Explore

Companies

Drugs

About·Data Management·Terms·Privacy

Stay informed

© 2026 VivoSeq. All rights reserved.

Kevzara

(Sarilumab)

ApprovedMonoclonal antibody

AAzienda U.S.L. 1 di Massa e Carrara

Sarilumab is used to treat moderate to severe rheumatoid arthritis, a disease where the immune system attacks joints causing pain and swelling. It can be used alone or with other arthritis medications to reduce symptoms and slow joint damage.[2] Kevzara is currently approved and in use across 22 indications[4].[1]

Kevzara is one of 518 small molecule programs targeting Polymyalgia Rheumatica. It is currently in Approved.

22

Indications

52

Total Trials

13

Active Trials

517

Competitors

1

FDA Application

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[4][1]

Indication

Polymyalgia RheumaticaRecruiting

Lung CancerActive, not recruiting

Systemic MastocytosisActive, not recruiting

Systemic Juvenile Idiopathic ArthritisActive, not recruiting

Immune System DiseaseUnknown

Severe Acute Respiratory SyndromeActive, not recruiting

SarcoidosisActive, not recruiting

Temporal ArteritisActive, not recruiting

PneumoniaActive, not recruiting

Contact DermatitisActive, not recruiting

Polymyalgia RheumaticaApproved

Recruiting

Lung CancerPhase 1

Active, not recruiting

Systemic MastocytosisPhase 2

Active, not recruiting

Systemic Juvenile Idiopathic ArthritisPhase 2

Active, not recruiting

Immune System DiseasePreclinical

Unknown

Severe Acute Respiratory SyndromePhase 2

Active, not recruiting

SarcoidosisPhase 2

Active, not recruiting

Temporal ArteritisPhase 3

Active, not recruiting

PneumoniaPhase 3

Active, not recruiting

Contact DermatitisPhase 2/Phase 3

Active, not recruiting

Showing 10 of 22 indications

Competition

Competitive Landscape

2828 competitors in Breast Cancer

#DrugCompanyPhaseTrials

Kevzara

AAzienda U.S.L. 1 di Massa e Carrara

Halaven

Prolia

Lexiscan

Voltaren

Lupron

EEastern Cooperative Oncology Group

Spravato

Chirocaine

PPurdue Pharma LP

Avastin

Vfend

PPrism Pharmaceuticals

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q1 2027

Phase 1/2Recruiting

Prostate Cancer

NCT05125016

Phase 1/2Recruiting

Ovarian Cancer

NCT03564340

Q4 2027

Phase 1/2Recruiting

Women

NCT04590326

Phase 2/3Recruiting

Contact Dermatitis

NCT05535738

Q1 2028

Phase 3Recruiting

Pneumonia

NCT02735707

Phase 2Recruiting

Melanoma

NCT05428007

Clinical

Trials by Indication[1]

Rheumatoid Arthritis14 trials

Effect of Sarilumab on Patient-reported Outcomes in Patients With Active Rheumatoid Arthritis

Completed· Sanofi logo

Sanofi·Phase 4·NCT03449758·84 enrolled

Treatment of Rheumatoid Arthritis With DMARDs: Predictors of Response

Recruiting·UUniversity of Nebraska·Phase 3·NCT03414502·400 enrolled

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)

Completed· Sanofi logo

Sanofi·Phase 3·NCT02293902·243 enrolled

Show 11 more trials

Single Ascending Dose Study of Safety and Tolerability of Sarilumab and Methotrexate in Japanese Patients With Rheumatoid Arthritis

Completed· Sanofi logo

Sanofi·Phase 1·NCT01850680·61 enrolled

Single-dose Study to Describe the Safety of Sarilumab and Tocilizumab in Patients With Rheumatoid Arthritis

Completed· Sanofi logo

Sanofi·Phase 1·NCT02404558·30 enrolled

To Evaluate the Immunogenicity and Safety of Sarilumab Administered as Monotherapy in Patients With Rheumatoid Arthritis (RA)

Completed· Sanofi logo

Sanofi·Phase 3·NCT02121210·132 enrolled

To Evaluate Sarilumab - SAR153191 (REGN88) - Auto-injector Device In Patients With Rheumatoid Arthritis

Completed· Sanofi logo

Sanofi·Phase 3·NCT02057250·217 enrolled

Evaluation of Sarilumab (SAR153191/REGN88) on Top of Methotrexate in Rheumatoid Arthritis Patients

Completed· Sanofi logo

Sanofi·Phase 2/3·NCT01061736·1,675 enrolled

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

Completed· GSK logo

GSK·Phase 3·NCT04134728·550 enrolled

Single-dose Study to Describe the Pharmacodynamics (PD) and Safety of Sarilumab (REGN88/SAR153191) and Tocilizumab in Adults With Rheumatoid Arthritis (RA)

Completed· Regeneron logo

Regeneron·Phase 1·NCT02097524·105 enrolled

Effect of SAR153191 (REGN88) With Methotrexate in Patients With Active Rheumatoid Arthritis Who Failed TNF-α Blockers

