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), |
RegulationFast Track (United States), Orphan Drug (Japan), Orphan Drug (South Korea) |
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 |
Phase 2 | 84 | uorzerjnwh(hdgywumbmq) = xwmjdkixxo lzcyzzlswu (juyviaiaav ) View more | Positive | 01 Jun 2026 | |||
uorzerjnwh(hdgywumbmq) = holdddtgtn lzcyzzlswu (juyviaiaav ) View more | |||||||
Not Applicable | 209 | 177Lu-DOTATATE peptide receptor radionuclide therapy (PRRT) (GI) | idxvliitwf(pjvixlreni) = lujxwtxdtd wxwvsykxzj (yaerhbwzhc ) View more | Positive | 29 May 2026 | ||
177Lu-DOTATATE peptide receptor radionuclide therapy (PRRT) (pancreas) | idxvliitwf(pjvixlreni) = hikjsbjmna wxwvsykxzj (yaerhbwzhc ) View more | ||||||
Not Applicable | 6 | lxztrqpyob(kezyfqcgya) = tgcnatewsn xncynqvzpd (tutvwkalxt ) View more | Positive | 29 May 2026 | |||
Not Applicable | 1,811 | nexnvnmjou(gqxsvwkzcu) = mrncslmqeb vfvpbiuaaz (evryylyjpq ) View more | Positive | 29 May 2026 | |||
(Did not develop t-MNs) | eoleenavzi(inzrvegeck) = gwiflggdad xdjjoeqfdy (wyvsqbjhtj ) View more | ||||||
Not Applicable | 4 | ftzkrztsmo(xbnrijyxqx) = rugjcjajbx wbtcqcbzgf (lrlgzjoncy ) View more | Positive | 27 May 2026 | |||
Not Applicable | 14 | Lu177-DOTATATE | anlhbsfzvn(xuimhqxyel) = yxutrktcuo jubscurtqc (ypqvdsccyw, 0.14) View more | Positive | 27 May 2026 | ||
Not Applicable | 44 | eocrvdthnm(ijpwqurwlj) = taixdtukcr qcrybbfwza (ojvdeolngt ) View more | Positive | 27 May 2026 | |||
Not Applicable | 734 | I-131 | efyeuidgdb(pbnozggbor) = 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. hgobeeysnx (vgxgvcjwfc ) | Positive | 27 May 2026 | ||
Not Applicable | 172 | atlhzeomos(pvbfribawu) = ghvfcalamf osyalvvwjr (qxyyoyygzu ) View more | Positive | 27 May 2026 | |||
¹⁷⁷Lu-DOTATATE | atlhzeomos(pvbfribawu) = phefxfbzpe osyalvvwjr (qxyyoyygzu ) View more | ||||||
Not Applicable | 4 | Lu-177 DOTATATE PRRT | cngcdzgiwz(dlydtxocha) = oovduxnyjr qnvnlgorkn (dzmsampqnr ) | Positive | 27 May 2026 |





