NDASUBCUTANEOUSSOLUTION
Approved
Oct 2023
Lifecycle
Growth
Competitive Pressure
0/100
Clinical Trials
14
Data completeness
5/8 — Partial
ZILBRYSQ (zilucoplan) by UCB Pharma is complement inhibitors [moa]. Approved for complement inhibitor [epc]. First approved in 2023.
Drug data last refreshed 4h ago · AI intelligence enriched 6d ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
ZILBRYSQ (zilucoplan) is a small-molecule complement inhibitor approved by the FDA in October 2023 for treating complement-mediated diseases. Administered subcutaneously as a solution, it works by inhibiting the complement cascade, a key immune pathway implicated in several rare and inflammatory conditions. The drug represents UCB Pharma's entry into the growing complement inhibition space.
Growth9.0 years to LOE
Early-stage growth product with limited commercial data; commercial team likely building market access and payer strategies in a nascent indication space.
Mechanism of Action
Complement Inhibitors
Pharmacologic Class:
Complement Inhibitor
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (14)
Zilucoplan for Severe gMG Exacerbations
Started Jan 2026
15 enrolled
Generalized Myasthenia Gravis (gMG)
A Study to Assess Zilucoplan Concentration in Breast Milk of Healthy Lactating Women
Started Jul 2025
15 enrolled
Healthy Participants
An Open-label Extension Study to Evaluate Subcutaneous Zilucoplan in Pediatric Participants With Generalized Myasthenia Gravis
Started Nov 2024
8 enrolled
Generalized Myasthenia Gravis
A Study to Evaluate Subcutaneous Zilucoplan in Pediatric Participants With Generalized Myasthenia Gravis
Started Oct 2024
8 enrolled
Generalized Myasthenia Gravis
A Study to Evaluate the Safe and Effective Use of a Zilucoplan Auto-injector by Study Participants With Generalized Myasthenia Gravis
Started Aug 2024
31 enrolled
Generalized Myasthenia Gravis
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.