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Sold as Zilbrysq. Every FDA application for this active ingredient.
As of Nov 15, 2026, FDA lists 1 application for Zilucoplan Sodium (sold as Zilbrysq), first approved Oct 17, 2023, with 1 new use approved and 0 published complete response letters.
First approved: Oct 17, 2023
Applications: 1
New uses approved: 1
Complete response letters: 0
Medicare spending, 2025: $125M
Orphan exclusivity until: Oct 17, 2030
First approved in the EU: Dec 1, 2023
First approved in Japan: Sep 25, 2023
Safety program: REMS
Medicare Spending
CMS Part D and Part B, 2025, before manufacturer rebates; matched by generic name
First approved in Japan 1 month before the US. PMDA's English list since 2008, matched by ingredient; see all Japanese approvals
Zilbrysq, new ingredientDrugs with a new active ingredient indicated for the treatment of generalized myasthenia gravis (for use only in patients who have not sufficiently… · UCB Japan Co., Ltd. · Sep 25, 2023 · Review report
Safety Programs (REMS)
FDA requires these when a drug's risks need more than a label: training, enrollment or extra checks before it is prescribed or dispensed
Program
Updated
Zilbrysq REMSRestricted: prescribers, pharmacies or patients must be certified or enrolled
Feb 28, 2025
Applications
NDAs, BLAs and generic ANDAs for this ingredient, oldest first; each opens its full history
Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient.Drugs@FDA
