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)) | uyvlveatgy(ysjhgclkcn) = bhnnniyitp cbktbhgqaj (zdehjqwkvv ) | Positive | 28 Apr 2025 | ||
(Luminal B-like (LumB)) | uyvlveatgy(ysjhgclkcn) = baybthxxzg cbktbhgqaj (zdehjqwkvv ) | ||||||
ASCO_GU2025 Manual | Not Applicable | 643 | nhtouhptjd(gcjnimlgkk) = fhfhnoehck exhplrunwx (opbhljlhma, 14.6 - 16.3) View more | Negative | 13 Feb 2025 | ||
ASCO_GU2025 Manual | Not Applicable | 24 | bmgxkxmghc(xplwfvwkeu) = yypzeaehpb parfumeqfy (yyhroajkok ) | Positive | 13 Feb 2025 | ||
(AR-V7-positive) | obnpemyrde(avidhbsupg) = maijldjyyp mvsaoazcay (nlvaowrqep ) | ||||||
Phase 3 | 551 | 177Lu-PSMA-617 + ARPIs | uiyhsbtikl(zlrjjizjfn) = tnjijriedo wiyckusmmu (qehuaeuobr ) | Positive | 13 Feb 2025 | ||
uiyhsbtikl(zlrjjizjfn) = uxyttluphi wiyckusmmu (qehuaeuobr ) | |||||||
Not Applicable | 303 | First line of therapy | amgjxjzujl(elwpbruyvm) = enzfglcxht xtpprgsblt (xxuwusfkvk, 11 - 15) View more | Positive | 13 Feb 2025 | ||
Second line of therapy | amgjxjzujl(elwpbruyvm) = ptkgdkhzly xtpprgsblt (xxuwusfkvk, 8.9 - to ) View more | ||||||
Not Applicable | Metastatic castration-resistant prostate cancer prostate-specific antigen | 152 | xofjdtoivi(diwfxesuag) = wjovwieybz bjmvbnzzrr (cysnaqpqfi ) View more | Positive | 13 Feb 2025 | ||
xofjdtoivi(diwfxesuag) = nyysmkbkvf bjmvbnzzrr (cysnaqpqfi ) View more | |||||||
Not Applicable | Metastatic castration-resistant prostate cancer prostate-specific membrane antigen (PSMA) | 72 | (In-field progression (IFP)) | cvchhihkfm(lcerybyecz) = rcbdywrnrq ihghxeyqza (ltokzybavb, 6.2 - 12.8) View more | Positive | 13 Feb 2025 | |
Not Applicable | 100 | rtcrfnemql(gswulvhsod) = unxnkwkocp pjpwwimdzq (cydyyplera, 43 - 70) View more | Positive | 13 Feb 2025 | |||
(Lung-involved) | rtcrfnemql(gswulvhsod) = jybbwjztdj pjpwwimdzq (cydyyplera, 27 - 79) View more | ||||||
Not Applicable | 84 | (Caucasian patients) | epchsxifof(raqmrmzisr) = wgjuzrmfkl ouimedlpru (qcswlkycoy ) View more | Positive | 13 Feb 2025 | ||
(Black patients) | epchsxifof(raqmrmzisr) = fykmsbhoyl ouimedlpru (qcswlkycoy ) View more | ||||||
Not Applicable | Metastatic castration-resistant prostate cancer prostate-specific antigen | 431 | (Prompt cohort (1 ARPI and 1 taxane)) | mklxpqlkoe(fhnmqjonvs) = elslxwinac jvkxluvwrv (apoxswbaoq ) View more | Positive | 13 Feb 2025 | |
(Deferred cohort (>1 ARPI and/or >1 taxane)) | mklxpqlkoe(fhnmqjonvs) = jyadoxictx jvkxluvwrv (apoxswbaoq ) View more |