Data updated: May 26, 2026
STELARA (ustekinumab)
Interleukin-12 Antagonists Genetically Validated
Trial Activity: Stable 27 active trials
Immunology
Approved 2009-09-25
STELARA is indicated for the treatment of Plaque Psoriasis; Psoriatic Arthritis; Crohn Disease; Ulcerative Colitis.
How STELARA Works
Ustekinumab is a monoclonal antibody that binds specifically to the p40 protein subunit shared by the IL-12 and IL-23 cytokines. By targeting this subunit, the drug prevents these cytokines from interacting with the IL-12Rβ1 cell-surface receptor. This disruption inhibits the signaling and cytokine cascades involved in inflammatory and immune responses, such as natural killer cell activation and T-cell differentiation.
Development Insights
Janssen Research & Development, LLC conducting 15 trials (16%)
47 indications explored (Broad Platform)
→ psoriasis (23 trials)
→ crohn disease (16 trials)
→ crohn's disease (7 trials)
11
Indications
--
Phase 3 Trials
16
Years on Market
Details
- Status
- Prescription
- First Approved
- 2009-09-25
- Patent Cliff
- 2023
- Revenue
- $1.4B (Q4-2025)
- Routes
- INJECTION
- Dosage Forms
- INJECTABLE
STELARA Approval History
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
74 FDA actions from 2009 to 2026 · 7 indication expansions
What STELARA Treats
4 indicationsSTELARA is approved for 4 conditions since its original approval in 2009. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Plaque Psoriasis
- Psoriatic Arthritis
- Crohn Disease
- Ulcerative Colitis
Source: FDA Label
STELARA Target & Pathway
ProTarget
STELARA 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 STELARA's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications STELARA 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 STELARA
3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
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Clinical Trial Registry
85 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT05092269 UNITED | CR109074 CNTO1275ISD3001, 2020-004457-76 | Ph 3 | active not recruiting | A Long-term Extension Study of Ustekinumab in Pediatric Participants |
| NCT06425549 BE TOGETHER | PS0021 U1111-1293-2383, 2023-503859-10-00 | Ph 3 | recruiting | A Study to Evaluate the Efficacy and Safety of Bimekizumab Compared to Ustekinumab in Children and Adolescents From 6 Years to Less Than 18 Years of Age With Moderate to Severe Plaque Psoriasis |
| 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 |
| NCT07116967 | IM011-1130 U1111-1291-5815, 2023-503766-24 | Ph 3 | recruiting | Long-Term Safety Study of Deucravacitinib Versus Ustekinumab in Participants With Psoriasis (PRAGMATYK) |
| NCT03167437 | 170101 17-I-0101 | Ph 1, Ph 2 | recruiting | An Open-Label, Proof of Consent Study of Vorinostat for the Treatment of Mdoerate-to-Severe Crohn s Disease and Maintenance Therapy With Ustekinumab |
| NCT03370133 BE VIVID results posted | PS0009 2016-003425-42 | Ph 3 | completed | A Study to Evaluate the Efficacy and Safety of Bimekizumab Compared to Placebo and an Active Comparator in Adult Subjects With Moderate to Severe Chronic Plaque Psoriasis |
| NCT04524611 SEQUENCE | M20-259 2020-002674-26, 2022-501645-70-00 | Ph 3 | active not recruiting | Study Comparing Intravenous (IV)/Subcutaneous (SC) Risankizumab to IV/SC Ustekinumab to Assess Change in Crohn's Disease Activity Index (CDAI) in Adult Participants With Moderate to Severe Crohn's Disease (CD) |
| 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 |
| NCT06934226 ICONIC-ASCEND | 77242113PSO3006 77242113PSO3006, 2024-515706-77-00 | Ph 3 | active not recruiting | A Study to Assess Efficacy and Safety of JNJ-77242113 Compared to Placebo and Ustekinumab in Participants With Moderate to Severe Plaque Psoriasis |
| NCT04245215 REScUE results posted | BIRD2018001 | Ph 3 | completed | Loss of RESponse to Ustekinumab Treated by Dose Escalation |
| NCT05270733 | STUDY20220893 | Ph 4 | recruiting | Development of Predictive Psoriasis Response Endotypes Using Single Cell Transcriptomics |
