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 Founding Year: 1886
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: 34
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 |
Diarrhea|Colitis |
2027-03-31 |
12% |
2025-10-08 |
Primary Completion Date|Primary Endpoints|Start Date|Study Completion Date|Treatments |
NCT05092269 |
UNITED | P3 |
Recruiting |
Arthritis, Psoriatic|Crohn Disease|Colitis, Ulcerative |
2027-09-29 |
52% |
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 |
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 |
|||
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 |
|
CTR20200092 |
CTR20200092 | P3 |
Completed |
Crohn Disease |
2023-10-02 |
2025-04-29 |
Patient Enrollment|Primary Completion Date|Study Completion 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 |
|
2023-507144-36-00 |
CNTO1275JPA3001 | P3 |
Recruiting |
Arthritis, Juvenile|Arthritis, Psoriatic |
2027-08-09 |
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 |
jRCT2041200098 |
jRCT2041200098 | P3 |
Recruiting |
Colitis, Ulcerative |
2025-07-31 |
|||
NCT05252533 |
U-POPS | P1 |
Completed |
Psoriasis|Arthritis, Psoriatic|Arthritis, Juvenile |
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 |
|
jRCT2031200345 |
jRCT2031200345 | P3 |
Recruiting |
Crohn Disease |
2025-07-31 |
|||
2024-512756-38-00 |
1425-0003 | P2 |
Completed |
Crohn Disease |
2024-08-08 |
2025-05-02 |
Treatments |
|
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 |
|
2023-504978-38-00 |
CNTO1275CRD3004 | P3 |
Completed |
Crohn Disease |
2025-03-03 |
92% |
2025-05-02 |
Treatments |
Recent News Events
Date |
Type |
Title |
|---|---|---|
|
02/10/2026 |
News Article |
Santa Ana Bio Announces the Appointment of Newman Yeilding as Chief Medical Officer |
|
02/05/2026 |
News Article |
Alvotech Announces Positive Top-Line Results from Pivotal Pharmacokinetic Study for Proposed Biosimilar to Entyvio® |
|
02/02/2026 |
News Article |
Alvotech enters supply and commercialization agreements for Canada and Australia & New Zealand covering multiple biosimilar candidates |
|
01/26/2026 |
News Article |
Samsung Epis Holdings Reports Fourth Quarter and Fiscal Year 2025 Financial Results |