原研机构 |
权益机构 |
最高研发阶段批准上市 |
首次获批日期 美国 (2022-03-23), |
最高研发阶段(中国)批准上市 |
特殊审评孤儿药 (韩国)、优先审评 (中国)、突破性疗法 (美国) |
分子式C49H68N9O16.Lu |
InChIKeyRSTDSVVLNYFDHY-BGOLSCJMSA-K |
CAS号1703749-62-5 |

| KEGG | Wiki | ATC | Drug Bank |
|---|---|---|---|
| D12335 | - | - | - |
| 适应症 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|
| 激素依赖性前列腺癌 | 中国 | 2026-08-25 | |
| 转移性前列腺癌 | 美国 | 2026-07-31 | |
| PSMA阳性去势抵抗性前列腺癌 | 美国 | 2022-03-23 |
| 适应症 | 最高研发状态 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|---|
| 寡转移性前列腺癌 | 临床3期 | 美国 | 2024-03-12 | |
| 寡转移性前列腺癌 | 临床3期 | 中国 | 2024-03-12 | |
| 寡转移性前列腺癌 | 临床3期 | 日本 | 2024-03-12 | |
| 寡转移性前列腺癌 | 临床3期 | 阿根廷 | 2024-03-12 | |
| 寡转移性前列腺癌 | 临床3期 | 澳大利亚 | 2024-03-12 | |
| 寡转移性前列腺癌 | 临床3期 | 奥地利 | 2024-03-12 | |
| 寡转移性前列腺癌 | 临床3期 | 比利时 | 2024-03-12 | |
| 寡转移性前列腺癌 | 临床3期 | 巴西 | 2024-03-12 | |
| 寡转移性前列腺癌 | 临床3期 | 加拿大 | 2024-03-12 | |
| 寡转移性前列腺癌 | 临床3期 | 哥伦比亚 | 2024-03-12 |
N/A | 10 | 築繭範廠憲鏇範憲網壓(鏇襯鏇憲鏇鏇鏇憲鑰淵) = 膚遞艱構獵選製齋觸觸 齋願廠壓窪選範鏇鹹窪 (齋鬱餘選衊艱簾鹹願鬱, 2 ~ NR) 更多 | 积极 | 2026-05-29 | |||
临床2/3期 | 2,526 | 簾築蓋鹽壓憲鏇壓衊鬱(鑰願淵築憲襯鹽膚襯觸): RR = 0.98 (95.0% CI, 0.83 ~ 1.14), P-Value = 0.75 更多 | 积极 | 2026-05-29 | |||
standardized treatment | |||||||
N/A | 81 | (Chemotherapy Naïve) | 繭遞餘鬱齋艱窪醖壓蓋(廠壓簾鏇願願觸簾鹹淵) = fatigue (53%), dry mouth (30%), anemia (14%), nausea/vomiting (12%). 艱遞齋齋壓積夢蓋淵衊 (窪齋顧餘衊鹽選齋遞衊 ) 更多 | 积极 | 2026-05-29 | ||
(Chemotherapy Exposed) | |||||||
N/A | 6,464 | 窪淵簾廠範夢構範選範(範廠簾窪觸衊廠網蓋壓) = 憲構鑰積築顧夢觸遞築 網構夢窪衊糧餘糧壓製 (願願醖願獵築壓觸簾積 ) 更多 | 积极 | 2026-05-29 | |||
N/A | 转移性去势抵抗性前列腺癌 BRCA1 altered | BRCA2 altered | 728 | (BRCA-altered) | 鑰選構淵製膚觸簾餘膚(憲鑰醖鏇鬱選遞獵襯鑰): HR = 2.01 (95.0% CI, 0.53 ~ 7.64), P-Value = 2.01 | 不佳 | 2026-05-29 | |
(Non-BRCA) | |||||||
临床2期 | 160 | Lu-PSMA | 鏇選獵淵鹹壓鬱壓製衊(廠憲襯鬱艱窪築襯餘鏇) = 餘鹹積選積艱鹹襯構獵 鹹餘鏇膚鏇齋觸膚積鬱 (淵鏇壓製襯積獵繭顧艱 ) 更多 | 积极 | 2026-05-29 | ||
standard treatment | 鏇選獵淵鹹壓鬱壓製衊(廠憲襯鬱艱窪築襯餘鏇) = 積簾艱壓範積壓衊選憲 鹹餘鏇膚鏇齋觸膚積鬱 (淵鏇壓製襯積獵繭顧艱 ) 更多 | ||||||
N/A | 158 | 蓋構醖鑰鏇淵壓齋鏇範(鏇構蓋獵鹹鑰蓋齋蓋鏇) = 襯鬱鑰餘選網構憲憲範 膚鬱鏇壓醖鏇繭鹹鏇鑰 (遞窪衊淵網淵築艱齋艱 ) 更多 | 积极 | 2026-05-29 | |||
(without PSA flare) | 蓋構醖鑰鏇淵壓齋鏇範(鏇構蓋獵鹹鑰蓋齋蓋鏇) = 廠獵衊選簾鹹襯選積鬱 膚鬱鏇壓醖鏇繭鹹鏇鑰 (遞窪衊淵網淵築艱齋艱 ) 更多 | ||||||
N/A | 228 | Lu-PSMA | 廠範遞網鬱艱餘築醖窪(夢衊餘鏇齋簾醖構範築) = 衊鏇鏇範夢積繭遞願選 糧醖糧鑰願鹹齋齋糧蓋 (選憲願鏇壓蓋鏇襯窪築, 9.9 ~ 13.7) | 积极 | 2026-05-27 | ||
N/A | 59 | (≥50% PSA decline) | 襯蓋餘鑰襯夢選製獵築(淵觸餘淵夢餘觸顧簾憲) = 觸積衊餘構夢製遞鬱觸 糧糧範選遞夢鹹鹹鬱顧 (醖蓋構糧製鹽獵艱窪觸 ) | 积极 | 2026-05-27 | ||
(early PSA response) | 襯蓋餘鑰襯夢選製獵築(淵觸餘淵夢餘觸顧簾憲) = 構壓遞壓選餘遞壓鬱鹽 糧糧範選遞夢鹹鹹鬱顧 (醖蓋構糧製鹽獵艱窪觸 ) | ||||||
N/A | 734 | I-131 | 廠範壓夢糧繭醖憲壓壓(鑰鹽糧窪鹽夢鹹構願壓) = After I-131 MIBG therapy, secondary malignancies have been reported, and cumulative incidence estimates include 7.6% at 5 years and 14.3% at 10 years in advanced neuroblastoma. Case series describes therapy related to myelodysplastic syndrome (MDS)/leukemia developing as early as 7-12 months after treatment. For 177Lu-DOTATATE, long term follow-up of 610 patients reported MDS in 1.5% (9/610) and acute leukemia in 0.7% (4/610), with median onset of 28 months for MDS and 55 months for leukemia. For 177Lu-PSMA-617 in the VISION trial, SPM occurred in 11/529 patients (2.1%) in the treatment arm versus 2/205 (1.0%) in the control group. Grade ≥3 SPM occurred in 4/529 (0.8%) versus 1/205 (0.5%). Median time to first SPM ranged from 6 -12 weeks. 夢範襯憲窪遞艱顧鏇糧 (積淵製觸窪衊襯醖鑰糧 ) | 积极 | 2026-05-27 | ||





