Dazodalibep dazodalibep PHASE3
Drug Profile
ModalityVHH domain antibody
RouteSC
Therapy AreaR&I
Peak Sales Est$2000M
Formulations[]
Companies
AMGN (ORIGINATOR)100%
Mechanism: CD40 ligand inhibitor
Expert: VH-only domain antibody (VHH) targeting CD40L. Inhibits CD40L-CD40 interaction, blocking T-cell co-stimulation, B-cell activation, and inflammatory cytokine production.
Everyday: Blocks the CD40L signal that tells immune cells to ramp up the attack. In autoimmune diseases like Sjogren's, the immune system wrongly attacks moisture-producing glands — this drug tells it to stand down.
Targets: ["CD40L"]
Programs (1)
IndicationStageKey StudyRegional Status
Sjogren's syndromePHASE3Two Ph3 studies (both fully enrolled)[]
Upcoming Catalysts (1)
Dazodalibep - Sjogren's - Ph3 Data (2 studies) 2026
Notes
First-in-class CD40L inhibitor. Two Phase 3 studies in Sjogren's syndrome BOTH fully enrolled, data expected 2026. Addresses major unmet need — no approved therapy for Sjogren's. Also positive Phase 2 in discoid lupus (daxdilimab).
Data from Supabase · Updated 2026-03-24