Tremfya

(Guselkumab)

ApprovedMonoclonal antibody

Guselkumab is used to treat moderate to severe plaque psoriasis, a skin condition that causes red, itchy, scaly patches on the skin.[2] Tremfya is currently approved and in use across 21 indications[4].[1]

Tremfya is one of 361 monoclonal antibody programs targeting Pyoderma Gangrenosum. It is currently in Approved.

Indications

Total Trials

Active Trials

360

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[4][1]

Indication

Pyoderma GangrenosumActive, not recruiting

Rheumatic DiseaseRecruiting

Non-Alcoholic Fatty Liver DiseaseActive, not recruiting

Psoriasis VulgarisUnknown

Immune System DiseaseUnknown

Autoimmune DiseaseActive, not recruiting

Contact DermatitisRecruiting

Inflammatory Bowel DiseaseActive, not recruiting

Hailey-Hailey DiseaseRecruiting

PsoriasisCompleted

Pyoderma GangrenosumPhase 2

Active, not recruiting

Rheumatic DiseasePhase 2

Recruiting

Non-Alcoholic Fatty Liver DiseasePreclinical

Active, not recruiting

Psoriasis VulgarisPreclinical

Unknown

Immune System DiseasePreclinical

Unknown

Autoimmune DiseasePreclinical

Active, not recruiting

Contact DermatitisPhase 3

Recruiting

Inflammatory Bowel DiseasePreclinical

Active, not recruiting

Hailey-Hailey DiseasePhase 2

Recruiting

PsoriasisApproved

Completed

Showing 10 of 21 indications

Competition

Competitive Landscape

116 competitors in Atopic Dermatitis

#DrugCompanyPhaseTrials

Tremfya

Johnson & Johnson

Approved

1 2

Cytosar

Teva

Phase 3

1 3

Fludara

Sanofi

Phase 3

1 4

Adtralza

LEO Pharma

Phase 3

17 5

Amlitelimab

Sanofi

Phase 3

2 6

DUPIXENT

Regeneron

Phase 3

1 7

Certolizumab

Johnson & Johnson

Phase 3

1 8

ICP-332

BBeijing InnoCare Pharma Tech Co., Ltd.

Phase 3

2 9

VC005

JJiangsu vcare pharmaceutical technology co., LTD

Phase 3

5 10

MG-K10

SShanghai Mabgeek Biotech.Co.Ltd

Phase 3

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

Timeline

Expected Milestones

Q4 2026

N/ARecruiting

NAFLD

NCT06586281

Active, not recruiting

Crohn's Disease

NCT06249555

Phase 2Recruiting

Hailey-Hailey Disease

NCT06651489

Phase 3Active, not recruiting

Psoriasis

NCT03451851

Phase 1Not yet recruiting

Study completion

NCT07788807

Q1 2027

Phase 3Active, not recruiting

Fistulizing Crohns Disease

NCT05347095

Clinical

Trials by Indication[1]

Psoriasis19 trials

Pharmacokinetic Study to Evaluate the Effect of a Single Dose of Guselkumab (CNTO 1959) on CYP 450 Enzyme Activities After Subcutaneous Administration in Participants With Psoriasis

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 1·NCT02397382·16 enrolled

A Study of Guselkumab in Naive or Bio-experienced Participants With Regional (Facial and Genital) Psoriasis

Completed· Johnson & Johnson logo

Johnson & Johnson··NCT04439526·356 enrolled

A Study of Guselkumab in the Treatment of Participants With Moderate to Severe Plaque-Type Psoriasis With Randomized Withdrawal and Retreatment

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 3·NCT02207244·992 enrolled

Show 16 more trials

A Study of Guselkumab in the Treatment of Participants With Moderate to Severe Plaque-Type Psoriasis

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 3·NCT02207231·837 enrolled

Dose Reduction of IL17 and IL23 Inhibitors in Psoriasis

Completed·RRadboud University Medical Center·Phase 4·NCT04340076·244 enrolled

A Study of Guselkumab in Participants With Moderate to Severe Plaque-type Psoriasis and an Inadequate Response to Ustekinumab

