Data updated: May 26, 2026
TREMFYA (guselkumab)
Interleukin-23 Antagonists Genetically Validated
Trial Activity: Expansion 28 active trials
Immunology
Approved 2017-07-13
TREMFYA is indicated for the treatment of Moderate-to-severe plaque psoriasis; Active psoriatic arthritis; Moderately to severely active ulcerative colitis; Moderately to severely active Crohn's disease.
How TREMFYA Works
Guselkumab is a human monoclonal antibody that selectively binds to the p19 subunit of interleukin-23 (IL-23). By binding to this subunit, the drug inhibits the interaction between IL-23 and its receptor. IL-23 is a naturally occurring cytokine that plays a key role in normal inflammatory and immune responses. By blocking this pathway, guselkumab prevents the release of proinflammatory cytokines and chemokines that contribute to disease pathology.
Development Insights
Janssen Research & Development, LLC conducting 32 trials (55%)
37 indications explored (Broad Platform)
→ psoriasis (13 trials)
→ arthritis, psoriatic (9 trials)
→ crohn's disease (6 trials)
8
Indications
--
Phase 3 Trials
3
Priority Reviews
8
Years on Market
Details
- Status
- Prescription
- First Approved
- 2017-07-13
- Patent Cliff
- 2034
- Revenue
- $1.6B (Q4-2025)
- Routes
- INJECTION
- Dosage Forms
- INJECTABLE
TREMFYA Approval History
2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
14 FDA actions from 2017 to 2025 · 7 indication expansions
What TREMFYA Treats
4 indicationsTREMFYA is approved for 4 conditions since its original approval in 2017. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Moderate-to-severe plaque psoriasis
- Active psoriatic arthritis
- Moderately to severely active ulcerative colitis
- Moderately to severely active Crohn's disease
Source: FDA Label
TREMFYA Target & Pathway
ProTarget
A cytokine that promotes Th17 cell development and maintenance. IL-23 is upstream of IL-17 in the inflammatory cascade driving psoriasis and inflammatory bowel disease. Blocking IL-23 provides sustained control of these conditions.
TREMFYA Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Direct competitors
10
Same target(s) AND same indication — head-to-head.
Indication competitors
10
Same indication, different mechanism — what else might this patient receive?
Unlock 16 more competitors across all three rings.
Upgrade to Pro Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
What's emerging in TREMFYA's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications TREMFYA treats. First-in-class if their pivotal trials read out positive.
Tulisokibart MK-7240 / PRA023
Merck Sharp & Dohme LLC TNFSF15 · monoclonal antibody (anti-TL1A) · 3 Phase 3 trials
Afimkibart RVT-3101 / PRA023
Hoffmann-La Roche TNFSF15 · monoclonal antibody (anti-TL1A) · 6 Phase 3 trials
Rocatinlimab AMG 451 / KHK4083 ✓ Won — Ph3 readout
Amgen TNFRSF4 · monoclonal antibody (anti-OX40, depleting) · 8 Phase 3 trials
Drugs Similar to TREMFYA
3 of 6FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
SKYRIZI
RISANKIZUMAB-RZAA
AbbVie
Shared indications:
Moderate-to-severe plaque psoriasisActive psoriatic arthritisModerately to severely active Crohn's disease +1 more
📋
Clinical Trial Registry
58 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT07577856 DUET ENCORE-UC | 78934804UCO3001 2026-525923-26-00 | Ph 3 | not yet recruiting | A Study of JNJ-78934804 in Participants With Moderately to Severely Active Ulcerative Colitis |
| NCT07577843 DUET ENCORE-CD | 78934804CRD3001 | Ph 3 | not yet recruiting | A Study of JNJ-78934804 in Participants With Moderately to Severely Active Crohn's Disease |
| NCT04929210 STAR | CR109043 CNTO1959PSA4002, 2021-000465-32 | Ph 4 | active not recruiting | A Study of Guselkumab Administered Subcutaneously in Bio-naive Participants With Active Psoriatic Arthritis Axial Disease |
| NCT05347095 FUZION CD | CR109189 CNTO1959CRD3005, 2021-000491-10 | Ph 3 | active not recruiting | A Study of Guselkumab in Participants With Fistulizing, Perianal Crohn's Disease |
| NCT06663332 TRILOGY | CNTO1959ISD3001 CNTO1959ISD3001, 2023-509560-16-00 | Ph 3 | recruiting | A Long-term Extension (LTE) Study of Guselkumab in Pediatric Participants |
| NCT03451851 PROTOSTAR results posted | CR108452 CNTO1959PSO3011, 2023-503378-19-00 | Ph 3 | active not recruiting | A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Subcutaneously Administered Guselkumab for the Treatment of Chronic Plaque Psoriasis in Pediatric Participants |
