KEVZARA (sarilumab)
KEVZARA is indicated for the treatment of Rheumatoid Arthritis; Polymyalgia Rheumatica; Polyarticular Juvenile Idiopathic Arthritis.
How KEVZARA Works
Sarilumab binds to both soluble and membrane-bound interleukin-6 (IL-6) receptors, effectively inhibiting IL-6-mediated signaling. IL-6 is a pro-inflammatory cytokine involved in diverse physiological processes, including T-cell activation, immunoglobulin secretion, and the initiation of hepatic acute phase protein synthesis. By blocking these receptors, the drug interferes with the inflammatory signaling produced by synovial and endothelial cells in joints affected by inflammatory processes.
Development Insights
Details
- Status
- Prescription
- First Approved
- 2017-05-22
- Patent Cliff
- 2029
- Revenue
- $145M (Q4-2025)
- Routes
- INJECTION
- Dosage Forms
- INJECTABLE
KEVZARA Approval History
What KEVZARA Treats
3 indicationsKEVZARA is approved for 3 conditions since its original approval in 2017. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Rheumatoid Arthritis
- Polymyalgia Rheumatica
- Polyarticular Juvenile Idiopathic Arthritis
KEVZARA Boxed Warning
RISK OF SERIOUS INFECTIONS Patients treated with KEVZARA are at increased risk for developing serious infections that may lead to hospitalization or death [see Warnings and Precautions (5.1) , Adverse Reactions (6.1) ]. Opportunistic infections have also been reported in patients receiving KEVZARA. Most patients who developed infections were taking concomitant immunosuppressants such as methotrexate or corticosteroids. Avoid use of KEVZARA in patients with an active infection. Reported infection...
WARNING: RISK OF SERIOUS INFECTIONS Patients treated with KEVZARA are at increased risk for developing serious infections that may lead to hospitalization or death [see Warnings and Precautions (5.1) , Adverse Reactions (6.1) ]. Opportunistic infections have also been reported in patients receiving KEVZARA. Most patients who developed infections were taking concomitant immunosuppressants such as methotrexate or corticosteroids. Avoid use of KEVZARA in patients with an active infection. Reported infections include: Active tuberculosis, which may present with pulmonary or extrapulmonary disease. Patients should be tested for latent tuberculosis before KEVZARA use and during therapy. Treatment for latent infection should be initiated prior to KEVZARA use. Invasive fungal infections, such as candidiasis, and pneumocystis. Patients with invasive fungal infections may present with disseminated, rather than localized, disease. Bacterial, viral and other infections due to opportunistic pathogens. Closely monitor patients for signs and symptoms of infection during treatment with KEVZARA. If a serious infection develops, interrupt KEVZARA until the infection is controlled. Consider the risks and benefits of treatment with KEVZARA prior to initiating therapy in patients with chronic or recurrent infection. WARNING: RISK OF SERIOUS INFECTIONS See full prescribing information for complete boxed warning . Serious infections leading to hospitalization or death including bacterial, viral, invasive fungal, and other opportunistic infections have occurred in patients receiving KEVZARA. ( 5.1 ) If a serious infection develops, interrupt KEVZARA until the infection is controlled. ( 5.1 ) Cases of tuberculosis (TB) have been reported. Prior to starting KEVZARA, test for latent TB; if positive, start treatment for TB. ( 5.1 ) Closely monitor patients for signs and symptoms of infection during treatment with KEVZARA. ( 5.1 )
KEVZARA Target & Pathway
ProTarget
A cytokine involved in inflammation and immune regulation. Elevated IL-6 drives inflammation in rheumatoid arthritis and is linked to cytokine release syndrome. Blocking IL-6 or its receptor reduces inflammatory responses in autoimmune conditions.
KEVZARA Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Direct competitors
Same target(s) AND same indication — head-to-head.
MoA expansion candidates
Same target(s), different indications — where else is this mechanism being explored?
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
What's emerging in KEVZARA's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications KEVZARA treats. First-in-class if their pivotal trials read out positive.
