Product Description
Ustekinumab injection is used to treat moderate to severe plaque psoriasis (skin disease in which red, scaly patches form on some areas of the body) in adults and children 6 years or older who may benefit from medications or phototherapy (a treatment that involves exposing the skin to ultraviolet light). It is also used alone or in combination with methotrexate (Otrexup, Rasuvo, Trexall) to treat psoriatic arthritis (a condition that causes joint pain and swelling and scales on the skin) in adults. Ustekinumab injection is also used to treat Crohn's disease (a condition in which the body attacks the lining of the digestive tract, causing pain, diarrhea, weight loss, and fever) in adults. Ustekinumab injection is also used to treat ulcerative colitis (a condition which causes swelling and sores in the lining of the colon [large intestine] and rectum) in adults. Ustekinumab injection is in a class of medications called monoclonal antibodies. It works by stopping the action of certain cells in the body that cause the symptoms of plaque psoriasis, psoriatic arthritis, Crohn's disease, and ulcerative colitis. (Sourced from: https://medlineplus.gov/druginfo/meds/a611013.html)
Mechanisms of Action: IL12 Inhibitor, IL23 Inhibitor
Novel Mechanism: No
Modality: Antibody
Route of Administration: Subcutaneous, Intravenous
FDA Designation: *
Approval Status: Approved
Approved Countries: Argentina | Australia | Austria | Belgium | Brazil | Canada | Chile | Colombia | Croatia | Cyprus | Czech | Denmark | Dominican Republic | Ecuador | Egypt | Estonia | European Medicines Agency | Finland | France | Germany | Greece | Hong Kong | Hungary | Iceland | Indonesia | Ireland | Israel | Italy | Japan | Jordan | Korea | Latvia | Lebanon | Lithuania | Luxembourg | Malaysia | Mexico | Netherlands | New Zealand | Norway | Peru | Philippines | Poland | Portugal | Romania | Russia | Saudi Arabia | Serbia | Singapore | Slovakia | Slovenia | South Africa | Spain | Sweden | Switzerland | Taiwan | Thailand | Tunisia | Turkey | Ukraine | United Arab Emirates | United Kingdom | United States | Uruguay | Venezuela | Vietnam
Approved Indications: None
Known Adverse Events: None
Company: Johnson & Johnson
Company Location: Eastern America
Company CEO: Joaquin Duato
Additional Commercial Interests: None
Clinical Description
Countries in Clinic: Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, China, Croatia, Czech Republic, Denmark, France, Georgia, Germany, Hungary, India, Israel, Italy, Japan, Latvia, Lithuania, Mexico, Netherlands, Poland, Romania, Russia, Serbia, Slovakia, South Korea, Spain, Switzerland, Ukraine, United Kingdom, United States, Unknown Location
Active Clinical Trial Count: 35
Recent & Upcoming Milestones
- The PDUFA target action date for AVT04 by Alvotech is likely in February 2025, pending a satisfactory FDA inspection.
Highest Development Phases
Phase 3: Arthritis, Juvenile|Arthritis, Psoriatic|Colitis, Ulcerative|Crohn Disease|Lupus Erythematosus, Systemic|Pouchitis|Psoriasis|Takayasu Arteritis|Type 1 Diabetes
Phase 2: Colitis|Diarrhea
Phase 1: Healthy Volunteers|Ichthyosis, Lamellar
Trial ID |
Trial |
Phase |
Trial Status |
Disease |
Primary Completion Date |
Probability of Success |
Latest Trial Update Date |
Data Updated |
|---|---|---|---|---|---|---|---|---|
NCT06738277 |
Biosimilar Ustekinumab | P1 |
Completed |
Psoriasis |
2025-07-12 |
50% |
2025-08-20 |
Primary Endpoints |
NCT04549792 |
NCT04549792 | P1 |
Completed |
Ichthyosis, Lamellar |
2024-01-12 |
12% |
2024-07-11 |
Primary Endpoints|Study Completion Date|Treatments|Trial Status |
NCT06807593 |
NCI-2025-00795 | P2 |
