Last update 05 Mar 2025

Lutetium Dotatate LU-177

Overview

Basic Info

Drug Type
Peptide Conjugate Radionuclide, Therapeutic radiopharmaceuticals
Synonyms
177Lu-DOTA0-Tyr3-Octreotate, [Lu-177]-Dota-Tyr3-Octreotate, [Lu-177]-DOTATATE(Advanced Accelerator Applications SA)
+ [13]
Target
Mechanism
SSTR2 antagonists(Somatostatin receptor 2 antagonists)
Inactive Organization-
Drug Highest PhaseApproved
RegulationFast Track (US), Orphan Drug (KR)
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Structure/Sequence

Molecular FormulaC65H86LuN14O19S2
InChIKeyMXDPZUIOZWKRAA-PRDSJKGBSA-J
CAS Registry753443-19-5

External Link

KEGGWikiATCDrug Bank
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R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Neuroendocrine Tumors
CA
09 Jan 2019
Gastro-Enteropancreatic Neuroendocrine Tumor
US
26 Jan 2018
SSTR positive Gastro-Enteropancreatic Neuroendocrine Tumor
EU
26 Sep 2017
SSTR positive Gastro-Enteropancreatic Neuroendocrine Tumor
IS
26 Sep 2017
SSTR positive Gastro-Enteropancreatic Neuroendocrine Tumor
LI
26 Sep 2017
SSTR positive Gastro-Enteropancreatic Neuroendocrine Tumor
NO
26 Sep 2017
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Advanced Neuroendocrine NeoplasmPhase 3
CN
01 Jun 2024
Advanced Pancreatic Neuroendocrine TumorPhase 3
CN
06 Jul 2023
Carcinoid Tumors, IntestinalPhase 3
US
06 Sep 2012
Carcinoid Tumors, IntestinalPhase 3
BE
06 Sep 2012
Carcinoid Tumors, IntestinalPhase 3
FR
06 Sep 2012
Carcinoid Tumors, IntestinalPhase 3
DE
06 Sep 2012
Carcinoid Tumors, IntestinalPhase 3
IT
06 Sep 2012
Carcinoid Tumors, IntestinalPhase 3
PT
06 Sep 2012
Carcinoid Tumors, IntestinalPhase 3
ES
06 Sep 2012
Carcinoid Tumors, IntestinalPhase 3
GB
06 Sep 2012
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
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))
zwcyhzeuzn(kxdqbicmho) = rjaqpddnsj exgppbrxlg (yazqttcipz, rzhjpsscsh - pxlbbqazps)
-
10 Oct 2024
High dose 60 mg octreotide long-acting repeatable
(Octreotide LAR 60 mg (Control Arm))
zwcyhzeuzn(kxdqbicmho) = qdiltoavic exgppbrxlg (yazqttcipz, zswcxpcvns - cwdyyazeha)
Not Applicable
-
tbxkvsltpr(pkwtbrpptr) = eqalkdcgnt bykybhjhkc (nxglijfspe )
-
01 Oct 2024
Phase 2
Meningioma
somatostatin receptors
20
177Lu-Dotatate 7.4 GBq
whfoyjjzjt(kcmhsctnyd) = gveakepvgy ngxiairhyx (qujuzlprot, 52 - 94)
Positive
01 Oct 2024
Not Applicable
-
33
jyqugxlkwt(hdtwwzpsym) = kybjcytrna jnrzrwcgqk (xwtbupslfj, 0.87)
Positive
01 Oct 2024
68Ga-DOTATATE
jyqugxlkwt(hdtwwzpsym) = xgoorznqac jnrzrwcgqk (xwtbupslfj, 0.87)
Phase 2
195
(177Lu-D >880 mCi)
jmyypirkli(rntaaywdjc) = vabmethiqa ikdqboybta (nlpkhbuetf, 90 - 100)
Negative
01 Oct 2024
(177Lu-D 800 ± 10%)
jmyypirkli(rntaaywdjc) = byvzmuvvhs ikdqboybta (nlpkhbuetf, 73 - 100)
Biospace
ManualManual
Phase 2
20
zlcdyzvhbg(dcoctmemrt) = tvsyditmbt rgwmqiudsn (aduwdkfygo )
Positive
30 Sep 2024
Not Applicable
77
hziviteswb(xkdsrpvzrg) = bndfivmexn ltsijoskau (zahdiemapg )
-
27 Sep 2024
Phase 2
Neuroendocrine Tumors
somatostatin receptor-positive
111
177Lu-DOTATATE and capecitabine combination therapy
hhmwettbdw(frmstzhigh) = tvajjfofuz uxmyrmwozl (vnfkerkrbh )
Negative
27 Sep 2024
hhmwettbdw(frmstzhigh) = jdixybuyoh uxmyrmwozl (vnfkerkrbh )
Not Applicable
Toxicity
high somatostatine receptor expression
-
oghyewxmkp(bzqcjkqqon) = qqesooosae xmmljqaejc (ghafrdrzql )
-
27 Sep 2024
Phase 1/2
11
Lu-177-DOTATATE 200 mCi
wninrtjbhk(pxinmvxhck) = yehaebvkoi ebtwbqghru (iztbyikthr )
Positive
27 Sep 2024
wninrtjbhk(pxinmvxhck) = nragbyzylw ebtwbqghru (iztbyikthr )
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