| NCT06408935 REASON | CNTO1959CRD3008 CNTO1959CRD3008, 2023-504040-34-00 | Ph 3 | active not recruiting | Transmural Healing and Disease-Modifying Effect of Guselkumab in Crohn's Disease Patients |
| NCT04882098 APEX results posted | CR108957 CNTO1959PSA3004, 2020-004981-20 | Ph 3 | active not recruiting | A Study of Guselkumab in Participants With Active Psoriatic Arthritis |
| NCT07141004 | CNTO1959PSA4018 CNTO1959PSA4018 | Ph 4 | recruiting | A Study of Guselkumab Administered Subcutaneously in Treatment of Indian Participants With Psoriatic Arthritis (PsA) |
| NCT05242471 DUET-CD | CR109178 78934804CRD2001, 2021-003314-39 | Ph 2 | active not recruiting | A Study of Combination Therapy With Guselkumab and Golimumab in Participants With Moderately to Severely Active Crohn's Disease |
| NCT04936308 SOLSTICE results posted | CR109039 CNTO1959PSA3005, 2021-000482-32 | Ph 3 | active not recruiting | Guselkumab in Active Psoriatic Arthritis Participants With Inadequate Response/Intolerance to One Prior Anti-TNF Alpha Agent |
| NCT04033445 QUASAR results posted | CR108657 CNTO1959UCO3001, 2018-004002-25 | Ph 2, Ph 3 | active not recruiting | A Study of Guselkumab in Participants With Moderately to Severely Active Ulcerative Colitis |
| NCT03466411 GALAXI results posted | CR108387 CNTO1959CRD3001, 2017-002195-13 | Ph 2, Ph 3 | active not recruiting | A Study of the Efficacy and Safety of Guselkumab in Participants With Moderately to Severely Active Crohn's Disease |
| NCT07499232 CHARGE | CNTO1959CRD3009 CNTO1959CRD3009 | Ph 3 | recruiting | A Study of Guselkumab Versus Risankizumab in Participants With Moderately to Severely Active Crohn's Disease |
| NCT05923073 MACARONI-23 | CR109212 CNTO1959PBCRD3007, 2021-006282-37 | Ph 3 | recruiting | A Study of Guselkumab in Pediatric Participants With Moderately to Severely Active Crohn's Disease |
| NCT06916390 GUARDIAN | GUARDIAN | Ph 4 | recruiting | GUselkumAb inteRvention and DIet evaluAtioN for Pouchitis |
| NCT06039189 SPECTREM results posted | CR109328 CNTO1959PSO3017 | Ph 3 | completed | Study of Guselkumab Versus Placebo for the Treatment of Low Body Surface Area Moderate Plaque Psoriasis |
| NCT05242484 DUET-UC | CR109179 78934804UCO2001, 2021-005528-39 | Ph 2 | active not recruiting | A Study of Combination Therapy With Guselkumab and Golimumab in Participants With Moderately to Severely Active Ulcerative Colitis |
| NCT05083182 PSUMMIT-Jr | CR109101 CNTO1275JPA3001, 2020-005503-40 | Ph 3 | active not recruiting | A Study of Ustekinumab or Guselkumab in Pediatric Participants With Active Juvenile Psoriatic Arthritis |
| NCT05071664 AFFINITY | CR109054 CNTO1959PSA2003, 2021-002012-31 | Ph 2 | completed | A Study of Guselkumab and Golimumab Combination Therapy in Participants With Active Psoriatic Arthritis |
| NCT05004727 PAMPA | 20-01158 | Ph 4 | recruiting | Multi-Center PAMPA Study |
| NCT04645355 TIG | 20-32273 | Ph 4 | active not recruiting | Guselkumab Immunogenetics |
| NCT04340076 BeNeBio | 80-85200-98-18562 2019-004230-42 | Ph 4 | completed | Dose Reduction of IL17 and IL23 Inhibitors in Psoriasis |
| NCT06563323 GEORGE | Guselkumab for treatment of PG | Ph 2 | recruiting | Guselkumab in the Treatment of Adults With Pyoderma Gangrenosum (PG) |
| NCT04397263 results posted | CR108801 CNTO1959CRD3003 | Ph 3 | completed | A Study of Guselkumab in Participants With Moderately to Severely Active Crohn's Disease |
| NCT03818035 GUIDE results posted | CR108514 2018-001238-16, CNTO1959PSO3012 | Ph 3 | completed | A Study to Evaluate Further Therapeutic Strategies With Guselkumab in Participants With Moderate-to-Severe Plaque-Type Psoriasis |
| NCT07352566 | 25-43621 | Ph 4 | not yet recruiting | Utilization of a Microdevice for Psoriasis and Atopic Dermatitis |
| NCT06651489 | 2000038224 | Ph 2 | recruiting | Efficacy of Guselkumab in Treating Hailey Hailey Disease |
| NCT05535738 | STUDY00000321 | Ph 2, Ph 3 | active not recruiting | Using a Contact Dermatitis Model With Biologic Medications to Study Skin Inflammation |
| NCT05669833 EVOLUTION | CNTO1959PSA3006 | Ph 3 | recruiting | Guselkumab vs Golimumab in PsA TNF Inadequate Responder Patients |
| NCT05272150 VISIBLE | CR109163 CNTO1959PSO3018 | Ph 3 | completed | Study of Guselkumab in Skin of Color Participants With Moderate-to-severe Plaque and/or Scalp Psoriasis |
