BLASUBCUTANEOUSINJECTABLEPriority Review
Approved
Jun 2023
Lifecycle
Growth
Competitive Pressure
30/100
Clinical Trials
20
Data completeness
5/8 — Partial
Priority Review
RYSTIGGO (rozanolixizumab) by UCB Pharma is neonatal fc receptor blockers [moa]. Approved for neonatal fc receptor blocker [epc]. First approved in 2023.
Drug data last refreshed 18h ago · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
RYSTIGGO (rozanolixizumab) is a monoclonal antibody that blocks the neonatal Fc receptor (FcRn), reducing circulating immunoglobulin levels. It is administered via subcutaneous injection for autoimmune conditions where pathogenic antibodies drive disease pathology. The mechanism works by preventing antibody recycling, thereby accelerating their clearance from the bloodstream.
$6MPart D
GrowthEarly-stage growth product with modest current penetration; commercial teams are building market awareness and infrastructure for scale.
Mechanism of Action
Neonatal Fc Receptor Blockers
Pharmacologic Class:
Neonatal Fc Receptor Blocker
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (20)
A Study to Evaluate The Long-Term Safety And Efficacy of Rozanolixizumab in Adult Participants With Ocular Myasthenia Gravis
Started Jul 2026
100 enrolled
Ocular Myasthenia Gravis
A Study to Evaluate the Efficacy and Safety of Rozanolixizumab in Adult Participants With Ocular Myasthenia Gravis
Started May 2026
120 enrolled
Ocular Myasthenia Gravis
Phase 4 Study Evaluating Efficacy and Safety of Rozanolixizumab in Adult Chinese Participants With Generalized Myasthenia Gravis
Started Dec 2025
40 enrolled
Myasthenia Gravis
A Study to Assess the Concentration of Rozanolixizumab in the Breast Milk of Healthy Lactating Women
Started Dec 2024
15 enrolled
Healthy Participants
An Extension Study Evaluating 6-week Treatment Cycles of Rozanolixizumab in Pediatric Study Participants With Generalized Myasthenia Gravis
Started Oct 2024
12 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.