Sarilumab
drug drugOn this page
Also known as KevzaraREG-N88REGN-88REGN88SAR-153191SAR153191
Summary
Sarilumab (CHEMBL2108730) is an approved antibody (ATC L04AC14) targeting IL6R; indicated across 18 conditions including rheumatoid arthritis and immune system disorder.
At a glance
- Status: Approved (max clinical phase 4)
- Modality: Antibody
- ATC class: L04AC14
- Targets: 1 (IL6R)
- Indications: 18 conditions
- Clinical trials: 56
Identifiers
Drug identity and classification
| Field | Value |
|---|---|
| ChEMBL ID | CHEMBL2108730 |
| Name | Sarilumab |
| Type | Antibody |
| Max phase | 4 |
| ATC | L04AC14 |
Also known as: Kevzara, REG-N88, REGN-88, REGN88, SAR-153191, SAR153191, Sarilumab, SARILUMAB
Targets
Targets
Primary targets (GtoPdb curated mechanism): the Cancer dependency column is the DepMap CRISPR fitness signal (% of screened cell lines dependent on the target).
| Gene | Target | Action | pAffinity | Cancer dependency | UniProt |
|---|---|---|---|---|---|
| IL6R | Interleukin-6 receptor, α subunit | Binding | 11.05 | 0.9% | P08887 |
Bioactivity
No ChEMBL bioactivity rows at pChembl ≥ 5 (expected for biologics / antibodies).
Target pathways
Aggregated over 1 target gene(s): IL6R.
Top Reactome pathways
7 total, by targets touching each:
| Pathway | Targets | Genes |
|---|---|---|
| Interleukin-6 signaling | 1 | IL6R |
| MAPK3 (ERK1) activation | 1 | IL6R |
| MAPK1 (ERK2) activation | 1 | IL6R |
| Interleukin-4 and Interleukin-13 signaling | 1 | IL6R |
| Transcriptional regulation of granulopoiesis | 1 | IL6R |
| Potential therapeutics for SARS | 1 | IL6R |
| Activation of STAT3 by cadherin engagement | 1 | IL6R |
Dominant GO biological processes
| GO term | Targets |
|---|---|
| hepatic immune response | 1 |
| neutrophil mediated immunity | 1 |
| monocyte chemotaxis | 1 |
| positive regulation of leukocyte chemotaxis | 1 |
| acute-phase response | 1 |
| positive regulation of cell population proliferation | 1 |
| vascular endothelial growth factor production | 1 |
| cytokine-mediated signaling pathway | 1 |
| endocrine pancreas development | 1 |
| negative regulation of interleukin-8 production | 1 |
| positive regulation of chemokine production | 1 |
| positive regulation of interleukin-6 production | 1 |
| negative regulation of collagen biosynthetic process | 1 |
| response to cytokine | 1 |
| positive regulation of MAPK cascade | 1 |
Indications & clinical
Indications
2 approved indications. FDA phase 4, plus an anticancer drug’s labelled cancer uses (which ChEMBL often logs at phase 3).
| Indication | Phase | MONDO | EFO |
|---|---|---|---|
| rheumatoid arthritis | 4 | MONDO:0008383 | EFO:0000685 |
| immune system disorder | 4 | MONDO:0005046 | EFO:0000540 |
13 diseases in clinical trials (phase 1–3, investigational — not approved indications). Highest ChEMBL trial phase per disease; a non-cancer approved use is occasionally logged at phase 3 here.
| Disease (in trials) | Phase | MONDO | EFO |
|---|---|---|---|
| polymyalgia rheumatica | 3 | MONDO:0019735 | EFO:0008518 |
| severe acute respiratory syndrome | 3 | MONDO:0005091 | EFO:0000694 |
| temporal arteritis | 3 | MONDO:0008538 | EFO:1001209 |
| pneumonia | 3 | MONDO:0005249 | EFO:0003106 |
| influenza | 3 | MONDO:0005812 | EFO:0007328 |
| ankylosing spondylitis | 2 | MONDO:0005306 | EFO:0003898 |
| juvenile idiopathic arthritis | 2 | MONDO:0011429 | EFO:0002609 |
| uveitis | 2 | MONDO:0020283 | EFO:1001231 |
| melanoma | 2 | MONDO:0005105 | EFO:0000756 |
| sarcoidosis | 2 | MONDO:0019338 | MONDO:0019338 |
| localized scleroderma | 1 | MONDO:0019562 | EFO:1001361 |
| lung neoplasm | 1 | MONDO:0021117 | MONDO:0008903 |
| fallopian tube neoplasm | 1 | MONDO:0021092 | MONDO:0002158 |
3 further indication records had no mapped disease name (EFO/MeSH-only) or were duplicates, and are omitted.