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 3·NCT02203032·872 enrolled

A Study to Evaluate the Comparative Efficacy of CNTO 1959 (Guselkumab) and Secukinumab for the Treatment of Moderate to Severe Plaque-type Psoriasis

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 3·NCT03090100·1,048 enrolled

A Study of Guselkumab (TREMFYA) in Chinese Participants With Moderate to Severe Plaque Psoriasis

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 4·NCT04914429·327 enrolled

An Explorative Psoriasis Biomarker Study

Terminated·CCentre for Human Drug Research, Netherlands·N/A·NCT04394936·37 enrolled

A Study of Ixekizumab (LY2439821) Compared to Guselkumab in Participants With Moderate-to-Severe Plaque Psoriasis

Completed· Eli Lilly logo

Eli Lilly·Phase 4·NCT03573323·1,027 enrolled

A Study to Compare the Efficacy of Guselkumab to Fumaric Acid Esters for the Treatment of Participants With Moderate to Severe Plaque Psoriasis

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 3·NCT02951533·119 enrolled

A Study to Evaluate Further Therapeutic Strategies With Guselkumab in Participants With Moderate-to-Severe Plaque-Type Psoriasis

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 3·NCT03818035·880 enrolled

Efficacy and Safety of Brodalumab Compared With Guselkumab in the Treatment of Plaque Psoriasis After Inadequate Response to Ustekinumab

Terminated· LEO Pharma logo

LEO Pharma·Phase 4·NCT04533737·113 enrolled

Study of Guselkumab Versus Placebo for the Treatment of Low Body Surface Area Moderate Plaque Psoriasis

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 3·NCT06039189·338 enrolled

Effect of Guselkumab on Cardiovascular Risk Surrogate Markers in Participants With Moderate to Severe Plaque Psoriasis

Terminated· Johnson & Johnson logo

Johnson & Johnson·Phase 4·NCT05125679·15 enrolled

Efficacy and Safety Study of Guselkumab in the Treatment of Participants With Moderate to Severe Plaque-Type Psoriasis

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 3·NCT02905331·78 enrolled

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)

Active, not recruiting· Johnson & Johnson logo

Johnson & Johnson·Phase 3·NCT03451851·120 enrolled

A Phase 4, Open-Label, Milk-Only Lactation Study to Assess Concentration of TREMFYA in Breast Milk of Lactating Women Who Are Receiving TREMFYA Therapeutically

Recruiting· Johnson & Johnson logo

Johnson & Johnson·Approved·NCT07654751·10 enrolled

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

Completed·UUniversity of California, San Francisco·Approved·NCT04645355·17 enrolled

Crohn's Disease11 trials

A Study of Guselkumab for the Treatment of Participants With Crohn's Disease After Surgical Resection

Terminated· Johnson & Johnson logo

Johnson & Johnson·Phase 3·NCT05784129·4 enrolled

Guselkumab Vs Ustekinumab in Stricturing Crohn's Disease

Recruiting·SSecond Affiliated Hospital, School of Medicine, Zhejiang University··NCT07444060·100 enrolled

Ultrasound and Proteomics for Guselkumab Response Assessment in Crohn's Disease (UPGRADE).

