Back to discover
Drug

Guselkumab

Approved · EMA
ClassInterleukin-23 inhibitorEmerging researchLate-stage development

Also known as Tremfya.

RxNorm1928588ChEMBLCHEMBL2364648ATCL04AC16UNII089658A12D
2
Research papers
33
Active clinical trials
2
Protein targets
1
Regulatory events
Latest activity
beta

Recent clinical, regulatory, research and industry developments relating to this drug.

A Phase 4, Multicenter, Randomized, Double-blind, Placebo-controlled Study Evaluating the Efficacy and Safety of Guselkumab Administered Subcutaneously in Bio-naive Participants With Active Psoriatic Arthritis Axial Disease

Clinical trial2026-08-04Primary completion · ClinicalTrials.gov

A Phase 3, Randomized, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Efficacy and Safety of Guselkumab in Participants With Fistulizing, Perianal Crohn's Disease

Clinical trial2026-07-31Results expected Q1 2027 · ClinicalTrials.gov

Immunosuppressant Management in Rheumatology Patients Undergoing Elective Total Shoulder Arthroplasty

Clinical trial2026-07-09Results expected Q1 2028 · ClinicalTrials.gov

A Phase 3B, Multicenter, Randomized, Double-blind, Placebo-controlled Study Evaluating the Efficacy and Safety of Guselkumab Administered Subcutaneously in Participants With Active Psoriatic Arthritis Who Had an Inadequate Response and/or Intolerance to One Prior Anti-Tumor Necrosis Factor Alpha Agent

Clinical trial2026-07-07Results posted · ClinicalTrials.gov

A Phase 2/3, Randomized, Double-blind, Placebo- and Active-controlled, Parallel-group, Multicenter Protocol to Evaluate the Efficacy and Safety of Guselkumab in Participants With Moderately to Severely Active Crohn's Disease

Clinical trial2026-07-06Results posted · ClinicalTrials.gov

A Phase 3 Randomized, Double-blind, and Active Controlled, Multi-center Study to Evaluate the Efficacy and Safety of JNJ-78934804 in Participants With Moderately to Severely Active Ulcerative Colitis

Clinical trial2026-07-06Results expected Q3 2028 · ClinicalTrials.gov

A Phase 3 Randomized, Open-label Induction, Double-blind Maintenance, Parallel-group, Multicenter Protocol to Evaluate the Efficacy, Safety, and Pharmacokinetics of Guselkumab in Pediatric Participants With Moderately to Severely Active Ulcerative Colitis

Clinical trial2026-07-06Results expected Q1 2027 · ClinicalTrials.gov

A Phase 3, Multicenter, Randomized, Placebo- and Active Comparator-Controlled Study Evaluating the Efficacy, Safety, and Pharmacokinetics of Subcutaneously Administered Guselkumab for the Treatment of Chronic Plaque Psoriasis in Pediatric Subjects (>=6 To <18 Years of Age)

Clinical trial2026-07-06Results posted · ClinicalTrials.gov

AbbVie’s Skyrizi narrowly slides ahead of J&J’s Tremfya in May drug ad spending rankings

Industry2026-06-09Fierce Pharma

Comparative Effectiveness of Bimekizumab and Guselkumab in Patients with Psoriatic Arthritis at 52 Weeks Assessed Using a Matching-Adjusted Indirect Comparison.

Research2024-03-15Rheumatology and therapy

Approval: Tremfya (EMA)

Regulatory2017-11-10EMA

Efficacy and safety of guselkumab, an anti-interleukin-23 monoclonal antibody, compared with adalimumab for the continuous treatment of patients with moderate to severe psoriasis: Results from the phase III, double-blinded, placebo- and active comparator-controlled VOYAGE 1 trial.

Research2017-01-02Journal of the American Academy of Dermatology

Evidence confidence

1 claim

How strongly the incorporated evidence supports specific clinical claims about this treatment. A confidence figure is a current summary of evidence strength, not a permanent verdict.

Achieves a PASI 75 response in plaque psoriasis
53%Moderate confidence
Uncertainty ±29%Evidence coverage: MinimalUpdated 30 May 2025

High point estimate, but substantial uncertainty remains.

Confidence has a moderate point estimate but a wide uncertainty band — the evidence is still sponsor-concentrated.

Profile

Identifiers & mechanism

Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.

Canonical name
Guselkumab
Aliases & brands
Tremfya
RxNorm CUI
1928588
ChEMBL ID
CHEMBL2364648
ATC codes
L04AC16
UNII
089658A12D
Primary mechanism
Interleukin-23 inhibitor
Regulatory jurisdictions
ema

Pharmacology & targets

2 targets

Known molecular targets and mechanisms supported by curated pharmacology databases.

Interleukin-12 subunit beta
IL12B · P29460
INHIBITORInterleukin-23 inhibitor
Interleukin-23 subunit alpha
IL23A · Q9NPF7
INHIBITORInterleukin-23 inhibitor

Regulatory timeline

1 event

The complete regulatory record, grouped by authority — approvals, safety advisories and label changes. Each authority shows its most recent events; expand one to read its full history.

