel and fistulizing Crohn’s disease lakefrontbio.com ↗
2016-12-15	Lakefront Biotherapeutics NV	The Lancet publishes FITZROY study results with filgotinib in Crohn’s disease lakefrontbio.com ↗
2016-12-08	Lakefront Biotherapeutics NV	Start Phase 2b/3 study with filgotinib in ulcerative colitis lakefrontbio.com ↗
2016-11-22	Lakefront Biotherapeutics NV	Phase 3 study with filgotinib initiated in Crohn’s disease lakefrontbio.com ↗
2016-09-27	Lakefront Biotherapeutics NV	Successful completion of regulatory consultations to progress filgotinib to Phase 3 in inflammatory bowel disease lakefrontbio.com ↗
2016-09-26	Lakefront Biotherapeutics NV	Endoscopic improvements with filgotinib are consistent with clinical remission rates in patients with Crohn’s disease lakefrontbio.com ↗
2016-09-26	Lakefront Biotherapeutics NV	Endoscopic improvements with filgotinib are consistent with clinical remission rates in patients with Crohn’s disease lakefrontbio.com ↗
2016-08-22	Lakefront Biotherapeutics NV	FINCH filgotinib Phase 3 program initiated in rheumatoid arthritis lakefrontbio.com ↗
2016-07-28	Lakefront Biotherapeutics NV	Focus on filgotinib and cystic fibrosis lakefrontbio.com ↗
2016-05-25	Lakefront Biotherapeutics NV	FITZROY Phase 2 study with filgotinib in Crohn’s Disease presented as late breaker at DDW 2016 lakefrontbio.com ↗
2016-04-21	Lakefront Biotherapeutics NV	Galapagos reports additional data with filgotinib from the Phase 2 FITZROY study lakefrontbio.com ↗
2016-03-18	Lakefront Biotherapeutics NV	Results from 10-week analysis of Phase 2 study with filgotinib in Crohn’s Disease presented at ECCO lakefrontbio.com ↗
2016-01-19	Gilead Sciences	Galapagos and Gilead Complete Closing of Their Global Collaboration for Filgotinib gilead.com ↗
2016-01-19	Lakefront Biotherapeutics NV	Galapagos and Gilead complete closing of their global collaboration for filgotinib lakefrontbio.com ↗
2016-01-13	Gilead Sciences	Galapagos and Gilead Cleared by U.S. Federal Trade Commission to Close Global Partnership on Filgotinib gilead.com ↗
2015-12-17	Gilead Sciences	Galapagos and Gilead Announce Global Partnership to Develop Filgotinib for the Treatment of Rheumatoid Arthritis and Other Inflammatory Diseases gilead.com ↗
2013-05-17	AbbVie	AbbVie and Galapagos Extend GLPG0634 Collaboration to Include Crohn's Disease abbvie.com ↗
2010-08-06	Lakefront Biotherapeutics NV	Galapagos initiates Phase I study for JAK inhibitor GLPG0634, acquires full rights to compound from GSK lakefrontbio.com ↗

Evidence & citations 20 cited values

Every value below carries the sentence it was read from. 64 sources stand behind the page.

