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
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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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Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| pylarify | New Drug Application | 2024-06-17 |
Indications
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Agency Specific
FDA
EMA
Expiration | Code | ||
|---|---|---|---|
PIFLUFOLASTAT F-18, PYLARIFY, PROGENICS PHARMS INC | |||
| 2026-05-26 | NCE | ||
HCPCS
Code | Description |
|---|---|
| A9595 | Piflufolastat f-18, diagnostic, 1 millicurie |
Clinical
Clinical Trials
81 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 neoplasms | D011471 | — | C61 | 14 | 24 | 10 | 5 | 22 | 69 |
| Adenocarcinoma | D000230 | — | — | — | 3 | 2 | 1 | 4 | 9 |
| Recurrence | D012008 | — | — | — | — | 2 | 1 | 3 | 6 |
| Castration-resistant prostatic neoplasms | D064129 | — | — | — | 1 | — | 2 | — | 3 |
| Hypersensitivity | D006967 | HP_0012393 | T78.40 | — | — | — | 1 | — | 1 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| Carcinoma | D002277 | — | C80.0 | 2 | 3 | — | — | 2 | 6 |
| Renal cell carcinoma | D002292 | EFO_0000376 | — | 1 | 2 | — | — | 2 | 4 |
| Hepatocellular carcinoma | D006528 | — | C22.0 | 1 | 2 | — | — | 1 | 4 |
| Neoplasms | D009369 | — | C80 | 1 | 3 | — | — | — | 4 |
| Liver neoplasms | D008113 | EFO_1001513 | C22.0 | 1 | 2 | — | — | — | 3 |
| Breast neoplasms | D001943 | EFO_0003869 | C50 | 1 | 1 | — | — | — | 2 |
| Triple negative breast neoplasms | D064726 | — | — | — | 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 |
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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 |
| Pancreatic neoplasms | D010190 | EFO_0003860 | C25 | 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 |
| Glioma | D005910 | EFO_0000520 | — | — | — | — | — | 1 | 1 |
| Ovarian neoplasms | D010051 | EFO_0003893 | C56 | — | — | — | — | 1 | 1 |
| Ovarian epithelial carcinoma | D000077216 | — | — | — | — | — | — | 1 | 1 |
| Disease progression | D018450 | — | — | — | — | — | — | 1 | 1 |
| Prostatectomy | D011468 | — | — | — | — | — | — | 1 | 1 |
| Kidney neoplasms | D007680 | EFO_0003865 | C64 | — | — | — | — | 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 among others, 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
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Trends
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Safety
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104 adverse events reported
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