Recruiting·UUniversity of Calgary··NCT07246460·90 enrolled

Show 8 more trials

A Phase 2b Randomized, Double-blind, Active-and Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Efficacy and Safety of Induction and Maintenance Combination Therapy With Guselkumab and Golimumab in Participants With Moderately to Severely Active Crohn's Disease

Active, not recruiting· Johnson & Johnson logo

Johnson & Johnson·Phase 2·NCT05242471·703 enrolled

A Phase 3b, Open-label, Multicenter Study to Evaluate Transmural Healing and Disease Modifying Effect of Guselkumab in Crohn's Disease Patients

Active, not recruiting· Johnson & Johnson logo

Johnson & Johnson·Phase 3·NCT06408935·120 enrolled

A Phase 3, Multicenter, Randomized, Platform Study of p19 Inhibition of the IL-23 Pathway to Establish Efficacy in Pediatric Crohn's Disease

Recruiting· Johnson & Johnson logo

Johnson & Johnson·Phase 3·NCT05923073·120 enrolled

CNTO1959ISD3001: A Phase 3, Multicenter, Open-label, Basket, Long-term Extension Study to Evaluate the Safety of Guselkumab in Pediatric Participants With Crohn's Disease, Ulcerative Colitis, or Juvenile Psoriatic Arthritis

Recruiting· Johnson & Johnson logo

Johnson & Johnson·Phase 3·NCT06663332·196 enrolled

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

Active, not recruiting· Johnson & Johnson logo

Johnson & Johnson·Preclinical·NCT03466411·1,409 enrolled

VOICE-Characterization of Early Response to Vedolizumab and IL-23 Antagonists in Participants With Crohn's Disease Using Patient-Reported Outcome Measures: A Prospective Observational Study

Active, not recruiting·AAlimentiv Inc.··NCT06249555·300 enrolled

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

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 3·NCT04397263·38 enrolled

GALAXI-1: Guselkumab in Crohn's Disease

Active, not recruiting· Johnson & Johnson logo

Johnson & Johnson·Phase 3·NCT04683029·780 enrolled

Arthritis, Psoriatic6 trials

A Phase 3b, Multicenter, Randomized, Double-blind, Placebo-controlled Study Evaluating the Efficacy and Safety of Subcutaneously Administered Guselkumab in Improving the Signs and Symptoms and Inhibiting Radiographic Progression in Participants With Active Psoriatic Arthritis

Active, not recruiting· Johnson & Johnson logo

Johnson & Johnson·Phase 3·NCT04882098·1,054 enrolled

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

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 3·NCT04936308·453 enrolled

Assessment of Guselkumab (Tremfya) and IL-17 Inhibitor Therapies in Patients With Psoriatic Arthritis in Routine Clinical Practice; A Prospective, Observational Cohort Study

Active, not recruiting· Johnson & Johnson logo

Johnson & Johnson··NCT05049798·1,314 enrolled

Show 3 more trials

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

Active, not recruiting· Johnson & Johnson logo

Johnson & Johnson·Approved·NCT04929210·411 enrolled

A Phase-IV, Multicenter, Non-Comparative, Open-Label Study Evaluating the Safety and Efficacy of Guselkumab Administered Subcutaneously in the Treatment of Indian Patients With Psoriatic Arthritis

Recruiting·JJohnson & Johnson Private Limited·Approved·NCT07141004·100 enrolled

A Phase 2a, Multicenter, Randomized, Double-blind Study Evaluating the Efficacy and Safety of Subcutaneously Administered Guselkumab and Golimumab Combination Therapy in Participants With Active Psoriatic Arthritis

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 2·NCT05071664·91 enrolled

Psoriatic Arthritis5 trials

A Study Evaluating the Efficacy and Safety of Guselkumab Administered Subcutaneously in Participants With Active Psoriatic Arthritis

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 3·NCT03158285·741 enrolled

A Study of Guselkumab in Participants With Active Psoriatic Arthritis and an Inadequate Response to Anti-Tumor Necrosis Factor Alpha (Anti-TNF Alpha) Therapy

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 3·NCT03796858·285 enrolled

Efficacy and Safety Study of Guselkumab in the Treatment of Participants With Active Psoriatic Arthritis (PsA)

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 2·NCT02319759·149 enrolled

Show 2 more trials

A Study of Guselkumab and Risankizumab in Healthy Participants and Participants With Psoriatic Arthritis