Terminated· Sanofi logo

Sanofi·Phase 2·NCT01217814·16 enrolled

Interleukin-6 Inhibitors and Drug-drug Interactions in Patients With Rheumatoid Arthritis

Terminated·UUniversity of Southern Denmark·Phase 1/2·NCT04842981·3 enrolled

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)

Completed· Sanofi logo

Sanofi·Phase 3·NCT02373202·91 enrolled

Efficacy and Safety of Sarilumab and Adalimumab Monotherapy in Patients With Rheumatoid Arthritis (SARIL-RA-MONARCH)

Completed· Sanofi logo

Sanofi·Phase 3·NCT02332590·369 enrolled

COVID-199 trials

Study on the Use of Sarilumab in Patients With COVID-19 Infection

Withdrawn·AASST Fatebenefratelli Sacco·Phase 1·NCT04386239

Sarilumab COVID-19

Completed· Sanofi logo

Sanofi·Phase 3·NCT04327388·420 enrolled

Study of Immune Modulatory Drugs and Other Treatments in COVID-19 Patients: Sarilumab, Azithromycin, Hydroxychloroquine Trial - CORIMUNO-19 - VIRO

Suspended·AAssistance Publique - Hôpitaux de Paris·Phase 2/3·NCT04341870·27 enrolled

Show 6 more trials

Sarilumab Treatment In cytoKinE Storm Caused by Infection With COVID-19

Unknown status·—·Phase 2·NCT04661527·60 enrolled

Evaluation of the Efficacy and Safety of Sarilumab in Hospitalized Patients With COVID-19

Completed· Regeneron logo

Regeneron·Phase 2/3·NCT04315298·1,912 enrolled

Sarilumab for Patients With Moderate COVID-19 Disease

Completed·WWestyn Branch-Elliman·Phase 2·NCT04359901·50 enrolled

Clinical Trial of Sarilumab in Adults With COVID-19

Completed·MMaimónides Biomedical Research Institute of Córdoba·Phase 2·NCT04357860·120 enrolled

Efficacy of Subcutaneous Sarilumab in Hospitalised Patients With Moderate-severe COVID-19 Infection (SARCOVID)

Completed·MMaria del Rosario Garcia de Vicuña Pinedo·Phase 2·NCT04357808·30 enrolled

Cohort Multiple Randomized Controlled Trials Open-label of Immune Modulatory Drugs and Other Treatments in COVID-19 Patients - Sarilumab Trial - CORIMUNO-19 - SARI

Completed·AAssistance Publique - Hôpitaux de Paris·Phase 2/3·NCT04324073·239 enrolled

Polymyalgia Rheumatica2 trials

Evaluation of the Efficacy and Safety of Sarilumab in Patients With Polymyalgia Rheumatica

Terminated· Sanofi logo

Sanofi·Phase 3·NCT03600818·118 enrolled

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

Recruiting· Sanofi logo

Sanofi·Approved·NCT07286214·300 enrolled

Ankylosing Spondylitis2 trials

Extension Study for Long Term Evaluation of SAR153191 (REGN88) in Patients With Ankylosing Spondylitis

Terminated· Sanofi logo

Sanofi·Phase 2·NCT01118728·223 enrolled

Dose Ranging Study to Evaluate the Efficacy and Safety of SAR153191 (REGN88) in Patients With Ankylosing Spondylitis

Completed· Sanofi logo

Sanofi·Phase 2·NCT01061723·301 enrolled

ESS2 trials

Study to Assess Sarilumab in Halting Progression of Morphea

Withdrawn·MMassachusetts General Hospital·Phase 1/2·NCT03679845

Effect of Sarilumab on Atherosclerotic Disease Assessed by PET/CET in Patients With RA (SARIPET)

Unknown status·IInstituto de Investigación Marqués de Valdecilla·Phase 4·NCT04350216·20 enrolled

22 more indications

Ovarian Cancer2 trials

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

Recruiting· Regeneron logo

Regeneron·Phase 1/2·NCT03564340·890 enrolled

Multi-Arm Phase 2 Platform Study of Ubamatamab (REGN4018; MUC16×CD3 Bispecific Antibody) With or Without Additional Agents in Platinum-Resistant Ovarian Cancer

Recruiting· Regeneron logo

Regeneron·Phase 2·NCT06787612·220 enrolled

Drug1 trial

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)

Completed· Sanofi logo

Sanofi·Phase 3·NCT01709578·546 enrolled

Women1 trial

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

Recruiting· Regeneron logo

Regeneron·Phase 1/2·NCT04590326·612 enrolled

Efficacy and Safety1 trial

Evaluation of Efficacy and Safety of Sarilumab in Patients With GCA

Terminated· Sanofi logo

Sanofi·Phase 3·NCT03600805·83 enrolled

Breast Cancer1 trial

I-SPY TRIAL: Neoadjuvant and Personalized Adaptive Novel Agents to Treat Breast Cancer