Earliest approval
2017-11-10
Latest approval
2017-11-10
Authorities
EMA
Total events
1
emaEuropean Medicines Agency· 1 event
2017-11-10Approval
Approval: Tremfya (EMA)
Indication: Adult plaque psoriasisTremfya is indicated for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy. Paediatric plaque… Show full indication

Adult plaque psoriasisTremfya is indicated for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy. Paediatric plaque psoriasisTremfya is indicated for the treatment of moderate to severe plaque psoriasis in children and adolescents from the age of 6 years who are candidates for systemic therapy.&nbsp; Psoriatic arthritisTremfya, alone or in combination with methotrexate (MTX), is indicated for the treatment of active psoriatic arthritis in adult patients who have had an inadequate response or who have been intolerant to a prior disease-modifying antirheumatic drug (DMARD) therapy.Ulcerative colitisTremfya is indicated for the treatment of adult patients with moderately to severely active ulcerative colitis who have had an inadequate response, lost response, or were intolerant to either conventional therapy, or a biologic treatment.Crohn’s diseaseTremfya is indicated for the treatment of adult patients with moderately to severely active Crohn’s disease who have had an inadequate response, lost response, or were intolerant to either conventional therapy or a biologic treatment.

Evidence ↗

Contains information from the European Medicines Agency (European Medicines Agency), © EMA, reused under CC BY 4.0.

Clinical trials

72 trials

The current development programme across all trial phases — status mix, phase distribution and the late-stage studies shaping the evidence base.

Development programme
CLINICALTRIALS.GOV · LIVE REGISTRY
72
registered trials across all phases
LATEST COMPLETION 2025
33
Active studies
20
Recruiting
52
Late-stage (III+)
31
Completed
8
Discontinued
PHASE DISTRIBUTIONn = 72
Early Phase 11Phase 19Phase 210Phase 2 / 33Phase 330Phase 416Phase N / A3

Late-stage studies

Phase III+ trials still open or recently active — where late-stage evidence is being generated.

Utilization of a Cutaneous Therapy In Situ Microdevice

Not yet recruitingPH IVUniversity of California, San Franciscon=102030

Guselkumab Intervention and Diet Evaluation for Pouchitis

RecruitingPH IVUniversitaire Ziekenhuizen KU Leuvenn=202029

Optimal Care With Guselkumab In Crohn's Disease

RecruitingPH IVGroupe d'Etude Therapeutique des Affections Inflammatoires Digestivesn=2102029

Preventing Arthritis in a Multi-Center Psoriasis At-Risk Cohort

RecruitingPH IVNYU Langone Healthn=1762028

Immune Spatial Features of Guselkumab Cutaneous Response

RecruitingPH IVUniversity of California, San Franciscon=102028

Recent completions

Trials that read out recently, adding to the completed evidence base.

A Phase 3, Open-label, Multicenter Study to Evaluate the Safety and Efficacy of Guselkumab in Participants With Moderately to Severely Active Crohn's Disease

CompletedPH IIIJanssen Pharmaceutical K.K.n=382025

CNTO1959PSO3018: A Phase 3b, Multicenter, Randomized, Double-blind, Placebo-controlled Study Evaluating the Safety and Efficacy of Guselkumab for the Treatment of Participants With Skin of Color Who Have Moderate-to-Severe Plaque Psoriasis and/or Moderate

CompletedPH IIIJanssen Research & Development, LLCn=2112025

A Phase 3b, Multicenter, Randomized, Double-blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of Guselkumab Versus Placebo for the Treatment of Low Body Surface Area (BSA) Moderate Plaque Psoriasis With Special Site Involvement

CompletedPH IIIJanssen Research & Development, LLCn=3382025

Immunogenetic Profiling of Guselkumab for the Treatment of Plaque and Guttate Psoriasis

CompletedPH IVUniversity of California, San Franciscon=172025

Dose Reduction of the New Generation Biologicals (IL17 and IL23 Inhibitors) in Psoriasis: A Pragmatic, Multicentre, Randomized, Controlled, Non-inferiority Study - BeNeBio Study

CompletedPH IVRadboud University Medical Centern=2442025

A Phase 3b, Randomized, Double-blind, Parallel Group, Multicenter Study to Evaluate Further Therapeutic Strategies With Guselkumab in Patients With Moderate-to-Severe Plaque-Type Psoriasis

CompletedPH IIIJanssen-Cilag International NVn=8802025

Research activity

2 papers

Key research shaping understanding of this drug, combining the latest publications with the most influential evidence.

Publications over time
20172024
Journals, researchers & institutions
Top journals
  • Journal of the American Academy of Dermatology1
  • Rheumatology and therapy1
Leading researchers
  • Blauvelt A1
  • Eells J1
  • Griffiths CE1
  • Grouin JM1
  • Kimball AB1
  • Li S1
  • Lyris N1
  • McInnes IB1
Leading institutions
free-text, unnormalised
  • College of Medical Veterinary and Life Sciences1
  • Dermatology Center1
  • Dermatology Centre1
  • Harvard Medical School and Beth Israel Deaconess Medical Center1
  • K. Papp Clinical Research and Probity Research Inc1
  • Oregon Medical Research Center1

Related drugs

2 matches

Drugs sharing diseases, protein targets and literature with this one. Ranked by graph evidence (shared targets + diseases weighted above co-mentions).

Adalimumab

Studied across the same disease area as Guselkumab in the shared literature.

1 shared disease1 shared paper
Bimekizumab

Frequently co-studied with Guselkumab in the research literature.

1 shared paper
References & data sources
  • RxNorm (U.S. National Library of Medicine) — drug identity
  • ChEMBL (EMBL-EBI) & UniProt — pharmacology and targets
  • Europe PMC — research literature
  • ClinicalTrials.gov — clinical trials
  • Regulatory event sources are credited in the Regulatory Timeline above.