Jyseleca

(Filgotinib)

Phase 3Small molecule

Jyseleca is a small molecule that works as a JAK1 Inhibitor.[2] It is being investigated across 5 indications, with its most advanced program in Phase 3.[1]

Jyseleca is one of 124 small molecule programs targeting Rheumatoid Arthritis. It is currently in Phase 3.

Indications

Total Trials

Active Trials

123

Competitors

Pipeline

Status by Indication[3][1]

Indication

Rheumatoid ArthritisActive, not recruiting

Juvenile Idiopathic Arthritis (JIA)Recruiting

Ulcerative ColitisActive, not recruiting

ArthritisActive, not recruiting

Inflammatory DiseaseRecruiting

Rheumatoid ArthritisPhase 3

Active, not recruiting

Juvenile Idiopathic Arthritis (JIA)Phase 3

Recruiting

Ulcerative ColitisPhase 3

Active, not recruiting

ArthritisPhase 3

Active, not recruiting

Inflammatory DiseasePhase 2

Recruiting

Competition

Competitive Landscape

181 competitors in Rheumatoid Arthritis

#DrugCompanyPhaseTrials

Jyseleca

Gilead

Phase 3

13 2

Actos

Takeda

Preclinical

2 3

Celexa

AbbVie

Preclinical

1 4

Voltaren

Cataflam

Plaquenil

Vibramycin

PPfizer's Upjohn has merged with Mylan to form Viatris Inc.

Preclinical

2 8

Velcade

SShilpa Grover, MD, MPH

Preclinical

2 9

Vancocin

HHikma Pharmaceuticals LLC

Preclinical

1 10

Solu-Medrol

MMassachusetts Eye and Ear Infirmary

Preclinical

—

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q4 2026

Phase 2Recruiting

Inflammatory Disease

NCT06285539

Q4 2027

ApprovedActive, not recruiting

Ulcerative Colitis

NCT06964113

Active, not recruiting

Ulcerative Colitis

NCT05817942

Phase 3Recruiting

Juvenile Idiopathic Arthritis (JIA)

NCT07553182

Q2 2028

Active, not recruiting

Rheumatoid Arthritis

NCT04871919

Phase 3Recruiting

Ulcerative Colitis

NCT06865417

Clinical

Trials by Indication[1]

Rheumatoid Arthritis13 trials

Long-term Follow-up Study of GLPG0634 in Active Rheumatoid Arthritis Participants

Completed·GGalapagos NV·Phase 2·NCT02065700·739 enrolled

Safety, Tolerability, and Efficacy of GS-9876 in Participants With Active Rheumatoid Arthritis on Background Therapy With Methotrexate

Completed· Gilead logo

Gilead·Phase 2·NCT02885181·83 enrolled

A Study of Filgotinib in Korean Participants With Rheumatoid Arthritis

Active, not recruiting· Eisai logo

Eisai·Phase 4·NCT06625242·118 enrolled

Show 10 more trials

Efficacy and Safety of Selective JAK 1 Inhibitor Filgotinib in Active Rheumatoid Arthritis Patients With Inadequate Response to Methotrexate

Unknown status·AAtsushi Kawakami·Phase 3·NCT05090410·400 enrolled

Prospective Observational Study of Filgotinib in Subjects With Rheumatoid Arthritis

Active, not recruiting·AAlfasigma S.p.A.··NCT04871919·1,304 enrolled

Filgotinib Effect on Proteomic Profile and Micro-RNA Expression in Patients With Active Rheumatoid Arthritis (RA)

Recruiting·UUniversita di Verona·Phase 4·NCT06527534·30 enrolled

Januse Kinase Inhibition With Filgotinib to Silence Autoreactive B Cells in Rheumatoid Arthritis

Unknown status·LLeiden University Medical Center·Phase 4·NCT05502731·40 enrolled

Prospective Observational Study of Filgotinib in Participants With Rheumatoid Arthritis in France

Active, not recruiting·AAlfasigma S.p.A.··NCT05323591·155 enrolled

Filgotinib Versus Placebo in Adults With Active Rheumatoid Arthritis (RA) Who Have an Inadequate Response to Biologic Disease-modifying Anti-rheumatic Drug(s) (DMARDs) Treatment

Completed· Gilead logo

Gilead·Phase 3·NCT02873936·449 enrolled

Filgotinib Alone and in Combination With Methotrexate (MTX) in Adults With Moderately to Severely Active Rheumatoid Arthritis Who Are Naive to MTX Therapy

Completed· Gilead logo

Gilead·Phase 3·NCT02886728·1,252 enrolled

Filgotinib in Combination With Methotrexate in Adults With Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Methotrexate

Completed· Gilead logo

Gilead·Phase 3·NCT02889796·1,759 enrolled

JAK Inhibitor Dose TAPering Strategy Study in Low Disease Activity Rheumatoid Arthritis Patients