| NCT06045754 | Vedolizumab-4051 MACS-2022-120102, EXPLORER 2.0 | Ph 4 | recruiting | A Study of Vedolizumab Intravenous (IV) and Adalimumab or Vedolizumab and Ustekinumab in Adults With Crohn's Disease |
| NCT06807593 | 2024-0417 NCI-2025-00795 | Ph 2 | recruiting | Treatment of Immune Checkpoint Inhibitor-related Diarrhea and/ or Colitis With Ustekinumab in Cancer Patients |
| NCT06520397 | 2024ZSLYEC-070 | Ph 4 | recruiting | Efficacy and Safety of Dual-targeted Therapy With Upadacitinib and Ustekinumab Versus Intensified Ustekinumab Therapy in Crohn's Disease |
| NCT07352566 | 25-43621 | Ph 4 | not yet recruiting | Utilization of a Microdevice for Psoriasis and Atopic Dermatitis |
| NCT04572815 | RG1005588 NCI-2020-02617, 10421 | Ph 2 | active not recruiting | Ustekinumab for the Prevention of Acute Graft-versus-Host Disease After Unrelated Donor Hematopoietic Cell Transplant |
| NCT07268534 BOOSTERS | APHP230831 2024-514848-88-00 | Ph 2 | not yet recruiting | Biologics in Folliculitis Decalvans : an Adaptative Trial Research |
| NCT04673357 UNITI Jr | CR108864 CNTO1275CRD3004, 2019-004225-24 | Ph 3 | completed | A Study of Ustekinumab in Pediatric Participants With Moderately to Severely Active Crohn's Disease |
| NCT03651518 PIMOC | P160906J 2017-000519-18 | Ph 2 | completed | Personalized Therapies in Inflammatory Complex Disease |
| NCT05535738 | STUDY00000321 | Ph 2, Ph 3 | active not recruiting | Using a Contact Dermatitis Model With Biologic Medications to Study Skin Inflammation |
| NCT04632927 AgAIN results posted | CAIN457FDE04 2019-004246-15 | Ph 3 | completed | Efficacy of Secukinumab Compared to Ustekinumab in Adults With Active Psoriatic Arthritis and Failure of TNFα-Inhibitor Treatment |
| NCT05029921 | CR109023 CNTO1275CRD4030 | Ph 4 | completed | A Study of Ustekinumab (STELARA) in Chinese Participants With Moderately to Severely Active Crohn's Disease |
| NCT07177118 | Risankizumab | Ph 3 | not yet recruiting | Risankizumab for Fibrostenotic Crohn's Disease Treatment |
| NCT05335356 STELLAR-2 results posted | BM12H-PSO-03-G-02 | Ph 3 | completed | Comparing Efficacy and Safety of Bmab 1200 and Stelara in Patients With Moderate to Severe Chronic Plaque Psoriasis |
| NCT04978493 results posted | 1425-0003 2020-004527-16 | Ph 2 | terminated | A Study to Test Whether BI 706321 Combined With Ustekinumab Helps People With Crohn's Disease |
| NCT07138898 | 25-00380 | Ph 2 | not yet recruiting | Immunosuppressant Management in Rheumatology Patients Undergoing Elective Total Shoulder Arthroplasty |
| NCT04435600 OptIMMize-1 results posted | M19-977 2023-504156-10-00 | Ph 3 | completed | A Study of Subcutaneous Risankizumab Injection for Pediatric Participants With Moderate to Severe Plaque Psoriasis to Assess Change in Disease Symptoms |
| NCT06453317 COMBO-UC | Combo/2022/3 2023-506452-25 | Ph 2 | recruiting | Comparison of Ustekinumab, Infliximab and Combination Therapy in Moderately to Severely Active Ulcerative Colitis |
| NCT04882072 results posted | CR108981 CNTO1275TAT3001 | Ph 3 | terminated | A Study of Ustekinumab in Participants With Takayasu Arteritis (TAK) |
| NCT03107793 STARDUST results posted | CR108276 2016-002918-43, CNTO1275CRD3005 | Ph 3 | completed | Study of Treat to Target Versus Routine Care Maintenance Strategies in Crohn's Disease Patients Treated With Ustekinumab |
| NCT02877134 TRIDENT results posted | CR108136 64304500CRD2001, 2016-000634-21 | Ph 2 | completed | Safety and Efficacy Study of JNJ-64304500 in Participants With Moderately to Severely Active Crohn's Disease |
| NCT05252533 U-POPS | CR109159 CNTO1275ISD1001 | Ph 1 | completed | A Study of Ustekinumab in Pediatric Participants (U-POPS) With Juvenile Psoriatic Arthritis or Psoriasis |
| NCT02968108 STELARA | CR108233 CNTO1275CRD1001, 2016-001956-22 | Ph 1 | completed | A Pharmacokinetic Study of Ustekinumab in Pediatric Subjects With Moderately to Severely Active Crohn's Disease |
