sarilumab
Trade name: kevzara
mAbapprovedCOVID-19
Approved
May 22, 2017
Sarilumab, sold under the brand name Kevzara, is a human monoclonal antibody medication against the interleukin-6 receptor. Regeneron Pharmaceuticals and Sanofi developed the drug for the treatment of rheumatoid arthritis (RA), for which it received US FDA approval on 22 May 2017 and European Medicines Agency approval on 23 June 2017. — Wikipedia
Clinical trial activity
56 trials · 38 clinical orgs · 3 marketing orgs
Phase 1
14
Phase 2
35
Phase 3
20
Phase 4
3
Earliest trial started Jul 1, 2008 (NCT01055899)
Timeline
2000s
- Jan 1, 2008
Earliest Phase 1 Sponsor(trial)
2010s
- Jan 1, 2010
- Jan 1, 2010
- May 22, 2017
Sanofi — Earliest FDA Approval
- May 22, 2017
Sanofi-Synthelabo — Marketing Organization
- May 22, 2017
Sanofi — NDA Organization
- May 22, 2017
Sanofi-Aventis — NDA Secondary Org
Indications
Approved for
Studied for
- Arthritis, Juvenile · Phase 2
- Atherosclerosis · Phase 4
- Breast · Phase 1/Phase 2
- Carcinoma, Non-Small-Cell Lung · Phase 2
- Coronavirus Infections · Phase 3
- COVID-19 · Phase 3
- Dermatitis, Allergic Contact · Phase 2/Phase 3
- Giant Cell Arteritis · Phase 3
- Inflammation · Phase 2/Phase 3
- Lung Neoplasms · Phase 1
- Mastocytosis, Systemic · Phase 2
- Melanoma · Phase 2
- Neoplasm Metastasis · Phase 1/Phase 2
- Neoplasms · Phase 1/Phase 2
- Ovarian Neoplasms · Phase 2
- Pneumonia, Viral · Phase 3
- Polymyalgia Rheumatica · Phase 3
- Sarcoidosis · Phase 2
- Severe Acute Respiratory Syndrome · Phase 2
- Skin Diseases · Early Phase 1
- Spondylitis, Ankylosing · Phase 2
- Triple Negative Breast Neoplasms · Phase 1/Phase 2
- Uveitis · Phase 2
Mechanism of action
- Interleukin-6 receptor alpha subunitANTAGONIST
IL6R antagonist
- Interleukin-6INHIBITOR
IL6 inhibitor
Approval history
- approvedMay 22, 2017
Chemistry & pharmacology
- Chirality
- Single Stereoisomer
- Inorganic
- No
- Polymer
- No
- Delivery
- Parenteral
- Availability
- Prescription Only
- Multi-specific
- No
Oral
No
Parenteral
Yes
Topical
No
Black box warning
Sources
- WikipediaSarilumab ↗
- NCATSNU90V55F8I ↗
- ChEMBLCHEMBL2108730 ↗
Also known as
- kevzara
- regn88
- regn88
- regn88
- regn-88
- sar153191
- sar153191
- sar-153191
- sarilumab
- sarilumab
- sarilumab
- sarilumab
- sarilumab
- sarilumab
Clinical trials
| NCT ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT07154290 | Phase 2 | Jan 26, 2026 | Regeneron |
| NCT07286214 | Phase 4 | Jan 19, 2026 | Regeneron, Sanofi |
| NCT06787612 | Phase 2 | May 1, 2025 | Regeneron |
| NCT05704634 | Phase 1 | Aug 18, 2023 | Regeneron, University of Texas at Houston |
| NCT05428007 | Phase 2 | Dec 1, 2022 | New York University |
| NCT05535738 | Phase 2/Phase 3 (Phase 3) | Sep 15, 2022 | University of Massachusetts |
| NCT04842981 | Phase 1/Phase 2 (Phase 2) | May 25, 2021 | Hospital of South West Jutland, King Christian X´Hospital for Rheumatic Diseases, Region Syddanmark, University of Southern Denmark |