Clinical trials
Total trials: 56.
Phase distribution
| Phase | Trials |
|---|---|
| PHASE2 | 17 |
| PHASE3 | 16 |
| PHASE1 | 10 |
| PHASE2/PHASE3 | 5 |
| PHASE1/PHASE2 | 4 |
| PHASE4 | 3 |
| Not specified | 1 |
Top trials by phase / activity
| NCT | Phase | Status | Title |
|---|---|---|---|
| NCT07286214 | PHASE4 | RECRUITING | Sarilumab Efficacy and Safety in Adults With Early Polymyalgia Rheumatica |
| NCT03449758 | PHASE4 | COMPLETED | Effect of Sarilumab on Patient-reported Outcomes in Patients With Active Rheumatoid Arthritis |
| NCT04350216 | PHASE4 | UNKNOWN | Effect of Sarilumab on Atherosclerotic Disease Assessed by PET/CET in Patients With RA (SARIPET) |
| NCT02735707 | PHASE3 | RECRUITING | Randomized, Embedded, Multifactorial Adaptive Platform Trial for Community- Acquired Pneumonia |
| NCT03414502 | PHASE3 | RECRUITING | Treatment of Rheumatoid Arthritis With DMARDs: Predictors of Response |
| NCT05535738 | PHASE2/PHASE3 | ACTIVE_NOT_RECRUITING | Using a Contact Dermatitis Model With Biologic Medications to Study Skin Inflammation |
| NCT01061736 | PHASE2/PHASE3 | COMPLETED | Evaluation of Sarilumab (SAR153191/REGN88) on Top of Methotrexate in Rheumatoid Arthritis Patients |
| NCT01146652 | PHASE3 | COMPLETED | Long Term Evaluation of Sarilumab in Rheumatoid Arthritis Patients (SARIL-RA-EXTEND) |
| NCT01709578 | PHASE3 | COMPLETED | To Evaluate The Effect Of SAR153191 (REGN88) Added To Other RA Drugs In Patients With RA Who Are Not Responding To Or Intolerant Of Anti-TNF Therapy (SARIL-RA-TARGET) |
| NCT01764997 | PHASE3 | TERMINATED | An Evaluation of Sarilumab Plus Methotrexate Compared to Etanercept Plus Methotrexate in RA Patients Not Responding to Adalimumab Plus Methotrexate |
| NCT01768572 | PHASE3 | COMPLETED | To Evaluate The Safety of SAR153191 (REGN88) and Tocilizumab Added to Other RA Drugs in Patients With RA Who Are Not Responding to or Intolerant of Anti-TNF Therapy (SARIL-RA-ASCERTAIN) |
| NCT02057250 | PHASE3 | COMPLETED | To Evaluate Sarilumab - SAR153191 (REGN88) - Auto-injector Device In Patients With Rheumatoid Arthritis |
| NCT02121210 | PHASE3 | COMPLETED | To Evaluate the Immunogenicity and Safety of Sarilumab Administered as Monotherapy in Patients With Rheumatoid Arthritis (RA) |
| NCT02293902 | PHASE3 | COMPLETED | A Study Assessing the Efficacy and Safety of Sarilumab Added to MTX in Japanese Patients With Moderately to Severely Active Rheumatoid Arthritis (SARIL-RA-KAKEHASI) |
| NCT02332590 | PHASE3 | COMPLETED | Efficacy and Safety of Sarilumab and Adalimumab Monotherapy in Patients With Rheumatoid Arthritis (SARIL-RA-MONARCH) |
| NCT02373202 | PHASE3 | COMPLETED | A Study Assessing the Safety and Efficacy of Sarilumab Added to Non-MTX DMARDs or as Monotherapy in Japanese Patients With Active Rheumatoid Arthritis (SARIL-RA-HARUKA) |
| NCT03535402 | PHASE3 | UNKNOWN | Measurement of the Structural Efficacy in Active RA Patients Treated With Sarilumab in Combination With MTX and Naive to Biologics |
| NCT03600805 | PHASE3 | TERMINATED | Evaluation of Efficacy and Safety of Sarilumab in Patients With GCA |
| NCT03600818 | PHASE3 | TERMINATED | Evaluation of the Efficacy and Safety of Sarilumab in Patients With Polymyalgia Rheumatica |
