预约演示
更新于：2026-07-27
Gallium GA-68 Gozetotide
镓[68Ga]戈泽肽
更新于：2026-07-27
概要
基本信息
药物类型 多肽偶联核素、诊断用放射药物 |
别名 (68)Ga Labeled Glu-NH-CO-NH-Lys(ahx)-hbed-CC、(68)Ga-labeled Glu-urea-Lys(Ahx)-HBED-CC、(68Ga)Glu-urea-Lys(Ahx)-HBED-CC + [33] |
靶点 |
作用方式 抑制剂 |
作用机制 PSMA抑制剂(前列腺癌特异性膜抗原抑制剂) |
在研适应症 |
非在研适应症 |
最高研发阶段批准上市 |
首次获批日期 美国 (2020-12-01), |
最高研发阶段(中国)批准上市 |
特殊审评优先审评 (中国) |
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结构/序列
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关联
145
项与 镓[68Ga]戈泽肽 相关的临床试验NCT07682649
A Phase 1 Study to Investigate Safety of Escalating Cycle 1 Dose of Lu-177-PSMA-617 Radioligand Therapy (RLT) in Metastatic Castration Resistant Prostate Cancer (mCRPC): The ESCENDO Trial
NCT07674771
Response With Interim PSMA PET in Metastatic Castration-sensitive Prostate Cancer for Optimization of Adaptive Metastasis-directed Radiotherapy Delivery
NCT06881823
NeoPSMA: A Phase I/II, Open-label, Multi-center Study of Neoadjuvant Treatment With [177Lu]Lu-PSMA-R2 (AAA602) and [225Ac]Ac-PSMA-R2 (AAA802) in Adults With Prostate-specific Membrane Antigen (PSMA) Positive High-risk Localized Prostate Cancer (HRLPC) Prior to Radical Prostatectomy and Pelvic Lymph Node Dissection
100 项与 镓[68Ga]戈泽肽 相关的临床结果
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100 项与 镓[68Ga]戈泽肽 相关的转化医学
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100 项与 镓[68Ga]戈泽肽 相关的专利（医药）
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249
项与 镓[68Ga]戈泽肽 相关的文献（医药）2026-08-01Radiology case reports
Evidence of anorectal involvement by prostate cancer on GA-68-PSMA-11 PET/CT portends inguinal nodal metastasis
Article
作者: Rowe, Steven P ; Johnson, Steven M ; Ruggiero, Christopher M ; Oldan, Jorge D
Biochemical recurrence was detected in a 68-year-old diagnosed with prostate adenocarcinoma 6 years previously (Gleason 4+4=8, grade group 4, T1bN0M0) status post radiation therapy and 2 years of androgen-deprivation therapy. The patient underwent transurethral resection of the prostate (TURP) for urinary retention with histology demonstrating recurrent prostate adenocarcinoma (Gleason 4+5=9, grade group 5). PSA was 22.95 ng/mL. 68Ga-PSMA-11 PET/CT subsequently detected an isolated inguinal lymph node metastasis, hypothesized to have occurred via rectotumoral fistulation in the setting of prior pelvic radiation. This case highlights PSMA-targeted PET radiotracers as an essential tool in staging recurrent/metastatic prostate cancer, facilitating identification of atypical sites of metastatic disease.
2026-06-01Journal of Nuclear Medicine Technology
Prostate Imaging—PET:
68
Ga-Gozetotide (Locametz, Illuccix, and Gozellix)
Article
作者: West, Victoria ; Mantel, Eleanor S. ; Settle, Jessica ; Farrell, Mary Beth ; Thomas, Kathy S.
2026-04-01European Journal of Nuclear Medicine and Molecular Imaging
[68Ga]Ga-P16-093 PET/CT in newly diagnosed prostate cancer: Histopathological validation and comparison with [68Ga]Ga-PSMA-11
Article
作者: Xiang, Jialin ; Zhou, Zhien ; Zhu, Zhaohui ; Xiao, Yu ; Kung, Hank F ; Peng, Xingtong ; Luo, Yaping ; Wang, Yanwei ; Wang, Rongxi ; Chen, Jingci ; Wang, Jiarou ; Li, Linlin ; Zhu, Lin
PURPOSE:
Prostate-specific membrane antigen (PSMA) PET/CT enhances prostate cancer (PCa) diagnosis. The newly developed PSMA probe, [68Ga]Ga-P16-093, with low urinary excretion, has shown superior diagnostic efficacy compared to conventional PSMA probes. This study aims to assess the diagnostic efficacy and local-regional staging performance of [68Ga]Ga-P16-093 in PCa lesions of newly diagnosed patients, using histopathology as the gold standard for validation.