| NCT07138898 | 25-00380 | Ph 2 | not yet recruiting | Immunosuppressant Management in Rheumatology Patients Undergoing Elective Total Shoulder Arthroplasty |
| NCT04633447 THEIA results posted | CR108887 CNTO1959GCA2001, 2020-000622-26 | Ph 2 | terminated | A Study to Evaluate Guselkumab for the Treatment of Participants With New-onset or Relapsing Giant Cell Arteritis |
| NCT06974474 GUPAIN | CNTO1959PSA4016 | Ph 4 | recruiting | Potential Role of Guselkumab in Modulating PAIN Perception and Related Gene Pathways: a Proof-of-concept Study. |
| NCT05784129 PROGRESS results posted | CR109292 2022-002389-33, CNTO1959CRD3007 | Ph 3 | terminated | A Study of Guselkumab for the Treatment of Participants With Crohn's Disease After Surgical Resection |
| NCT05125679 G-CARE results posted | CR109033 2020-004061-39, CNTO1959PSO4015 | Ph 4 | terminated | Effect of Guselkumab on Cardiovascular Risk Surrogate Markers in Participants With Moderate to Severe Plaque Psoriasis |
| NCT04533737 COBRA results posted | LP0160-1510 2019-004099-20, U1111-1283-7584 | Ph 4 | terminated | Efficacy and Safety of Brodalumab Compared With Guselkumab in the Treatment of Plaque Psoriasis After Inadequate Response to Ustekinumab |
| NCT02641730 results posted | CR108046 CNTO1959PPP3001 | Ph 3 | completed | An Efficacy and Safety of Guselkumab in Participants With Palmoplantar Pustulosis |
| NCT02319759 results posted | CR105964 2014-003697-17, CNTO1959PSA2001 | Ph 2 | completed | Efficacy and Safety Study of Guselkumab in the Treatment of Participants With Active Psoriatic Arthritis (PsA) |
| NCT02905331 results posted | CR108203 CNTO1959PSO3006, 2016-002022-37 | Ph 3 | completed | Efficacy and Safety Study of Guselkumab in the Treatment of Participants With Moderate to Severe Plaque-Type Psoriasis |
| NCT04147338 | CR108698 CNTO1959CRD1003, 2020-003725-32 | Ph 1 | completed | A Study of Subcutaneously-administered Guselkumab Delivered by 3 Different Devices in Healthy Participants |
| NCT03649971 | CR108515 CNTO1959COR1001, 2019-001980-57 | Ph 1 | completed | A Study of Guselkumab in Participants With Familial Adenomatous Polyposis |
| NCT02570373 | CR107879 CNTO1959NAP1002 | Ph 1 | completed | A Study to Characterize the Elimination of Guselkumab Glycoform Variants in Healthy Participants |
| NCT04704843 | CR108914 2020-003539-40, 64304500CLD1001 | Ph 1 | withdrawn | A Study of Guselkumab in Adult Participants With Celiac Disease |
| NCT03975153 results posted | 00019343 | Ph 2 | completed | Guselkumab in the Treatment of Pityriasis Rubra Pilaris (PRP) |
| NCT04061395 HiGUS | CNTO1959HDS2002 | Ph 2 | completed | Guselkumab for Hidradenitis Suppurativa, a Mode of Action Study. |
| NCT04914429 | CR109025 CNTO1959PSO4009 | Ph 4 | completed | A Study of Guselkumab (TREMFYA) in Chinese Participants With Moderate to Severe Plaque Psoriasis |
| NCT05858632 | 21-35862 | Ph 4 | recruiting | Immune Spatial Features of Guselkumab Cutaneous Response |
| NCT03158285 results posted | CR108219 CNTO1959PSA3002, 2016-001224-63 | Ph 3 | completed | A Study Evaluating the Efficacy and Safety of Guselkumab Administered Subcutaneously in Participants With Active Psoriatic Arthritis |
| NCT05083078 | CR109047 2021-000896-35, CNTO1959PSA1001 | Ph 1 | terminated | A Study of Guselkumab and Risankizumab in Healthy Participants and Participants With Psoriatic Arthritis |
Showing 50 of 58 trials
🔬
Pro Active Pipeline
Ongoing clinical trials by development phase
Loading...
⭐
Pro Key Completed Trials
Completed studies with published results, ranked by significance
Loading...
📊
Trial Timeline
Full development history with FDA approval milestones
|
Loading...
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
TREMFYA FDA Label Details
Indications & Usage
FDA Label (PDF)TREMFYA is indicated for the treatment of Moderate-to-severe plaque psoriasis; Active psoriatic arthritis; Moderately to severely active ulcerative colitis; Moderately to severely active Crohn's disease.
Pro Intelligence Preview
Deep insights for TREMFYA
Revenue Insights
- • Q4-2025: $1.6B
- • Historical trend analysis
Patent Timeline
- • Cliff: 2034
- • Generic/biosimilar risk
Trial Analysis
- • 58 total trials
- • Stage: Expansion
Competitive Landscape
- • 6 similar drugs
- • Same target/indication analysis
Unlock Full Intelligence
Full approval history • All patents • Revenue trends • Competitor analysis
Related Intelligence
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment