Product Dossier
ZILBRYSQ
Product Dossier for ZILBRYSQ (zilucoplan, UCB). ARTG record, PBS listing, PBAC outcomes, AusPAR — compiled by arcimedes.
- Sponsor: UCB
- Active ingredient: zilucoplan
- Therapeutic area: Immunology
- Same area: COSENTYX
- Same area: HYRIMOZ
What it is
ZILBRYSQ is zilucoplan (as tetrasodium) supplied as a solution for injection in pre-filled syringes in three strengths: 16.6 mg/0.416 mL, 23.0 mg/0.574 mL, and 32.4 mg/0.810 mL.
Approved indications
— Generalised myasthenia gravis (gMG).
PBS listing
ZILBRYSQ was recommended by PBAC in March 2025 for generalised myasthenia gravis. PBS listing details including restriction type and ex-manufacturer price are not yet available.
Regulatory history
ZILBRYSQ was first listed on the ARTG on 20 August 2024 in three pre-filled syringe strengths. PBAC initially did not recommend the medicine in July 2024 for generalised myasthenia gravis in patients who are anti-acetylcholine receptor (AChR) antibody positive, but recommended it in March 2025 for generalised myasthenia gravis.