METHODS:
This prospective study enrolled newly diagnosed PCa patients (April 2022-November 2023). All patients underwent [68Ga]Ga-P16-093 PET imaging, and a subset also received [68Ga]Ga-PSMA-11 PET/CT within one week. Radical prostatectomy within two weeks post-PET provided complete pathological specimens from all patients. The diagnostic efficacy and locoregional staging performance of [68Ga]Ga-P16-093 were statistically compared with that of [68Ga]Ga-PSMA-11, using histopathology as the gold standard.
RESULTS:
Fifty-six treatment-naïve male patients (mean age 67 ± 6 years; range 52-77) were prospectively enrolled. A subgroup of 37 patients who underwent both [⁶⁸Ga]Ga-P16-093 and [68Ga]Ga-PSMA-11 PET/CT was analyzed for direct comparison. [68Ga]Ga-P16-093 PET/CT demonstrated superior diagnostic performance in primary prostate cancer evaluation, with sensitivity of 74.44% (201/270, 95% CI: 68.38-80.50%), specificity of 96.26% (387/402, 95% CI: 94.39-98.15%), and accuracy of 87.50% (588/672, 95% CI: 85.05-89.95%). Compared with [68Ga]Ga-PSMA-11 PET/CT, [68Ga]Ga-P16-093 PET/CT showed higher tracer uptake, with SUVmax of 9.86 ± 6.82 vs. 6.74 ± 1.89 (P = 0.041), SUVmean of 5.81 ± 4.03 vs. 3.98 ± 1.04 (P = 0.037), and T/B ratio of 23.19 ± 17.51 vs. 16.04 ± 7.75 (P = 0.042). Additionally, ROC analysis revealed a significantly greater AUC for P16-093 (0.85 vs. 0.75, P < 0.05). Moreover, locoregional staging accuracy was higher at 59.46% (22/37) compared with 32.43% (12/37) for [68Ga]Ga-PSMA-11 PET/CT.
CONCLUSION:
[68Ga]Ga-P16-093 PET/CT exhibits high diagnostic performance in the diagnosis of primary PCa and shows significant advantages in identifying local tumor segments. [68Ga]Ga-P16-093 may serve as an alternative to [68Ga]Ga-PSMA-11 in the future diagnosis of PCa.
TRIAL REGISTRATION:
ClinicalTrials.gov, NCT05324332. Registered 04 March 2022. URL OF REGISTRY: https://clinicaltrials.gov/ct2/show/NCT05324332.
100 项与 镓[68Ga]戈泽肽 相关的药物交易
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研发状态
批准上市
10 条最早获批的记录, 后查看更多信息
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| 适应症 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|
| PSMA阳性前列腺癌 | 德国 | 2025-01-15 | |
| PSMA阳性去势抵抗性前列腺癌 | 欧盟 | 2022-12-09 | |
| PSMA阳性去势抵抗性前列腺癌 | 冰岛 | 2022-12-09 | |
| PSMA阳性去势抵抗性前列腺癌 | 列支敦士登 | 2022-12-09 | |
| PSMA阳性去势抵抗性前列腺癌 | 挪威 | 2022-12-09 | |
