Product Description
Etanercept is used alone or with other medications to relieve the symptoms of certain autoimmune disorders (conditions in which the immune system attacks healthy parts of the body and causes pain, swelling, and damage). Etanercept is in a class of medications called tumor-necrosis factor (TNF) inhibitors. It works by blocking the action of TNF, a substance in the body that causes inflammation. Etanercept injection comes as a solution (liquid) in a prefilled syringe and an automatic injection device, and as a powder to be mixed with a provided liquid. Etanercept is injected subcutaneously (under the skin). It is usually injected once a week.
Mechanisms of Action: TNF Inhibitor
Novel Mechanism: No
Modality: Fusion Protein
Route of Administration: Subcutaneous
FDA Designation: *
Approval Status: Approved
Approved Countries: Algeria | Argentina | Australia | Austria | Belgium | Bosnia | Brazil | Canada | Chile | China | Colombia | Croatia | Cyprus | Czech | Denmark | Dominican Republic | Ecuador | Egypt | Estonia | European Medicines Agency | Finland | France | Germany | Greece | Hong Kong | Hungary | Iceland | India | Indonesia | Ireland | Israel | Italy | Japan | Jordan | Korea | Latvia | Lebanon | Lithuania | Luxembourg | Malaysia | Mexico | Morocco | Netherlands | New Zealand | Norway | Pakistan | 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: Amgen
Company Location: Western America
Company CEO:
Additional Commercial Interests: Pfizer
Clinical Description
Countries in Clinic: Australia, Bulgaria, China, Hungary, Italy, Moldova, Netherlands, Poland, Romania
Active Clinical Trial Count: 8
Recent & Upcoming Milestones
Highest Development Phases
Phase 3: Acute Respiratory Distress Syndrome|Arthritis, Juvenile|Arthritis, Rheumatoid
Phase 2: Colorectal Cancer|Liver Cancer|Type 2 Diabetes
Phase 1: Autoimmune Disease Unspecified|Healthy Volunteers|Spondylitis, Ankylosing
Trial ID |
Trial |
Phase |
Trial Status |
Disease |
Primary Completion Date |
Probability of Success |
Latest Trial Update Date |
Data Updated |
|---|---|---|---|---|---|---|---|---|
NCT06392074 |
MB04-A-01-23 | P1 |
Completed |
Autoimmune Disease Unspecified|Healthy Volunteers |
2025-05-12 |
50% |
2025-10-01 |
|
NCT03728478 |
STARS | P3 |
Recruiting |
Arthritis, Juvenile|Arthritis, Rheumatoid |
2025-02-28 |
23% |
2024-10-16 |
Primary Endpoints |
2012-001145-40 |
2012-001145-40 | P3 |
Completed |
Arthritis, Juvenile|Acute Respiratory Distress Syndrome|Arthritis, Rheumatoid |
2024-11-17 |
2025-06-30 |
Primary Completion Date|Start Date|Study Completion Date|Treatments|Trial Status |
|
ACTRN12617001268336p |
2006-7041-83/hah | P2 |
Not yet recruiting |
Liver Cancer|Colorectal Cancer |
2019-11-10 |
|||
NCT06160544 |
2023TXI01 | P2 |
Not yet recruiting |
Type 2 Diabetes |
2026-01-01 |
50% |
2023-12-08 |
|
NCT06596772 |
MB04-C-01-23 | P3 |
Recruiting |
Arthritis, Rheumatoid |
2025-10-01 |
34% |
2024-09-20 |
Primary Endpoints|Treatments |
CTR20150555 |
CTR20150555 | P1 |
Active, not recruiting |
Spondylitis, Ankylosing |
None |
2025-04-29 |
Patient Enrollment|Treatments |
|
2024-510826-16-00 |
MB04-C-01-23 | P3 |
Active, not recruiting |
Arthritis, Rheumatoid |
2025-04-15 |
2025-05-02 |
Treatments |
Recent News Events
Date |
Type |
Title |
|---|---|---|
|
01/12/2026 |
News Article |
Kiniksa Pharmaceuticals Provides Corporate Update |
|
12/11/2025 |
News Article |
Fusion Proteins Market to Hit $64.9 Billion by 2030 |
|
11/04/2025 |
News Article |
BOSTON ONCOLOGY ARABIA and LOCAL CONTENT & GOVERNMENT PROCUREMENT AUTHORITY Sign Agreement to Localize Advanced Biologic Medicines in Saudi Arabia |
|
10/24/2025 |
News Article |
Spyre Therapeutics Announces Poster Presentations at American College of Rheumatology (ACR) Convergence 2025 |