| NCT04655807 DUET | CR108898 2020-002701-26, 64304500CRD2002 | Ph 2 | withdrawn | A Study of JNJ-64304500 as Add-on Therapy in Participants With Active Crohn's Disease |
| NCT04816513 | CR108948 CNTO1275EDI1001 | Ph 1 | completed | A Study to Assess the Bioequivalence of Ustekinumab by Two Different Injection Devices in Healthy Participants |
| NCT04305327 EMBRACE 1 results posted | LP0160-1396 2019-001868-30, U1111-1282-4459 | Ph 3 | terminated | Efficacy and Safety of Brodalumab in Adolescents From 12 to 17 Years of Age With Moderate-to-severe Plaque Psoriasis |
| NCT03941132 UST1D2 | H19-00411 | Ph 2, Ph 3 | active not recruiting | Clinical Phase II/III Trial of Ustekinumab to Treat Type 1 Diabetes (UST1D2) |
| NCT05299931 REScUE-OLE | BIRD2020001 | Ph 3 | active not recruiting | An Open-Label Extension and Long-term Efficacy and Safety Monitoring Study of Patients with Crohn's Disease Previously Included in the Loss of RESponse to Ustekinumab Treated by Dose Escalation Study |
| 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) |
| NCT05725876 VIDEO | 83371 | Ph 1 | recruiting | Quantitative Fluorescence Molecular Imaging of Ustekinumab-800CW to Elucidate the Drug Distribution Throughout Inflamed Tissue in Crohn's Disease and Psoriasis. |
| NCT03926130 VIVID-1 results posted | 16590 I6T-MC-AMAM, 2018-004614-18 | Ph 3 | completed | A Study of Mirikizumab (LY3074828) in Participants With Crohn's Disease |
| NCT04607980 results posted | 20190232 2020-003184-25 | Ph 3 | completed | A Study to Investigate ABP 654 for the Treatment of Participants With Moderate to Severe Plaque Psoriasis |
| NCT04089345 SOCRATES | CNTO1275UCO2001 | Ph 3 | completed | Stelara fOr ChRonic AntibioTic rEfractory pouchitiS |
| NCT03629379 STRAUSS | S61472 | Ph 4 | completed | Response to Ustekinumab for Anti-tnf Induced Psoriasiform Skin Lesions |
| NCT04629196 results posted | 19-01401 | Ph 4 | terminated | Induction Optimization With Stelara for Crohn's Disease |
| NCT03366142 | 180022 18-I-0022 | Ph 1, Ph 2 | completed | Ustekinumab (Anti-IL-12/23p40 Monoclonal Antibody) in Patients With Leukocyte Adhesion Deficiency Type 1 (LAD1) Who Have Inflammatory Pathology |
| NCT04496063 USTAP | GT-2019-01 | Ph 4 | active not recruiting | USTekinumab in Fistulising Perianal Crohn's Disease (USTAP) |
| NCT04093531 results posted | Ustekinumab for PSS | Ph 1 | completed | Pilot Trial of Ustekinumab for Primary Sjögren's Syndrome |
| NCT01704534 HiTS | 662507 2011-002091-16 | Ph 2 | completed | A Proof of Concept Study to Evaluate the Effectiveness of Ustekinumab in Hidradenitis Suppurativa |
| NCT04785326 Opportuniti results posted | DMB-3115-2 | Ph 3 | completed | Efficacy, Safety, and Immunogenicity of Subcutaneous DMB-3115 Versus Stelara® in Patients With Moderate to Severe Chronic Plaque Psoriasis |
Showing 50 of 85 trials
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Ongoing clinical trials by development phase
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Pro Key Completed Trials
Completed studies with published results, ranked by significance
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Trial Timeline
Full development history with FDA approval milestones
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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.
STELARA FDA Label Details
Indications & Usage
FDA Label (PDF)STELARA is indicated for the treatment of Plaque Psoriasis; Psoriatic Arthritis; Crohn Disease; Ulcerative Colitis.
Pro Intelligence Preview
Deep insights for STELARA
Revenue Insights
- • Q4-2025: $1.4B
- • Historical trend analysis
Patent Timeline
- • Cliff: 2023
- • Generic/biosimilar risk
Trial Analysis
- • 96 total trials
- • Stage: Stable
Competitive Landscape
- • 20 similar drugs
- • Same target/indication analysis
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Full approval history • All patents • Revenue trends • Competitor analysis
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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