sarilumab
sarilumab: developed by 2 companies · 7 clinical trials tracked · 1 FDA decision.
sarilumab evidence translation
What we can confirm
1 FDA record · 7 tracked trials
What it means
What to watch
Prepared research question
What is verified about sarilumab, and what remains unknown?
Traceable citations · Unknowns marked
See linked entities and source evidence8 indications · 0 study sponsors
Related indications
Study sponsors
No additional listed-company sponsor is linked.
Development Pipeline (4)
| Company | Phase |
|---|---|
| REGENERON PHARMACEUTICALS, INC. (REGN) Systemic juvenile idiopathic arthritis (sJIA) | Phase 2 |
| Sanofi (SNY) Polymyalgia Rheumatica; Rheumatoid Arthritis | Phase 4 |
| Sanofi (SNY) | Approved |
| Sanofi (SNY) Polymyalgia Rheumatica; Rheumatoid Arthritis | Phase 4 |
Clinical Trials (7)
A Randomized Open Label, Phase 1b/2 Study to Evaluate Intravenous Administration With Long Dosing Interval Regimens of Sarilumab in Adult Participants With Rheumatoid Arthritis
Primary endpoint: Part A: Assessment of Pharmacokinetic (PK) parameters of sarilumab in serum: area under the concentration-time curve [AUClast] for IV doses
A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Each of Two Dose Levels of Sarilumab in Adults With Early Polymyalgia Rheumatica
Primary endpoint: Sustained remission at Week 52 (yes/no) in participants with early relapsing polymyalgia rheumatica (PMR) who received sarilumab 200 mg q2w with 52-week prednisone taper
A Phase 2 Study to Investigate Ubamatamab With and Without Marlotamig (REGN7075) in Treatment-Experienced Participants With Advanced/Metastatic Non-Small Cell Lung Cancer (NSCLC)
Primary endpoint: Objective response as assessed by the investigator per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
Multi-Arm Phase 2 Platform Study of Ubamatamab (REGN4018; MUC16×CD3 Bispecific Antibody) With or Without Additional Agents in Platinum-Resistant Ovarian Cancer
Primary endpoint: Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 by investigator assessment
A Phase Ib Study to Evaluate the Safety and Preliminary Efficacy of IL6-receptor Antibody Sarilumab in Combination With antiPD1 Antibody Cemiplimab for Patients With Non-small Cell Lung Cancer.
Primary endpoint: Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
A Phase 1/2 Study of REGN5668 (MUC16xCD28, a Costimulatory Bispecific Antibody) Administered in Combination With Other Agents in MUC16 + Malignancies
Primary endpoint: Incidence of Dose Limiting Toxicities (DLT)
A Phase 1/2 Study of REGN4018 (Ubamatamab), a MUC16×CD3 Bispecific Antibody, Administered Alone or in Combination With Cemiplimab in Patients With Recurrent Ovarian Cancer or Other Recurrent MUC16+ Cancers
Primary endpoint: Number of participants with Dose-limiting toxicity (DLTs) for ubamatamab monotherapy
FDA Decisions1 records
Frequently asked questions
Who is developing sarilumab?
sarilumab is being developed by REGENERON PHARMACEUTICALS, INC., Sanofi.
How many clinical trials involve sarilumab?
BioSniper tracks 7 clinical trials involving sarilumab.
What is sarilumab's latest FDA decision?
The most recent tracked FDA decision for sarilumab is Approval for 1 INDICATIONS AND USAGE KEVZARA ® is an interleukin-6 (IL-6) receptor antagonist indicated for treatment of: adult patients with moderately to severely active rheumatoid arthritis (RA) who have had an inadequate response or intolerance to one or more disease-modifying antirheumatic drugs (DMARDs). ( 1.1 ) adult patients with polymyalgia rheumatica (PMR) who have had an inadequate response to corticosteroids or who cannot tolerate corticosteroid taper. ( 1.2 ) patients who weigh 63 kg or greater , dated May 22, 2017.