Recruiting·QQuantumLeap Healthcare Collaborative·Phase 2·NCT01042379·5,000 enrolled

Systemic Juvenile Idiopathic Arthritis1 trial

A Repeated Dose-finding Study of Sarilumab in Children and Adolescents With Systemic Juvenile Idiopathic Arthritis (SKYPS)

Recruiting· Sanofi logo

Sanofi·Phase 2·NCT02991469·51 enrolled

Observational Study1 trial

An Observational Study on Sarilumab-exposed Pregnancies

Completed· Sanofi logo

Sanofi··NCT03378219·113 enrolled

Tocilizumab1 trial

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)

Completed· Sanofi logo

Sanofi·Phase 3·NCT01768572·202 enrolled

Statin1 trial

Sarilumab Effect on the Pharmacokinetics of Simvastatin

Completed· Sanofi logo

Sanofi·Phase 1·NCT02017639·19 enrolled

Pneumonia1 trial

Randomized, Embedded, Multifactorial Adaptive Platform Trial for Community- Acquired Pneumonia

Recruiting·UUMC Utrecht·Phase 3·NCT02735707·20,000 enrolled

Juvenile Idiopathic Arthritis1 trial

An Open-label, Ascending, Repeated Dose-finding Study of Sarilumab in Children and Adolescents With Polyarticular-course Juvenile Idiopathic Arthritis (pcJIA)

Completed· Sanofi logo

Sanofi·Phase 2·NCT02776735·102 enrolled

Sarcoidosis1 trial

Sarilumab in Patients With Glucocorticoid-Dependent Sarcoidosis

Completed·SStanford University·Phase 2·NCT04008069·16 enrolled

Refractory1 trial

IL6-receptor Inhibitor Iwith Belumosudil for the Treatment of Belumosudil-refractory cGVHD

Not yet recruiting·SStanford University·Phase 1·NCT07484113·10 enrolled

Systemic Mastocytosis1 trial

Safety and Efficacy of Subcutaneous Sarilumab in Improving the Quality of Life in People With Indolent Systemic Mastocytosis

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 2·NCT03770273·21 enrolled

Melanoma1 trial

Interleukin-6 Receptor Inhibitor Sarilumab in Combination With Ipilimumab, Nivolumab and Relatlimab in Patients With Unresectable Stage III or Stage IV Melanoma

Recruiting·NNYU Langone Health·Phase 2·NCT05428007·105 enrolled

Prostate Cancer1 trial

A Trial to Find Out if REGN4336 is Safe and How Well it Works Alone and in Combination With Cemiplimab or REGN5678 for Adult Participants With Advanced Prostate Cancer

Recruiting· Regeneron logo

Regeneron·Phase 1/2·NCT05125016·370 enrolled

Hospitalized Patients1 trial

Subcutaneous Sarilumab vs Placebo in Hospitalized Patients With Respiratory Distress Caused by COVID 19

Withdrawn·—·Phase 2·NCT07196306

Uveitis1 trial

Phase II Study to Analyze Sarilumab in Non-Infectious Uveitis

Completed· Sanofi logo

Sanofi·Phase 2·NCT01900431·58 enrolled

Methotrexate1 trial

An Evaluation of Sarilumab Plus Methotrexate Compared to Etanercept Plus Methotrexate in RA Patients Not Responding to Adalimumab Plus Methotrexate

Terminated· Sanofi logo

Sanofi·Phase 3·NCT01764997·776 enrolled

Contact Dermatitis1 trial

Using a Contact Dermatitis Model With Biologic Medications to Study Skin Inflammation

Recruiting·WWei-Che Ko·Phase 2/3·NCT05535738·45 enrolled

Biologics1 trial

Measurement of the Structural Efficacy in Active RA Patients Treated With Sarilumab in Combination With MTX and Naive to Biologics

Unknown status·GGaylis, Norman B., M.D.·Phase 3·NCT03535402·20 enrolled

Non-Small Cell Lung Carcinoma1 trial

A Phase 2 Study to Investigate Ubamatamab With and Without REGN7075 in Treatment-Experienced Participants With Advanced/Metastatic Non-Small Cell Lung Cancer (NSCLC)

Recruiting· Regeneron logo

Regeneron·Phase 2·NCT07154290·300 enrolled

Regulatory

FDA Approval Timeline[5]

May 22, 2017

KEVZARA

BLA BLA761037

Sources

References

[1]
ClinicalTrials.gov — 52 trial records for Sarilumab. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Kevzara drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — Sarilumab compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for Sarilumab. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (BLA BLA761037). U.S. Food & Drug Administration.
[6]
SEC EDGAR — Azienda U.S.L. 1 di Massa e Carrara company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Interleukin-6 Receptor Alpha Subunit Antagonist[3]
Modality: Monoclonal antibody[3]
Highest Phase: Approved[1]
Company: AAzienda U.S.L. 1 di Massa e Carrara

Related News