RYSTIGGO (rozanolixizumab-noli)
RYSTIGGO is indicated for the treatment of Myasthenia Gravis.
How RYSTIGGO Works
Rozanolixizumab-noli is a humanized IgG4 monoclonal antibody that binds to the neonatal Fc receptor (FcRn). By binding to this receptor, the drug blocks its interaction with immunoglobulin G (IgG). This mechanism results in a reduction of circulating IgG levels, which includes the autoantibodies responsible for the symptoms of generalized myasthenia gravis.
Development Insights
Details
- Status
- Prescription
- First Approved
- 2023-06-26
- Patent Cliff
- 2030
- Routes
- SUBCUTANEOUS
- Dosage Forms
- INJECTABLE
RYSTIGGO Approval History
What RYSTIGGO Treats
1 indicationsRYSTIGGO is approved for 1 conditions since its original approval in 2023. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Myasthenia Gravis
RYSTIGGO Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Direct competitors
Same target(s) AND same indication — head-to-head.
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
Drugs Similar to RYSTIGGO
3 of 5FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
20 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT06540144 | MG0008 2022-502075-34, U1111-1286-3581 | Ph 3 | enrolling by invitation | An Extension Study Evaluating 6-week Treatment Cycles of Rozanolixizumab in Pediatric Study Participants With Generalized Myasthenia Gravis |
| NCT06149559 roMyG | MG0006 2022-502074-16-00, U1111-1285-0787 | Ph 2, Ph 3 | recruiting | A Study of Rozanolixizumab in Pediatric Study Participants With Moderate to Severe Generalized Myasthenia Gravis |
| NCT05063162 cosMOG | MOG001 2021-000352-19, 2023-509237-39 | Ph 3 | active not recruiting | A Study to Evaluate the Efficacy and Safety of Rozanolixizumab in Adult Participants With Myelin Oligodendrocyte Glycoprotein (MOG) Antibody-associated Disease (MOGAD) |
| NCT06720714 | UP0141 | Ph 1 | completed | A Study to Assess the Concentration of Rozanolixizumab in the Breast Milk of Healthy Lactating Women |
| NCT07246564 | MG0033 | Ph 4 | recruiting | Phase 4 Study Evaluating Efficacy and Safety of Rozanolixizumab in Adult Chinese Participants With Generalized Myasthenia Gravis |
| NCT07463521 MyVision | MG0038 | Ph 3 | not yet recruiting | A Study to Evaluate the Efficacy and Safety of Rozanolixizumab in Adult Participants With Ocular Myasthenia Gravis |
| NCT07465289 | MG0039 | Ph 3 | not yet recruiting | A Study to Evaluate The Long-Term Safety And Efficacy of Rozanolixizumab in Adult Participants With Ocular Myasthenia Gravis |
| NCT03971422 results posted | MG0003 2019-000968-18 | Ph 3 | completed | A Study to Test Efficacy and Safety of Rozanolixizumab in Adult Patients With Generalized Myasthenia Gravis |
| NCT05681715 results posted | MG0020 2022-003870-21 | Ph 3 | completed | A Phase 3, Open-label, Crossover Study to Evaluate Self-administration of Rozanolixizumab by Study Participants With Generalized Myasthenia Gravis (gMG) |
| NCT05643794 results posted | FM0001 | Ph 2 | completed | A Proof-of-concept Study to Evaluate the Efficacy and Safety of Rozanolixizumab to Treat Adult Study Participants With Severe Fibromyalgia Syndrome |
| NCT04875975 results posted | AIE001 2019-004778-25 | Ph 2 | terminated | A Study to Test the Efficacy, Safety, and Pharmacokinetics of Rozanolixizumab in Adult Study Participants With Leucine-Rich Glioma Inactivated 1 Autoimmune Encephalitis |
| NCT04650854 results posted | MG0007 2020-003230-20 | Ph 3 | completed | A Study to Evaluate Rozanolixizumab in Study Participants With Generalized Myasthenia Gravis |
| NCT04200456 myOpportunITy1 results posted | TP0003 2019-000884-26 | Ph 3 | terminated | A Study to Evaluate the Efficacy, Safety, and Tolerability of Rozanolixizumab in Adult Study Participants With Persistent or Chronic Primary Immune Thrombocytopenia (ITP) |
| NCT04828343 results posted | UP0106 | Ph 1 | completed | A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Rozanolixizumab Administered Subcutaneously Via Manual Push Versus Syringe Driver to Healthy Participants |
| NCT04596995 myOpportunITy3 results posted | TP0004 2019-000883-40 | Ph 3 | terminated | A Study to Investigate the Long-term Safety, Tolerability, and Efficacy of Rozanolixizumab in Study Participants With Persistent or Chronic Primary Immune Thrombocytopenia (ITP) |
| NCT04124965 results posted | MG0004 2019-000969-21 | Ph 3 | completed | A Study to Investigate the Long-term Safety, Tolerability, and Efficacy of Rozanolixizumab in Adult Patients With Generalized Myasthenia Gravis |
| NCT04224688 myOpportunITy2 results posted | TP0006 2019-003451-11 | Ph 3 | terminated | A Study to Assess the Efficacy, Safety, and Tolerability of Rozanolixizumab in Adult Study Participants With Persistent or Chronic Primary Immune Thrombocytopenia (ITP) |
| NCT03861481 MyCIDPchoice results posted | CIDP01 2016-002411-17 | Ph 2 | completed | A Study to Assess the Efficacy, Safety and Tolerability of Rozanolixizumab in Subjects With Chronic Inflammatory Demyelinating Polyradiculoneuropathy |
| NCT04051944 results posted | CIDP04 2018-004392-12 | Ph 2 | completed | A Study to Assess Long-term Safety, Tolerability and Efficacy of Rozanolixizumab in Subjects With Chronic Inflammatory Demyelinating Polyradiculoneuropathy |
| NCT03859219 | UP0060 2018-004485-34 | Ph 1 | completed | 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 |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
RYSTIGGO FDA Label Details
Indications & Usage
FDA Label (PDF)RYSTIGGO is indicated for the treatment of Myasthenia Gravis.
Track RYSTIGGO with TheraRadar Pro
Watchlist alerts, full database access, CSV exports across 14,000+ drugs.
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment