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Drug ReportsPiflufolastat f-18
Piflufolastat f18
Pylarify (piflufolastat f18) is a small molecule pharmaceutical. Piflufolastat f18 was first approved as Pylarify on 2021-05-26.
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Drug Products
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New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
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Brand Name
Status
Last Update
pylarifyNew Drug Application2024-06-17
Indications
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EMA
Expiration
Code
PIFLUFOLASTAT F-18, PYLARIFY, PROGENICS PHARMS INC
2026-05-26NCE
Patent Expiration
Patent
Expires
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FDA Information
Piflufolastat F-18, Pylarify, Progenics Pharms Inc
109471972037-06-09DS, DPU-3130
118514072037-06-09DS, DPU-3130
87783052030-09-21DS, DPU-3130
98617132029-07-31DS, DPU-3130
84871292027-11-07DS, DP
ATC Codes
V: Various drug classes in atc
V09: Diagnostic radiopharmaceuticals
V09I: Tumour detection radiopharmaceuticals
V09IX: Other diagnostic radiopharmaceuticals for tumour detection in atc
V09IX16: Piflufolastat (18f)
HCPCS
Code
Description
A9595
Piflufolastat f-18, diagnostic, 1 millicurie
Clinical
Clinical Trials
83 clinical trials
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Indications Phases 4
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Indications Phases 3
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Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Renal cell carcinomaD002292EFO_0000376111
CarcinomaD002277C80.0111
Indications Phases 1
No data
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common namePiflufolastat f18
INNpiflufolastat (18f)
Description
Piflufolastat F-18, sold under the brand name Pylarify among others, is a radioactive diagnostic agent used for positron emission tomography (PET) imaging. It is given by intravenous injection.
Classification
Small molecule
Drug classenzyme inhibitors: folate hydrolose (also called Prostate Specific Membrane Antigen (PSMA) or glutamate carboxypeptidase II) inhibitors
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Structure (InChI/SMILES or Protein Sequence)
O=C(O)CC[C@H](NC(=O)N[C@@H](CCCCNC(=O)c1ccc([18F])nc1)C(=O)O)C(=O)O
Identifiers
PDB
CAS-ID1207181-29-0
RxCUI
ChEMBL IDCHEMBL4297334
ChEBI ID
PubChem CID52950901
DrugBankDB14805
UNII ID3934EF02T7 (ChemIDplus, GSRS)
Target
No data
Variants
No data
Financial
No data
Trends
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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115 adverse events reported
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