| NCT04333706 | Phase 1/Phase 2 (Phase 2) | Jun 30, 2020 | National Institutes of Health (NIH), University of Florida |
| NCT04386239 | Early Phase 1 (Phase 1) | May 31, 2020 | Government of Italy, University of Milan |
| NCT07196306 | Phase 2 | May 7, 2020 | BayCare Health System |
| NCT04321993 | Phase 2 | Apr 30, 2020 | Dalhousie University, Government of Canada, Government of Nova Scotia |
| NCT04350216 | Phase 4 | Apr 30, 2020 | hospital universitario marques Valdecilla, University of Cantabria |
| NCT04357860 | Phase 2 | Apr 27, 2020 | Government of Spain, Hospital Universitario Reina Sofía, Universidad de Cordoba |
| NCT04661527 | Phase 2 | Apr 22, 2020 | Clinica Universidad de Navarra, Hospital Universitario Infanta Leonor, Sanofi |
| NCT04345289 | Phase 3 | Apr 20, 2020 | University of Copenhagen |
| NCT04357808 | Phase 2 | Apr 13, 2020 | Universidad Autonoma de Madrid, Universitario de la Princesa |
| NCT04341870 | Phase 2/Phase 3 (Phase 3) | Apr 11, 2020 | Assistance Publique - Hôpitaux de Paris |
| NCT04359901 | Phase 2 | Apr 10, 2020 | Department of Veteran Affairs |
| NCT04322773 | Phase 2 | Apr 5, 2020 | The Parker Institute, University of Copenhagen |
| NCT04327388 | Phase 2/Phase 3 (Phase 3) | Mar 29, 2020 | Regeneron, Sanofi |
Showing 20 of 56 trials
Page 1 / 3
Organizations
Research & Development (38)
| Organization | Org type | Trials | As lead sponsor | Phases | Earliest year |
|---|---|---|---|---|---|
| Regeneron | For profit | 32 | 7 | 4 | 2008 |
| Sanofi | For profit | 32 | 26 | 4 | 2008 |
| Assistance Publique - Hôpitaux de Paris | Academic/Hospital | 2 | 2 | 1 | 2020 |
| Stanford University | Academic/Hospital | 2 | 1 | 2 | 2010 |
| University of Copenhagen | Academic/Hospital | 2 | 2 | 2 | 2020 |
| BayCare Health System | Academic/Hospital | 1 | 1 | 1 | 2020 |
| Clinica Universidad de Navarra | Academic/Hospital | 1 | 1 | 1 | 2020 |
| Dalhousie University | Academic/Hospital | 1 | 0 | 1 | 2020 |
| Department of Veteran Affairs | Government | 1 | 1 | 1 | 2020 |
| Gaylis, Norman B., M.D. | Academic/Hospital | 1 | 1 | 1 | 2018 |
| GlaxoSmithKline | For profit | 1 | 1 | 1 | 2019 |
| Government of Canada | Government | 1 | 0 | 1 | 2020 |
| Government of Italy | Government | 1 | 1 | 1 | 2020 |
| Government of Nova Scotia | Government | 1 | 1 | 1 | 2020 |
| Government of Spain | Government | 1 | 0 | 1 | 2020 |
| Harvard University | Academic/Hospital | 1 | 1 | 1 | 2018 |
| Hospital of South West Jutland | Academic/Hospital | 1 | 0 | 1 | 2021 |
| Hospital Universitario Infanta Leonor | Academic/Hospital | 1 | 0 | 1 | 2020 |
| hospital universitario marques Valdecilla | Academic/Hospital | 1 | 0 | 1 | 2020 |
| Hospital Universitario Reina Sofía | Academic/Hospital | 1 | 0 | 1 | 2020 |
38 organizations
Page 1 / 2
Marketing (3)
| Organization | Org type | Relationship | Date |
|---|---|---|---|
| Sanofi | For profit | NDA | May 22, 2017 |
| Sanofi-Aventis | For profit | NDA2 | May 22, 2017 |
| Sanofi-Synthelabo | For profit | MKTG | May 22, 2017 |