Drugs Similar to KEVZARA
3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
32 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT06787612 | R4018-ONC-2445 2024-517806-27-00 | Ph 2 | recruiting | Investigation of Ubamatamab Combination Therapy in Adult Participants With Platinum-Resistant Ovarian Cancer |
| NCT03564340 | R4018-ONC-1721 2024-510783-23-00, 2019-003298-24 | Ph 1, Ph 2 | 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 |
| NCT07154290 | R4018-ONC-2476 | Ph 2 | recruiting | A Study to Investigate Ubamatamab With and Without REGN7075 in Adult Participants With Advanced/Metastatic Non-Small Cell Lung Cancer (NSCLC) |
| NCT07484113 | IRB-83208 | Ph 1 | not yet recruiting | IL6-receptor Inhibitor Iwith Belumosudil for the Treatment of Belumosudil-refractory cGVHD |
| NCT07286214 | EFC18055 2024-511296-15-00, U1111-1310-5173 | Ph 4 | recruiting | Sarilumab Efficacy and Safety in Adults With Early Polymyalgia Rheumatica |
| NCT05428007 | 22-00325 | Ph 2 | recruiting | Interleukin-6 Receptor Inhibitor Sarilumab in Combination With Ipilimumab, Nivolumab and Relatlimab in Patients With Unresectable Stage III or Stage IV Melanoma |
| NCT04590326 | R5668-ONC-1938 2022-501904-83-00 | Ph 1, Ph 2 | 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 |
| NCT05535738 | STUDY00000321 | Ph 2, Ph 3 | active not recruiting | Using a Contact Dermatitis Model With Biologic Medications to Study Skin Inflammation |
| NCT04324073 CORIMUNO-SARI results posted | APHP200375-2 | Ph 2, Ph 3 | completed | Cohort Multiple Randomized Controlled Trials Open-label of Immune Modulatory Drugs and Other Treatments in COVID-19 Patients - Sarilumab Trial - CORIMUNO-19 - SARI |
| NCT03770273 results posted | 190027 19-I-0027 | Ph 2 | completed | Safety and Efficacy of Subcutaneous Sarilumab in Improving the Quality of Life in People With Indolent Systemic Mastocytosis |
| NCT02776735 SKYPP results posted | DRI13925 U1111-1177-3487, 2015-003999-79 | Ph 2 | completed | An Open-label, Ascending, Repeated Dose-finding Study of Sarilumab in Children and Adolescents With Polyarticular-course Juvenile Idiopathic Arthritis (pcJIA) |
| NCT02735707 REMAP-CAP | U1111-1189-1653 2015-002340-14, 602525 | Ph 3 | recruiting | Randomized, Embedded, Multifactorial Adaptive Platform Trial for Community- Acquired Pneumonia |
| NCT04359901 results posted | IRB 3305 | Ph 2 | completed | Sarilumab for Patients With Moderate COVID-19 Disease |
| NCT04008069 results posted | 48375 | Ph 2 | completed | Sarilumab in Patients With Glucocorticoid-Dependent Sarcoidosis |
| NCT04134728 contRAst 3 results posted | 202018 | Ph 3 | 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 |
| NCT04842981 | AKF-398 | Ph 1, Ph 2 | terminated | Interleukin-6 Inhibitors and Drug-drug Interactions in Patients With Rheumatoid Arthritis |
| NCT03449758 SariPRO results posted | SARILL08755 U1111-1197-7699, 2017-002951-27 | Ph 4 | completed | Effect of Sarilumab on Patient-reported Outcomes in Patients With Active Rheumatoid Arthritis |
| NCT02332590 results posted | EFC14092 2014-002541-22, U1111-1160-6154 | Ph 3 | completed | Efficacy and Safety of Sarilumab and Adalimumab Monotherapy in Patients With Rheumatoid Arthritis (SARIL-RA-MONARCH) |
| NCT04315298 results posted | 6R88-COV-2040 | Ph 2, Ph 3 | completed | Evaluation of the Efficacy and Safety of Sarilumab in Hospitalized Patients With COVID-19 |
