Last update 05 Jul 2025

Lutetium Dotatate LU-177

Overview

Basic Info

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)
Inactive Organization-
Drug Highest PhaseApproved
First Approval Date
RegulationFast Track (United States), Orphan Drug (South Korea)
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Structure/Sequence

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

KEGGWikiATCDrug Bank
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R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
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
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Gastro-Enteropancreatic Neuroendocrine TumorNDA/BLA
United States
09 Jul 2024
Neuroendocrine CarcinomaPhase 3
China
11 Jun 2024
Neuroendocrine TumorsPhase 3
China
11 Jun 2024
Advanced Neuroendocrine NeoplasmPhase 3
China
01 Jun 2024
Advanced Pancreatic Neuroendocrine TumorPhase 3
China
06 Jul 2023
Carcinoid Tumors, IntestinalPhase 3
United States
06 Sep 2012
Carcinoid Tumors, IntestinalPhase 3
Belgium
06 Sep 2012
Carcinoid Tumors, IntestinalPhase 3
France
06 Sep 2012
Carcinoid Tumors, IntestinalPhase 3
Germany
06 Sep 2012
Carcinoid Tumors, IntestinalPhase 3
Italy
06 Sep 2012
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Not Applicable
Olfactory Esthesioneuroblastoma
First line | Second line
somatostatin receptor (SSTR)
-
howgjiwwmw(lfgodiydfv) = obqntdrhik crgabxejnd (lhenxbjntv, 8.29 - NE)
Positive
30 May 2025
Not Applicable
-
kpzxbcxyff(eafaxxnany) = potentially novel case of acute pulmonary hypersensitivity reaction to Lu-177 psmbefvtov (jmoifberox )
-
16 May 2025
Phase 3
226
Sandostatin LAR+Lys-Arg+Octreotide long acting repeatable+Lutathera
(Lutathera® Plus Octreotide LAR 30 mg (Investigational Arm))
lnirvekvnd(melpwhqmhv) = pbhabaovof opfdonzwfh (dplqadzbey, khfbikrziy - uhnajttyvu)
-
10 Oct 2024
(Octreotide LAR 60 mg (Control Arm))
lnirvekvnd(melpwhqmhv) = bqczqltjxx opfdonzwfh (dplqadzbey, dcvddshljl - xoyeekxsiv)
Not Applicable
-
hevghublzk(ozyszgzcdt) = llyjfrgtsv oragrpbthb (vvshfursoj )
-
01 Oct 2024
Phase 2
Meningioma
somatostatin receptors
20
177Lu-Dotatate 7.4 GBq
osbgshgmkd(imswzsdfzu) = owlgmpsoek cubqlryoht (aiakopaadi, 52 - 94)
Positive
01 Oct 2024
Phase 2
195
(177Lu-D >880 mCi)
haghnijwwi(batzenizac) = spschkbgru hikvbolnsa (ddbgahzcto, 90 - 100)
Negative
01 Oct 2024
(177Lu-D 800 ± 10%)
haghnijwwi(batzenizac) = nwgucqiyld hikvbolnsa (ddbgahzcto, 73 - 100)
Not Applicable
-
33
yzvfcugpmy(iomeynldrc) = uwysxkybac uyrlszaaam (qhicocuwxu, 0.87)
Positive
01 Oct 2024
68Ga-DOTATATE
yzvfcugpmy(iomeynldrc) = eteoyaessr uyrlszaaam (qhicocuwxu, 0.87)
Biospace
ManualManual
Phase 2
20
imiightfwv(qsxrikpznf) = dieouusvza nhlxoanmzd (zewyteamjr )
Positive
30 Sep 2024
Not Applicable
77
lxhwldoveu(xeflinghvf) = zpngagzeel rrwghuhjnf (jarzfzltku )
-
27 Sep 2024
Not Applicable
-
pieovsdywy(yfjclwglea) = 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. sbzlrkwoyb (nommdgvcfs )
Positive
27 Sep 2024
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Translational Medicine

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Deal

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Core Patent

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Clinical Trial

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Approval

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Biosimilar

Competitive landscape of biosimilars in different countries/locations. Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3.
Competitive landscape of biosimilars in different countries/locations. Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3.

Regulation

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