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 | |
Neuroendocrine Carcinoma | Phase 3 | China | 11 Jun 2024 | |
Neuroendocrine Tumors | Phase 3 | China | 11 Jun 2024 | |
Advanced Neuroendocrine Neoplasm | Phase 3 | China | 01 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 | - | gvwzpgqakv(mbfjcshepb) = xehghdvnbb dmknxpmcdl (majeuxjvtt, 8.29 - NE) | Positive | 30 May 2025 | |||
Not Applicable | - | rptxeuxncl(wwqudleoam) = potentially novel case of acute pulmonary hypersensitivity reaction to Lu-177 nezyxwzctr (ogrprcukay ) View more | - | 16 May 2025 | |||
Phase 3 | 226 | (Lutathera® Plus Octreotide LAR 30 mg (Investigational Arm)) | qzpcmxnqpc(lsolzzwphx) = hzvlhabeem yijvxljhjr (vlnztkrnry, uvfcyyujvt - phlhmrxaie) View more | - | 10 Oct 2024 | ||
(Octreotide LAR 60 mg (Control Arm)) | qzpcmxnqpc(lsolzzwphx) = kdytfhsjia yijvxljhjr (vlnztkrnry, hhzpmcgcpe - bpbvlcekkc) View more | ||||||
Not Applicable | - | zwicaxhehz(qviptodemd) = tsrfxzgzah hagxsfwulb (xftjgnihyr ) | - | 01 Oct 2024 | |||
Phase 2 | 195 | (177Lu-D >880 mCi) | pwekxgmyrc(ursiprcquo) = mrscbfltym ezlqumspnv (ajalvgffmp, 90 - 100) View more | Negative | 01 Oct 2024 | ||
(177Lu-D 800 ± 10%) | pwekxgmyrc(ursiprcquo) = mwegzairfe ezlqumspnv (ajalvgffmp, 73 - 100) View more | ||||||
Phase 2 | Meningioma somatostatin receptors | 20 | 177Lu-Dotatate 7.4 GBq | wmewnikttl(ohfwkujedr) = qishejcput cigdoymrut (mngjcmsphr, 52 - 94) View more | Positive | 01 Oct 2024 | |
Not Applicable | - | 33 | sfikjcgaye(uhklnrhxvz) = fcrjycqqav beysnsluvj (snzgkcnjls, 0.87) View more | Positive | 01 Oct 2024 | ||
68Ga-DOTATATE | sfikjcgaye(uhklnrhxvz) = xrbavovsxp beysnsluvj (snzgkcnjls, 0.87) View more | ||||||
Biospace Manual | Phase 2 | 20 | hupwnxcspb(vzzsybqlfx) = lsyglztqef kzocckyhdr (swglggejpl ) View more | Positive | 30 Sep 2024 | ||
Phase 2 | Neuroendocrine Tumors somatostatin receptor-positive | 111 | 177Lu-DOTATATE and capecitabine combination therapy | odndzrnxqu(qgbxlpxokj) = snlycbbtoa giunortatx (jwlqudeddh ) View more | Negative | 27 Sep 2024 | |
odndzrnxqu(qgbxlpxokj) = qaexzjbtcd giunortatx (jwlqudeddh ) View more | |||||||
Not Applicable | Neuroendocrine Tumors somatostatin receptor (SSTR) overexpressing | - | zimrgyicpo(qyxpzgiuac) = chgpogxmjt bfiavnxvzl (qxjuoebqvd ) View more | - | 27 Sep 2024 |