| NCT03679845 | 2018P002128 | Ph 1, Ph 2 | withdrawn | Study to Assess Sarilumab in Halting Progression of Morphea |
| NCT04357808 SARCOVID | SARCOVID 2020-001634-36 | Ph 2 | completed | Efficacy of Subcutaneous Sarilumab in Hospitalised Patients With Moderate-severe COVID-19 Infection (SARCOVID) |
| NCT04341870 CORIMUNO-VIRO | APHP200375-3 | Ph 2, Ph 3 | suspended | Study of Immune Modulatory Drugs and Other Treatments in COVID-19 Patients: Sarilumab, Azithromycin, Hydroxychloroquine Trial - CORIMUNO-19 - VIRO |
| NCT02373202 results posted | LTS13618 U1111-1160-6525 | Ph 3 | 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) |
| NCT01217814 results posted | ACT11575 2010-021020-94, U1111-1115-3763 | Ph 2 | terminated | Effect of SAR153191 (REGN88) With Methotrexate in Patients With Active Rheumatoid Arthritis Who Failed TNF-α Blockers |
| NCT01709578 results posted | EFC10832 U1111-1115-8466, 2011-003538-16 | Ph 3 | 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) |
| NCT01061723 ALIGN results posted | DRI11073 2009-016068-35 | Ph 2 | completed | Dose Ranging Study to Evaluate the Efficacy and Safety of SAR153191 (REGN88) in Patients With Ankylosing Spondylitis |
| NCT01764997 RA-COMPARE results posted | EFC11574 2012-001984-66, U1111-1131-6653 | Ph 3 | terminated | An Evaluation of Sarilumab Plus Methotrexate Compared to Etanercept Plus Methotrexate in RA Patients Not Responding to Adalimumab Plus Methotrexate |
| NCT01061736 RA-MOBILITY results posted | EFC11072 2009-016266-90 | Ph 2, Ph 3 | completed | Evaluation of Sarilumab (SAR153191/REGN88) on Top of Methotrexate in Rheumatoid Arthritis Patients |
| NCT01118728 SUSTAIN results posted | LTS11298 2010-019263-11 | Ph 2 | terminated | Extension Study for Long Term Evaluation of SAR153191 (REGN88) in Patients With Ankylosing Spondylitis |
| NCT01900431 SARILNIUSATURN results posted | ACT13480 2012-004845-34, U1111-1130-6500 | Ph 2 | completed | Phase II Study to Analyze Sarilumab in Non-Infectious Uveitis |
| NCT02057250 SARIL-RA-EASY results posted | MSC12665 2012-004339-21, U1111-1130-9931 | Ph 3 | completed | To Evaluate Sarilumab - SAR153191 (REGN88) - Auto-injector Device In Patients With Rheumatoid Arthritis |
| NCT02097524 | 6R88-RA-1309 | Ph 1 | completed | Single-dose Study to Describe the Pharmacodynamics (PD) and Safety of Sarilumab (REGN88/SAR153191) and Tocilizumab in Adults With Rheumatoid Arthritis (RA) |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
KEVZARA FDA Label Details
Indications & Usage
FDA Label (PDF)KEVZARA is indicated for the treatment of Rheumatoid Arthritis; Polymyalgia Rheumatica; Polyarticular Juvenile Idiopathic Arthritis.
WARNING: RISK OF SERIOUS INFECTIONS Patients treated with KEVZARA are at increased risk for developing serious infections that may lead to hospitalization or death [see Warnings and Precautions (5.1) , Adverse Reactions (6.1) ]. Opportunistic infections have also been reported in patients receiving ...
Pro Intelligence Preview
Deep insights for KEVZARA
Revenue Insights
- • Q4-2025: $145M
- • Historical trend analysis
Patent Timeline
- • Cliff: 2029
- • Generic/biosimilar risk
Trial Analysis
- • 34 total trials
- • Stage: Stable
Competitive Landscape
- • 20 similar drugs
- • Same target/indication analysis
Full approval history • All patents • Revenue trends • Competitor analysis
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment