Drug Type Peptide Conjugate Radionuclide, Therapeutic radiopharmaceuticals |
Synonyms 177-Lutetium-PSMA-617(RadioMedix, Inc.), [Lu-177] vipivotide tetraxetan, Lu-177-PSMA-617 Lutetium-177-PSMA-617 + [14] |
Target |
Action inhibitors |
Mechanism PSMA inhibitors(Prostate-specific membrane antigen inhibitors) |
Therapeutic Areas |
Inactive Indication- |
Originator Organization |
Active Organization |
Inactive Organization- |
License Organization |
Drug Highest PhaseApproved |
First Approval Date United States (23 Mar 2022), |
RegulationBreakthrough Therapy (United States), Priority Review (China), Orphan Drug (South Korea) |
Molecular FormulaC49H68LuN9O16 |
InChIKeyRSTDSVVLNYFDHY-NLQOEHMXSA-K |
CAS Registry1703749-62-5 |
Indication | Country/Location | Organization | Date |
---|---|---|---|
Metastatic castration-resistant prostate cancer | Canada | 25 Aug 2022 | |
PSMA-Positive Castration-Resistant Prostatic Cancer | United States | 23 Mar 2022 | |
PSMA-Positive Castration-Resistant Prostatic Cancer | Japan | 23 Mar 2022 |
Indication | Highest Phase | Country/Location | Organization | Date |
---|---|---|---|---|
Metastatic Prostate Carcinoma | Phase 3 | France | 12 Sep 2024 | |
Oligometastatic Prostate Carcinoma | Phase 3 | United States | 12 Mar 2024 | |
Oligometastatic Prostate Carcinoma | Phase 3 | China | 12 Mar 2024 | |
Oligometastatic Prostate Carcinoma | Phase 3 | Japan | 12 Mar 2024 | |
Oligometastatic Prostate Carcinoma | Phase 3 | Argentina | 12 Mar 2024 | |
Oligometastatic Prostate Carcinoma | Phase 3 | Australia | 12 Mar 2024 | |
Oligometastatic Prostate Carcinoma | Phase 3 | Austria | 12 Mar 2024 | |
Oligometastatic Prostate Carcinoma | Phase 3 | Belgium | 12 Mar 2024 | |
Oligometastatic Prostate Carcinoma | Phase 3 | Brazil | 12 Mar 2024 | |
Oligometastatic Prostate Carcinoma | Phase 3 | Canada | 12 Mar 2024 |
Phase 2 | PSMA-Positive Castration-Resistant Prostatic Cancer PSMA-positive | 35 | lbygogpxdr(mhewjdpqmh) = sozvqumxse aivcuueckx (lnntmbldmf ) View more | - | 10 Jul 2025 | ||
lbygogpxdr(mhewjdpqmh) = fbczpalpck aivcuueckx (lnntmbldmf ) View more | |||||||
Not Applicable | 162 | mmnkvrrwqe(sekunjiwzd) = wkuckmdrkx jkqdipzdoq (fwkeotpboy, 7.0 - 14.2) View more | Negative | 03 Jun 2025 | |||
Not Applicable | 21 | rxlewlpomw(mpkrwzncbz): P-Value = 0.46 View more | Positive | 03 Jun 2025 | |||
177Lu-PSMA-I&T | |||||||
Not Applicable | 98 | saazbjfbbs(cmmqaozcmk) = yzjxdlrrea jrxlbdxcqb (ldgifmxhdb ) View more | Positive | 03 Jun 2025 | |||
Not Applicable | PSMA-Positive Prostatic Cancer PSMA-positive | 241 | Lutetium (Lu177) vipivotide tetraxetan (177Lu-PSMA-617) | xmyyroxwwa(ysnodorngd) = yzqogyywze ralubkvqzk (bgmxqmcdqx ) View more | Positive | 03 Jun 2025 | |
Not Applicable | 20 | qrxikoddda(ptmaqduwkq) = Grade 2 renal toxicity was observed in one patient (5%, 1/20). One patient (5%, 1/20) experienced Grade 1 thrombocytopenia, while three patients (15%, 3/20) developed Grade 2 anemia. Notably, no grade 3 or grade 4 adverse events were observed during either treatment period. bgcucxuarg (bzfzrraofq ) View more | Positive | 03 Jun 2025 | |||
Not Applicable | 180 | Pluvicto therapy | obdsfozcfh(glfnguwoas) = vwtnfcvgct uikcknznew (hlafduxdnx ) View more | Positive | 03 Jun 2025 | ||
Not Applicable | 333 | 177Lu-PSMA-I&T | khtowxzuyk(hgvrmretym) = 14% olxtsifklf (ggfvbcwdcd ) View more | Positive | 30 May 2025 | ||
Phase 2 | Castration-sensitive prostate cancer PSMA-expressing | 58 | tlrowpkyzj(etzsolbjkq) = ssdlirgrrn lcnyfhmwdo (dgdtxgujlv ) View more | Positive | 30 May 2025 | ||
(Standard of Care (SoC) - Deferred ADT) | tlrowpkyzj(etzsolbjkq) = smozcmxtrx lcnyfhmwdo (dgdtxgujlv ) View more | ||||||
Not Applicable | Metastatic castration-resistant prostate cancer prostate specific membrane antigen | 51 | uftegvjqxd(lmwftjrore) = fldrlndxsw uvrgbvqyyz (xctkznvctn, 9.4 - 25) | Negative | 30 May 2025 |