piflufolastat f-18 piflufolastat f-18 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. piflufolastat f-18clinical datatrade namespylarifyother names18f-dcfpyllicense data us dailymed: piflufolastat routes ofadministrationintravenousatc codev09ix16 (who) legal statuslegal status us: ℞-only identifierscas number1423758-00-2 ypiflufolastat: 1423758-00-2 ypubchem cid52950901drugbankdb14805chemspider32702072unii3934ef02t7piflufolastat: 82vh67yon8 ykeggd12132chemblchembl4297334chemical and physical dataformulac18h23n4o8molar mass441.4 g/mol3d model (jsmol)interactive image smiles oc(=o)cc(nc(=o)n(ccccnc(=o)c1=cc=c()n=c1)c(o)=o)c(o)=o inchi 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/i19-1key:olwvrjunlxqdsp-mvbosphxsa-n the most common adverse reactions include headache, altered taste, and fatigue. piflufolastat f-18 was approved for medical use in the united states in may 2021. it is the second psma-targeted pet imaging drug approved by the u.s. food and drug administration (fda). the first approved psma-targeted pet imaging drug is ga 68 psma-11. medical uses piflufolastat f-18 is indicated for people with suspected prostate cancer metastasis (when cancer cells spread from the place where they first formed to another part of the body) who are potentially curable by surgery or other therapy. piflufolastat f-18 is also indicated for people with suspected prostate cancer recurrence based on elevated serum prostate-specific antigen (psa) levels. history the safety and efficacy of piflufolastat f-18 were evaluated in two prospective clinical trials with a total of 593 men with prostate cancer who each received one injection of piflufolastat f-18. in the first trial, a cohort of 268 participants with biopsy-proven prostate cancer underwent pet/ct scans performed with piflufolastat f-18. these participants were candidates for surgical removal of the prostate gland and pelvic lymph nodes and were considered at higher risk for metastasis. among the participants who proceeded to surgery, those with positive readings in the pelvic lymph nodes on piflufolastat f-18 pet had a clinically important rate of metastatic cancer confirmed by surgical pathology. the second trial enrolled 208 participants who had rising serum psa levels after initial prostate surgery or other definitive therapy, and thus had biochemical evidence of recurrent prostate cancer. prior to a single piflufolastat f-18 pet/ct scan, all of these participants had baseline conventional imaging performed that did not show definite spread of prostate cancer. piflufolastat f-18 pet detected at least one positive lesion in at least one body region (bone, prostate bed, pelvic lymph node, other lymph nodes, or soft tissue) in 60% of these participants. in participants with positive piflufolastat f-18 pet readings who had correlative tissue pathology from biopsies, results from baseline or follow-up imaging by conventional methods, or serial psa levels available for comparison, local recurrence or metastasis of prostate cancer was confirmed in an estimated 85% to 87% of cases, depending on the reader. thus, the second trial demonstrated that piflufolastat f-18 pet can detect sites of disease in participants with biochemical evidence of recurrent prostate cancer, thereby providing important information that may impact the approach to therapy. the u.s. food and drug administration (fda) granted approval of pylarify to progenics pharmaceuticals, inc.