Guselkumab
drugOn this page
Also known as CNTO 1959CNTO-1959Tremfya
Summary
Guselkumab (CHEMBL2364648) is an approved antibody (ATC L04AC16); indicated across 17 conditions including psoriasis and immune system disorder.
At a glance
- Status: Approved (max clinical phase 4)
- Modality: Antibody
- ATC class: L04AC16
- Indications: 17 conditions
- Clinical trials: 85
Identifiers
Drug identity and classification
| Field | Value |
|---|---|
| ChEMBL ID | CHEMBL2364648 |
| Name | Guselkumab |
| Type | Antibody |
| Max phase | 4 |
| ATC | L04AC16 |
Also known as: CNTO 1959, CNTO-1959, Guselkumab, Tremfya, GUSELKUMAB
Targets
Targets
No target linkage available.
Bioactivity
No ChEMBL bioactivity rows at pChembl ≥ 5 (expected for biologics / antibodies).
Target pathways
No target-pathway data for this drug (no mapped target genes).
Indications & clinical
Indications
17 indications (5 at ChEMBL trial phase 4). Phase below is the highest clinical-trial phase recorded for this drug against each disease — not the molecule’s overall approval status (that is in the Summary).
| Indication | Trial phase | MONDO | EFO |
|---|---|---|---|
| psoriasis | 4 | MONDO:0005083 | EFO:0000676 |
| immune system disorder | 4 | MONDO:0005046 | EFO:0000540 |
| psoriatic arthritis | 4 | MONDO:0011849 | EFO:0003778 |
| Crohn disease | 3 | MONDO:0005011 | EFO:0000384 |
| ulcerative colitis | 3 | MONDO:0005101 | EFO:0000729 |
| juvenile idiopathic arthritis | 3 | MONDO:0011429 | EFO:0002609 |
| rheumatoid arthritis | 2 | MONDO:0008383 | EFO:0000685 |
| hidradenitis suppurativa | 2 | MONDO:0006559 | EFO:1000710 |
| systemic sclerosis | 2 | MONDO:0005100 | EFO:0000717 |
| lupus nephritis | 2 | MONDO:0005556 | EFO:0005761 |
| temporal arteritis | 2 | MONDO:0008538 | EFO:1001209 |
| pityriasis rubra pilaris | 2 | MONDO:0100017 | MONDO:0100017 |
| celiac disease | 1 | MONDO:0005130 | EFO:0001060 |
| alcoholic liver disease | 1 | MONDO:0043693 | EFO:0008573 |
3 further indication records had no mapped disease name (EFO/MeSH-only) or were duplicates, and are omitted.
Clinical trials
Total trials: 85.
Phase distribution
| Phase | Trials |
|---|---|
| PHASE3 | 30 |
| Not specified | 16 |
| PHASE4 | 14 |
| PHASE2 | 12 |
| PHASE1 | 9 |
| PHASE2/PHASE3 | 3 |
| EARLY_PHASE1 | 1 |
Top trials by phase / activity
| NCT | Phase | Status | Title |
|---|---|---|---|
| NCT04645355 | PHASE4 | ACTIVE_NOT_RECRUITING | Guselkumab Immunogenetics |
| NCT04929210 | PHASE4 | ACTIVE_NOT_RECRUITING | A Study of Guselkumab Administered Subcutaneously in Bio-naive Participants With Active Psoriatic Arthritis Axial Disease |
| NCT05004727 | PHASE4 | RECRUITING | Multi-Center PAMPA Study |
| NCT05858632 | PHASE4 | RECRUITING | Immune Spatial Features of Guselkumab Cutaneous Response |
| NCT06916390 | PHASE4 | RECRUITING | GUselkumAb inteRvention and DIet evaluAtioN for Pouchitis |
| NCT06974474 | PHASE4 | RECRUITING | Potential Role of Guselkumab in Modulating PAIN Perception and Related Gene Pathways: a Proof-of-concept Study. |
| NCT07141004 | PHASE4 | RECRUITING | A Study of Guselkumab Administered Subcutaneously in Treatment of Indian Participants With Psoriatic Arthritis (PsA) |
| NCT07310095 | PHASE4 | RECRUITING | A Study to Evaluate the Efficacy of Guselkumab in Chinese Participants With Crohn’s Disease (CD) |
| NCT07352566 | PHASE4 | NOT_YET_RECRUITING | Utilization of a Microdevice for Psoriasis and Atopic Dermatitis |
| NCT03573323 | PHASE4 | COMPLETED | A Study of Ixekizumab (LY2439821) Compared to Guselkumab in Participants With Moderate-to-Severe Plaque Psoriasis |
| NCT04340076 | PHASE4 | COMPLETED | Dose Reduction of IL17 and IL23 Inhibitors in Psoriasis |
| NCT04533737 | PHASE4 | TERMINATED | Efficacy and Safety of Brodalumab Compared With Guselkumab in the Treatment of Plaque Psoriasis After Inadequate Response to Ustekinumab |
| NCT04914429 | PHASE4 | COMPLETED | A Study of Guselkumab (TREMFYA) in Chinese Participants With Moderate to Severe Plaque Psoriasis |
| NCT05125679 | PHASE4 | TERMINATED | Effect of Guselkumab on Cardiovascular Risk Surrogate Markers in Participants With Moderate to Severe Plaque Psoriasis |
