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 11h ago · AI intelligence enriched 1w 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 subcutaneously and treats autoimmune conditions driven by pathogenic antibodies. The drug represents a novel mechanism targeting antibody recycling rather than production.
$0.006BPart D
GrowthEarly-stage growth trajectory with 186 Part D claims in 2023; commercial infrastructure expansion likely as market penetration increases.
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 Sep 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.