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Drug ReportsRetifanlimab
Retifanlimab
Zynyz (retifanlimab) is an antibody pharmaceutical. Retifanlimab was first approved as Zynyz on 2023-03-22. It is used to treat merkel cell carcinoma in the USA. It is known to target programmed cell death protein 1.
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FDA approval date
EMA approval date
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Study first post date
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Completion date
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
infectionsD007239
neoplasmsD009369
Trade Name
FDA
EMA
Zynyz
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)
Retifanlimab
Tradename
Proper name
Company
Number
Date
Products
Zynyzretifanlimab-dlwrIncyteN-761334 RX2023-03-22
1 products
Labels
FDA
EMA
Brand Name
Status
Last Update
zynyzBiologic Licensing Application2024-04-17
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
merkel cell carcinomaEFO_1001471D015266C4A
Agency Specific
FDA
EMA
Expiration
Code
retifanlimab, Zynyz, Incyte Corporation
2030-03-22Orphan excl.
Patent Expiration
No data
ATC Codes
L: Antineoplastic and immunomodulating agents
— L01: Antineoplastic agents
— L01F: Monoclonal antibodies and antibody drug conjugates
— L01FF: Pd-1/pdl-1 (programmed cell death protein 1/death ligand 1) inhibitors
— L01FF10: Retifanlimab
HCPCS
No data
Clinical
Clinical Trials
56 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
CarcinomaD002277—C80.02122——15
Squamous cell carcinomaD002294——262——9
Non-small-cell lung carcinomaD002289——422——7
Squamous cell carcinoma of head and neckD000077195——351——7
Head and neck neoplasmsD006258——231——5
Breast neoplasmsD001943EFO_0003869C50231——4
Lung neoplasmsD008175HP_0100526C34.90212——4
Stomach neoplasmsD013274EFO_0003897C16121——2
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
NeoplasmsD009369—C80136———15
GlioblastomaD005909EFO_0000515—23———5
MelanomaD008545——33———4
Colorectal neoplasmsD015179——42———4
Triple negative breast neoplasmsD064726——22———3
Pancreatic neoplasmsD010190EFO_0003860C2512———3
Merkel cell carcinomaD015266EFO_1001471C4A—3———3
AdenocarcinomaD000230——12———3
GliomaD005910EFO_0000520——2———2
SarcomaD012509——12———2
Show 24 more
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Pancreatic ductal carcinomaD021441——2————2
Malignant mesotheliomaD000086002——1————1
MesotheliomaD008654—C451————1
Ovarian neoplasmsD010051EFO_0003893C561————1
Hepatocellular carcinomaD006528—C22.01————1
Urinary bladder neoplasmsD001749—C671————1
Liver neoplasmsD008113EFO_1001513C22.01————1
Gastrointestinal diseasesD005767——1————1
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameRetifanlimab
INNretifanlimab
Description
Retifanlimab, sold under the brand name Zynyz, is an anti-cancer medication used for the treatment of Merkel cell carcinoma. Retifanlimab is a programmed death receptor-1 (PD-1)–blocking monoclonal antibody.
Classification
Antibody
Drug classmonoclonal antibodies
Image (chem structure or protein)Loading
Structure (InChI/SMILES or Protein Sequence)—
Identifiers
PDB—
CAS-ID2079108-44-2
RxCUI—
ChEMBL IDCHEMBL4298037
ChEBI ID—
PubChem CID—
DrugBankDB15766
UNII ID2Y3T5IF01Z (ChemIDplus, GSRS)
Target
Agency Approved
No data
Alternate
PDCD1
PDCD1
Organism
Homo sapiens
Gene name
PDCD1
Gene synonyms
PD1
NCBI Gene ID
Protein name
programmed cell death protein 1
Protein synonyms
CD279, programmed cell death 1 protein, protein PD-1, systemic lupus erythematosus susceptibility 2
Uniprot ID
Mouse ortholog
Pdcd1 (18566)
programmed cell death protein 1 (Q02242)
Variants
No data
Financial
Revenue by drug
$
€
£
â‚£
Zynyz – Incyte
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Estimated US medical usage
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 441 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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86 adverse events reported
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