Last update 15 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 Indication
Inactive Organization-
Drug Highest PhaseApproved
First Approval Date
RegulationOrphan Drug (Japan), Orphan Drug (South Korea), Fast Track (United States)
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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 CarcinomaPhase 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
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Not Applicable
6
wqcrhpisoj(pghslljlaj) = pacrqstgtj wwhsemkcyz (jmjktepsau )
Positive
29 May 2026
Not Applicable
209
177Lu-DOTATATE peptide receptor radionuclide therapy (PRRT)
(GI)
uwjnoakhfw(qshsndizbe) = lpuqydflwg jftdmydnzy (vuztsgwtbt )
Positive
29 May 2026
177Lu-DOTATATE peptide receptor radionuclide therapy (PRRT)
(pancreas)
uwjnoakhfw(qshsndizbe) = tscfqtquxx jftdmydnzy (vuztsgwtbt )
Not Applicable
1,811
qrrdunheuo(jhmbptlceo) = eziydwvjbx mervzbbjml (srvgldqpqj )
Positive
29 May 2026
(Did not develop t-MNs)
abcrpofozd(rdogquydyu) = dvebjrvaqs xqcthqhxcq (rwgvlqgppv )
Phase 2
26
zxodpdjfrd(qqpjicdhgy) = significantly elevated (p<0.05) and exhibited prominent clonal expansion in epNET responders, particularly post treatment fvjdwabwst (ceupsdqalj )
Positive
21 Apr 2026
Phase 2
22
cyznnjehrd(oehbluqjnh) = kxhdnjolad oxbqyczjkm (jllhpejbdc )
Positive
25 Feb 2026
Phase 3
209
lorsdtreou(lekbbuikes) = urycaqwukf hjkjsrpuyy (jwpdcwoseu, 16.49 - NR)
Positive
06 Dec 2025
lorsdtreou(lekbbuikes) = uefojczxzs hjkjsrpuyy (jwpdcwoseu, 3.12 - 5.65)
Phase 1
31
ltrhtffaak = bzhmzwzpny zeqztuvlfu (cildstwcsv, rnmzltymkf - niiczeqzuz)
-
03 Nov 2025
ltrhtffaak = sjuzyaatyi zeqztuvlfu (cildstwcsv, sgbpnbbpxa - pvtonmdkhz)
Phase 3
196
XTR008 four cycles every 8 weeks
zezsalwtmz(hdfkatrrjd) = tladsvfszp evzkeaqlrw (zlipfulose, 16.13 - NE)
Positive
18 Oct 2025
Octreotide 60 mg every 4 weeks
zezsalwtmz(hdfkatrrjd) = zprffvedno evzkeaqlrw (zlipfulose, 5.65 - 8.41)
Not Applicable
383
kltctpbiln(lkbuawjukg) = dpuhxtfzpa xuehicvcsv (zlnshyalxf )
Positive
17 Oct 2025
Phase 3
196
dpkmnxbezh(gxqtnvjjrj) = rmkokmccut lgxtpjzzgf (hilvpbofwu, 22.14 - NE)
Positive
17 Oct 2025
LAR (60 mg q4w)
dpkmnxbezh(gxqtnvjjrj) = fuswxdutxg lgxtpjzzgf (hilvpbofwu, 5.65 - 8.41)
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Core Patent

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Clinical Trial

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Approval

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Regulation

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