| NCT03451851 | PHASE3 | 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 |
| NCT03466411 | PHASE2/PHASE3 | ACTIVE_NOT_RECRUITING | A Study of the Efficacy and Safety of Guselkumab in Participants With Moderately to Severely Active Crohn’s Disease |
| NCT04033445 | PHASE2/PHASE3 | ACTIVE_NOT_RECRUITING | A Study of Guselkumab in Participants With Moderately to Severely Active Ulcerative Colitis |
| NCT04882098 | PHASE3 | ACTIVE_NOT_RECRUITING | A Study of Guselkumab in Participants With Active Psoriatic Arthritis |
| NCT04936308 | PHASE3 | ACTIVE_NOT_RECRUITING | Guselkumab in Active Psoriatic Arthritis Participants With Inadequate Response/Intolerance to One Prior Anti-TNF Alpha Agent |
| NCT05083182 | PHASE3 | ACTIVE_NOT_RECRUITING | A Study of Ustekinumab or Guselkumab in Pediatric Participants With Active Juvenile Psoriatic Arthritis |
| NCT05347095 | PHASE3 | ACTIVE_NOT_RECRUITING | A Study of Guselkumab in Participants With Fistulizing, Perianal Crohn’s Disease |
| NCT05535738 | PHASE2/PHASE3 | ACTIVE_NOT_RECRUITING | Using a Contact Dermatitis Model With Biologic Medications to Study Skin Inflammation |
| NCT05669833 | PHASE3 | RECRUITING | Guselkumab vs Golimumab in PsA TNF Inadequate Responder Patients |
| NCT05923073 | PHASE3 | RECRUITING | A Study of Guselkumab in Pediatric Participants With Moderately to Severely Active Crohn’s Disease |
| NCT06260163 | PHASE3 | ACTIVE_NOT_RECRUITING | A Study of Guselkumab in Pediatric Participants With Moderately to Severely Active Ulcerative Colitis |
| NCT06408935 | PHASE3 | ACTIVE_NOT_RECRUITING | Transmural Healing and Disease-Modifying Effect of Guselkumab in Crohn’s Disease Patients |
| NCT06663332 | PHASE3 | RECRUITING | A Long-term Extension (LTE) Study of Guselkumab in Pediatric Participants |
| NCT07499232 | PHASE3 | RECRUITING | A Study of Guselkumab Versus Risankizumab in Participants With Moderately to Severely Active Crohn’s Disease |
| NCT07577843 | PHASE3 | NOT_YET_RECRUITING | A Study of JNJ-78934804 in Participants With Moderately to Severely Active Crohn’s Disease |
| NCT07577856 | PHASE3 | NOT_YET_RECRUITING | A Study of JNJ-78934804 in Participants With Moderately to Severely Active Ulcerative Colitis |
| NCT02203032 | PHASE3 | COMPLETED | A Study of Guselkumab in Participants With Moderate to Severe Plaque-type Psoriasis and an Inadequate Response to Ustekinumab |
| NCT02207231 | PHASE3 | COMPLETED | A Study of Guselkumab in the Treatment of Participants With Moderate to Severe Plaque-Type Psoriasis |
| NCT02207244 | PHASE3 | COMPLETED | A Study of Guselkumab in the Treatment of Participants With Moderate to Severe Plaque-Type Psoriasis With Randomized Withdrawal and Retreatment |
| NCT02343744 | PHASE3 | COMPLETED | An Efficacy and Safety Study of CNTO1959 (Guselkumab) in the Treatment of Participants With Generalized Pustular Psoriasis or Erythrodermic Psoriasis |
| NCT02641730 | PHASE3 | COMPLETED | An Efficacy and Safety of Guselkumab in Participants With Palmoplantar Pustulosis |
| NCT02905331 | PHASE3 | COMPLETED | Efficacy and Safety Study of Guselkumab in the Treatment of Participants With Moderate to Severe Plaque-Type Psoriasis |
| NCT02951533 | PHASE3 | COMPLETED | A Study to Compare the Efficacy of Guselkumab to Fumaric Acid Esters for the Treatment of Participants With Moderate to Severe Plaque Psoriasis |
| NCT03090100 | PHASE3 | COMPLETED | A Study to Evaluate the Comparative Efficacy of CNTO 1959 (Guselkumab) and Secukinumab for the Treatment of Moderate to Severe Plaque-type Psoriasis |
| NCT03158285 | PHASE3 | COMPLETED | A Study Evaluating the Efficacy and Safety of Guselkumab Administered Subcutaneously in Participants With Active Psoriatic Arthritis |
| NCT03162796 | PHASE3 | COMPLETED | 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) |
Clinical evidence (CIViC)
No CIViC predictive evidence (expected for non-precision-medicine drugs).
Pharmacology
Pharmacogenomics
No PharmGKB pharmacogenomic data curated for this drug.
Related molecules
Related molecules
No competitor molecules sharing a primary target (ChEMBL phase ≥2 or PubChem drug-class).