Bimzelx
bimekizumab
APPROVED
Drug Profile
ModalityAntibody
RouteSC
Therapy AreaImmunology
Launch2023-10-17
US LOE2034-10-01
Peak Sales Est$4000M
Formulations[{"id":"bimzelx-sc","doses":"320mg (single 2mL injection or two 160mg injections)","notes":"Inductio
Mechanism: IL-17A/F inhibitor
Expert: Bispecific mAb neutralizing both IL-17A and IL-17F via the same IL-17RA/IL-17RC receptor complex. IL-17F is regulated by STAT5-inducing cytokines (IL-2, IL-7, IL-15) and IL-1beta, leading to preferential IL-17F overproduction in psoriatic lesions (~8-fold elevation vs ~6.7-fold for IL-17A). Dual blockade achieves PASI 100 ~62% Wk16 vs ~35-40% with IL-17A-only. BE RADIANT crossover data confirms IL-17F-driven residual disease: Cosentyx→Bimzelx switch improved PASI 100 from 52.8% to 76.6%. Higher oral candidiasis (10-21%) reflects disruption of both IL-17A and IL-17F-mediated mucosal neutrophil chemotaxis via CXCL1/CXCL5/CXCL8 and antimicrobial peptides (beta-defensins, S100A). Transcriptomic normalization by Wk8; deepening clinical response reflects epidermal remodeling kinetics. Median time to PASI 75 loss after discontinuation: 32 weeks (BE READY), suggesting partial immunological reset.
Everyday: Blocks both IL-17A and IL-17F — two inflammatory proteins that directly damage skin in psoriasis.
IN HEALTHY PEOPLE: IL-17A and IL-17F are part of your immune defense system. Both proteins call in neutrophils (first-responder white blood cells) to fight infections, especially yeast (Candida) in your mouth and throat. They signal through the same receptor (IL-17RA/RC) on skin and mucosal cells. IL-17F is actually produced in HIGHER quantities than IL-17A — it is the more abundant defender.
IN PSORIASIS: Both IL-17A and IL-17F are massively overproduced in skin plaques. IL-17F levels are elevated ~8-fold in affected skin (vs ~6.7-fold for IL-17A). The inflamed environment of a psoriatic plaque specifically amplifies IL-17F production through STAT5 signaling. Both proteins cause keratinocytes (skin cells) to multiply too fast, recruit more immune cells, and sustain chronic inflammation.
WHY DUAL BLOCKADE IS BETTER FOR SKIN: Blocking IL-17A alone (Cosentyx) removes one fuel source, but IL-17F keeps driving residual inflammation — creating a ceiling at ~50-60% PASI 90. Bimzelx blocks BOTH fuels, achieving ~86-91% PASI 90. Direct proof: in BE RADIANT, patients on Cosentyx who switched to Bimzelx saw their remaining patches clear — confirming IL-17F sustained the residual disease.
WHY DUAL BLOCKADE CAUSES MORE THRUSH: In your mouth, both IL-17A and IL-17F work as alarm signals calling neutrophils to fight yeast. Cosentyx cuts one alarm wire — IL-17F still works as backup (thrush ~2-5%). Bimzelx cuts BOTH wires — no alarm at all, yeast grows unchecked (thrush ~10-21%, though 99.3% mild/moderate, treatable with antifungals).
WHY RESPONSE DEEPENS OVER TIME: By completely normalizing the IL-17 inflammatory gene signature in skin (by week 8 per transcriptomic data), Bimzelx allows the skin to physically remodel — thickening resolves, blood vessels normalize, immune infiltrates clear. This physical healing takes months after the molecular fire is extinguished.
Targets: ["IL-17A","IL-17F"]
Revenue History
| Period | Revenue ($M) |
|---|
| 2023 | $170M |
| 2024 | $700M |
| H1 2024 | $250M |
| H2 2024 | $450M |
Programs (8)
| Indication | Stage | Key Study | Regional Status |
|---|
| Atopic dermatitis | PHASE3 | BE VIVID, BE COOL | [] |
| Psoriatic arthritis | APPROVED | BE OPTIMAL, BE COMPLETE | [{"stage":"APPROVED","region":"US","approval_date":"2024-10-17"},{"stage":"APPRO |
| Axial spondyloarthritis | APPROVED | BE MOBILE 1/2 | [{"stage":"APPROVED","region":"US","approval_date":"2024-10-17"},{"stage":"APPRO |
| Hidradenitis suppurativa | PHASE3 | BE HEARD I/II | [] |
| Pediatric psoriasis | PHASE3 | BE KIDDS | [] |
| Plaque psoriasis | APPROVED | BE VIVID, BE READY, BE SURE | [{"stage":"APPROVED","region":"US","approval_date":"2024-10-17"},{"stage":"APPRO |
| Palmoplantar pustulosis | PHASE3 | BE CONNECTED | [] |
| Mod-sev PsO | APPROVED | — | [] |
Clinical Studies (2)
Primary EP: [{"id":"pasi100-w16","name":"PASI 100 at Week 16","type":"PRIMARY","unit":"%","results":[{"value":61.7,"arm_id":"bimzelx-arm","p_value":0.001,"vs_placebo":"vs secukinumab"},{"value":48.9,"arm_id":"sec
Primary EP: [{"id":"pasi90-w16","name":"PASI 90 at Week 16","type":"PRIMARY","unit":"%","results":[{"value":85,"arm_id":"bkzx-arm","p_value":0.001},{"value":49.7,"arm_id":"ust-arm"},{"value":4.8,"arm_id":"pbo-arm
Upcoming Catalysts (2)
Bimzelx - Commercial Momentum Updates
2026
Bimzelx vs Risankizumab - PsA - Head-to-Head Data
H2 2026
Notes
First-in-class IL-17A/F dual inhibitor. FASTEST and DEEPEST skin clearance in psoriasis (PASI 90 86-91% Wk16, PASI 100 59-68%). Trade-off: highest candidiasis rate (~10-21%, almost all mild/moderate). Beat Cosentyx H2H in BE RADIANT (PASI 100: 61.7% vs 48.9% Wk16, gap widened to 67% vs 46.2% Wk48). Beat Humira in BE SURE and Stelara in BE VIVID. Response deepens over time (PASI 100 ~73.5% Wk48). Approved: PsO (EU 2021, US 2023), PsA, AS, nr-axSpA, HS. UCB peak estimate EUR 7B multi-indication. US LOE ~2033-2035.
Data from Supabase · Updated 2026-03-24