Drugs / Filgotinib
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
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | EU (EMA) | Jyseleca | — | 2020-09-24 | europa.eu ↗ |
Trials 55 · a red edge is where a trial was stopped
| 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 |
| 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 | ||||||
| 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 | No outcome recorded |
| 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 | No outcome recorded |
| Phase 2 | NCT03100942 | May 2017 → Jan 2019 | Sjogren syndrome | Gilead Sciences | Completed | No outcome recorded |
| Phase 2 | NCT03046056 | Apr 2017 → Jul 2020 | small bowel Crohn disease | Gilead Sciences | Completed | No outcome recorded |
| Phase 2 | NCT03077412 | Apr 2017 → Jan 2021 | Crohn disease | Gilead Sciences | Completed | No outcome recorded |
| Phase 2 | NCT03101670 | Mar 2017 → Mar 2018 | psoriatic arthritis | Lakefront Biotherapeutics NV | Completed | No outcome recorded |
| Phase 2 | NCT03117270 | Mar 2017 → Jul 2018 | ankylosing spondylitis | Lakefront Biotherapeutics NV | Completed | No outcome recorded |
| Phase 2 | NCT02885181 | Sep 2016 → Aug 2017 | rheumatoid arthritis | Gilead Sciences | Completed | No outcome recorded |
| 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 | No outcome recorded |
| Phase 2 | NCT01894516 | Oct 2013 → Mar 2015 | rheumatoid arthritis | Lakefront Biotherapeutics NV | Completed | No outcome recorded |
| Phase 2 | NCT01888874 | Jul 2013 → Feb 2015 | rheumatoid arthritis | Lakefront Biotherapeutics NV | Completed | No outcome recorded |
| Phase 2 | NCT01668641 | May → Sep 2012 | rheumatoid arthritis | Lakefront Biotherapeutics NV | Completed | No outcome recorded |
| Phase 2 | NCT01384422 | Jun → Nov 2011 | rheumatoid arthritis | Lakefront Biotherapeutics NV | Completed | No outcome recorded |
| Phase 318 trials | ||||||
| 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 | No outcome recorded |
| 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 | NCT04483700 | Dec 2020 → Oct 2022 | ankylosing spondylitis | Gilead Sciences | Withdrawn | No outcome recorded |
| Phase 3 | NCT04483687 | Dec 2020 → Jan 2023 | ankylosing spondylitis | Gilead Sciences | Withdrawn | No outcome recorded |
| Phase 3 | NCT04115748 | Dec 2019 → Jan 2021 | psoriatic arthritis | Gilead Sciences | Terminated | No outcome recorded |
| Phase 3 | NCT04115839 | Nov 2019 → Jan 2021 | psoriatic arthritis | Gilead Sciences | Terminated | No outcome recorded |
| 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 expected | ulcerative colitis | Alfasigma S.p.A. | Active not recruiting | 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 | No outcome recorded |
| Phase 3 | NCT02889796 | Aug 2016 → Jul 2018 | rheumatoid arthritis | Gilead Sciences | Completed | No outcome recorded |
| Phase 3 | NCT02886728 | Aug 2016 → Oct 2018 | rheumatoid arthritis | Gilead Sciences | Completed | No outcome recorded |
| Phase 3 | NCT02873936 | Jul 2016 → Mar 2018 | rheumatoid arthritis | Gilead Sciences | Completed | No outcome recorded |
| Phase 47 trials | ||||||
| Phase 4 | NCT07576452 | Jun 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 |
Also used as a comparator or background therapy in 3 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT01915667 Comparator | Jul → Sep 2013 | — | Lakefront Biotherapeutics NV | Completed | No outcome recorded |
| Phase 42 trials | ||||||
| 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 |
Press releases naming this drug 31 releases
| Date | Issuer | Release |
|---|---|---|
| 2020-12-15 | Gilead Sciences | Gilead and Galapagos Announce New Commercialization and Development Agreement for Jyseleca® (Filgotinib) gilead.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 ↗ |
| 2020-08-18 | 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 ↗ |
| 2019-03-28 | 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 ↗ |
| 2018-09-06 | Gilead Sciences | Gilead and Galapagos Announce TORTUGA Phase 2 Study of Filgotinib in Ankylosing Spondylitis Achieves Primary Endpoint gilead.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 ↗ |
| 2016-01-19 | Gilead Sciences | Galapagos and Gilead Complete Closing of Their Global Collaboration for Filgotinib gilead.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 ↗ |
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 201650“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 ↗ |
| 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 |
| 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 20163“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 20153“Tyrosine-protein kinase JAK2 inhibitor” CHEMBL3301607 ↗ “Tyrosine-protein kinase TYK2 inhibitor” CHEMBL3301607 ↗ “Tyrosine-protein kinase JAK3 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 ↗ |