| NCT04134728 | PHASE3 | COMPLETED | Efficacy and Safety of GSK3196165 (Otilimab) Versus Placebo and Sarilumab in Participants With Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Biological Disease-modifying Antirheumatic Drug (DMARDs) and/or Janus Kinase (JAK) Inhibitors |
| NCT04315298 | PHASE2/PHASE3 | COMPLETED | Evaluation of the Efficacy and Safety of Sarilumab in Hospitalized Patients With COVID-19 |
| NCT04324073 | PHASE2/PHASE3 | COMPLETED | Cohort Multiple Randomized Controlled Trials Open-label of Immune Modulatory Drugs and Other Treatments in COVID-19 Patients - Sarilumab Trial - CORIMUNO-19 - SARI |
| NCT04327388 | PHASE3 | COMPLETED | Sarilumab COVID-19 |
| NCT04341870 | PHASE2/PHASE3 | SUSPENDED | Study of Immune Modulatory Drugs and Other Treatments in COVID-19 Patients: Sarilumab, Azithromycin, Hydroxychloroquine Trial - CORIMUNO-19 - VIRO |
| NCT01042379 | PHASE2 | RECRUITING | I-SPY TRIAL: Neoadjuvant and Personalized Adaptive Novel Agents to Treat Breast Cancer |
| NCT02991469 | PHASE2 | RECRUITING | A Repeated Dose-finding Study of Sarilumab in Children and Adolescents With Systemic Juvenile Idiopathic Arthritis (SKYPS) |
| NCT03564340 | PHASE1/PHASE2 | RECRUITING | Study of REGN4018 (Ubamatamab) Administered Alone or in Combination With Cemiplimab in Adult Patients With Recurrent Ovarian Cancer or Other Recurrent Mucin-16 Expressing (MUC16+) Cancers |
| NCT04590326 | PHASE1/PHASE2 | RECRUITING | A Study to Find Out How Safe REGN5668 is and How Well it Works In Adult Women When Given With Either Cemiplimab, or Cemiplimab + Fianlimab, or Ubamatamab |
| NCT05428007 | PHASE2 | RECRUITING | Interleukin-6 Receptor Inhibitor Sarilumab in Combination With Ipilimumab, Nivolumab and Relatlimab in Patients With Unresectable Stage III or Stage IV Melanoma |
| NCT06787612 | PHASE2 | RECRUITING | Investigation of Ubamatamab Combination Therapy in Adult Participants With Platinum-Resistant Ovarian Cancer |
| NCT07154290 | PHASE2 | RECRUITING | A Study to Investigate Ubamatamab With and Without REGN7075 in Adult Participants With Advanced/Metastatic Non-Small Cell Lung Cancer (NSCLC) |
| NCT01061723 | PHASE2 | COMPLETED | Dose Ranging Study to Evaluate the Efficacy and Safety of SAR153191 (REGN88) in Patients With Ankylosing Spondylitis |
| NCT01118728 | PHASE2 | TERMINATED | Extension Study for Long Term Evaluation of SAR153191 (REGN88) in Patients With Ankylosing Spondylitis |
| NCT01217814 | PHASE2 | TERMINATED | Effect of SAR153191 (REGN88) With Methotrexate in Patients With Active Rheumatoid Arthritis Who Failed TNF-α Blockers |
| NCT01900431 | PHASE2 | COMPLETED | Phase II Study to Analyze Sarilumab in Non-Infectious Uveitis |
| NCT02776735 | PHASE2 | COMPLETED | An Open-label, Ascending, Repeated Dose-finding Study of Sarilumab in Children and Adolescents With Polyarticular-course Juvenile Idiopathic Arthritis (pcJIA) |
| NCT03679845 | PHASE1/PHASE2 | WITHDRAWN | Study to Assess Sarilumab in Halting Progression of Morphea |
| NCT03770273 | PHASE2 | COMPLETED | Safety and Efficacy of Subcutaneous Sarilumab in Improving the Quality of Life in People With Indolent Systemic Mastocytosis |
| NCT04008069 | PHASE2 | COMPLETED | Sarilumab in Patients With Glucocorticoid-Dependent Sarcoidosis |
| NCT04357808 | PHASE2 | COMPLETED | Efficacy of Subcutaneous Sarilumab in Hospitalised Patients With Moderate-severe COVID-19 Infection (SARCOVID) |
