Rozanolixizumab
Rystiggo (rozanolixizumab) is an antibody pharmaceutical. Rozanolixizumab was first approved as Rystiggo on 2023-06-26. It is known to target IgG receptor FcRn large subunit p51.
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2Y
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FDA approval date
EMA approval date
Patent expiration date
Study first post date
Last update post date
Start date
Primary completion date
Completion date
Results first post date
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Commercial
Therapeutic Areas
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Trade Name
FDA
EMA
Rystiggo
Drug Products
FDA
EMA
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| rystiggo | Biologic Licensing Application | 2025-06-27 |
Indications
FDA
EMA
No data
Agency Specific
FDA
EMA
Expiration | Code | ||
|---|---|---|---|
rozanolixizumab, Rystiggo, UCB, Inc. | |||
| 2030-06-26 | Orphan excl. | ||
Patent Expiration
No data
ATC Codes
No data
HCPCS
No data
Clinical
Clinical Trials
22 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Myasthenia gravis | D009157 | EFO_0004991 | G70.0 | — | 2 | 6 | 1 | — | 8 |
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Thrombocytopenic purpura idiopathic | D016553 | EFO_0007160 | D69.3 | — | 1 | 3 | — | — | 4 |
| Thrombocytopenia | D013921 | HP_0001873 | D69.6 | — | 1 | 3 | — | — | 4 |
| Muscle weakness | D018908 | — | — | — | 1 | 2 | — | — | 3 |
| Myelin oligodendrocyte glycoprotein antibody-associated disease | D000098542 | — | — | — | — | 1 | — | — | 1 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Chronic inflammatory demyelinating polyradiculoneuropathy | D020277 | EFO_1000868 | G61.81 | — | 2 | — | — | 1 | 3 |
| Polyradiculoneuropathy | D011129 | EFO_1001116 | — | — | 2 | — | — | — | 2 |
| Glioma | D005910 | EFO_0000520 | — | — | 1 | — | — | — | 1 |
| Autoimmune diseases of the nervous system | D020274 | — | — | — | 1 | — | — | — | 1 |
| Hashimoto disease | D050031 | EFO_0003779 | E06.3 | — | 1 | — | — | — | 1 |
| Encephalitis | D004660 | — | — | — | 1 | — | — | — | 1 |
| Partial epilepsies | D004828 | EFO_0004263 | — | — | 1 | — | — | — | 1 |
| Myofascial pain syndromes | D009209 | EFO_1001054 | — | — | 1 | — | — | — | 1 |
| Fibromyalgia | D005356 | EFO_0005687 | M79.1 | — | 1 | — | — | — | 1 |
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Healthy volunteers/patients | — | — | — | 3 | — | — | — | — | 3 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Polyneuropathies | D011115 | EFO_0009562 | A69.22 | — | — | — | — | 1 | 1 |
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Rozanolixizumab |
| INN | rozanolixizumab |
| Description | Rozanolixizumab, sold under the brand name Rystiggo, is a monoclonal antibody used for the treatment of myasthenia gravis. Rozanolixizumab is a humanized and chimeric monoclonal antibody; and is a neonatal Fc receptor blocker.
|
| Classification | Antibody |
| Drug class | monoclonal antibodies |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | >6FGB:H|1519.g57- Heavy chain
EVPLVESGGGLVQPGGSLRLSCAVSGFTFSNYGMVWVRQAPGKGLEWVAYIDSDGDNTYYRDSVKGRFTISRDNAKSSLY
LQMNSLRAEDTAVYYCTTGIVRPFLYWGQGTLVTVSSASTKGPSVFPLAPSSKSTSGGTAALGCLVKDYFPEPVTVSWNS
GALTSGVHTFPAVLQSSGLYSLSSVVTVPSSSLGTQTYICNVNHKPSNTKVDKKVEPKSCDKTHTCAA
>6FGB:L|1519.g57- Light chain
DIQMTQSPSSLSASVGDRVTITCKSSQSLVGASGKTYLYWLFQKPGKAPKRLIYLVSTLDSGIPSRFSGSGSGTEFTLTI
SSLQPEDFATYYCLQGTHFPHTFGQGTKLEIKRTVAAPSVFIFPPSDEQLKSGTASVVCLLNNFYPREAKVQWKVDNALQ
SGNSQESVTEQDSKDSTYSLSSTLTLSKADYEKHKVYACEVTHQGLSSPVTKSFNRGEC |
Identifiers
| PDB | 6FGB |
| CAS-ID | 1584645-37-3 |
| RxCUI | — |
| ChEMBL ID | CHEMBL4297820 |
| ChEBI ID | — |
| PubChem CID | — |
| DrugBank | DB14919 |
| UNII ID | P7186074QC (ChemIDplus, GSRS) |
Target
Agency Approved
No data
Alternate
FCGRT
FCGRT
Organism
Homo sapiens
Gene name
FCGRT
Gene synonyms
FCRN
NCBI Gene ID
Protein name
IgG receptor FcRn large subunit p51
Protein synonyms
Fc fragment of IgG receptor and transporter, Fc fragment of IgG, receptor, transporter, alpha, FcRn alpha chain, heavy chain of the major histocompatibility complex class I-like Fc receptor, IgG Fc fragment receptor transporter alpha chain, immunoglobulin receptor, intestinal, heavy chain, major histocompatibility complex class I-like Fc receptor, Neonatal Fc receptor, neonatal Fc-receptor for Ig, transmembrane alpha chain of the neonatal receptor
Uniprot ID
Mouse ortholog
Fcgrt (14132)
IgG receptor FcRn large subunit p51 (Q9R2A5)
Variants
No data
Financial
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 406 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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711 adverse events reported
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