Auto-Injector Formulation of Zilbrysq for Generalized Myasthenia Gravis Evaluated in Studies Presented at AAN 2026
KEY TAKEAWAYS
- A prefilled auto-injector formulation of Zilbrysq demonstrated pharmacokinetic bioequivalence to the prefilled syringe.
- Patients with generalized myasthenia gravis successfully self-administered the auto-injector with high satisfaction and a favorable safety profile.
A prefilled auto-injector formulation of Zilbrysq (zilucoplan; UCB, Brussels, Belgium) demonstrated pharmacokinetic equivalence and high rates of successful self-administration in individuals with generalized myasthenia gravis (gMG), according to results from the phase 1 DV0012 (NCT06511076) and phase 3b DV0013 (NCT06471361) studies presented at the 2026 American Academy of Neurology (AAN) Annual Meeting. The findings support the auto-injector as a potential alternative delivery method for Zilbrysq, a complement C5 inhibitor currently administered via prefilled syringe.
DV0012 was a phase 1, open-label, crossover trial conducted in 14 healthy participants to assess pharmacokinetic equivalence between the Zilbrysq auto-injector and prefilled syringe. Participants were randomized 1:1 to receive a single subcutaneous dose of the auto-injector followed by the pre-filled syringe, or the alternate sequence.
DV0013 was a phase 3b, open-label, multicenter trial evaluating real-world use of the auto-injector in 31 patients with gMG who were either enrolled in an extension study or receiving commercial Zilbrysq. The primary end point was successful self-administration, defined as complete dose delivery by day 14, along with patient-reported satisfaction and safety.
Key Findings
- In DV0012, pharmacokinetic parameters met bioequivalence criteria, with geometric least-squares mean ratios for auto-injector vs syringe of 0.98 (95% CI, 0.95 to 1.01) for AUC, 0.98 (95% CI, 0.95 to 1.01) for AUC0–t, and 1.00 (95% CI, 0.96 to 1.04) for Cmax.
- In DV0013, complete dose delivery was achieved in 99.8% of injections (95% CI, 98.8 to 100).
- Patient satisfaction with self-injection was high, with a median score of 8.9 (range, 6 to 10) on the Self-Injection Assessment Questionnaire at day 14.
- Treatment-emergent adverse events occurred in 22.6% of patients and were all mild and non-serious.
Source
Petrulis M, Howard JF, Hussain Y. Bioequivalence and effectiveness of auto-injector delivered, self-administered zilucoplan compared with pre-filled syringe. Presented at: American Academy of Neurology Annual Meeting; April 18-22, 2026; Chicago, IL.