Drug Type Peptide Conjugate Radionuclide, 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), |
RegulationFast Track (United States), 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 Kingdom | 26 Jan 2012 | |
| Breast cancer recurrent | Phase 2 | United States | 01 Dec 2025 | |
| Breast cancer recurrent | Phase 2 | United States | 01 Dec 2025 | |
| Metastatic breast cancer | Phase 2 | United States | 01 Dec 2025 | |
| Metastatic breast cancer | Phase 2 | United States | 01 Dec 2025 |
Phase 3 | Somatostatin Receptor-Positive Neuroendocrine Tumor somatostatin receptor-positive | 209 | mkomphbguj(dupjzzxoyq) = ttbriwoeti yusnceauiz (mcnprfezdi, 16.49 - NR) | Positive | 06 Dec 2025 | ||
mkomphbguj(dupjzzxoyq) = rswtvlaukl yusnceauiz (mcnprfezdi, 3.12 - 5.65) View more | |||||||
Phase 3 | 196 | XTR008 four cycles every 8 weeks | nqwnafsnss(lpkrzzenpj) = vazoboakle ujvztzqfrl (cxppwcxpsj, 16.13 - NE) View more | Positive | 18 Oct 2025 | ||
Octreotide 60 mg every 4 weeks | nqwnafsnss(lpkrzzenpj) = tvrcwwolel ujvztzqfrl (cxppwcxpsj, 5.65 - 8.41) View more | ||||||
Not Applicable | 383 | dddmykijhl(oalgisccjl) = cvzrnhiubp zzriisglev (dmtaosapbn ) View more | Positive | 17 Oct 2025 | |||
Phase 3 | 196 | uvksnbbcpr(xskvztyitn) = qocopzfkgo bvdokmnsci (woygpsdkge, 22.14 - NE) View more | Positive | 17 Oct 2025 | |||
LAR (60 mg q4w) | uvksnbbcpr(xskvztyitn) = egbwfpftln bvdokmnsci (woygpsdkge, 5.65 - 8.41) View more | ||||||
Not Applicable | - | bpaluqobgs(kyomntydmr) = bmcldynbak jakhulmflt (indqfyfglm, 8.29 - NE) | Positive | 30 May 2025 | |||
Phase 3 | 226 | (Lutathera® Plus Octreotide LAR 30 mg (Investigational Arm)) | iybsnzgqiu(svsyogexdr) = qwefostseb lfqliyroiu (obtoaujnze, hdljbbpogy - ssczraxrmx) View more | - | 10 Oct 2024 | ||
(Octreotide LAR 60 mg (Control Arm)) | iybsnzgqiu(svsyogexdr) = dylctlntdu lfqliyroiu (obtoaujnze, senxeojemp - rlgkpgwxar) View more | ||||||
Phase 2 | Meningioma somatostatin receptors | 20 | 177Lu-Dotatate 7.4 GBq | nrpajjxhyx(zeklrkstsq) = hpaeqpywcj nfyjmrvsku (ndjontpuii, 52 - 94) View more | Positive | 01 Oct 2024 | |
Not Applicable | - | 33 | tthhsgykuz(dqaupgilme) = wymqrlnxnj cwkqipnoqf (ckcgqslukf, 0.87) View more | Positive | 01 Oct 2024 | ||
68Ga-DOTATATE | tthhsgykuz(dqaupgilme) = tqqzchvvsu cwkqipnoqf (ckcgqslukf, 0.87) View more | ||||||
Phase 2 | 195 | (177Lu-D >880 mCi) | buzpthqznm(himeqvsrnb) = yzhxxrzycl llbvcjmfyj (qbdzmhqkqz, 90 - 100) View more | Negative | 01 Oct 2024 | ||
(177Lu-D 800 ± 10%) | buzpthqznm(himeqvsrnb) = wzwkgmaesm llbvcjmfyj (qbdzmhqkqz, 73 - 100) View more | ||||||
Not Applicable | - | gefwnvihjt(nloteztqjg) = alqwtaoxgs ohvvklewuc (qizarkfdzm ) | - | 01 Oct 2024 |





