Rozanolixizumab

Neonatal Fc Receptor Blocker — ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS

Key facts

Rozanolixizumab is a drug in the Neonatal Fc Receptor Blocker class catalogued in DrugCentral. It was first approved by the FDA in 2023. Its mechanism of action is classified as Neonatal Fc Receptor Blockers. DrugCentral lists 1 molecular target, including FCGRT. Recorded indications include Generalized myasthenia gravis.

• Drug class: Neonatal Fc Receptor Blocker.
• Mechanism of action: Neonatal Fc Receptor Blockers.
• Molecular targets: FCGRT (1 listed in DrugCentral).
• Indications: Generalized myasthenia gravis.
• ATC code: L04AL02 (Neonatal fragment crystallizable receptor (FcRn) inhibitors).

Indications & contraindications

Drug–disease relationships curated by DrugCentral (OMOP / SNOMED concepts).

Indications (1)

• Generalized myasthenia gravis

Mechanism & targets

• Mechanism of action (MoA): Neonatal Fc Receptor Blockers
• Established pharmacologic class: Neonatal Fc Receptor Blocker

Molecular targets (1)

Target	Gene	Action	Activity
IgG receptor FcRn large subunit p51	FCGRT	other	Kd 10.47

Regulatory approvals (1)

Date	Agency	Marketed as	Applicant	Orphan
2023-06-26	FDA	—	UCB INC	Yes

ATC classification

ATC code	Therapeutic hierarchy
L04AL02	ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS › IMMUNOSUPPRESSANTS › IMMUNOSUPPRESSANTS › Neonatal fragment crystallizable receptor (FcRn) inhibitors

Pharmacogenomics

Drug-label and guideline annotations from PharmGKB and CPIC.

• FDA label: CHRNA1, CHRNA3, CHRNA4, CHRNA5, CHRNA6

Reported adverse-event signals

Strongest FDA FAERS disproportionality signals (log-likelihood ratio). A signal is a statistical association in spontaneous reports, not proof that the drug causes the event.

MedDRA term	LLR
Myasthenia gravis crisis	94.3
Headache	88.8
Meningitis aseptic	74.6
Hospitalisation	57.5

Chemical structure

• Molecular formula: —
• Molecular weight: —
• CAS number: 1584645-37-3
• InChIKey: —
• PubChem CID: —

Frequently asked questions

Answers are generated from the structured data on this page, not written by hand.

What is Rozanolixizumab used for?

DrugCentral lists the following indications for Rozanolixizumab: Generalized myasthenia gravis.

How does Rozanolixizumab work?

Rozanolixizumab is classified as Neonatal Fc Receptor Blockers; its molecular targets in DrugCentral include FCGRT.

When was Rozanolixizumab first approved?

Rozanolixizumab was first approved by the FDA in 2023.

What drug class does Rozanolixizumab belong to?

Rozanolixizumab is in the Neonatal Fc Receptor Blocker class.

Sources

• DrugCentral drug card 5735 — structure, indications, targets, approvals, pharmacologic classes (CC BY-SA 4.0)
• ChEMBL CHEMBL4297820 — compound record and bioactivity
• DrugBank DB14919 — drug record
• FDA UNII P7186074QC — substance identity
• DailyMed: FDA labels for Rozanolixizumab — current prescribing information (label search)
• UniProt P55899 (FCGRT) — target protein
• FDA Adverse Event Reporting System (openFDA FAERS) — adverse-event signals, as aggregated by DrugCentral
• PharmGKB / CPIC — pharmacogenomic label annotations

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