Recruiting·UUniversity Hospital, Toulouse·Approved·NCT06687551·308 enrolled

A Multicenter, Open-label, Long Term Extension Study to Assess the Safety and Efficacy of Filgotinib in Subjects With Rheumatoid Arthritis

Completed·AAlfasigma S.p.A.·Phase 3·NCT03025308·2,731 enrolled

Ulcerative Colitis6 trials

A Study Evaluating the Effect of Filgotinib Dose De-escalation in Participants With Ulcerative Colitis (UC) in Remission

Terminated·GGalapagos NV·Phase 3·NCT05479058·22 enrolled

Study to Evaluate the Efficacy and Safety of Filgotinib in the Induction and Maintenance of Remission in Adults With Moderately to Severely Active Ulcerative Colitis

Completed· Gilead logo

Gilead·Phase 3·NCT02914522·1,351 enrolled

Prospective Observational Study of Effectiveness and Safety of Filgotinib in Participants With Ulcerative Colitis (UC)

Active, not recruiting·AAlfasigma S.p.A.··NCT05817942·509 enrolled

Show 3 more trials

A Long-Term Extension Study to Evaluate the Safety of Filgotinib in Subjects With Ulcerative Colitis

Completed·AAlfasigma S.p.A.·Phase 3·NCT02914535·1,173 enrolled

A Multicenter Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of Filgotinib, With Single Arm Induction and Maintenance, in Pediatric Subjects (8 to <18 Years of Age) With Moderately to Severely Active Ulcerative Colitis

Recruiting·AAlfasigma S.p.A.·Phase 3·NCT06865417·80 enrolled

A Multi-center, Open-Label, Single-Arm, Phase 4 Study to Evaluate the Efficacy and Safety of Filgotinib 200 mg in Korean Patients With Moderately to Severely Active Ulcerative Colitis Under Routine Clinical Practice

Active, not recruiting· Eisai logo

Eisai·Approved·NCT06964113·94 enrolled

Ankylosing Spondylitis4 trials

Study to Evaluate the Efficacy and Safety of Filgotinib in Participants With Active Ankylosing Spondylitis Who Have an Inadequate Response to Biologic Disease-Modifying Antirheumatic Drug Therapy

Withdrawn· Gilead logo

Gilead·Phase 3·NCT04483687

Study to Evaluate the Effect of Filgotinib on Semen Parameters in Adult Males With Active Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis, or Non-radiographic Axial Spondyloarthritis

Completed·GGalapagos NV·Phase 2·NCT03926195·109 enrolled

A Study to Assess Efficacy and Safety of Filgotinib in Ankylosing Spondylitis

Completed·GGalapagos NV·Phase 2·NCT03117270·116 enrolled

Show 1 more trial

Study to Evaluate the Efficacy and Safety of Filgotinib in Participants With Active Ankylosing Spondylitis Who Are Naive to Biologic Disease-Modifying Antirheumatic Drug Therapy

Withdrawn· Gilead logo

Gilead·Phase 3·NCT04483700

Psoriatic Arthritis4 trials

An Open-label, Long-term Extension Study With Filgotinib in Active Psoriatic Arthritis.

Terminated·GGalapagos NV·Phase 2·NCT03320876·122 enrolled

Study to Evaluate the Efficacy and Safety of Filgotinib in Participants With Active Psoriatic Arthritis Who Are Naive to Biologic DMARD Therapy

Terminated· Gilead logo

Gilead·Phase 3·NCT04115748·67 enrolled

A Study to Assess Efficacy and Safety of Filgotinib in Active Psoriatic Arthritis

Completed·GGalapagos NV·Phase 2·NCT03101670·131 enrolled

Show 1 more trial

Study to Evaluate the Efficacy and Safety of Filgotinib in Participants With Active Psoriatic Arthritis Who Have an Inadequate Response or Are Intolerant to Biologic DMARD Therapy

Terminated· Gilead logo

Gilead·Phase 3·NCT04115839·106 enrolled

Crohn's Disease2 trials

Filgotinib in the Induction and Maintenance of Remission in Adults With Moderately to Severely Active Crohn's Disease

Completed·GGalapagos NV·Phase 3·NCT02914561·1,372 enrolled

Filgotinib in Long-Term Extension Study of Adults With Crohn's Disease

Terminated·GGalapagos NV·Phase 3·NCT02914600·1,188 enrolled

15 more indications

Drug Interactions1 trial

Study to Evaluate Organic Anion Transporting Polypeptide (OATP) Transporter-Mediated Drug-Drug Interactions Between Filgotinib and Statins as Probe Drugs in Healthy Participants

Completed· Gilead logo

Gilead·Phase 1·NCT04608344·27 enrolled

Patient Preference1 trial

Better After CHoosing. Randomly Allocated or Patient Preference Based Treatment With Filgotinib or TNFi in RA (BACH)

Recruiting·RR.Bos·Phase 4·NCT04985435·100 enrolled

Uveitis1 trial

Study to Evaluate the Efficacy and Safety of Filgotinib in Adults With Active Noninfectious Uveitis

