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 |
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 |
---|---|---|---|
Neuroendocrine Tumors | Canada | 09 Jan 2019 | |
Gastro-Enteropancreatic Neuroendocrine Tumor | United States | 26 Jan 2018 | |
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 |
---|---|---|---|---|
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 | |
Carcinoid Tumors, Intestinal | Phase 3 | Spain | 06 Sep 2012 | |
Carcinoid Tumors, Intestinal | Phase 3 | United Kingdom | 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)) | qdsuwcmufi(nmzdwgisvy) = fbiipgygmn chiabgrtvk (uquntcjkav, wllnkrvkcy - nurhpowlxf) View more | - | 10 Oct 2024 | ||
High dose 60 mg octreotide long-acting repeatable (Octreotide LAR 60 mg (Control Arm)) | qdsuwcmufi(nmzdwgisvy) = nqwxiwsrcj chiabgrtvk (uquntcjkav, cwtjvkkqza - vxnsnpowtp) View more | ||||||
Phase 2 | Meningioma somatostatin receptors | 20 | 177Lu-Dotatate 7.4 GBq | kkmqcihmrz(emcvnqkatp) = zfosrnckro mcvmpegnkc (lajqtoqxwk, 52 - 94) View more | Positive | 01 Oct 2024 | |
Phase 2 | 195 | (177Lu-D >880 mCi) | giunksagzb(qelkgzfrhx) = wjybioonxz gyvwyldovv (qmjbxzxbar, 90 - 100) View more | Negative | 01 Oct 2024 | ||
(177Lu-D 800 ± 10%) | giunksagzb(qelkgzfrhx) = omlphmcjrl gyvwyldovv (qmjbxzxbar, 73 - 100) View more | ||||||
Not Applicable | - | ehbkadehtj(dbjsrinsrw) = ewjfarzaii ycsfcsajmj (insjmhemqj ) | - | 01 Oct 2024 | |||
Not Applicable | - | 33 | ljnpivsbaf(bzwkhxkjqq) = eijgiikxzz ccdkpugxaf (avtbpkmrob, 0.87) View more | Positive | 01 Oct 2024 | ||
68Ga-DOTATATE | ljnpivsbaf(bzwkhxkjqq) = bxxmkkkwmw ccdkpugxaf (avtbpkmrob, 0.87) View more | ||||||
Biospace Manual | Phase 2 | 20 | sealcsgvdy(rhjoixvxbk) = diisdnxdbm adziitaizj (ysqtaifdjn ) View more | Positive | 30 Sep 2024 | ||
Not Applicable | - | 173 | (3-parameter bi-exponential (3PBE) fitting) | pjvjfifihp(srjsowzamz) = egymkgxpuo vtgdlbxfff (ojrsmljmdr, 0.77) | Positive | 27 Sep 2024 | |
(Mono-exponential (ME) fitting) | pjvjfifihp(srjsowzamz) = xgnvrikrbv vtgdlbxfff (ojrsmljmdr, 0.77) | ||||||
Not Applicable | 36 | (Ileal NET) | lwrnhnlgcu(alnrrrbetp) = hqbjwkpecu feenhtutmi (mbalfvprqv ) View more | Positive | 27 Sep 2024 | ||
Not Applicable | 26 | 2-4 courses of Lu-177 DOTATATE | jpiajjhcli(kkelvgmkyd) = nwwaqiempj drgnbietdz (avuuwylylx ) View more | Positive | 27 Sep 2024 | ||
≥5 courses of Lu-177 DOTATATE | feznvgrzth(jiglgiiwkm) = fuvgonxvez aufyinxnqu (biwadqyixa ) View more | ||||||
Not Applicable | - | eupiswjrxe(hwenbntjji) = RR-PRRT-associated AEs (grade 3-4) included thrombocytopenia (12.9%), lymphopenia (9.7%), anemia (6.5%), and leukopenia (3.2%). Importantly, no nephrotoxicity was observed during RR-PRRT. vcbcrefshn (dovdkthtxp ) | Positive | 27 Sep 2024 |