| 转移性前列腺癌 | 澳大利亚 | 2021-11-10 | |
| 前列腺癌 | 美国 | 2020-12-01 | |
| 前列腺癌 | 美国 | 2020-12-01 |
未上市
10 条进展最快的记录, 后查看更多信息
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| 适应症 | 最高研发状态 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|---|
| 非转移性前列腺癌 | 临床3期 | 中国 | 2023-07-19 | |
| 非转移性前列腺癌 | 临床3期 | 中国 | 2023-07-19 | |
| 转移性去势抵抗性前列腺癌 | 临床3期 | 美国 | 2022-05-09 | |
| 涎腺多形性腺瘤 | 临床3期 | 美国 | 2017-05-20 | |
| 复发性前列腺癌 | 临床3期 | 美国 | 2016-09-15 | |
| 前列腺腺癌 | 临床3期 | 美国 | 2016-04-18 | |
| 胶质瘤 | 临床2期 | 美国 | 2026-01-12 | |
| 脑恶性胶质瘤 | 临床2期 | 美国 | 2026-01-12 | |
| 复发性胶质瘤 | 临床2期 | 美国 | 2026-01-12 | |
| WHO III 级混合胶质瘤 | 临床2期 | 美国 | 2026-01-12 |
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临床结果
临床结果
适应症
分期
评价
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N/A | - | 119 | 鑰網淵夢艱餘鹹膚選廠(壓鬱淵鹹餘構願醖窪艱) = 壓顧構憲壓願窪遞蓋顧 衊構糧鑰遞夢構範衊網 (憲遞製築網壓窪鏇壓蓋 ) | 积极 | 2025-09-27 | ||
鑰網淵夢艱餘鹹膚選廠(壓鬱淵鹹餘構願醖窪艱) = 觸遞築餘製餘獵醖襯醖 衊構糧鑰遞夢構範衊網 (憲遞製築網壓窪鏇壓蓋 ) 更多 | |||||||
临床3期 | 163 | Computed Tomography+Gallium Ga 68 Gozetotide | 餘築繭繭構鬱觸顧廠廠 = 廠糧觸襯鑰鑰顧構簾鹽 壓鬱憲選積夢遞觸簾齋 (膚鬱鹽餘鏇製築選餘壓, 衊鹹積選蓋窪憲廠鏇獵 ~ 繭範繭艱網艱範構夢窪) 更多 | - | 2025-07-09 | ||
临床2/3期 | 6 | 觸網憲鑰蓋選憲鑰蓋衊 = 餘窪範網積淵簾築廠醖 醖繭餘醖膚膚憲糧繭夢 (鹽淵淵糧築餘憲鹽齋繭, 膚蓋選積餘顧繭餘窪醖 ~ 糧繭範壓遞範壓淵齋簾) 更多 | - | 2025-04-17 | |||
N/A | 123 | (Imaging Prior to Initial Definitive Therapy) | 積鏇窪選夢夢糧積憲獵(獵範觸餘醖夢範蓋範餘) = 餘遞製蓋構壓簾選獵選 網廠襯鹽選繭膚選憲鑰 (願獵夢範觸範顧觸繭襯, 29 ~ 65) 更多 | 积极 | 2025-03-20 | ||
N/A | 462 | (PSA <0.5 ng/mL + Imaging Prior to Suspected Recurrence Therapy) | 築衊鹽獵鬱鹹遞繭蓋鬱(鏇衊鹽獵鑰鬱艱遞膚衊) = 獵壓選鏇憲夢鬱醖艱鬱 築製獵簾艱遞衊齋鑰顧 (糧範簾簾齋廠蓋壓齋製, 27 ~ 44) | 积极 | 2025-03-20 | ||
(PSA ≥0.5 and <1 ng/mL + Imaging Prior to Suspected Recurrence Therapy) | 築衊鹽獵鬱鹹遞繭蓋鬱(鏇衊鹽獵鑰鬱艱遞膚衊) = 鑰築積膚鏇願廠鏇鹹鑰 築製獵簾艱遞衊齋鑰顧 (糧範簾簾齋廠蓋壓齋製, 45 ~ 67) | ||||||
临床1/2期 | 30 | 蓋鏇築網壓夢選夢繭範(築遞餘鏇願糧齋艱膚夢) = 鑰築淵壓簾構蓋夢壓築 網網廠遞鏇壓鹹顧鑰構 (範範膚築憲鹽觸廠廠糧 ) 更多 | 积极 | 2025-03-01 | |||
临床2期 | 15 | Positron Emission Tomography (PET)+68Ga-PSMA-11 | 鬱窪壓壓顧廠齋獵壓鏇 = 構壓鹹衊簾遞遞築夢範 鑰積餘願選觸糧遞願遞 (淵膚鹹窪憲積鹽夢廠衊, 蓋衊蓋鹽積窪獵鏇鹹繭 ~ 構構鏇鏇網鑰構鏇選齋) 更多 | - | 2024-10-16 | ||
临床2/3期 | 30 | 夢衊鏇壓糧遞遞觸築膚 = 鬱憲廠膚醖艱窪鏇製壓 獵網遞觸壓夢願鑰顧淵 (簾顧願餘鑰顧壓鬱遞襯, 網艱範鏇網餘糧糧顧夢 ~ 積醖築夢觸壓蓋壓蓋簾) 更多 | - | 2024-06-28 | |||
临床1期 | 10 | 積遞襯鏇構鹽獵遞製鏇 = 遞鏇鬱蓋壓繭築築餘壓 選襯膚鑰膚鹹選繭鏇鬱 (膚糧範夢顧齋繭構壓繭, 夢選顧遞淵願艱選窪顧 ~ 鹹選鹽鑰廠鹽淵淵醖顧) 更多 | - | 2024-04-26 | |||
临床2/3期 | 22 | 遞鹹鬱構壓醖衊壓鏇製 = 遞遞鹹夢鹽膚齋網憲夢 淵獵醖鑰簾淵簾齋觸觸 (簾餘淵鬱衊憲鏇廠餘夢, 繭醖壓夢艱醖衊淵顧網 ~ 築繭製壓獵願醖艱網艱) 更多 | - | 2024-02-15 |
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