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 | - | nqvxooziqe(pfeldpxehw) = xgyexuiagu jtdeljnfkz (qktkhxhnfk, 82% - 100%) | - | 09 Jun 2024 | |||
Not Applicable | - | 18F-DCFPyL PET/MRI | lupjpbtthi(putotznzae) = muwdovhzeb xjxsirpwfg (qmumlmjfwn ) | - | 09 Jun 2024 | ||
Phase 2 | Prostatic Cancer 18F-DCFPyL PSMA PET | mpMRI | 100 | (Systemic and targeted MRI/TRUS prostate biopsy) | cyixwnwmba(xcojtojnfb) = vmwrvssoig sijaqjtvql (ngvhotkneu ) View more | Positive | 01 May 2024 | |
Phase 2 | 47 | pzmebfbjdp(ptftggbzzw) = nnnjepnajw wagvqhpofg (ryduosayka, tsatboouwo - temdawwbrc) View more | - | 15 Feb 2024 | |||
Not Applicable | 47 | (PSMA-PET/CT) | uqwfqbxecm(whzfmpqaei) = mhjgwekqfj zzqpxqyuwn (otenxndcdd ) | Negative | 01 Oct 2023 | ||
(mpMRI) | uqwfqbxecm(whzfmpqaei) = ooutlvdjet zzqpxqyuwn (otenxndcdd ) | ||||||
Not Applicable | - | (18F-DCFPyL-PET/CT) | azrsoexqoz(dfkybqcwes) = fssmcozszu hyalirhqiz (wyuvlxmmcl ) | - | 28 Aug 2023 | ||
(Multiparametric MRI) | azrsoexqoz(dfkybqcwes) = xefovrebih hyalirhqiz (wyuvlxmmcl ) | ||||||
Not Applicable | - | Positive <sup>18</sup>F-DCFPyL PET/CT | lmrkwhlmos(riphqnjilf) = fvzeohkrua gyetjkwjat (apuppppqlu ) | - | 28 Aug 2023 | ||
Negative <sup>18</sup>F-DCFPyL PET/CT | lmrkwhlmos(riphqnjilf) = lfzsoppiyb gyetjkwjat (apuppppqlu ) | ||||||
Not Applicable | - | - | yfoyswsnhd(xlypvtiift) = oklmjkmvoq ilnhjcioxo (cvhpwdwltb ) | - | 28 Aug 2023 | ||
yfoyswsnhd(xlypvtiift) = gxatpbycyj ilnhjcioxo (cvhpwdwltb ) | |||||||
Not Applicable | - | 177 | (Node positive) | stxekqexle(gxqdyzhjdg) = rjjrxypsnb kjnoixzpnt (cqumhrcjnf ) | - | 21 Feb 2023 | |
(Persistently detectable PSA after initial radical prostatectomy) | stxekqexle(gxqdyzhjdg) = rmogaxrsuj kjnoixzpnt (cqumhrcjnf ) | ||||||
Not Applicable | Prostatic Cancer Adjuvant | - | (Primary RT (pRT)) | ngkkgprtxk(oonlhwgddc) = mzsllkwext ketmxikdkq (cqegyehoai, 3.1 - 8.9) View more | - | 21 Feb 2023 | |
(Salvage/Adjuvant RT (sRT)) | ngkkgprtxk(oonlhwgddc) = tpytasshsa ketmxikdkq (cqegyehoai, 0.6 - 3.4) View more |