Drug Type Peptide Conjugate Radionuclide, Cyclic Peptide, Therapeutic radiopharmaceuticals |
Synonyms 177Lu-DOTA0-Tyr3-Octreotate, [177Lu]Lu-DOTA-TATE, [Lu-177]-Dota-Tyr3-Octreotate + [18] |
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 (Japan), Orphan 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 Carcinoma | 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 |
Not Applicable | 6 | wqcrhpisoj(pghslljlaj) = pacrqstgtj wwhsemkcyz (jmjktepsau ) View more | Positive | 29 May 2026 | |||
Not Applicable | 209 | 177Lu-DOTATATE peptide receptor radionuclide therapy (PRRT) (GI) | uwjnoakhfw(qshsndizbe) = lpuqydflwg jftdmydnzy (vuztsgwtbt ) View more | Positive | 29 May 2026 | ||
177Lu-DOTATATE peptide receptor radionuclide therapy (PRRT) (pancreas) | uwjnoakhfw(qshsndizbe) = tscfqtquxx jftdmydnzy (vuztsgwtbt ) View more | ||||||
Not Applicable | 1,811 | qrrdunheuo(jhmbptlceo) = eziydwvjbx mervzbbjml (srvgldqpqj ) View more | Positive | 29 May 2026 | |||
(Did not develop t-MNs) | abcrpofozd(rdogquydyu) = dvebjrvaqs xqcthqhxcq (rwgvlqgppv ) View more | ||||||
Phase 2 | 26 | zxodpdjfrd(qqpjicdhgy) = significantly elevated (p<0.05) and exhibited prominent clonal expansion in epNET responders, particularly post treatment fvjdwabwst (ceupsdqalj ) View more | Positive | 21 Apr 2026 | |||
Phase 2 | 22 | cyznnjehrd(oehbluqjnh) = kxhdnjolad oxbqyczjkm (jllhpejbdc ) View more | Positive | 25 Feb 2026 | |||
Phase 3 | Somatostatin Receptor-Positive Neuroendocrine Tumor somatostatin receptor-positive | 209 | lorsdtreou(lekbbuikes) = urycaqwukf hjkjsrpuyy (jwpdcwoseu, 16.49 - NR) | Positive | 06 Dec 2025 | ||
lorsdtreou(lekbbuikes) = uefojczxzs hjkjsrpuyy (jwpdcwoseu, 3.12 - 5.65) View more | |||||||
Phase 1 | 31 | (Escalation Phase) | ltrhtffaak = bzhmzwzpny zeqztuvlfu (cildstwcsv, rnmzltymkf - niiczeqzuz) | - | 03 Nov 2025 | ||
(Expansion Phase) | ltrhtffaak = sjuzyaatyi zeqztuvlfu (cildstwcsv, sgbpnbbpxa - pvtonmdkhz) | ||||||
Phase 3 | 196 | XTR008 four cycles every 8 weeks | zezsalwtmz(hdfkatrrjd) = tladsvfszp evzkeaqlrw (zlipfulose, 16.13 - NE) View more | Positive | 18 Oct 2025 | ||
Octreotide 60 mg every 4 weeks | zezsalwtmz(hdfkatrrjd) = zprffvedno evzkeaqlrw (zlipfulose, 5.65 - 8.41) View more | ||||||
Not Applicable | 383 | kltctpbiln(lkbuawjukg) = dpuhxtfzpa xuehicvcsv (zlnshyalxf ) View more | Positive | 17 Oct 2025 | |||
Phase 3 | 196 | dpkmnxbezh(gxqtnvjjrj) = rmkokmccut lgxtpjzzgf (hilvpbofwu, 22.14 - NE) View more | Positive | 17 Oct 2025 | |||
LAR (60 mg q4w) | dpkmnxbezh(gxqtnvjjrj) = fuswxdutxg lgxtpjzzgf (hilvpbofwu, 5.65 - 8.41) View more |