Terminated· Johnson & Johnson logo

Johnson & Johnson·Phase 1·NCT05083078·11 enrolled

A Study Evaluating the Efficacy and Safety of Guselkumab Administered Subcutaneously in Participants With Active Psoriatic Arthritis Including Those Previously Treated With Biologic Anti -Tumor Necrosis Factor (TNF) Alpha Agent(s)

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 3·NCT03162796·383 enrolled

Colitis, Ulcerative4 trials

A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Efficacy and Safety of Guselkumab Subcutaneous Induction Therapy in Participants With Moderately to Severely Active Ulcerative Colitis

Active, not recruiting· Johnson & Johnson logo

Johnson & Johnson·Phase 3·NCT05528510·418 enrolled

Active, not recruiting· Johnson & Johnson logo

Johnson & Johnson·Phase 2·NCT05242484·577 enrolled

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

Active, not recruiting· Johnson & Johnson logo

Johnson & Johnson·Phase 3·NCT06260163·112 enrolled

Show 1 more trial

78934804UCO3001: A Phase 3 Randomized, Double-blind, and Active Controlled, Multicenter Study to Evaluate the Efficacy and Safety of JNJ-78934804 in Participants With Moderately to Severely Active Ulcerative Colitis

Recruiting· Johnson & Johnson logo

Johnson & Johnson·Phase 3·NCT07577856·644 enrolled

37 more indications

Crohn Disease4 trials

A Phase 3b, Multicenter, Randomized, Open-Label, Active-Controlled Study to Compare the Efficacy and Safety of Guselkumab Versus Risankizumab in the Treatment of Participants With Moderately to Severely Active Crohn's Disease

Recruiting· Johnson & Johnson logo

Johnson & Johnson·Phase 3·NCT07499232·530 enrolled

Efficacy of Guselkumab in Chinese Participants With Crohn's Disease Following Loss of Response to Ustekinumab

Recruiting· Johnson & Johnson logo

Johnson & Johnson·Approved·NCT07310095·78 enrolled

A Phase 3, Randomized, Double-blind, and Active-controlled Multicenter Study to Evaluate the Efficacy and Safety of JNJ-78934804 in Participants With Moderately to Severely Active Crohn's Disease

Recruiting· Johnson & Johnson logo

Johnson & Johnson·Phase 3·NCT07577843·460 enrolled

Show 1 more trial

CNTO1959CRD3004: A Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Efficacy and Safety of Guselkumab Subcutaneous Induction Therapy in Participants With Moderately to Severely Active Crohn's Disease

Active, not recruiting· Johnson & Johnson logo

Johnson & Johnson·Phase 3·NCT05197049·350 enrolled

Hidradenitis Suppurativa3 trials

A Study to Evaluate the Efficacy, Safety, and Tolerability of Guselkumab for the Treatment of Participants With Moderate to Severe Hidradenitis Suppurativa (HS)

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 2·NCT03628924·184 enrolled

Biomarkers in Participants With Hidradenitis Suppurativa Receiving Guselkumab.

Withdrawn·RRockefeller University·Phase 1·NCT04084665

Guselkumab for Hidradenitis Suppurativa, a Mode of Action Study.

Completed·UUniversity Medical Center Groningen·Phase 2·NCT04061395·20 enrolled

Liver2 trials

A Study of Subcutaneously-administered Guselkumab Delivered by 3 Different Devices in Healthy Participants

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 1·NCT04147338·440 enrolled

A Study to Assess the Pharmacokinetic Comparability of Guselkumab (CNTO1959) When Delivered by 2 Different Devices and as 2 Formulations in Healthy Participants

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 1·NCT01866007·141 enrolled

Familial adenomatous polyposis2 trials

Post-Trial Access for Guselkumab in Participants With Familial Adenomatous Polyposis

No longer available· Johnson & Johnson logo

Johnson & Johnson··NCT04948398

A Study of Guselkumab in Participants With Familial Adenomatous Polyposis

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 1·NCT03649971·77 enrolled

Ulcerative Colitis2 trials

A Study of Efficacy and Safety of Combination Therapy With Guselkumab and Golimumab in Participants With Moderately to Severely Active Ulcerative Colitis

