Bioequivalence and Effectiveness of Auto-Injector-Delivered, Self-administered Zilucoplan Compared With Pre-filled Syringe (P11-9.009)

Mary Petrulis; James F. Howard; Yessar Hussain; Jan Ilkowski; Bhupendra Khatri; M. Isabel Leite; Richard J. Nowak; Syed Shah; Tuan Vu; Babak Boroojerdi; Melissa Brock; Ann Cleverly; Eumorphia Maria Delicha; Amirhossein Hajihosseini; Miguel Angel Hernandez; Puneet Singh; Marek Smilowski

doi:10.1212/wnl.0000000000215163

June 9, 2026Neurology

Bioequivalence and Effectiveness of Auto-Injector-Delivered, Self-administered Zilucoplan Compared With Pre-filled Syringe (P11-9.009)

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Key Points

To establish bioequivalence of zilucoplan pharmacokinetics between auto-injector and pre-filled syringe, and to evaluate its effectiveness in patients with generalized myasthenia gravis.
Conducted two studies: DV0012 for pharmacokinetics in healthy volunteers (NCT06511076) and DV0013 for effectiveness in gMG patients (NCT06471361).
Both studies involved single subcutaneous injections, comparing delivery methods.
Zilucoplan delivered via auto-injector demonstrated comparable pharmacokinetics to that delivered by pre-filled syringe.
Effective self-administration of zilucoplan was observed in patients with generalized myasthenia gravis.

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Implication

Evaluates bioequivalence and effectiveness of self-administered zilucoplan in gMG patients, indicating potential for improved delivery methods.

Abstract

DV0012 study (NCT06511076): establish bioequivalence of zilucoplan pharmacokinetics (PK) after a single subcutaneous injection with zilucoplan pre-filled auto-injector pen (ZLP-AI) and pre-filled syringe (ZLP-PFS) in healthy volunteers. DV0013 study (NCT06471361): evaluate effectiveness and safety of ZLP-AI self-administration in patients with generalized myasthenia gravis (gMG).

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Petrulis et al. (2026) studied this question.

synapsesocial.com/papers/6a2cf32afaef96ed7f055bad https://doi.org/10.1212/wnl.0000000000215163

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Bioequivalence and Effectiveness of Auto-Injector-Delivered, Self-administered Zilucoplan Compared With Pre-filled Syringe (P11-9.009)

Key Points

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Implication

Abstract

Discussion

Cite This Study

Bioequivalence and Effectiveness of Auto-Injector-Delivered, Self-administered Zilucoplan Compared With Pre-filled Syringe (P11-9.009)

Key Points

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Implication

Abstract

Discussion

Cite This Study

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