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Rysodeg

(Rozanolixizumab)

ApprovedMonoclonal antibody

It is used to treat generalized myasthenia gravis, a condition where the immune system attacks muscles and causes weakness and fatigue. The drug helps reduce the antibodies that are attacking the muscle receptors, allowing muscles to work better.[2] Rysodeg is currently approved and in use across 4 indications[4].[1]

Rysodeg is one of 37 small molecule programs targeting Generalized Myasthenia Gravis. It is currently in Approved.

4

Indications

21

Total Trials

6

Active Trials

36

Competitors

1

FDA Application

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[4][1]

Indication

Generalized Myasthenia GravisEnrolling by invitation

Myelin Oligodendrocyte Glycoprotein Antibody-Associated Disease (MOGAD)Active, not recruiting

Myasthenia GravisRecruiting

Ocular Myasthenia GravisNot yet recruiting

Generalized Myasthenia GravisPhase 3

Enrolling by invitation

Myelin Oligodendrocyte Glycoprotein Antibody-Associated Disease (MOGAD)Phase 3

Active, not recruiting

Myasthenia GravisApproved

Recruiting

Ocular Myasthenia GravisPhase 3

Not yet recruiting

Competition

Competitive Landscape

27 competitors in Myasthenia Gravis

#DrugCompanyPhaseTrials

Ultomiris

Vyvgart

Rituxan

Proair HFA

GGlaxo Dba Glaxosmithkline

Rayos

RRoxane Laboratories

Rysodeg

Fabhalta

Johnson & Johnson

Blincyto

Actemra

UPLIZNA

HHorizon Therapeutics Ireland DAC

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q4 2026

PreclinicalActive, not recruiting

Generalized Myasthenia Gravis

NCT06149559

Q3 2027

Phase 3Active, not recruiting

Myelin Oligodendrocyte Glycoprotein Antibody-Associated Disease (MOGAD)

NCT05063162

Q4 2027

ApprovedRecruiting

Myasthenia Gravis

NCT07246564

Q1 2029

Phase 3Recruiting

Ocular Myasthenia Gravis

NCT07463521

Clinical

Trials by Indication[1]

Generalized Myasthenia Gravis5 trials

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

Active, not recruiting· UCB logo

UCB·Preclinical·NCT06149559·14 enrolled

A Randomized, Open-Label Extension Study to Investigate the Long-Term Safety, Tolerability, and Efficacy of Rozanolixizumab in Adult Patients With Generalized Myasthenia Gravis

Completed· UCB logo

UCB·Phase 3·NCT04124965·71 enrolled

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

Completed· UCB logo

UCB·Phase 3·NCT04650854·165 enrolled

Show 2 more trials

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating Efficacy and Safety of Rozanolixizumab in Adult Patients With Generalized Myasthenia Gravis

Completed· UCB logo

UCB·Phase 3·NCT03971422·200 enrolled

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

Enrolling by invitation· UCB logo

UCB·Phase 3·NCT06540144·12 enrolled

Immune Thrombocytopenia3 trials

A Study to Evaluate the Efficacy, Safety, and Tolerability of Rozanolixizumab in Adult Study Participants With Persistent or Chronic Primary Immune Thrombocytopenia (ITP)

Terminated· UCB logo

UCB·Phase 3·NCT04200456·33 enrolled

A Study to Investigate the Long-term Safety, Tolerability, and Efficacy of Rozanolixizumab in Study Participants With Persistent or Chronic Primary Immune Thrombocytopenia (ITP)

Terminated· UCB logo

UCB·Phase 3·NCT04596995·43 enrolled

A Study to Assess the Efficacy, Safety, and Tolerability of Rozanolixizumab in Adult Study Participants With Persistent or Chronic Primary Immune Thrombocytopenia (ITP)

Terminated· UCB logo

UCB·Phase 3·NCT04224688·30 enrolled

Myasthenia Gravis2 trials

A Phase 3, Open-label, Crossover Study to Evaluate Self-administration of Rozanolixizumab by Study Participants With Generalized Myasthenia Gravis (gMG)

Completed· UCB logo

UCB·Phase 3·NCT05681715·62 enrolled

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

Recruiting· UCB logo

UCB·Approved·NCT07246564·40 enrolled

Chronic Inflammatory Demyelinating Polyradiculoneuropathy2 trials

A Study to Assess the Efficacy, Safety and Tolerability of Rozanolixizumab in Subjects With Chronic Inflammatory Demyelinating Polyradiculoneuropathy

Completed· UCB logo

UCB·Phase 2·NCT03861481·34 enrolled

A Study to Assess Long-term Safety, Tolerability and Efficacy of Rozanolixizumab in Subjects With Chronic Inflammatory Demyelinating Polyradiculoneuropathy

Completed· UCB logo

UCB·Phase 2·NCT04051944·21 enrolled

Ocular Myasthenia Gravis2 trials

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

Recruiting· UCB logo

UCB·Phase 3·NCT07463521·120 enrolled

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

Not yet recruiting· UCB logo

UCB·Phase 3·NCT07465289·100 enrolled

7 more indications

Trial1 trial

CIDP07 Rozanolixizumab Post Trial Access Program (the PTA)

No longer available· UCB logo

UCB··NCT05014724

Concentration1 trial

A Study to Assess the Concentration of Rozanolixizumab in the Breast Milk of Healthy Lactating Women

Completed· UCB logo

UCB·Phase 1·NCT06720714·15 enrolled

Fibromyalgia1 trial

A Proof-of-concept Study to Evaluate the Efficacy and Safety of Rozanolixizumab to Treat Adult Study Participants With Severe Fibromyalgia Syndrome

Completed· UCB logo

UCB·Phase 2·NCT05643794·63 enrolled

Autoimmune Encephalitis1 trial

A Study to Test the Efficacy, Safety, and Pharmacokinetics of Rozanolixizumab in Adult Study Participants With Leucine-Rich Glioma Inactivated 1 Autoimmune Encephalitis

Terminated· UCB logo

UCB·Phase 2·NCT04875975·12 enrolled

Tics1 trial

A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Rozanolixizumab Administered Subcutaneously Via Manual Push Versus Syringe Driver to Healthy Participants

Completed· UCB logo

UCB·Phase 1·NCT04828343·32 enrolled

Single Ascending Dose1 trial

A Study to Evaluate Safety and Tolerability of Single Ascending Doses of Rozanolixizumab Administered by Subcutaneous Infusion in Healthy Japanese, Chinese and Caucasian Study Participants

Completed· UCB logo

UCB·Phase 1·NCT03859219·65 enrolled

Myelin Oligodendrocyte Glycoprotein Antibody-associated Disease (MOGAD)1 trial

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)

Active, not recruiting· UCB logo

UCB·Phase 3·NCT05063162·113 enrolled

Regulatory

FDA Approval Timeline[5]

Jun 26, 2023

RYSTIGGO

BLA BLA761286

Sources

References

[1]
ClinicalTrials.gov — 21 trial records for Rozanolixizumab. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Rysodeg drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — Rozanolixizumab compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for Rozanolixizumab. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (BLA BLA761286). U.S. Food & Drug Administration.
[6]
SEC EDGAR — UCB company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Igg Receptor Fcrn Large Subunit P51 Inhibitor[3]
Modality: Monoclonal antibody[3]
Highest Phase: Approved[1]
Company: UCB

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