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 2·NCT03662542·214 enrolled

CNTO1959UCO3001: A Phase 2b/3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Protocol to Evaluate the Efficacy and Safety of Guselkumab in Participants With Moderately to Severely Active Ulcerative Colitis

Active, not recruiting· Johnson & Johnson logo

Johnson & Johnson·Preclinical·NCT04033445·1,064 enrolled

Intravenous2 trials

Study of Guselkumab and Ustekinumab Following a Single Intravenous or Subcutaneous Administration in Healthy Chinese Participants

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 1·NCT04030533·60 enrolled

A Study of Intravenous Formulation of Guselkumab Using Prefilled Syringes and Final Vialed Product in Healthy Participants

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 1·NCT04617691·140 enrolled

Plaque Psoriasis2 trials

A Multicenter, Randomized, Double-Blind, Parallel, Active-Controlled Phase 3 Clinical Study to Compare the Efficacy and Safety of QL2106 Injection to Tremfya® in Patients With Moderate to Severe Plaque Psoriasis

Active, not recruiting· Qilu Pharmaceutical Co., Ltd. logo

Qilu Pharmaceutical Co., Ltd.·Phase 3·NCT07511647·318 enrolled

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

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 3·NCT05272150·211 enrolled

Non-Alcoholic Fatty Liver Disease1 trial

Shared Pathways Between Non-Alcoholic Fatty Liver Disease and Psoriatic Disease With Guselekumab Therapy

Withdrawn·UUniversity of California, San Diego··NCT07255781

Lupus Nephritis1 trial

A Study of Guselkumab in Participants With Active Lupus Nephritis

Terminated· Johnson & Johnson logo

Johnson & Johnson·Phase 2·NCT04376827·33 enrolled

Intravenous Administration1 trial

A Study to Assess the Safety, Tolerability and Pharmacokinetics of Guselkumab Following a Single Intravenous Administration in Healthy Japanese Participants

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 1·NCT03536325·24 enrolled

Atopic Dermatitis1 trial

Utilization of a Microdevice for Psoriasis and Atopic Dermatitis

Not yet recruiting·UUniversity of California, San Francisco·Phase 4·NCT07352566·10 enrolled

ART1 trial

A Study to Characterize the Elimination of Guselkumab Glycoform Variants in Healthy Participants

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 1·NCT02570373·8 enrolled

MPA1 trial

Multi-Center PAMPA Study

Recruiting·NNYU Langone Health·Phase 4·NCT05004727·176 enrolled

Palmoplantar Pustulosis1 trial

An Efficacy and Safety of Guselkumab in Participants With Palmoplantar Pustulosis

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 3·NCT02641730·159 enrolled

Pustular Psoriasis1 trial

A Study of Guselkumab for the Treatment of Palmoplantar-non-Pustular Psoriasis

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 3·NCT03998683·117 enrolled

Pityriasis Rubra Pilaris1 trial

Guselkumab in the Treatment of Pityriasis Rubra Pilaris (PRP)

Completed·OOregon Health and Science University·Phase 2·NCT03975153·15 enrolled

Autoimmune Disease1 trial

Stelara and Tremfya Pregnancy Exposure Registry OTIS Autoimmune Diseases in Pregnancy Project

Recruiting·UUniversity of California, San Diego··NCT02103361·200 enrolled

GIST1 trial

Costa Rican Registry of IL-23 Inhibitors in Psoriatic Disease

Not yet recruiting·CCaja Costarricense de Seguro Social··NCT07448402·50 enrolled

Liver Disease1 trial

Guselkumab (Anti-IL 23 Monoclonal Antibody) for Alcohol Associated Liver Disease

Completed·UUniversity of California, San Diego·Phase 1·NCT04736966·13 enrolled

Contact Dermatitis1 trial

Using a Contact Dermatitis Model With Biologic Medications to Study Skin Inflammation

