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 | xjqklqyjfm(jtmdgxinxk) = ybuhesvmsi dgghtccnxz (ibbfrdbhvr ) View more | Positive | 05 Dec 2025 | |||
Phase 2 | Metastatic Clear Cell Renal Cell Carcinoma PSMA-positive | 48 | cszusddgju(zpsvocwgqq) = The most common grade ≥3 adverse events were neutropenia (15%, mainly grade 3), fatigue (10%), and thrombocytopenia (8%) pckmexxyuk (bacagbvfhq ) View more | Positive | 01 Dec 2025 | ||
Not Applicable | 81 | mrmykwgvfn(utcixgshga) = 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. mkhoozofrv (pdjyomuvei ) | Positive | 17 Oct 2025 | |||
Not Applicable | 50 | (CH+) | nvowfucpwn(yyieyrqeag) = rkxwdrvkgk aurzimpqtf (hkatnwyamr ) View more | Positive | 17 Oct 2025 | ||
(CH-) | nvowfucpwn(yyieyrqeag) = qdgeuifkvi aurzimpqtf (hkatnwyamr ) View more | ||||||
Not Applicable | Metastatic castration-resistant prostate cancer PSMA-positive | 3,198 | gtlvhjslxg(spzuytuzhw) = 3.8% qvcfldunkv (ibfmbodgcu ) View more | Positive | 17 Oct 2025 | ||
Phase 3 | Metastatic castration-resistant prostate cancer PSMA-positive | 2,390 | fkzhnhrcuj(pvkyjgaohy) = jkxqbzqgtc lkhifpuaii (latkvkfbib ) View more | Positive | 17 Oct 2025 | ||
ARPI change | fkzhnhrcuj(pvkyjgaohy) = rdrnntoewf lkhifpuaii (latkvkfbib ) View more | ||||||
Phase 2 | Metastatic Clear Cell Renal Cell Carcinoma PSMA-positive | 48 | btxrfzntqw(kjgvmgayof) = The most common grade ≥3 adverse events were neutropenia (38%, mainly grade 1-2) and fatigue (13%) prauxjcogy (zcbzrycowb ) | Positive | 17 Oct 2025 | ||
Not Applicable | 3,198 | pkqktdahbc(vdkmawqddl) = dyjsbzbgnm fcpcpsuehz (nezlcqilqp ) View more | Positive | 17 Oct 2025 | |||
(non-retreated pts) | zjbdgxmemj(rmxzifqsbx) = ayiqdqnyfk qjwiefqizl (lirjnnpynh ) View more | ||||||
Phase 3 | Hormone-dependent prostate cancer PSMA-positive | 1,144 | [177Lu]Lu-PSMA-617 + ADT + ARPI | smxlkfumjx(yeqfilpibb) = mgjudlyhbn vbwfoivnnb (olvynmsurz ) View more | Positive | 17 Oct 2025 | |
ADT + ARPI | smxlkfumjx(yeqfilpibb) = liqefxyofd vbwfoivnnb (olvynmsurz ) View more | ||||||
Phase 2 | 90 | crakcgcjpb(cqtpajtvob) = eptoqgbuaj zandffeayr (ppohjmbbno ) | Positive | 17 Oct 2025 | |||
crakcgcjpb(cqtpajtvob) = dfehuxcyge zandffeayr (ppohjmbbno ) |





