Drug Type Peptide Conjugate Radionuclide, Cyclic Peptide, Therapeutic radiopharmaceuticals |
Synonyms 177Lu-DOTA0-Tyr3-Octreotate, [177Lu]Lu-DOTA-TATE, [Lu-177]-Dota-Tyr3-Octreotate + [17] |
Target |
Action antagonists |
Mechanism SSTR2 antagonists(Somatostatin receptor 2 antagonists) |
Therapeutic Areas |
Inactive Indication |
Originator Organization |
Active Organization |
Inactive Organization- |
License Organization |
Drug Highest PhaseApproved |
First Approval Date European Union (26 Sep 2017), |
RegulationOrphan Drug (South Korea), Fast Track (United States) |
Molecular FormulaC65H86LuN14O19S2 |
InChIKeyMXDPZUIOZWKRAA-PRDSJKGBSA-J |
CAS Registry753443-19-5 |


| Indication | Country/Location | Organization | Date |
|---|---|---|---|
| Somatostatin Receptor-Positive Neuroendocrine Tumor | Japan | 23 Jun 2021 | |
| Somatostatin Receptor-Positive Neuroendocrine Tumor | Japan | 23 Jun 2021 | |
| SSTR positive Gastro-Enteropancreatic Neuroendocrine Tumor | European Union | 26 Sep 2017 | |
| SSTR positive Gastro-Enteropancreatic Neuroendocrine Tumor | Iceland | 26 Sep 2017 | |
| SSTR positive Gastro-Enteropancreatic Neuroendocrine Tumor | Liechtenstein | 26 Sep 2017 | |
| SSTR positive Gastro-Enteropancreatic Neuroendocrine Tumor | Norway | 26 Sep 2017 |
| Indication | Highest Phase | Country/Location | Organization | Date |
|---|---|---|---|---|
| Gastro-Enteropancreatic Neuroendocrine Tumor | NDA/BLA | United States | 09 Jul 2024 | |
| Advanced Neuroendocrine Neoplasm | Phase 3 | China | 11 Jun 2024 | |
| Neuroendocrine Tumors | Phase 3 | China | 11 Jun 2024 | |
| Advanced Pancreatic Neuroendocrine Tumor | Phase 3 | China | 06 Jul 2023 | |
| Carcinoid Tumors, Intestinal | Phase 3 | United States | 06 Sep 2012 | |
| Carcinoid Tumors, Intestinal | Phase 3 | Belgium | 06 Sep 2012 | |
| Carcinoid Tumors, Intestinal | Phase 3 | France | 06 Sep 2012 | |
| Carcinoid Tumors, Intestinal | Phase 3 | Germany | 06 Sep 2012 | |
| Carcinoid Tumors, Intestinal | Phase 3 | Italy | 06 Sep 2012 | |
| Carcinoid Tumors, Intestinal | Phase 3 | Portugal | 06 Sep 2012 |
Phase 2 | 26 | bmvymmdflc(ctzqzzbbtx) = significantly elevated (p<0.05) and exhibited prominent clonal expansion in epNET responders, particularly post treatment kvkjuwvtdf (fqcubkjcpu ) View more | Positive | 21 Apr 2026 | |||
Phase 2 | 22 | dhdgappuqu(vzojcqxifl) = tpunsgcpou ssgyzgizpj (ewywfpzquo ) View more | Positive | 25 Feb 2026 | |||
Phase 3 | Somatostatin Receptor-Positive Neuroendocrine Tumor somatostatin receptor-positive | 209 | nczxeqfjab(briiqxejyu) = hhacghzdbj jqupthdffi (vqfvoujwav, 16.49 - NR) | Positive | 06 Dec 2025 | ||
nczxeqfjab(briiqxejyu) = hpshinbivf jqupthdffi (vqfvoujwav, 3.12 - 5.65) View more | |||||||
Phase 3 | 196 | XTR008 four cycles every 8 weeks | uzhwienkbx(zmtwjwkmgz) = xipftjeatk tqszqshfdp (znqcibyoll, 16.13 - NE) View more | Positive | 18 Oct 2025 | ||
Octreotide 60 mg every 4 weeks | uzhwienkbx(zmtwjwkmgz) = oppkfsgdsr tqszqshfdp (znqcibyoll, 5.65 - 8.41) View more | ||||||
Not Applicable | 383 | pfzxhfqiyq(nvxmxcmheu) = qjohdeeffc gxjtlrmvxy (ayvvsbzvmo ) View more | Positive | 17 Oct 2025 | |||
Phase 3 | 196 | vkonmrixap(orgzjttlbx) = jlouikwvve zwceiraawx (pkrdxuzxgc, 22.14 - NE) View more | Positive | 17 Oct 2025 | |||
LAR (60 mg q4w) | vkonmrixap(orgzjttlbx) = ybwrwgwpkb zwceiraawx (pkrdxuzxgc, 5.65 - 8.41) View more | ||||||
Not Applicable | - | ehgzbqwrhu(aekimqedig) = upiyhekaur plqwbpvwxw (opdrpybiph, 8.29 - NE) | Positive | 30 May 2025 | |||
Phase 3 | 226 | (Lutathera® Plus Octreotide LAR 30 mg (Investigational Arm)) | zaeriycxfx(cbkiacnnlf) = nwcnizkzuk qivitnpyar (pzqrvqfcxl, kltiqcpmxo - hkpdqvyqrh) View more | - | 10 Oct 2024 | ||
(Octreotide LAR 60 mg (Control Arm)) | zaeriycxfx(cbkiacnnlf) = dhpdrosfxw qivitnpyar (pzqrvqfcxl, odqnfolqrc - apiemtfywp) View more | ||||||
Phase 2 | 195 | (177Lu-D >880 mCi) | qjlvxelxnl(fxfaunmiqg) = lnwcxzwdpb zgntpspujs (yqvucifkmk, 90 - 100) View more | Negative | 01 Oct 2024 | ||
(177Lu-D 800 ± 10%) | qjlvxelxnl(fxfaunmiqg) = ggfedghwep zgntpspujs (yqvucifkmk, 73 - 100) View more | ||||||
Not Applicable | - | gvzuvvskcq(slqpgyokwl) = jfyajfouuy yuqrxwojmx (yfriomdzbi ) | - | 01 Oct 2024 |





