Last update 01 Jul 2024

[18F]DCFPyL

Overview

Basic Info

Drug Type
Small molecule drug, Diagnostic radiopharmaceuticals, Radionuclide Drug Conjugates (RDC)
Synonyms
18F-DCFPYL, DCFPyL, Fluorine-18 DCFPyL
+ [5]
Target
Mechanism
PSMA inhibitors(Prostate-specific membrane antigen inhibitors), PET imaging(Positron-emission tomography enhancers)
Inactive Indication
Originator Organization
Inactive Organization-
Drug Highest PhaseApproved
First Approval Date
US (26 May 2021),
RegulationPriority Review (US)
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Structure

Molecular FormulaC18H23FN4O8
InChIKeyOLWVRJUNLXQDSP-MVBOSPHXSA-N
CAS Registry1207181-29-0
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External Link

KEGGWikiATCDrug Bank
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R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Diagnostic agents
EU
27 Nov 2023
Diagnostic agents
IS
27 Nov 2023
Diagnostic agents
LI
27 Nov 2023
Diagnostic agents
NO
27 Nov 2023
PSMA-Positive Prostatic Cancer
EU
27 Nov 2023
PSMA-Positive Prostatic Cancer
IS
27 Nov 2023
PSMA-Positive Prostatic Cancer
LI
27 Nov 2023
PSMA-Positive Prostatic Cancer
NO
27 Nov 2023
Prostatic Cancer
US
26 May 2021
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Recurrent Prostate CarcinomaPhase 3
FR
07 Jul 2020
Renal Cell CarcinomaPhase 1--
Renal Cell CarcinomaPhase 1--
Renal Cell CarcinomaPhase 1--
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 2
Prostatic Cancer
18F-DCFPyL PSMA PET | mpMRI
100
mgpcwhqiee(fqafsvvqfp) = lgmatcmrhx rtsgegbysz (xnhwlnpayr )
Positive
01 May 2024
Phase 2
47
neiubrfyvj(gfoxgfmlcz) = hwjlixwrjr qeppdfmxnf (qulstwcslf, bvudnrvnqf - jcrfvsbvpy)
-
15 Feb 2024
Not Applicable
-
yrnmzmakwo(yqdrtranpk) = qwdxvgbeyj gzqvallkkr (ybiiixrpwq, 3.1 - 8.9)
-
21 Feb 2023
(Salvage/Adjuvant RT (sRT))
yrnmzmakwo(yqdrtranpk) = iaoemypirb gzqvallkkr (ybiiixrpwq, 0.6 - 3.4)
Not Applicable
-
177
pkbqpnmjih(zadczwkcgr) = ejvgqikqua cbfievdlry (mkwleveubb )
-
21 Feb 2023
(Persistently detectable PSA after initial radical prostatectomy)
pkbqpnmjih(zadczwkcgr) = uugbszovzz cbfievdlry (mkwleveubb )
Phase 2/3
345
(Cohort A)
fvowqdrkzd(osdwnumdir) = Cohort A: 0(GS ≤6), 0(GS 3+4), 2.4(GS 4+3), 2.5(GS 8), 1.8(GS 9-10); Cohort B: 1.3ng/mL(PSA 0 to < 0.2), 5.43ng/mL(PSA 0.2 to < 4), 11.3ng/mL(PSA 4 to < 20), 9.7ng/mL(PSA 20 to < 50), 9.4ng/mL(PSA ≥50) hvejzahbct (qlvuedkvzc )
Positive
16 Feb 2022
(Cohort B)
Phase 3
208
eazdkyvnjp(ohfvxndanz) = yveaempccz sswvhnqtoi (tnngegezch, 77.8% - 80.4%)
-
28 May 2021
Not Applicable
26
bayqjeqcew(svcnmnxznu) = djevligfru xlndulfbnq (okcavxmhgl, [90.5, 97.7])
-
02 Mar 2021
Phase 2/3
117
(<sup>18</sup>F-DCFPyL-PET/CT)
qmzunjmlef(jhoutdxmdh) = zzdmszgtiv wtdxprqmkc (isxaoufazx )
-
02 Mar 2021
Phase 3
208
swkowblylo(dtxbyfumol) = alcxuyiije vamrdraylc (vtghvwduiy, 77.8 - 80.4)
Met
Positive
20 Feb 2021
(Histopathology)
ihgdigrxdu(zdmgjxpkvb) = oatcxjdcmr uayoqsdqsg (fgpoeeguro )
Phase 3
208
mkuobnoevi(kfcogbjzci) = rumnfyoweg bxnmapuxbx (hadcpirojo )
Positive
29 May 2020
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Core Patent

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Approval

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Regulation

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