Product Description
Sarilumab (Kevzara®), a monoclonal antibody against the interleukin-6 (IL-6) receptor, is approved in various countries, including the USA, those of the EU, and Japan, as a subcutaneous treatment administered every 2 weeks for moderately to severely active rheumatoid arthritis (RA) in adults who have responded inadequately to, or are intolerant of, one or more DMARDs (Sourced from: https://pubmed.ncbi.nlm.nih.gov/29931592/)
Mechanisms of Action: IL6 Inhibitor
Novel Mechanism: No
Modality: Antibody
Route of Administration: Subcutaneous,Intravenous
FDA Designation: None *
Approval Status: Approved
Approved Countries: Argentina | Austria | Belgium | Canada | Croatia | Czech | Denmark | Estonia | European Medicines Agency | Finland | France | Germany | Greece | Hong Kong | Hungary | Iceland | Ireland | Israel | Italy | Japan | Latvia | Lithuania | Luxembourg | Netherlands | Norway | Poland | Portugal | Russia | Saudi Arabia | Slovakia | Slovenia | Spain | Sweden | Switzerland | Taiwan | United Arab Emirates | United Kingdom | United States
Approved Indications: None
Known Adverse Events: None
Company: Sanofi
Company Location: PARIS I0 75008
Company CEO: Paul Hudson
Additonal Commercial Interests: None
Clinical Description
Countries in Clinic: Argentina, Australia, Belgium, Bulgaria, Canada, Chile, Colombia, Croatia, Czech Republic, Estonia, Finland, France, Germany, Hungary, India, Ireland, Israel, Italy, Japan, Mexico, Nepal, Netherlands, New Zealand, Pakistan, Poland, Portugal, Romania, Russia, Saudi Arabia, Serbia, Slovenia, Spain, Switzerland, United Kingdom, United States
Active Clinical Trial Count: 7
Highest Development Phases
Phase 3: COVID-19|Influenza, Human|Pneumonia
Phase 2: Arthritis, Juvenile
Phase 1: Lung Cancer
Trial |
Phase |
Trial Status |
Disease |
Primary Completion Date |
Probability of Success |
|---|---|---|---|---|---|
| DRI13926 | P2 |
Unknown Status |
Arthritis, Juvenile |
2029-02-19 |
|
| SKYPS | P2 |
Recruiting |
Arthritis, Juvenile |
2026-04-01 |
|
| REMAP-CAP | P3 |
Recruiting |
COVID-19|Influenza, Human|Pneumonia |
2026-02-01 |
|
| NCT05704634 | P1 |
Recruiting |
Lung Cancer |
2026-01-01 |