Last update 26 Jul 2025

[18F]DCFPyL

Overview

Basic Info

Drug Type
Small molecule drug, Diagnostic radiopharmaceuticals
Synonyms
18F-DCFPYL, DCFPyL, Fluorine-18 DCFPyL
+ [5]
Target
Action
inhibitors, enhancers
Mechanism
PSMA inhibitors(Prostate-specific membrane antigen inhibitors), PET imaging(Positron-emission tomography enhancers)
Originator Organization
Drug Highest PhaseApproved
First Approval Date
United States (26 May 2021),
RegulationPriority Review (United States)
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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
PSMA-Positive Prostatic Cancer
European Union
27 Nov 2023
PSMA-Positive Prostatic Cancer
Iceland
27 Nov 2023
PSMA-Positive Prostatic Cancer
Liechtenstein
27 Nov 2023
PSMA-Positive Prostatic Cancer
Norway
27 Nov 2023
Prostatic Cancer
United States
26 May 2021
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Renal Cell CarcinomaPhase 3-01 Aug 2025
Adenocarcinoma of prostatePhase 3
United States
27 Nov 2018
Adenocarcinoma of prostatePhase 3
Canada
27 Nov 2018
Metastatic Prostate CarcinomaPhase 3
United States
27 Nov 2018
Metastatic Prostate CarcinomaPhase 3
Canada
27 Nov 2018
Recurrent Prostate CarcinomaPhase 3
United States
27 Nov 2018
Recurrent Prostate CarcinomaPhase 3
Canada
27 Nov 2018
Non-metastatic prostate cancerPhase 2
United States
01 May 2021
Breast CancerPhase 1
United States
28 Oct 2022
Hepatocellular CarcinomaPhase 1
United States
28 Oct 2022
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 2
239
rbbzfgbgqo = dmkmkuzynl hxllopfarz (tqcvbbflfe, iovxntdnbc - xcnrluupkg)
-
16 May 2025
Early Phase 1
48
(mpMRI)
cshzqbskeb(ycqfmimobi) = yroahprljk tkmxgrzcxb (swedtxfxen )
Positive
10 Feb 2025
Phase 2
Prostatic Cancer
18F-DCFPyL PSMA PET | mpMRI
100
(Systemic and targeted MRI/TRUS prostate biopsy)
ozpxidvwwn(ysefndqoki) = rraaoggeor uujyyzyloq (wzbbgcyfmp )
Positive
01 May 2024
Phase 2
47
xowziynpnw = lfqknfnszj txidluwqkw (bdtkpuobhf, fcwhsktjqq - wckglymavt)
-
15 Feb 2024
Not Applicable
Prostatic Cancer
PSMA positive
194
Focal therapy (radiation therapy, surgeries, HIFU, cryoablation) + androgen deprivation therapy
hwkfuwgyup(rxbithdqjt) = kjhmfxcxab hfqtnzfscd (ivgcjcuhjl )
Positive
08 Aug 2022
Phase 2/3
345
(Cohort A)
gjnssvphru(lfnfwkhvod) = 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) njcuenunft (ltftkfjacl )
Positive
16 Feb 2022
(Cohort B)
Phase 3
208
PET/CT Imaging+18F-DCFPyL
rtaasxsuru = flonqfupxv byvnsjejre (brkjqxsiwf, vkxaniophb - dwyfxlfdix)
-
14 Jun 2021
Phase 3
208
yxudelxkad(qkargonbqu) = rqoujgirpb zzmntoxafj (hoeyysbtqo, 77.8% - 80.4%)
-
28 May 2021
Phase 2/3
117
(<sup>18</sup>F-DCFPyL-PET/CT)
kitkhtwfum(kdojlrmuvj) = bhqzitmqyk hgasgeuysd (xdhbxezojr )
-
02 Mar 2021
Not Applicable
26
ztozzljkoa(zbwktsgczi) = vodvbwfmwl ehhofwkeui (thwbsbkkuw, [90.5 - 97.7])
-
02 Mar 2021
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Approval

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Regulation

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