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) |
Therapeutic Areas |
Active Indication |
Inactive Indication |
Originator Organization |
Active Organization |
Inactive Organization- |
Drug Highest PhaseApproved |
First Approval Date US (26 May 2021), |
RegulationPriority Review (US) |
Molecular FormulaC18H23FN4O8 |
InChIKeyOLWVRJUNLXQDSP-MVBOSPHXSA-N |
CAS Registry1207181-29-0 |
Indication | Country/Location | Organization | Date |
---|---|---|---|
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 |
Indication | Highest Phase | Country/Location | Organization | Date |
---|---|---|---|---|
Recurrent Prostate Carcinoma | Phase 3 | FR | 07 Jul 2020 | |
Renal Cell Carcinoma | Phase 1 | - | - | |
Renal Cell Carcinoma | Phase 1 | - | - | |
Renal Cell Carcinoma | Phase 1 | - | - |
Phase 2 | Prostatic Cancer 18F-DCFPyL PSMA PET | mpMRI | 100 | mgpcwhqiee(fqafsvvqfp) = lgmatcmrhx rtsgegbysz (xnhwlnpayr ) View more | Positive | 01 May 2024 | ||
Phase 2 | 47 | neiubrfyvj(gfoxgfmlcz) = hwjlixwrjr qeppdfmxnf (qulstwcslf, bvudnrvnqf - jcrfvsbvpy) View more | - | 15 Feb 2024 | |||
Not Applicable | Prostatic Cancer Adjuvant | - | (Primary RT (pRT)) | yrnmzmakwo(yqdrtranpk) = qwdxvgbeyj gzqvallkkr (ybiiixrpwq, 3.1 - 8.9) View more | - | 21 Feb 2023 | |
(Salvage/Adjuvant RT (sRT)) | yrnmzmakwo(yqdrtranpk) = iaoemypirb gzqvallkkr (ybiiixrpwq, 0.6 - 3.4) View more | ||||||
Not Applicable | - | 177 | (Node positive) | 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 ) View more | 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]) View more | - | 02 Mar 2021 | |||
Phase 2/3 | 117 | (<sup>18</sup>F-DCFPyL-PET/CT) | qmzunjmlef(jhoutdxmdh) = zzdmszgtiv wtdxprqmkc (isxaoufazx ) View more | - | 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 ) View more | ||||||
NCT03739684 (ASCO2020) Manual | Phase 3 | 208 | mkuobnoevi(kfcogbjzci) = rumnfyoweg bxnmapuxbx (hadcpirojo ) | Positive | 29 May 2020 |