Prescription medicine
Zilucoplan Brand names: Zilbrysq
Zilucoplan (Zilbrysq) is a prescription medicine with an FDA approval on record since 2023. No generic is listed in FDA's NDC Directory.
- No generic listed
- Boxed warning
Check it at the source: the zilucoplan FDA label on DailyMed (effective February 3, 2026, UCB, Inc.); the NDA 216834 record on Drugs@FDA; every zilucoplan label on DailyMed.
Highlights of the record
FDA label of February 3, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
SERIOUS MENINGOCOCCAL INFECTIONS ZILBRYSQ,.
a complement inhibitor, increases the risk of serious infections caused by Neisseria meningitidis [see Warnings and Precautions (5.1) ]. Life-threatening and fatal meningococcal infections have occurred in patients treated with complement inhibitors. These infections may become rapidly life-threatening or fatal if not recognized and treated early. Complete or update vaccination for meningococcal bacteria (for serogroups A, C, W, Y, and B) at least 2 weeks prior to the first dose of ZILBRYSQ, unless the risks of delaying therapy outweigh the risk of developing a serious infection. Comply with the most current Advisory Committee on Immunization Practices (ACIP) recommendations for vaccination against meningococcal bacteria in patients receiving a complement inhibitor. See Warnings and Precautions (5.1) for additional guidance on the management of the risk of serious infections caused by meningococcal bacteria. Patients receiving ZILBRYSQ are at increased risk for invasive disease caused by Neisseria meningitidis, even if they develop antibodies following vaccination. Monitor patients for early signs and symptoms of serious meningococcal infections and evaluate immediately if infection is suspected. […]
Used for
From the label: indications and usageZILBRYSQ is indicated for the treatment of generalized myasthenia gravis (gMG) in adult patients who are anti-acetylcholine receptor (AChR) antibody positive.
Forms and strengths
- 40 mg/ml
Injection (solution).
On the market
- Earliest approval on file
- October 17, 2023 Zilbrysq, Ucb Inc; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 1 of which 0 under generic applications, 1 under brand applications, repackagers included
- Last listed patent
- June 12, 2035 Zilbrysq injection; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 817 through July 30, 2026
What is zilucoplan used for?
From the label: indications and usageZILBRYSQ is indicated for the treatment of generalized myasthenia gravis (gMG) in adult patients who are anti-acetylcholine receptor (AChR) antibody positive. ZILBRYSQ is a complement inhibitor indicated for the treatment of generalized myasthenia gravis (gMG) in adult patients who are anti-acetylcholine receptor (AChR) antibody positive.
FDA pharmacologic class: Complement Inhibitor.
Source: FDA drug label (ZILBRYSQ), NDA216834 (Ucb Inc), as published by UCB, Inc., effective February 3, 2026 (SPL set 9f1d53d6-e495-4a3a-8bb9-680a15d25034), via openFDA; the full label on DailyMed
What does the patient leaflet for zilucoplan say first?
The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.
From the patient leaflet: What is the most important information I should know about ZILBRYSQ?ZILBRYSQ is a medicine that affects part of your immune system. ZILBRYSQ may lower the ability of your immune system to fight infections. ZILBRYSQ increases your chance of getting serious meningococcal infections caused by Neisseria meningitidis bacteria. Meningococcal infections may quickly become life-threatening or cause death if not recognized and treated early. You must complete or update your meningococcal vaccine(s) at least 2 weeks before your first dose of ZILBRYSQ. If you have not completed your meningococcal vaccines and ZILBRYSQ must be started right away, you should receive the required vaccine(s) as soon as possible. If you have not been vaccinated and ZILBRYSQ must be started right away, you should also receive antibiotics to take for as long as your healthcare provider tells you. If you had a meningococcal vaccine in the past, you might need additional vaccines before starting ZILBRYSQ. Your healthcare provider will decide if you need additional meningococcal vaccines. Meningococcal vaccines do not prevent all meningococcal infections. Call your healthcare provider or get emergency medical care right away if you get any of these signs and symptoms of a meningococcal infection: fever fever with high heart rate headache and fever confusion muscle aches with flu-like symptoms fever and a rash headache with nausea or vomiting headache with a stiff neck or stiff back eyes sensitive to light Your healthcare provider will give you a Patient Safety Card about the risk of serious meningococcal infection. Carry it with you at all times during treatment and for 2 months after your last ZILBRYSQ dose. Your risk of meningococcal infection may continue for several weeks after your last dose of ZILBRYSQ. […]
From the patient leaflet: How should I store ZILBRYSQ?ZILBRYSQ prefilled syringes may be stored in the refrigerator between 36°F to 46°F (2°C to 8°C) until the expiration date on the carton. Do not freeze ZILBRYSQ. Keep the prefilled syringes in the original carton until ready for use to protect from light. ZILBRYSQ prefilled syringes may be stored at room temperature up to 86°F (30°C) in the original carton to protect them from light for a single period of up to 3 months. Write the date you removed the prefilled syringes from the refrigerator in the space provided on the carton. After ZILBRYSQ prefilled syringes have been stored at room temperature, do not place them back in the refrigerator and throw them away if not used within the 3-month period or if the expiration date has passed, whichever occurs first. Throw away any unused portion. Keep ZILBRYSQ prefilled syringes and all medicines out of the reach of children.
Source: FDA drug label (ZILBRYSQ), NDA216834 (Ucb Inc), as published by UCB, Inc., effective February 3, 2026 (SPL set 9f1d53d6-e495-4a3a-8bb9-680a15d25034), via openFDA; the full label on DailyMed
Is there a generic for zilucoplan (Zilbrysq)?
No generic zilucoplan is approved (Drugs@FDA, October 8, 2026).
The Orange Book lists 9 patents for Zilbrysq injection: the compound patent runs to June 12, 2035. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 2023 earliest approval on file
- 2035 last listed patent
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do FAERS reports show for zilucoplan?
The FDA Adverse Event Reporting System holds 817 reports that list zilucoplan among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 40 are coded as a death and 329 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What next?
- Other complement inhibitors
- the pharmacologic class, with prices and generics
- Zilucoplan side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other