Not yet recruiting |
Colitis|Diarrhea |
2027-03-31 |
12% |
2025-10-08 |
Primary Completion Date|Primary Endpoints|Start Date|Study Completion Date|Treatments |
NCT05092269 |
UNITED | P3 |
Recruiting |
Crohn Disease|Colitis, Ulcerative|Arthritis, Psoriatic |
2027-09-29 |
53% |
2024-02-29 |
Primary Endpoints|Study Completion Date |
NCT05083182 |
PSUMMIT-Jr | P3 |
Active, not recruiting |
Arthritis, Juvenile |
2026-12-10 |
45% |
2025-12-20 |
Primary Endpoints|Trial Status |
NCT05299931 |
REScUE-OLE | P3 |
Active, not recruiting |
Crohn Disease |
2026-06-01 |
82% |
2025-02-06 |
Primary Completion Date|Primary Endpoints|Study Completion Date|Treatments |
NCT03941132 |
UST1D2 | P3 |
Active, not recruiting |
Type 1 Diabetes |
2026-02-01 |
68% |
2025-02-26 |
Primary Completion Date|Primary Endpoints|Treatments|Trial Status |
jRCT2041200098 |
jRCT2041200098 | P3 |
Recruiting |
Colitis, Ulcerative |
2025-07-31 |
|||
jRCT2061210007 |
jRCT2061210007 | P3 |
Active, not recruiting |
Takayasu Arteritis |
2025-06-11 |
|||
JapicCTI-183973 |
JapicCTI-183973 | P3 |
Active |
Lupus Erythematosus, Systemic |
2023-06-23 |
|||
2019-003151-11 |
SOCRATES study | P3 |
Active, not recruiting |
Pouchitis |
2022-05-08 |
|||
2023-504978-38-00 |
CNTO1275CRD3004 | P3 |
Completed |
Crohn Disease |
2025-03-03 |
92% |
2025-05-02 |
Treatments |
NCT04673357 |
UNITI Jr | P3 |
Completed |
Crohn Disease |
2024-11-28 |
92% |
2025-04-26 |
Primary Completion Date|Primary Endpoints|Study Completion Date|Trial Status |
NCT04245215 |
REScUE | P3 |
Completed |
Crohn Disease |
2024-09-25 |
53% |
2024-10-02 |
|
NCT06274554 |
FUN-CD | P3 |
Recruiting |
Crohn Disease |
2028-12-01 |
2024-11-01 |
Primary Endpoints|Start Date|Treatments|Trial Status |
|
2022-501067-40-00 |
CNTO1275ISD3001 | P3 |
Recruiting |
Colitis, Ulcerative|Crohn Disease|Arthritis, Juvenile|Arthritis, Psoriatic |
2027-12-15 |
2025-05-02 |
Treatments |
|
NCT05252533 |
U-POPS | P1 |
Completed |
Arthritis, Psoriatic|Arthritis, Juvenile|Psoriasis |
2024-01-26 |
53% |
2024-03-02 |
Primary Completion Date|Primary Endpoints|Study Completion Date|Treatments|Trial Status |
NCT05890118 |
RT-111-001 | P1 |
Completed |
Healthy Volunteers |
2023-11-28 |
69% |
2024-01-12 |
|
2023-507144-36-00 |
CNTO1275JPA3001 | P3 |
Recruiting |
Arthritis, Psoriatic|Arthritis, Juvenile |
2027-08-09 |
2025-05-02 |
Treatments |
|
2024-512756-38-00 |
1425-0003 | P2 |
Completed |
Crohn Disease |
2024-08-08 |
2025-05-02 |
Treatments |
|
2020-005503-40 |
PSUMMIT-Jr | P3 |
Active, not recruiting |
Arthritis, Psoriatic|Arthritis, Juvenile |
2027-05-25 |
45% |
2025-05-06 |
Treatments |
jRCT2031200345 |
jRCT2031200345 | P3 |
Recruiting |
Crohn Disease |
2025-07-31 |
|||
2023-504977-19-00 |
CNTO1275PUC3001 | P3 |
Active, not recruiting |
Colitis, Ulcerative |
2025-06-01 |
93% |
2025-05-02 |
Treatments |
NCT04630028 |
UNIFI Jr | P3 |
Completed |
Colitis, Ulcerative |
2025-05-08 |
93% |
2025-07-19 |
Primary Endpoints |
NCT06488664 |
UKM-PS-III | P3 |
Active, not recruiting |
Psoriasis |
2025-04-30 |
99% |
2025-07-31 |
Recent News Events
Date |
Type |
Title |
|---|---|---|
|
01/20/2026 |
News Article |
Biologics and Cross-Border Trade Drive the Next Phase of Growth in Cold Chain Pharmaceuticals Market |
|
01/06/2026 |
News Article |
Fresenius Kabi Introduces New Presentation of Otulfi® (ustekinumab-aauz), a Biosimilar to Stelara® |
|
01/05/2026 |
News Article |
CivicaScript announces availability of low-cost insulin and biosimilar for chronic inflammatory conditions in the US |
|
01/05/2026 |
News Article |
Accord BioPharma's HERCESSI™ (trastuzumab-strf) Gains Preferred Status on Express Scripts National Commercial Formularies |