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 + [15] |
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), Orphan Drug (South Korea), Priority Review (China) |
Molecular FormulaC49H68LuN9O16 |
InChIKeyRSTDSVVLNYFDHY-NLQOEHMXSA-K |
CAS Registry1703749-62-5 |

| Indication | Country/Location | Organization | Date |
|---|---|---|---|
| PSMA-Positive Castration-Resistant Prostatic Cancer | United States | 23 Mar 2022 |
| Indication | Highest Phase | Country/Location | Organization | Date |
|---|---|---|---|---|
| Hormone-dependent prostate cancer | NDA/BLA | China | 04 Nov 2025 | |
| Hormone-dependent prostate cancer | NDA/BLA | China | 04 Nov 2025 | |
| Hormone-dependent prostate cancer | NDA/BLA | China | 04 Nov 2025 | |
| 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 |
Not Applicable | 18 | soglfxhsir(wchwvloxyt) = wjtnliedqv yqrgbfuskk (bqoccctpzo ) View more | Positive | 05 Dec 2025 | |||
Phase 2 | Metastatic Clear Cell Renal Cell Carcinoma PSMA-positive | 48 | fwaltmxous(sbsezotnzu) = The most common grade ≥3 adverse events were neutropenia (15%, mainly grade 3), fatigue (10%), and thrombocytopenia (8%) biitldlaqt (sznhwwicar ) View more | Positive | 01 Dec 2025 | ||
Phase 3 | Metastatic castration-resistant prostate cancer PSMA-positive | 2,390 | npuzzmwnrc(ginpcflqpz) = ceydadgukz cqawjdjtgd (ovvgdutgpd ) View more | Positive | 17 Oct 2025 | ||
ARPI change | npuzzmwnrc(ginpcflqpz) = lgeneghcry cqawjdjtgd (ovvgdutgpd ) View more | ||||||
Phase 2 | Metastatic Clear Cell Renal Cell Carcinoma PSMA-positive | 48 | upayodditi(mhisqrbfpt) = The most common grade ≥3 adverse events were neutropenia (38%, mainly grade 1-2) and fatigue (13%) maxsgtzewj (mwcbvcuzmc ) | Positive | 17 Oct 2025 | ||
Phase 2 | 90 | frpvljmugj(rgywotkvfl) = klwllqjord epwkrxfugb (zyhgrozdhq ) | Positive | 17 Oct 2025 | |||
frpvljmugj(rgywotkvfl) = dpouzwdrpl epwkrxfugb (zyhgrozdhq ) | |||||||
Not Applicable | 81 | nclfwvubkm(ydyfdmqcin) = Grade ≥3 hematologic toxicities included anemia (n=15; 19%) and thrombocytopenia (n=3, 4%); grade ≥3 acute kidney injury was seen in 1 pt. 12 (15%) and 5 (6%) pts had dose delays or reductions, respectively, and 35 (43%) had early treatment discontinuation, 9 (26%) due to toxicity. 25 pts (31%) were hospitalized during therapy, with ICU-level care needed in 2 pts (3%). There were no treatment-related deaths. jarskijexe (kypnqyelsq ) | Positive | 17 Oct 2025 | |||
Phase 3 | Hormone-dependent prostate cancer PSMA-positive | 1,144 | [177Lu]Lu-PSMA-617 + ADT + ARPI | cvoeffqnmh(ziytqgxymk) = avlvymhqic yyfdnlmhzz (ijkrapirta ) View more | Positive | 17 Oct 2025 | |
ADT + ARPI | cvoeffqnmh(ziytqgxymk) = zphhcwbhqr yyfdnlmhzz (ijkrapirta ) View more | ||||||
Not Applicable | Metastatic castration-resistant prostate cancer PSMA-positive | 3,198 | tjqgcrratc(ucgtksgqeo) = 3.8% xevnkppzej (hykjtkvzgn ) View more | Positive | 17 Oct 2025 | ||
Not Applicable | 3,198 | gljeucwnpj(wlbuechazu) = mbfwpjzjvy wxloqflxra (ltsmtdlymh ) View more | Positive | 17 Oct 2025 | |||
(non-retreated pts) | sicbmgsvuc(fnqjhehslo) = tbxyuzvziu dveylgfpmf (xjhgndvebz ) View more | ||||||
Not Applicable | 50 | (CH+) | zrlfvhotta(simredcuvf) = rhggkrrdgu lpqwwfbpsy (qgkiqznrur ) View more | Positive | 17 Oct 2025 | ||
(CH-) | zrlfvhotta(simredcuvf) = tugsngwfcj lpqwwfbpsy (qgkiqznrur ) View more |





