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
FDA Designation: *
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: Europe
Company CEO: Paul Hudson
Additional Commercial Interests: None
Clinical Description
Countries in Clinic: Argentina, Australia, Belgium, Bulgaria, Canada, Colombia, Croatia, Czech Republic, Estonia, Finland, France, Germany, Hungary, India, Ireland, Israel, Italy, Japan, Nepal, Netherlands, New Zealand, Pakistan, Portugal, Romania, Russia, Saudi Arabia, Serbia, Slovenia, Spain, Switzerland, United Kingdom, United States
Active Clinical Trial Count: 6
Recent & Upcoming Milestones
Highest Development Phases
Phase 3: COVID-19|Influenza, Human|Pneumonia
Phase 2: Arthritis, Juvenile
Phase 1: Lung Cancer
Trial ID |
Trial |
Phase |
Trial Status |
Disease |
Primary Completion Date |
Probability of Success |
Latest Trial Update Date |
Data Updated |
|---|---|---|---|---|---|---|---|---|
NCT05704634 |
NCI-2023-00573 | P1 |
Active, not recruiting |
Lung Cancer |
2026-01-01 |
50% |
2025-05-09 |
Primary Endpoints |
NCT02991469 |
SKYPS | P2 |
Recruiting |
Arthritis, Juvenile |
2026-04-01 |
12% |
2025-06-28 |
Primary Endpoints |
NCT02735707 |
REMAP-CAP | P3 |
Recruiting |
Pneumonia|COVID-19|Influenza, Human |
2026-02-01 |
2024-11-27 |
||
2024-512701-11-00 |
DRI13926 | P2 |
Recruiting |
Arthritis, Juvenile |
2029-02-19 |
2025-05-02 |
Treatments |
|
2020-002037-15 |
2020-002037-15 | P2 |
Active, not recruiting |
Pneumonia|COVID-19 |
2021-04-22 |
2022-03-13 |
Treatments |
|
2020-001854-23 |
AMMURAVID | P3 |
Active, not recruiting |
COVID-19 |
2020-08-27 |
2022-03-13 |
Treatments |