Terminated· Gilead logo

Gilead·Phase 2·NCT03207815·74 enrolled

Inflammatory Bowel Disease1 trial

Study to Evaluate the Testicular Safety of Filgotinib in Adult Males With Moderately to Severely Active Inflammatory Bowel Disease

Terminated·GGalapagos NV·Phase 2·NCT03201445·139 enrolled

Cutaneous Lupus Erythematosus1 trial

Study to Evaluate Safety and Efficacy of Filgotinib and Lanraplenib in Females With Moderately-to-Severely Active Cutaneous Lupus Erythematosus (CLE)

Completed· Gilead logo

Gilead·Phase 2·NCT03134222·47 enrolled

Small Bowel Crohn's Disease1 trial

Study to Evaluate the Efficacy and Safety of Filgotinib in the Treatment of Small Bowel Crohn's Disease (SBCD)

Completed· Gilead logo

Gilead·Phase 2·NCT03046056·78 enrolled

Arthritis1 trial

A Study Evaluating the Effect of Filgotinib in Participants With Active Axial Spondyloarthritis

Active, not recruiting·AAlfasigma S.p.A.·Phase 3·NCT05785611·495 enrolled

Inflammatory Disease1 trial

Drug Rediscovery for Rare Immune Mediated Inflammatory Diseases

Recruiting·UUMC Utrecht·Phase 2·NCT06285539·60 enrolled

Membranous Nephropathy1 trial

Study to Evaluate the Safety and Efficacy of Filgotinib and Lanraplenib in Adults With Lupus Membranous Nephropathy (LMN)

Completed· Gilead logo

Gilead·Phase 2·NCT03285711·9 enrolled

Efficacy and Safety1 trial

Study to Evaluate the Efficacy and Safety of Filgotinib in the Treatment of Perianal Fistulizing Crohn's Disease

Completed· Gilead logo

Gilead·Phase 2·NCT03077412·57 enrolled

Safety and Efficacy1 trial

Study to Assess Safety and Efficacy of Filgotinib, Lanraplenib and Tirabrutinib in Adults With Active Sjogren's Syndrome

Completed· Gilead logo

Gilead·Phase 2·NCT03100942·152 enrolled

Oral1 trial

Relative Bioavailability and Effect of Food Study With an Oral Mini-tablet Formulation of Filgotinib in Healthy Subjects

Completed·GGalapagos NV·Phase 1·NCT06043739·12 enrolled

Hepatic Function1 trial

Study to Evaluate the Pharmacokinetics of Filgotinib in Participants With Impaired Hepatic Function

Completed· Gilead logo

Gilead·Phase 1·NCT03417778·20 enrolled

Juvenile Idiopathic Arthritis (JIA)1 trial

Open-label Extension (OLE), Multiple Dose Study to Evaluate Safety, Tolerability, and Efficacy of Filgotinib in Children and Adolescents From 8 Years to Less Than 18 Years of Age With Juvenile Idiopathic Arthritis (JIA)

Recruiting·AAlfasigma S.p.A.·Phase 3·NCT07553182·80 enrolled

Juvenile Idiopathic Arthritis1 trial

An Open-label, Multiple Dose, Multicenter Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Filgotinib in Children and Adolescents From 8 to Less Than 18 Years of Age With Juvenile Idiopathic Arthritis

Terminated·AAlfasigma S.p.A.·Phase 1·NCT06222034·9 enrolled

Sources

References

[1]
ClinicalTrials.gov — 44 trial records for Filgotinib. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Filgotinib compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Filgotinib. EMBL-EBI & Wellcome Sanger Institute.
[4]
PubMed — 1 publication indexed for Filgotinib. U.S. National Library of Medicine.
[5]
SEC EDGAR — Gilead company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: JAK1 Inhibitor[2]
Modality: Small molecule[2]
Highest Phase: Phase 3[1]
Company: Gilead

Key Publications[4]

Filgotinib in Moderately to Severely Active Rheumatoid Arthritis: FINCH-1

Ann Rheum DisMar 17, 2022DOI: 10.1136/ard-2021-221441

Jyseleca

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q4 2026

Q4 2027

Q2 2028

Trials by Indication[1]

Rheumatoid Arthritis13 trials

Ulcerative Colitis6 trials

Ankylosing Spondylitis4 trials

Psoriatic Arthritis4 trials

Crohn's Disease2 trials

Drug Interactions1 trial

Patient Preference1 trial

Uveitis1 trial

Inflammatory Bowel Disease1 trial

Cutaneous Lupus Erythematosus1 trial

Small Bowel Crohn's Disease1 trial

Arthritis1 trial

Inflammatory Disease1 trial

Membranous Nephropathy1 trial

Efficacy and Safety1 trial

Safety and Efficacy1 trial

Oral1 trial

Hepatic Function1 trial

Juvenile Idiopathic Arthritis (JIA)1 trial

Juvenile Idiopathic Arthritis1 trial

References

Drug Info

Quick Facts

Key Publications[4]

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