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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Commercial
Therapeutic Areas
No data
Trade Name
FDA
EMA
Pylarify
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Piflufolastat f-18
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| PYLARIFY | Progenics Pharmaceuticals | N-214793 RX | 2021-05-26 | 1 products, RLD, RS |
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| pylarify | New Drug Application | 2022-07-20 |
Indications
FDA
EMA
No data
Agency Specific
FDA
EMA
Expiration | Code | ||
|---|---|---|---|
PIFLUFOLASTAT F-18, PYLARIFY, PROGENICS PHARMS INC | |||
| 2026-05-26 | NCE | ||
ATC Codes
No data
HCPCS
Code | Description |
|---|---|
| A9595 | Piflufolastat f-18, diagnostic, 1 millicurie |
Clinical
Clinical Trials
58 clinical trials
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Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Adenocarcinoma | D000230 | — | 2 | 2 | — | 3 | 6 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Renal cell carcinoma | D002292 | — | 1 | — | — | 2 | 3 | ||
| Castration-resistant prostatic neoplasms | D064129 | 2 | 2 | — | — | — | 2 | ||
| Breast neoplasms | D001943 | EFO_0003869 | C50 | — | 1 | — | — | 1 | 2 |
| Liver neoplasms | D008113 | EFO_1001513 | C22.0 | — | 1 | — | — | 1 | 2 |
| Triple negative breast neoplasms | D064726 | — | 1 | — | — | — | 1 | ||
| Neoplasms | D009369 | C80 | — | 1 | — | — | — | 1 | |
| Urogenital neoplasms | D014565 | EFO_0003863 | D07 | — | 1 | — | — | — | 1 |
| Neoplasms by site | D009371 | — | 1 | — | — | — | 1 | ||
| Male genital diseases | D005832 | EFO_0009555 | N50.9 | — | 1 | — | — | — | 1 |
| Prostatic diseases | D011469 | N42.9 | — | 1 | — | — | — | 1 |
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Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Neurilemmoma | D009442 | EFO_0000693 | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Neuroblastoma | D009447 | EFO_0000621 | — | — | — | — | 1 | 1 | |
| Neuroendocrine tumors | D018358 | EFO_1001901 | D3A.8 | — | — | — | — | 1 | 1 |
| Paraganglioma | D010235 | — | — | — | — | 1 | 1 | ||
| Carcinoid tumor | D002276 | D3A.00 | — | — | — | — | 1 | 1 | |
| Hepatocellular carcinoma | D006528 | C22.0 | — | — | — | — | 1 | 1 | |
| Glioma | D005910 | EFO_0000520 | — | — | — | — | 1 | 1 | |
| Ovarian neoplasms | D010051 | EFO_0003893 | C56 | — | — | — | — | 1 | 1 |
| Kidney neoplasms | D007680 | EFO_0003865 | C64 | — | — | — | — | 1 | 1 |
| Pancreatic neoplasms | D010190 | EFO_0003860 | C25 | — | — | — | — | 1 | 1 |
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | PIFLUFOLASTAT F18 |
| INN | piflufolastat (18f) |
| Description | Piflufolastat F-18, sold under the brand name Pylarify, is a radioactive diagnostic agent used for positron emission tomography (PET) imaging. It is given by intravenous injection.
|
| Classification | Small molecule |
| Drug class | enzyme inhibitors: folate hydrolose (also called Prostate Specific Membrane Antigen (PSMA) or glutamate carboxypeptidase II) inhibitors |
| Image (chem structure or protein) | |
| 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-ID | 1207181-29-0 |
| RxCUI | — |
| ChEMBL ID | CHEMBL4297334 |
| ChEBI ID | — |
| PubChem CID | 52950901 |
| DrugBank | DB14805 |
| UNII ID | 3934EF02T7 (ChemIDplus, GSRS) |
Target
Agency Approved
No data
Alternate
No data
Variants
Clinical Variant
No data
Financial
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 38 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
0 adverse events reported
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