| NCT04357860 | PHASE2 | COMPLETED | Clinical Trial of Sarilumab in Adults With COVID-19 |
| NCT04359901 | PHASE2 | COMPLETED | Sarilumab for Patients With Moderate COVID-19 Disease |
| NCT04661527 | PHASE2 | UNKNOWN | Sarilumab Treatment In cytoKinE Storm Caused by Infection With COVID-19 |
| NCT04842981 | PHASE1/PHASE2 | TERMINATED | Interleukin-6 Inhibitors and Drug-drug Interactions in Patients With Rheumatoid Arthritis |
| NCT07196306 | PHASE2 | WITHDRAWN | Subcutaneous Sarilumab vs Placebo in Hospitalized Patients With Respiratory Distress Caused by COVID 19 |
| NCT05704634 | PHASE1 | ACTIVE_NOT_RECRUITING | 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. |
| NCT07484113 | PHASE1 | NOT_YET_RECRUITING | IL6-receptor Inhibitor Iwith Belumosudil for the Treatment of Belumosudil-refractory cGVHD |
| NCT01011959 | PHASE1 | COMPLETED | A Multiple-dose Study of the Safety and Tolerability of REGN88(SAR153191) in Rheumatoid Arthritis Subjects |
| NCT01026519 | PHASE1 | COMPLETED | A Safety and Tolerability Study of REGN88(SAR153191) in Subjects With Rheumatoid Arthritis |
| NCT01055899 | PHASE1 | COMPLETED | Safety Study of a Single Dose of REGN88(SAR153191)in Patients With Rheumatoid Arthritis |
| NCT01328522 | PHASE1 | COMPLETED | Comparison of the Safety and Pharmacokinetics of Two SAR153191 (REGN88) Drug Products in Rheumatoid Arthritis Patients |
| NCT01850680 | PHASE1 | COMPLETED | Single Ascending Dose Study of Safety and Tolerability of Sarilumab and Methotrexate in Japanese Patients With Rheumatoid Arthritis |
| NCT02017639 | PHASE1 | COMPLETED | Sarilumab Effect on the Pharmacokinetics of Simvastatin |
| NCT02097524 | PHASE1 | COMPLETED | Single-dose Study to Describe the Pharmacodynamics (PD) and Safety of Sarilumab (REGN88/SAR153191) and Tocilizumab in Adults With Rheumatoid Arthritis (RA) |
| NCT02404558 | PHASE1 | COMPLETED | Single-dose Study to Describe the Safety of Sarilumab and Tocilizumab in Patients With Rheumatoid Arthritis |
| NCT03378219 | Not specified | COMPLETED | An Observational Study on Sarilumab-exposed Pregnancies |
Clinical evidence (CIViC)
No CIViC predictive evidence (expected for non-precision-medicine drugs).
Pharmacology
Pharmacogenomics
No PharmGKB pharmacogenomic data curated for this drug.
Related molecules
Related molecules
Molecules sharing ≥1 of this drug’s curated primary targets, merged from two biobtree sources and ranked by shared-target count, then clinical phase: ChEMBL clinical-stage candidates (development phase ≥2) and PubChem drug-class bioactivity (approved / known drugs acting on the target). Deduplicated by drug name; the drug’s own salt forms are excluded. Note: for a drug with few primary targets a shared-target match can reflect off-target / promiscuous binding rather than the same therapeutic mechanism — the phase ordering surfaces bona-fide therapeutics first.
1 molecules share ≥1 primary target. Top 1 by shared-target count:
| Molecule | Source | Status | Shared targets |
|---|---|---|---|
| Raloxifene | PubChem | Approved | IL6R |
Related Atlas pages
- Genes: IL6R
- Indicated for: rheumatoid arthritis, immune system disorder
- In clinical trials for: polymyalgia rheumatica, severe acute respiratory syndrome, temporal arteritis, pneumonia, influenza, ankylosing spondylitis, juvenile idiopathic arthritis, uveitis, melanoma, sarcoidosis
- Drugs: Raloxifene