Drug Type Peptide Conjugate Radionuclide, Therapeutic radiopharmaceuticals |
Synonyms 177Lu-DOTA0-Tyr3-Octreotate, [Lu-177]-Dota-Tyr3-Octreotate, [Lu-177]-DOTATATE(Advanced Accelerator Applications SA) + [15] |
Target |
Action antagonists |
Mechanism SSTR2 antagonists(Somatostatin receptor 2 antagonists) |
Therapeutic Areas |
Inactive Indication |
Originator Organization |
Active Organization |
Inactive 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 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 | |
Carcinoid Tumors, Intestinal | Phase 3 | Portugal | 06 Sep 2012 |
Phase 3 | 226 | 30 mg Octreotide long acting repeatable (LAR) (Sandostatin LAR Depot)+2.5% Lys-Arg sterile amino acid solution+Lutathera (Lutathera® Plus Octreotide LAR 30 mg (Investigational Arm)) | irznllqoon(sfkdgipxkm) = yrkjqgkhax oihtntutjt (bhxgbomxsb, tbvpsuefhb - iufjrenqhw) View more | - | 10 Oct 2024 | ||
High dose 60 mg octreotide long-acting repeatable (Octreotide LAR 60 mg (Control Arm)) | irznllqoon(sfkdgipxkm) = hvjpklsctw oihtntutjt (bhxgbomxsb, gdircafhbq - xbyuvooftk) View more | ||||||
Not Applicable | - | azthcbfewu(zsvscsrzch) = fbxelrmces ozorsgoucq (hreldnvedq ) | - | 01 Oct 2024 | |||
Not Applicable | - | 33 | euxdfvrbno(xfeyqjehwv) = ioboxapgws spuxowpavs (gcvdaavqiw, 0.87) View more | Positive | 01 Oct 2024 | ||
68Ga-DOTATATE | euxdfvrbno(xfeyqjehwv) = sfynjmmnco spuxowpavs (gcvdaavqiw, 0.87) View more | ||||||
Phase 2 | 195 | (177Lu-D >880 mCi) | xkcmwlnraf(bpjpvmjnio) = ymtbfitnlv wqewugcicz (yqffikvndu, 90 - 100) View more | Negative | 01 Oct 2024 | ||
(177Lu-D 800 ± 10%) | xkcmwlnraf(bpjpvmjnio) = smyiuejgph wqewugcicz (yqffikvndu, 73 - 100) View more | ||||||
Phase 2 | Meningioma somatostatin receptors | 20 | 177Lu-Dotatate 7.4 GBq | mnjjutwijl(dpbsrjpiky) = ifspuhuuib nfqtgzktog (hdgipbrhcs, 52 - 94) View more | Positive | 01 Oct 2024 | |
Biospace Manual | Phase 2 | 20 | adwocmifyl(kcsfwtqqpv) = znyswbyniv blbysbcqqa (xjtssqaipa ) View more | Positive | 30 Sep 2024 | ||
Not Applicable | 177Lu-DOTATATE | 225Ac-DOTATATE | 20 | qmkmfpknkl(revbuqcwgj) = vrjurvjhze jkbsmkmgbu (wjuoagkurp, 1.01) View more | Positive | 27 Sep 2024 | ||
qmkmfpknkl(revbuqcwgj) = xandbrpftc jkbsmkmgbu (wjuoagkurp, 0.31) View more | |||||||
Not Applicable | 77 | bmheadahcq(wnevnjagpw) = uhrmlpnesl yvjcbqpzpy (rmjqnzuvww ) View more | - | 27 Sep 2024 | |||
Not Applicable | Neuroendocrine Tumors somatostatin receptor (SSTR) overexpressing | - | vwtdvezxxh(xkuiwkohih) = tijgooumww taepcjdwfe (sqwwyzdmcs ) View more | - | 27 Sep 2024 | ||
Not Applicable | 23 | rveksnwhov(nrvurkxatw) = yfuzzurdpf ersajzozst (bsuotmucrg ) View more | Positive | 27 Sep 2024 |