Stelara
(Ustekinumab)ApprovedMonoclonal antibody
Johnson & JohnsonUstekinumab is used to treat autoimmune diseases like psoriasis, psoriatic arthritis, Crohn's disease, and ulcerative colitis by calming down an overactive immune system.[2] Stelara is currently approved and in use across 16 indications[4].[1]
Stelara is one of 358 small molecule programs targeting Crohn's Disease. It is currently in Approved.
16
Indications
158
Total Trials
36
Active Trials
357
Competitors
3
FDA Applications
NDA/BLA/ANDA regulatory filings
Pipeline
Status by Indication[4][1]
Indication
Showing 10 of 15 indications
Competition
Competitive Landscape
127 competitors in Atopic Dermatitis
#DrugCompanyPhaseTrials
1Stelara
Johnson & JohnsonApproved
Fludara
SanofiPhase 3
Cytosar
TevaPhase 3
Adtralza
LEO PharmaPhase 3
Amlitelimab
SanofiPhase 3
DUPIXENT
RegeneronPhase 3
Certolizumab
Johnson & JohnsonPhase 3
Jaktinib
SSuzhou Zelgen Biopharmaceuticals Co.,Ltd
Phase 3
ICP-332
BBeijing InnoCare Pharma Tech Co., Ltd.
Phase 3
VC005
JJiangsu vcare pharmaceutical technology co., LTD
Phase 3
Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.
Timeline
Expected Milestones
Clinical
Trials by Indication[1]
Psoriasis36 trials
Show 33 more trials
A Study to Evaluate the Effectiveness of STELARA ™ (USTEKINUMAB) in the Treatment of Scalp Psoriasis
Unknown status·—·Phase 4·NCT01558310·30 enrolled
Crohn's Disease21 trials
Effectiveness and Safety of Ustekinumab Intensification in Crohn's Disease
Unknown status·SSecond Affiliated Hospital, School of Medicine, Zhejiang University··NCT05705856·200 enrolled
Show 18 more trials
Guselkumab Vs Ustekinumab in Stricturing Crohn's Disease
Recruiting·SSecond Affiliated Hospital, School of Medicine, Zhejiang University··NCT07444060·100 enrolled
An Open-Label, Proof of Concept Study of Vorinostat for the Treatment of Moderate-to-Severe Crohn's Disease, Ulcerative Colitis, and Chronic Granulomatous Disease Colitis Patients and Maintenance Therapy With Ustekinumab
Recruiting·NNational Institute of Allergy and Infectious Diseases (NIAID)·Preclinical·NCT03167437·35 enrolled
Ulcerative Colitis11 trials
Show 8 more trials
Psoriatic Arthritis8 trials
Show 5 more trials
Efficacy and Safety5 trials
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
Active, not recruiting·BBelgian Inflammatory Bowel Disease Research and Development (BIRD) VZW·Phase 3·NCT05299931·108 enrolled
53 more indications
Safety and Efficacy4 trials
Crohn Disease4 trials
Show 1 more trial
Loss of RESponse to Ustekinumab Treated by Dose Escalation
Completed·BBelgian Inflammatory Bowel Disease Research and Development (BIRD) VZW·Phase 3·NCT04245215·108 enrolled
Systemic Lupus Erythematosus3 trials
Observational Study3 trials
Arthritis3 trials
Atopic Dermatitis3 trials
Intravenous2 trials
Psoriasis Vulgaris2 trials
Efficacy of Ustekinumab Followed by Abatacept for the Treatment of Psoriasis Vulgaris
Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 2·NCT01999868·108 enrolled
The Difference of Microparticles in Patients With Psoriasis Vulgaris Who Received Stelara(Ustekinumab)
Unknown status·—·Phase 4·NCT02693470·100 enrolled
Acute Graft Versus Host Disease2 trials
Uveitis2 trials
Gene Polymorphism2 trials
Maintenance Therapy2 trials
Plaque Psoriasis2 trials
Monoclonal1 trial
Treatment1 trial
Impact of Concomitant MTX on Efficacy, Safety and Adherence of Ustekinumab-treatment in Patients With Active PsA
Completed·—·Phase 3·NCT03148860·186 enrolled
Inflammatory Bowel Disease1 trial
TED1 trial
Pustular Psoriasis1 trial
Sarcoidosis1 trial
Contact Dermatitis1 trial
Rheumatoid Arthritis1 trial
ART1 trial
Primary Biliary Cirrhosis1 trial
Dermatomyositis1 trial
Necrosis1 trial
Genetic Polymorphism1 trial
Ichthyosis1 trial
Fibrostenotic Crohn's Disease1 trial
Risankizumab for Fibrostenotic Crohn's Disease Treatment
Not yet recruiting·FFirst Affiliated Hospital of Wenzhou Medical University·Phase 3·NCT07177118·260 enrolled
Autoimmune Disease1 trial
Perianal Crohn's Disease1 trial
USTekinumab in Fistulising Perianal Crohn's Disease (USTAP)
Active, not recruiting·GGroupe d'Etude Therapeutique des Affections Inflammatoires Digestives·Phase 4·NCT04496063·33 enrolled
Hidradenitis Suppurativa1 trial
Ankylosing Spondylitis1 trial
Ustekinumab for the Treatment of Patients With Active Ankylosing Spondylitis
Completed·—·Phase 2·NCT01330901·22 enrolled
Moderate-to-severe Plaque Psoriasis1 trial
Ulcerative Colitis (UC)1 trial
Arthritis, Juvenile1 trial
Inflamatory Bowel Disease1 trial
Rheumatic Disease1 trial
Unspecified4 trials
Regulatory
FDA Approval Timeline[5]
Sep 25, 2009
USTEKINUMAB
BLA BLA125261
Sep 23, 2016
USTEKINUMAB
BLA BLA761044
Nov 29, 2024
YESINTEK
BLA BLA761406
Sources
References
- [1]
- [2]MedlinePlus Drug Information — Stelara drug information. U.S. National Library of Medicine, National Institutes of Health.
- [3]
- [4]Open Targets Platform — Drug–disease associations for Ustekinumab. EMBL-EBI & Wellcome Sanger Institute.
- [5]
- [6]
Details
Drug Info
Quick Facts
- Mechanism of Action
- Interleukin-12 Inhibitor; Interleukin-23 Inhibitor[3]
- Modality
- Monoclonal antibody[3]
- Highest Phase
- Approved[1]
- Company