Asset profile

Levilimab

Monoclonal antibody

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Reliablesignal

Evidence outlook · lead readout

SOLAR (NCT04227366) · Rheumatoid Arthritis

The completed lead evidence has the design features that historically survive confirmatory trials: randomized, controlled, and adequately powered against a prespecified clinically accepted endpoint.

SOLAR (NCT04227366): This was a randomized, double-blind, placebo-controlled trial in 154 patients that measured ACR20 response, a validated rheumatoid arthritis disease-activity measure, at week 12. Levilimab combined with methotrexate produced a much higher response rate than placebo combined with methotrexate (68.6% vs 38.5%).

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Competitive landscape

60 competitors in this universe: 2 direct rivals (same mechanism and indication), 0 same-class, 58 same-indication; 25 further along in development.

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DrugStageModalityMechanismEvidence signalReported efficacygraded featured trials
Levilimab: this drugPhase 3Monoclonal antibodyIL-6 receptor
SarilumabApprovedMonoclonal antibodyIL-6 receptor
Tocilizumab (Actemra / RoActemra)ApprovedMonoclonal antibodyIL-6 receptor, IL-6R antagonist
Abatacept (Orencia)ApprovedProtein / enzyme therapeuticCD80/CD86 (CTLA-4-Ig), Selective T Cell Costimulation Modulator, CD80/CD86 (B7-1/B7-2) on antigen-presenting cells
Adalimumab (Humira)ApprovedMonoclonal antibodyTNF-alpha
Adalimumab-Adbm (Cyltezo)ApprovedMonoclonal antibodyTNF-alpha
Adalimumab-Ryvk (Simlandi)Approved—TNF-alpha
Aldesleukin (Proleukin)ApprovedRecombinant Cytokine (il-2)Interleukin-2 receptor (IL-2R)
Anakinra (r-metHuIL-1ra)ApprovedProtein / enzyme therapeuticInterleukin-1 receptor (IL-1R), Interleukin-1 receptor type 1 (IL-1R1)
Baricitinib (Olumiant)ApprovedSmall moleculeJAK, JAK1/2
Certolizumab Pegol (Cimzia)ApprovedAntibody fragmentTNF-alpha
CT-P13 (Inflectra / Remsima)ApprovedMonoclonal antibodyTNF-alpha
CT-P47 (tocilizumab) (Avtozma)ApprovedMonoclonal antibodyIL-6R antagonist
DenosumabApprovedMonoclonal antibodyRANKL
Etanercept (Enbrel)ApprovedProtein / enzyme therapeuticTNF-alpha, TNF-alpha / TNF-beta (lymphotoxin-alpha)
Golimumab (Simponi)ApprovedMonoclonal antibodyTNF-alpha

…and 45 more. Research shows the complete landscape.

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Research adds each competitor's evidence grade and sourced trial results, aligned per race, so you can see who actually has the data.

Upcoming events

No upcoming readouts on record for this asset.

All registered studies

Every ClinicalTrials.gov study of this drug's own program, grouped by indication and phase. Research unlocks the studies themselves: titles, statuses, dates and featured-trial cross-links.

Phase 3 (3)
Phase 2 (1)
Phase 1 (1)