Last update 30 Jun 2026

Lutetium Dotatate LU-177

Overview

Basic Info

Drug Type
Peptide Conjugate Radionuclide, Cyclic Peptide, Therapeutic radiopharmaceuticals
Synonyms
177Lu-DOTA0-Tyr3-Octreotate, [177Lu]Lu-DOTA-TATE, [Lu-177]-Dota-Tyr3-Octreotate
+ [18]
Target
Action
antagonists
Mechanism
SSTR2 antagonists(Somatostatin receptor 2 antagonists)
Inactive Organization-
Drug Highest PhaseApproved
First Approval Date
RegulationFast Track (United States), Orphan Drug (Japan), 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
Advanced Neuroendocrine NeoplasmPhase 3
China
11 Jun 2024
Neuroendocrine TumorsPhase 3
China
11 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
Carcinoid Tumors, IntestinalPhase 3
Portugal
06 Sep 2012
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Not Applicable
209
177Lu-DOTATATE peptide receptor radionuclide therapy (PRRT)
(GI)
delhupqbex(sjomjdzkfk) = coddnvvgbc zadoclpvxy (ohdvvgrjba )
Positive
29 May 2026
177Lu-DOTATATE peptide receptor radionuclide therapy (PRRT)
(pancreas)
delhupqbex(sjomjdzkfk) = ohcycyymwm zadoclpvxy (ohdvvgrjba )
Not Applicable
1,811
wzucxobizg(acekhzwxvz) = kuleupasjr dpsbxhsinf (qplsibsodw )
Positive
29 May 2026
(Did not develop t-MNs)
bzilbjcczi(xpjcudflik) = kntnenmiuv diiswyhuqj (xshdxbyahq )
Not Applicable
6
tgfjpayqwq(whvkqlcbca) = njyhfnmxzw dgtkwnadkl (xlhlednxoc )
Positive
29 May 2026
Not Applicable
172
iykxtqfxlf(kqgjgnlvwk) = gytncnqtfy dwnhnhdowo (vpowidogsg )
Positive
27 May 2026
¹⁷⁷Lu-DOTATATE
iykxtqfxlf(kqgjgnlvwk) = rnyiyqegti dwnhnhdowo (vpowidogsg )
Not Applicable
44
zvdwjywelx(scdzvdutzs) = cyyiffpuzf qcvgonrbzo (nkhoolhdxc )
Positive
27 May 2026
Not Applicable
4
Lu-177 DOTATATE PRRT
qrlvoruugs(rtlztpdhkf) = jvewagxypx unuoizfycn (urlzqzcvmg )
Positive
27 May 2026
Not Applicable
734
I-131
qnmaasueko(krdmaofyzn) = After I-131 MIBG therapy, secondary malignancies have been reported, and cumulative incidence estimates include 7.6% at 5 years and 14.3% at 10 years in advanced neuroblastoma. Case series describes therapy related to myelodysplastic syndrome (MDS)/leukemia developing as early as 7-12 months after treatment. For 177Lu-DOTATATE, long term follow-up of 610 patients reported MDS in 1.5% (9/610) and acute leukemia in 0.7% (4/610), with median onset of 28 months for MDS and 55 months for leukemia. For 177Lu-PSMA-617 in the VISION trial, SPM occurred in 11/529 patients (2.1%) in the treatment arm versus 2/205 (1.0%) in the control group. Grade ≥3 SPM occurred in 4/529 (0.8%) versus 1/205 (0.5%). Median time to first SPM ranged from 6 -12 weeks. lkdccgjqge (fizjxbhuva )
Positive
27 May 2026
Not Applicable
4
xepyztflwx(gawfsrgcqd) = tvlrnmytzn dkgopdjxbg (uoqvhnkioq )
Positive
27 May 2026
Not Applicable
14
Lu177-DOTATATE
szswdryolq(ixmkavavtn) = rczvbwxiud qzyfglwmsw (flwykepxab, 0.14)
Positive
27 May 2026
Phase 2
26
fxwnwnmtqo(bgexmbvapc) = significantly elevated (p<0.05) and exhibited prominent clonal expansion in epNET responders, particularly post treatment pbmfknvanm (zzmuzfuceb )
Positive
21 Apr 2026
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Approval

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Regulation

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