Recruiting·WWei-Che Ko·Phase 2/3·NCT05535738·45 enrolled

Celiac Disease1 trial

A Study of Guselkumab in Adult Participants With Celiac Disease

Withdrawn· Johnson & Johnson logo

Johnson & Johnson·Phase 1·NCT04704843

NAFLD1 trial

Elucidating Shared Mechanisms Contributing to NAFLD and PsA Disease Severity With Guselkumab Therapy

Recruiting·UUniversity of California, San Diego·N/A·NCT06586281·20 enrolled

Giant Cell Arteritis1 trial

A Study to Evaluate Guselkumab for the Treatment of Participants With New-onset or Relapsing Giant Cell Arteritis

Terminated· Johnson & Johnson logo

Johnson & Johnson·Phase 2·NCT04633447·53 enrolled

Recruiting·UUniversity of California, San Francisco·Phase 4·NCT05858632·10 enrolled

Pouchitis1 trial

GUselkumAb inteRvention and DIet evaluAtioN for Pouchitis

Not yet recruiting·UUniversitaire Ziekenhuizen KU Leuven·Phase 4·NCT06916390·20 enrolled

Generalized Pustular Psoriasis1 trial

An Efficacy and Safety Study of CNTO1959 (Guselkumab) in the Treatment of Participants With Generalized Pustular Psoriasis or Erythrodermic Psoriasis

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 3·NCT02343744·21 enrolled

Fistulizing Crohns Disease1 trial

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

Active, not recruiting· Johnson & Johnson logo

Johnson & Johnson·Phase 3·NCT05347095·288 enrolled

Ulcerative Colitis (Disorder)1 trial

Efficacy and Safety of Guselkumab in Patients With Moderate-to-Severe Ulcerative Colitis:A Real-World Prospective Cohort Study.

Recruiting·SSecond Affiliated Hospital of Wenzhou Medical University··NCT07726888·97 enrolled

Pyoderma Gangrenosum1 trial

A Single-arm Open-label Study Assessing Short-term (Week 6, 16) and Long-term (Week 32) Efficacy of Guselkumab in Adult Participants With Pyoderma Gangrenosum

Active, not recruiting·OOregon Health and Science University·Phase 2·NCT06563323·17 enrolled

Inflammatory Bowel Disease (IBD)1 trial

SHIFT-IBD: Switching to High-efficacy Anti-IL-23 Guselkumab in Ustekinumab-exposed Persons With Active IBD

Recruiting·TTIDHI Innovation Inc.··NCT07245394·200 enrolled

Arthritis, Juvenile1 trial

A Phase 3 Multicenter, Open-label Study to Evaluate the Efficacy, Pharmacokinetics, Safety, and Immunogenicity of Subcutaneously Administered Ustekinumab or Guselkumab in Pediatric Participants With Active Juvenile Psoriatic Arthritis (PSUMMIT-Jr)

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 3·NCT05083182·48 enrolled

Rheumatic Disease1 trial

Immunosuppressant Management in Rheumatology Patients Undergoing Elective Total Shoulder Arthroplasty

Recruiting·NNYU Langone Health·Phase 2·NCT07138898·80 enrolled

Crohn Disease (CD)1 trial

Optimal Care With Guselkumab In Crohn's Disease

Recruiting·GGroupe d'Etude Therapeutique des Affections Inflammatoires Digestives·Approved·NCT07616687·210 enrolled

Hailey-Hailey disease1 trial

Efficacy of Guselkumab in the Treatment of Hailey Hailey Disease: An Open-label, Proof of Concept Study

Recruiting·YYale University·Phase 2·NCT06651489·10 enrolled

Unspecified3 trials

Real-Life Evaluation of Guselkumab Dosing Interval Adjustments

Recruiting·—··NCT07430319·100 enrolled

Guselkumab vs Golimumab in PsA TNF Inadequate Responder Patients

Recruiting·UUniversity of Pennsylvania·Phase 3·NCT05669833·63 enrolled

An Open-label, Phase 1, Pharmacokinetic Study of a Single Dose of Transcolonically Administered Adalimumab and Guselkumab in Healthy Adult Participants

