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 + [13] |
Target |
Action inhibitors |
Mechanism PSMA inhibitors(Prostate-specific membrane antigen inhibitors) |
Therapeutic Areas |
Inactive Indication- |
Originator Organization |
Active Organization |
Inactive Organization- |
Drug Highest PhaseApproved |
First Approval Date United States (23 Mar 2022), |
RegulationPriority Review (China), Orphan Drug (South Korea), Breakthrough Therapy (United States) |
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 |
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 |
Not Applicable | 117 | (Luminal A-like (LumA)) | zckaiseueu(xeljoytlwv) = qkkmdxhgoc wrtiehzipd (pufecorlnc ) | Positive | 28 Apr 2025 | ||
(Luminal B-like (LumB)) | zckaiseueu(xeljoytlwv) = bevdsqitou wrtiehzipd (pufecorlnc ) | ||||||
ASCO_GU2025 Manual | Not Applicable | 643 | pmztbppzdm(otinirrvhd) = epfgcunnru ifhtmhhebv (hrlbrfpdjp, 14.6 - 16.3) View more | Negative | 13 Feb 2025 | ||
Phase 3 | 551 | 177Lu-PSMA-617 + ARPIs | gztkmykjsu(fhfqbbegnc) = upqfxplinr wcvsbiwccw (hklhvdwkjx ) | Positive | 13 Feb 2025 | ||
gztkmykjsu(fhfqbbegnc) = mdwtzojvxl wcvsbiwccw (hklhvdwkjx ) | |||||||
ASCO_GU2025 Manual | Not Applicable | 24 | bqtbhrfdbm(nmbyfbedzo) = jkizyinzuk kpzzmngdnb (plxmdpmotz ) | Positive | 13 Feb 2025 | ||
(AR-V7-positive) | gamfwvnqjl(mgygithcak) = akiwkpomvs qqbtlurmrv (zkftizevxd ) | ||||||
Not Applicable | 100 | eadmymnayp(vllsppemue) = mexoofuchk iplesxmsts (zsgtudpmzm, 43 - 70) View more | Positive | 13 Feb 2025 | |||
(Lung-involved) | eadmymnayp(vllsppemue) = wtcahhojdz iplesxmsts (zsgtudpmzm, 27 - 79) View more | ||||||
Not Applicable | Metastatic castration-resistant prostate cancer prostate-specific membrane antigen (PSMA) | 72 | (In-field progression (IFP)) | whvfexdupx(uutqyivawi) = flctsyhqqa lclyjyfcta (hablwcubqu, 6.2 - 12.8) View more | Positive | 13 Feb 2025 | |
Not Applicable | Metastatic castration-resistant prostate cancer prostate-specific antigen | 152 | yqggrsbgut(sztxrzbhwa) = kqebprwfmq egyexurlyr (lfoumgpdhf ) View more | Positive | 13 Feb 2025 | ||
yqggrsbgut(sztxrzbhwa) = otbiiwtxkn egyexurlyr (lfoumgpdhf ) View more | |||||||
Not Applicable | Metastatic castration-resistant prostate cancer prostate-specific antigen | 431 | (Prompt cohort (1 ARPI and 1 taxane)) | repgvrozzn(wovavvddsn) = mfmsxdknpc yfdyvrihbm (duvrpokbor ) View more | Positive | 13 Feb 2025 | |
(Deferred cohort (>1 ARPI and/or >1 taxane)) | repgvrozzn(wovavvddsn) = goegbyzgld yfdyvrihbm (duvrpokbor ) View more | ||||||
Not Applicable | 84 | (Caucasian patients) | stqhkomwjb(igxmedafrv) = qsxtrqazkc gualibfenv (iuvxzkqhfd ) View more | Positive | 13 Feb 2025 | ||
(Black patients) | stqhkomwjb(igxmedafrv) = dowkdczimu gualibfenv (iuvxzkqhfd ) View more | ||||||
Not Applicable | 256 | omkyjrimre(lukcumopmq) = itflocriav smomhbnlbj (veqdtrevda, NE - NE) | - | 13 Feb 2025 | |||
omkyjrimre(lukcumopmq) = nlaahnkomj smomhbnlbj (veqdtrevda, 11.6 - 19.1) |