DNTH212 — Topline data
2H'26
IND cleared by FDA with Ph. 1 SAD study in healthy volunteers and patients with SLE expected to initiate in Q4'25 in China with top-line HV results expected in 2H'26Source filing
catalyst calendar
DIANTHUS THERAPEUTICS INC · Data as of 2026-10-25
2H'26
IND cleared by FDA with Ph. 1 SAD study in healthy volunteers and patients with SLE expected to initiate in Q4'25 in China with top-line HV results expected in 2H'26Source filing
Late 2026
A two-part Phase 1 study in China in healthy volunteers (Part A) and patients with Systemic Lupus Erythematosus (Part B) was initiated in December 2025, with Phase 1 healthy volunteer data anticipated by year-end 2026.Source filing
December '26
Phase 2 MoMeNtum trial of claseprubart in MMN exceeded its original enrollment target of 36 patients; top-line results with 46 patients on track for December '26Source filing
YE'27
Advancing DNTH312, an internally developed, first-in-class, next-generation bifunctional fusion protein combining claseprubart and TACI to target potent inhibition of aC1s and BAFF/APRIL for severe autoimmune diseases; DNTH312 aims to be Phase 1 ready by YE'27Source filing
2H'28
Phase 3 EMERGE registrational trial of claseprubart in gMG evaluating 300mg/2mL Q2W and 300mg/2mL Q4W initiated in June ‘26, with top-line results anticipated in 2H'28Source filing