Not yet recruiting·SSurmount Services, Inc.·Phase 1·NCT07788807·18 enrolled

Regulatory

FDA Approval Timeline[5]

Jul 13, 2017

TREMFYA

BLA BLA761061

Jan 29, 2019

TREMFYA

NDA BLA761061

Apr 4, 2019

TREMFYA

NDA BLA761061

Nov 22, 2019

TREMFYA

NDA BLA761061

Jun 1, 2020

TREMFYA

NDA BLA761061

Jul 13, 2020

TREMFYA

NDA BLA761061

Jun 29, 2023

TREMFYA

NDA BLA761061

Sep 11, 2024

TREMFYA

NDA BLA761061

Mar 20, 2025

TREMFYA

NDA BLA761061

Mar 25, 2025

TREMFYA

NDA BLA761061

Jun 17, 2025

TREMFYA

NDA BLA761061

Sep 19, 2025

TREMFYA

NDA BLA761061

Sep 26, 2025

TREMFYA

NDA BLA761061

Sep 26, 2025

TREMFYA

NDA BLA761061

May 28, 2026

TREMFYA

NDA BLA761061

Sources

References

[1]
ClinicalTrials.gov — 94 trial records for Guselkumab. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Tremfya drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — Guselkumab compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for Guselkumab. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA BLA761061). U.S. Food & Drug Administration.
[6]
PubMed — 1 publication indexed for Guselkumab. U.S. National Library of Medicine.
[7]
SEC EDGAR — Johnson & Johnson company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Il-23p19 Inhibitor[3]
Modality: Monoclonal antibody[3]
Highest Phase: Approved[1]
Company: Johnson & Johnson

Key Publications[6]

Guselkumab in Psoriatic Arthritis: DISCOVER-2 Extended Results

LancetJan 12, 2023DOI: 10.1016/S0140-6736(23)00024-5

Tremfya

Status by Indication[4][1]

Competitive Landscape

Expected Milestones

Q4 2026

Q1 2027

Trials by Indication[1]

Psoriasis19 trials

Crohn's Disease11 trials

Arthritis, Psoriatic6 trials

Psoriatic Arthritis5 trials

Colitis, Ulcerative4 trials

Crohn Disease4 trials

Hidradenitis Suppurativa3 trials

Liver2 trials

Familial adenomatous polyposis2 trials

Ulcerative Colitis2 trials

Intravenous2 trials

Plaque Psoriasis2 trials

Non-Alcoholic Fatty Liver Disease1 trial

Lupus Nephritis1 trial

Intravenous Administration1 trial

Atopic Dermatitis1 trial

ART1 trial

MPA1 trial

Palmoplantar Pustulosis1 trial

Pustular Psoriasis1 trial

Pityriasis Rubra Pilaris1 trial

Autoimmune Disease1 trial

GIST1 trial

Liver Disease1 trial

Contact Dermatitis1 trial

Celiac Disease1 trial

NAFLD1 trial

Giant Cell Arteritis1 trial

Inflammatory Bowel Disease1 trial

Pain Perception1 trial

Immune1 trial

Pouchitis1 trial

Generalized Pustular Psoriasis1 trial

Fistulizing Crohns Disease1 trial

Ulcerative Colitis (Disorder)1 trial

Pyoderma Gangrenosum1 trial

Inflammatory Bowel Disease (IBD)1 trial

Arthritis, Juvenile1 trial

Rheumatic Disease1 trial

Crohn Disease (CD)1 trial

Hailey-Hailey disease1 trial

Unspecified3 trials

FDA Approval Timeline[5]

References

Drug Info

Quick Facts

Key Publications[6]

Related News