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Drug ReportsRozanolixizumab
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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Clinical
Drug
Target
Variants
Financial
Trends
Safety
Events Timeline
5D
1M
3M
6M
YTD
1Y
2Y
5Y
Max
Events
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
No data
Trade Name
FDA
EMA
Rystiggo
Drug Products
FDA
EMA
Reference product - 351(a)
Reference product - 351(a)
Interchangeable product - 351(k)
Interchangeable product - 351(k)
Biosimilar product - 351(k)
Biosimilar product - 351(k)
Rozanolixizumab
Tradename
Proper name
Company
Number
Date
Products
Rystiggorozanolixizumab-noliUCBN-761286 RX2023-06-26
1 products
Labels
FDA
EMA
Brand Name
Status
Last Update
rystiggoBiologic Licensing Application2024-06-25
Indications
FDA
EMA
No data
Agency Specific
FDA
EMA
Expiration
Code
rozanolixizumab, Rystiggo, UCB, Inc.
2030-06-26Orphan excl.
Patent Expiration
No data
ATC Codes
No data
HCPCS
No data
Clinical
Clinical Trials
20 clinical trials
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Indications Phases 4
No data
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Myasthenia gravisD009157EFO_0004991G70.0—26——7
Muscle weaknessD018908HP_0001324——26——7
Thrombocytopenic purpura idiopathicD016553EFO_0007160D69.3—13——4
ThrombocytopeniaD013921HP_0001873D69.6—13——4
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Chronic inflammatory demyelinating polyradiculoneuropathyD020277EFO_1000868G61.81—2——13
PolyradiculoneuropathyD011129EFO_1001116——2———2
GliomaD005910EFO_0000520——1———1
Autoimmune diseases of the nervous systemD020274———1———1
Hashimoto diseaseD050031EFO_0003779E06.3—1———1
EncephalitisD004660HP_0002383——1———1
Partial epilepsiesD004828EFO_0004263——1———1
Myofascial pain syndromesD009209EFO_1001054——1———1
FibromyalgiaD005356EFO_0005687M79.1—1———1
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Healthy volunteers/patients———2————2
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
PolyneuropathiesD011115EFO_0009562A69.22————11
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameRozanolixizumab
INNrozanolixizumab
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 classmonoclonal antibodies
Image (chem structure or protein)Loading
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
PDB6FGB
CAS-ID1584645-37-3
RxCUI—
ChEMBL IDCHEMBL4297820
ChEBI ID—
PubChem CID—
DrugBankDB14919
UNII IDP7186074QC (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 269 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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96 adverse events reported
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