FDA Approves UCB's ZILBRYSQ Autoinjector for gMG; Launch Set for Q1 2027
Atlanta – October 16, 2026 -- The U.S. Food and Drug Administration (FDA) has approved a once-daily autoinjector for UCB's ZILBRYSQ (zilucoplan), with complete dose delivery in 99.8% of 449 administrations, UCB said. Commercial availability is expected in Q1 2027.
The device is cleared for adults with generalized myasthenia gravis (gMG) who are anti-acetylcholine receptor (AChR) antibody positive. UCB (Euronext Brussels: UCB) describes ZILBRYSQ as the first and only macrocyclic peptide C5 inhibitor approved as a self-administered, once-daily subcutaneous autoinjector for gMG in the U.S.
Autoinjector adds a second self-administration route alongside the prefilled syringe
Before this approval, ZILBRYSQ was available only as a self-administered prefilled syringe (PFS). The autoinjector automatically delivers a pre-defined dose when activated against the skin. Patients or their care partners now have two portable options.