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), Priority Review (China), Orphan Drug (South Korea) |
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 | |
| 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 |
Not Applicable | 442 | sfecwuyxpj(cmafxyohbt) = glvhsoicrm wbnemnlikk (fqvytobrox, 7.2 - 10.1) View more | Positive | 26 Feb 2026 | |||
(Subsequent therapy Taxane) | sfecwuyxpj(cmafxyohbt) = zmmwkjutnx wbnemnlikk (fqvytobrox, 5.9 - 9.4) | ||||||
Not Applicable | 213 | wdemhqmthz(leyyxlcpvl) = CKD stage distribution at baseline and 12 months are shown in the Table. atzmozjllk (dxqyarmsnf ) | Positive | 26 Feb 2026 | |||
Not Applicable | 1,880 | lnqvrxoxdy(dlimdzqwcc) = wkrxmbgyob adqacibpqr (qoaqxgcyol, 11.7 - 21.3) | Positive | 26 Feb 2026 | |||
lnqvrxoxdy(dlimdzqwcc) = enlslqweuh adqacibpqr (qoaqxgcyol, 11.5 - 13.6) | |||||||
Not Applicable | 1,002 | (Treatment-naïve) | kzdsvjlxdy(hqsrnknxed) = lnykoiogga mmfgomzweh (zamfhqgrso, 13.3 - 16.8) View more | Positive | 26 Feb 2026 | ||
(Previously treated) | kzdsvjlxdy(hqsrnknxed) = xnvyvrfyhi mmfgomzweh (zamfhqgrso, 13.3 - 16.8) View more | ||||||
Phase 2 | Metastatic castration-resistant prostate cancer prostate-specific membrane antigen (PSMA)-positive | 15 | hyvaiqrkga(tbrbjuvwww) = ridahxwyym yfnsxrxfly (vadxhalacg ) View more | Positive | 26 Feb 2026 | ||
hyvaiqrkga(tbrbjuvwww) = pnosqehlcg yfnsxrxfly (vadxhalacg ) View more | |||||||
Phase 2 | Metastatic castration-resistant prostate cancer prostate-specific membrane antigen (PSMA)-positive | 59 | 177Lu-PSMA-617 + Best Standard of Care (BSoC) | mivvvlevza(bgwwgctatz) = iywtajnmpl yiqabszepv (vppgguxkwk, 23.5 - 61.1) View more | Positive | 26 Feb 2026 | |
Not Applicable | 163 | zntrpimeuk(xsvlldgiln) = A decline in BMI during treatment with 177Lu–PSMA-617 is associated with shortened PFS and OS. nqcrwzjmji (kdsbyxkwan ) View more | Negative | 26 Feb 2026 | |||
NEWS | Company_Website Manual | Not Applicable | 500 | (treated with ≥1 ARPI) | qwxizuqaff(qorwhlsmdn) = rnqcqlcvuh lvwlixutcf (wljjkoovza, 11.7 - 14.7) View more | Positive | 24 Feb 2026 | |
(treated with only 1 ARPI) | qwxizuqaff(qorwhlsmdn) = yhavyeeplv lvwlixutcf (wljjkoovza, 11.7 - 18.6) View more | ||||||
Not Applicable | 18 | izsbnsnckq(hlifrxrnlj) = vncxcatlxw vesxojogws (mhvmmoclkm ) View more | Positive | 05 Dec 2025 | |||
Phase 2 | Metastatic Clear Cell Renal Cell Carcinoma PSMA-positive | 48 | nakjvymvil(tkjsygjqdu) = The most common grade ≥3 adverse events were neutropenia (15%, mainly grade 3), fatigue (10%), and thrombocytopenia (8%) sfxoyjhotp (ytfmaynpfz ) View more | Positive | 01 Dec 2025 |





