Drug

Rozanolixizumab

Approved · EMA

Emerging researchLate-stage developmentRising momentum

Also known as Rystiggo.

RxNorm2642274UNIIP7186074QC

Research papers

Active clinical trials

Regulatory events

Latest activity

beta

Recent clinical, regulatory, research and industry developments relating to this drug.

An Open-label, Single-arm Study Evaluating the Activity, Safety, and Pharmacokinetics of Rozanolixizumab in Pediatric Study Participants With Moderate to Severe Generalized Myasthenia Gravis

Clinical trial2026-07-17Results expected Q3 2026 · ClinicalTrials.gov

A Randomized, Double-Blind, Placebo-Controlled, Multicenter, Phase 3, Pivotal Study With an Open-Label Extension Period to Evaluate the Efficacy and Safety of Rozanolixizumab in Adult Participants With Myelin Oligodendrocyte Glycoprotein (MOG) Antibody-Associated Disease (MOG-AD)

Clinical trial2026-07-06Results expected Q2 2027 · ClinicalTrials.gov

An Open-label Extension Study to Evaluate Rozanolixizumab in Pediatric Study Participants With Generalized Myasthenia Gravis

Clinical trial2026-07-06Results expected Q3 2027 · ClinicalTrials.gov

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Rozanolixizumab in Adult Participants With Ocular Myasthenia Gravis

Clinical trial2026-06-16Results expected Q4 2028 · ClinicalTrials.gov

An Open-Label, Single-Dose Study to Assess the Concentration of Rozanolixizumab in the Breast Milk of Healthy Lactating Women

Clinical trial2026-06-04Results posted · ClinicalTrials.gov

An Open-label, Prospective, Single-arm Study Assessing the Efficacy and Safety of Rozanolixizumab in Adult Chinese Participants With Generalized Myasthenia Gravis

Clinical trial2026-05-22Results expected Q4 2027 · ClinicalTrials.gov

A Phase 3, Open-Label, Extension Study to Evaluate The Long-Term Safety And Efficacy of Rozanolixizumab in Adult Participants With Ocular Myasthenia Gravis

Clinical trial2026-03-11Results expected Q1 2031 · ClinicalTrials.gov

Measuring the effect of rozanolixizumab using the Myasthenia Gravis Impairment Index: analyses from the randomized phase 3 MycarinG study.

Research2025-11-08Journal of neurology

Self-administration of rozanolixizumab via manual push and infusion pump methods in patients with generalised myasthenia gravis: a randomised, phase 3, open-label, crossover study.

Research2025-10-11Journal of neurology

Improvement in Patient-Reported Symptoms of Generalised Myasthenia Gravis With Rozanolixizumab in the Randomised Phase 3 MycarinG Study Using the MG Symptoms PRO.

Research2025-08-01European journal of neurology

Efficacy and safety of rozanolixizumab in patients with muscle-specific tyrosine kinase autoantibody-positive generalised myasthenia gravis: a subgroup analysis of the randomised, double-blind, placebo-controlled, adaptive phase III MycarinG study.

Research2024-09-12Therapeutic advances in neurological disorders

Approval: Rystiggo (EMA)

Regulatory2024-01-05EMA

Profile

Identifiers & mechanism

Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.

Canonical name

Rozanolixizumab

Aliases & brands

Rystiggo

RxNorm CUI

2642274

UNII

P7186074QC

Regulatory jurisdictions

ema

Regulatory timeline

1 event

The complete regulatory record, grouped by authority — approvals, safety advisories and label changes. Each authority shows its most recent events; expand one to read its full history.

Earliest approval

2024-01-05

Latest approval

2024-01-05

Authorities

EMA

Total events

emaEuropean Medicines Agency· 1 event

2024-01-05Approval

Approval: Rystiggo (EMA)

Indication: Rystiggo is indicated as an add-on to standard therapy for the treatment of generalised myasthenia gravis (gMG) in adult patients who are anti-acetylcholine receptor (AChR) or… Show full indication

Rystiggo is indicated as an add-on to standard therapy for the treatment of generalised myasthenia gravis (gMG) in adult patients who are anti-acetylcholine receptor (AChR) or anti-muscle-specific tyrosine kinase (MuSK) antibody positive.

Evidence ↗

Contains information from the European Medicines Agency (European Medicines Agency), © EMA, reused under CC BY 4.0.