Is Zilucoplan legal in the US?
Yes, FDA approved for generalized myasthenia gravis in adults.
Zilucoplan is approved by the FDA as Zilbrysq (October 2023) for generalized myasthenia gravis in adults who are anti-acetylcholine receptor antibody positive. It carries a boxed warning for serious meningococcal infections, requires meningococcal vaccination, and is available only through a restricted REMS program. 2
Yes. Zilbrysq was approved in October 2023 for adults with generalized myasthenia gravis who test positive for acetylcholine receptor antibodies. It is the first complement inhibitor for the disease that patients inject themselves. 2
More on Zilucoplan
Citations
- Howard 2023, Lancet Neurol: Safety and efficacy of zilucoplan in generalized myasthenia gravis (RAISE), phase 3 trial doi.org
- FDA 2024: Zilbrysq (zilucoplan) prescribing information accessdata.fda.gov
- Tammam 2026, J Neuromuscul Dis: Real-world effectiveness and safety of zilucoplan in anti-AChR myasthenia gravis, French early-access cohort pubmed.ncbi.nlm.nih.gov
Reference information only, not medical advice. Drawn from the Zilucoplan article, fact-checked against the cited sources. No dosing anywhere on this site.