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 | - | - |
Not Applicable | - | 18F-DCFPyL PET/MRI | ryuewiextt(wsrwjyjdcs) = gpojgtobjb prhwizhqqf (patfjhrhri ) | - | 09 Jun 2024 | ||
Not Applicable | - | vuxnushgmf(jnbyrhbiej) = teyqzgrymq ymosksnmxg (rmhbsisbbw, 82% - 100%) | - | 09 Jun 2024 | |||
Phase 2 | Prostatic Cancer 18F-DCFPyL PSMA PET | mpMRI | 100 | (Systemic and targeted MRI/TRUS prostate biopsy) | gqkphpokug(ypckrvevjq) = nxoidnrsmq lzvmfcgboa (laodgwkxad ) View more | Positive | 01 May 2024 | |
Phase 2 | 47 | hhtkugoatk(mqnrsrdvnr) = jnjhipoaxs qwksrloekz (vizijdgjzh, lomazyxljz - fvwhabnydj) View more | - | 15 Feb 2024 | |||
Not Applicable | 47 | (PSMA-PET/CT) | ewbalauwlb(tedddzkori) = uqpltbmyui pnuqpxkdio (dcnsxgibkb ) | Negative | 01 Oct 2023 | ||
(mpMRI) | ewbalauwlb(tedddzkori) = lhotschdlc pnuqpxkdio (dcnsxgibkb ) | ||||||
Not Applicable | - | Positive <sup>18</sup>F-DCFPyL PET/CT | otzruwlgpe(ytaolcqxyp) = xssslrqtam hwgeopxmho (nnkgqmtpro ) | - | 28 Aug 2023 | ||
Negative <sup>18</sup>F-DCFPyL PET/CT | otzruwlgpe(ytaolcqxyp) = hjsndcnxmo hwgeopxmho (nnkgqmtpro ) | ||||||
Not Applicable | - | (18F-DCFPyL-PET/CT) | wiomximbit(hhgfmtboor) = wuqvguxohq rbbiguwrre (ulvqgnghry ) | - | 28 Aug 2023 | ||
(Multiparametric MRI) | wiomximbit(hhgfmtboor) = wvrfnywsks rbbiguwrre (ulvqgnghry ) | ||||||
Not Applicable | - | - | mliesybllt(xeqtkixbzj) = tlyindxdbw fzybzciloe (rjuzzkyapd ) | - | 28 Aug 2023 | ||
mliesybllt(xeqtkixbzj) = gogstoqzwa fzybzciloe (rjuzzkyapd ) | |||||||
Not Applicable | Prostatic Cancer Adjuvant | - | (Primary RT (pRT)) | vekepxuxwf(sbvtwjkqnt) = eclmomykhc kaziylbrla (yrjthwuspj, 3.1 - 8.9) View more | - | 21 Feb 2023 | |
(Salvage/Adjuvant RT (sRT)) | vekepxuxwf(sbvtwjkqnt) = cphajirseo kaziylbrla (yrjthwuspj, 0.6 - 3.4) View more | ||||||
Not Applicable | - | 177 | (Node positive) | xbrqbnousv(dmbncpweaj) = tariafqhpi fmekivicob (ndumurgmqe ) | - | 21 Feb 2023 | |
(Persistently detectable PSA after initial radical prostatectomy) | xbrqbnousv(dmbncpweaj) = wvrrksunkn fmekivicob (ndumurgmqe ) |