PIFLUFOLASTAT F-18

Details

Stereochemistry	ABSOLUTE
Molecular Formula	C18H23FN4O8
Molecular Weight	441.3982
Optical Activity	UNSPECIFIED
Defined Stereocenters	2 / 2
E/Z Centers	0
Charge	0

SHOW SMILES / InChI

Structure Search

SMILES

OC(=O)CC[C@H](NC(=O)N[C@@H](CCCCNC(=O)C1=CC=C([18F])N=C1)C(O)=O)C(O)=O

InChI

InChIKey=OLWVRJUNLXQDSP-MVBOSPHXSA-N

InChI=1S/C18H23FN4O8/c19-13-6-4-10(9-21-13)15(26)20-8-2-1-3-11(16(27)28)22-18(31)23-12(17(29)30)5-7-14(24)25/h4,6,9,11-12H,1-3,5,7-8H2,(H,20,26)(H,24,25)(H,27,28)(H,29,30)(H2,22,23,31)/t11-,12-/m0/s1/i19-1

HIDE SMILES / InChI

Molecular Formula	C18H23FN4O8
Molecular Weight	441.3982
Charge	0
Count

Stereochemistry	ABSOLUTE
Additional Stereochemistry	No
Defined Stereocenters	2 / 2
E/Z Centers	0
Optical Activity	UNSPECIFIED

Description
Sources: https://www.cancer.gov/publications/dictionaries/cancer-drug/def/fluorine-f-18-dcfpyl |https://www.ncbi.nlm.nih.gov/pubmed/28641974

DCFPYL F-18 is an urea-based radiotracer composed of the prostate-specific membrane antigen (PSMA)-targeting agent DCFPyL and labeled with the positron-emitting isotope, fluorine F 18, that can potentially be used for positron-emitting tomography (PET) imaging. Upon administration of fluorine F 18 DCFPyL, the DCFPyL moiety binds to PSMA expressed on tumor cells. The fluorine F 18 moiety facilitates PET imaging of PSMA-expressing tumor cells. DCFPYL F-18 is investigated in a number of clinical trials in patients with prostate cancer and neuroendocrine tumors.

Approval Year

Doses

Dose	Population	Adverse events
11070 uCi single, intravenous Highest studied dose Dose: 11070 uCi Route: intravenous Route: single Dose: 11070 uCi Sources: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/214793Orig1s000MultidisciplineR.pdf	unhealthy, ADULT Health Status: unhealthy Age Group: ADULT Sex: M Sources: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/214793Orig1s000MultidisciplineR.pdf	Other AEs: No toxicities were reported... Other AEs: No toxicities were reported Sources: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/214793Orig1s000MultidisciplineR.pdf
340 MBq single, intravenous Recommended Dose: 340 MBq Route: intravenous Route: single Dose: 340 MBq Sources: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/214793Orig1s000RiskR.pdf	unhealthy, ADULT Health Status: unhealthy Age Group: ADULT Sex: M Sources: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/214793Orig1s000RiskR.pdf	Other AEs: No toxicities were reported... Other AEs: No toxicities were reported Sources: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/214793Orig1s000RiskR.pdf

AEs

AE	Significance	Dose	Population
No toxicities were reported		11070 uCi single, intravenous Highest studied dose Dose: 11070 uCi Route: intravenous Route: single Dose: 11070 uCi Sources: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/214793Orig1s000MultidisciplineR.pdf	unhealthy, ADULT Health Status: unhealthy Age Group: ADULT Sex: M Sources: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/214793Orig1s000MultidisciplineR.pdf
No toxicities were reported		340 MBq single, intravenous Recommended Dose: 340 MBq Route: intravenous Route: single Dose: 340 MBq Sources: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/214793Orig1s000RiskR.pdf	unhealthy, ADULT Health Status: unhealthy Age Group: ADULT Sex: M Sources: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/214793Orig1s000RiskR.pdf

Substance Class	Chemical Created by `admin` on `Mon Mar 31 21:28:58 GMT 2025` Edited by `admin` on `Mon Mar 31 21:28:58 GMT 2025`
Record UNII	3934EF02T7
Record Status	`Validated (UNII)`
Record Version

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Name

Type

Language

PIFLUFOLASTAT F18

Preferred Name

English

PIFLUFOLASTAT F-18

Common Name

English

PYLARIFY

Brand Name

English

PIFLUFOLASTAT F-18 [ORANGE BOOK]

Common Name

English

piflufolastat (¹?F) [INN]

Common Name

English

18F-DCFPYL

Common Name

English

(18F)DCFPYL

Common Name

English

L-GLUTAMIC ACID, N-((((1S)-1-CARBOXY-5-(((6-(FLUORO-18F)-3-PYRIDINYL)CARBONYL)AMINO)PENTYL)AMINO)CARBONYL)-

Systematic Name

English

DCFPYL F-18

Common Name

English

2-(3-(1-CARBOXY-5-((6-(18F)FLUORO-PYRIDINE-3-CARBONYL)-AMINO)-PENTYL)-UREIDO)-PENTANEDIOIC ACID

Systematic Name

English

Piflufolastat (18F) [WHO-DD]

Common Name

English

PIFLUFOLASTAT (18F)

Official Name

English

PIFLUFOLASTAT F18 [USAN]

Common Name

English

2-(3-(1-CARBOXY-5-((6-(18F) FLUORO-PYRIDINE-3-CARBONYL)-AMINO)-PENTYL)-UREIDO)PENTANEDIOIC ACID

Systematic Name

English

Code System Code Type Description

USAN

HI-146