Field	Value	Cited text
Known as	Filgotinib	“Filgotinib (GLPG0634/GS-6034), an oral JAK1 selective inhibitor, is effective in combination with methotrexate (MTX) in patients with active rheumatoid arthritis and...” PMID 27993829 ↗ Dec 2016 50 “Filgotinib (GLPG0634) is a selective inhibitor of Janus kinase 1 (JAK1) currently in development for the treatment of rheumatoid arthritis and Crohn's disease.” PMID 25681059 ↗ Aug 2015 “received filgotinib (GLPG0634, GS-6034) oral capsules (100 mg twice daily or 30, 75, 150, 200, or 300 mg once daily) or placebo” PMID 28622463 ↗ Aug 2017 “Filgotinib (GLPG0634, GS-6034) oral capsules (100 mg twice daily or 30, 75, 150, 200, or 300 mg once daily) or placebo” PMID 28622463 ↗ Aug 2017 “Filgotinib (GLPG0634, GS-6034) is a once-daily, orally administered, Janus kinase 1 (JAK1)-selective inhibitor.” PMID 27988142 ↗ Dec 2016 “Filgotinib (GLPG0634/GS-6034), an oral selective JAK1 inhibitor” PMID 27993828 ↗ Dec 2016 “Methotrexate or leflunomide + filgotinib or” NCT02714634 ↗ “Filgotinib 200 mg once daily” NCT07160231 ↗ NCT02914535 ↗ NCT06625242 ↗ NCT02886728 ↗ Show 40 more sources
Known as	FIL	“filgotinib (FIL), a Janus kinase 1 inhibitor” PMID 34498056 ↗ May 2022
Known as	FILGOTINIB (GLPG0634)	ChEMBL registry synonym — accepted as the source's own label CHEMBL3301607 ↗
Known as	FILGOTINIB HYDROCHLORIDE	ChEMBL registry synonym — accepted as the source's own label CHEMBL3301607 ↗
Known as	Filgotinib hydrochloride trihydrate	ChEMBL registry synonym — accepted as the source's own label CHEMBL3301607 ↗
Known as	Filgotinib Maleate	“Drug: Filgotinib Maleate” NCT06964113 ↗
Known as	FILGOTINIB??GLPG0643)	ChEMBL registry synonym — accepted as the source's own label CHEMBL3301607 ↗
Known as	G-146034	ChEMBL registry synonym — accepted as the source's own label CHEMBL3301607 ↗
Known as	G-146034_101	ChEMBL registry synonym — accepted as the source's own label CHEMBL3301607 ↗
Known as	GLPG0634	“received filgotinib (GLPG0634, GS-6034) oral capsules (100 mg twice daily or 30, 75, 150, 200, or 300 mg once daily) or placebo” PMID 28622463 ↗ Aug 2017 12 NCT01894516 ↗ NCT02048618 ↗ NCT02084199 ↗ NCT01179581 ↗ NCT01798979 ↗ NCT01384422 ↗ NCT02162355 ↗ NCT01915667 ↗ NCT01419990 ↗ NCT01888874 ↗ Show 2 more sources
Known as	GS-6034	“Filgotinib (GLPG0634/GS-6034), an oral JAK1 selective inhibitor, is effective in combination with methotrexate (MTX) in patients with active rheumatoid arthritis and...” PMID 27993829 ↗ Dec 2016 3 “Filgotinib (GLPG0634, GS-6034) oral capsules (100 mg twice daily or 30, 75, 150, 200, or 300 mg once daily) or placebo” PMID 28622463 ↗ Aug 2017 “Filgotinib (GLPG0634, GS-6034) is a once-daily, orally administered, Janus kinase 1 (JAK1)-selective inhibitor.” PMID 27988142 ↗ Dec 2016 “Filgotinib (GLPG0634/GS-6034), an oral selective JAK1 inhibitor” PMID 27993828 ↗ Dec 2016
Known as	GS-6034 FREE BASE	ChEMBL registry synonym — accepted as the source's own label CHEMBL3301607 ↗
Known as	Jyseleca	ChEMBL registry synonym — accepted as the source's own label CHEMBL3301607 ↗
Action	Inhibit	“a selective inhibitor of Janus kinase 1 (JAK1)” PMID 25681059 ↗ Aug 2015 3 “Tyrosine-protein kinase JAK3 inhibitor” CHEMBL3301607 ↗ “Tyrosine-protein kinase TYK2 inhibitor” CHEMBL3301607 ↗ “Tyrosine-protein kinase JAK2 inhibitor” CHEMBL3301607 ↗
Modality	Small molecule	“Filgotinib is a small molecule” NCT05502731 ↗
Route	Oral	“single ascending doses, oral solution (1 to 10 mg/dose) and capsules (10 to 200 mg/dose)” NCT01179581 ↗
Target	JAK1	“a selective inhibitor of Janus kinase 1 (JAK1)” PMID 25681059 ↗ Aug 2015
Target	JAK2	“Tyrosine-protein kinase JAK2 inhibitor” CHEMBL3301607 ↗
Target	JAK3	“Tyrosine-protein kinase JAK3 inhibitor” CHEMBL3301607 ↗
Target	TYK2	“Tyrosine-protein kinase TYK2 inhibitor” CHEMBL3301607 ↗