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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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FDA
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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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Labels
FDA
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Brand Name
Status
Last Update
pylarifyNew Drug Application2024-06-17
Indications
FDA
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Agency Specific
FDA
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
82 clinical trials
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Prostatic neoplasmsD011471—C6114241062270
AdenocarcinomaD000230———32149
RecurrenceD012008————2136
NeoplasmsD009369—C8013—1—5
Castration-resistant prostatic neoplasmsD064129———1—3—4
Urogenital neoplasmsD014565EFO_0003863D07—1—1—2
Neoplasms by siteD009371———1—1—2
Male genital diseasesD005832EFO_0009555N50.9—1—1—2
Prostatic diseasesD011469—N42.9—1—1—2
Male genital neoplasmsD005834———1—1—2
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Indications Phases 3
No data
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
CarcinomaD002277—C80.023——26
Renal cell carcinomaD002292EFO_0000376—12——24
Hepatocellular carcinomaD006528—C22.012——14
Liver neoplasmsD008113EFO_1001513C22.012———3
Breast neoplasmsD001943EFO_0003869C5011———2
Triple negative breast neoplasmsD064726———1———1
Female genital neoplasmsD005833———1———1
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
NeurilemmomaD009442EFO_0000693—1————1
Pancreatic neoplasmsD010190EFO_0003860C251————1
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
NeuroblastomaD009447EFO_0000621—————11
Neuroendocrine tumorsD018358EFO_1001901D3A.8————11
ParagangliomaD010235——————11
Carcinoid tumorD002276—D3A.00————11
GliomaD005910EFO_0000520—————11
Ovarian neoplasmsD010051EFO_0003893C56————11
Ovarian epithelial carcinomaD000077216——————11
Disease progressionD018450——————11
ProstatectomyD011468——————11
Kidney neoplasmsD007680EFO_0003865C64————11
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
No data
Safety
Black-box Warning
No Black-box warning
Adverse Events
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104 adverse events reported
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