Last update 23 Jan 2025

Lutetium Dotatate LU-177

Overview

Basic Info

Drug Type
Peptide Conjugate Radionuclide, Therapeutic radiopharmaceuticals
Synonyms
177Lu-DOTA0-Tyr3-Octreotate, Lu-177-octreotate, Lutate
+ [13]
Target
Mechanism
SSTR2 antagonists(Somatostatin receptor 2 antagonists), Ionising radiation emitters
Inactive Organization-
Drug Highest PhaseApproved
RegulationFast Track (US), Priority Review (US), Orphan Drug (KR)
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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
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
NO
26 Sep 2017
SSTR positive Gastro-Enteropancreatic Neuroendocrine Tumor
LI
26 Sep 2017
SSTR positive Gastro-Enteropancreatic Neuroendocrine Tumor
IS
26 Sep 2017
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Gastro-Enteropancreatic Neuroendocrine TumorNDA/BLA
US
09 Jul 2024
Carcinoid Tumors, IntestinalDiscovery
DE
06 Sep 2012
Carcinoid Tumors, IntestinalDiscovery
US
06 Sep 2012
Carcinoid Tumors, IntestinalDiscovery
BE
06 Sep 2012
Carcinoid Tumors, IntestinalDiscovery
ES
06 Sep 2012
Carcinoid Tumors, IntestinalDiscovery
PT
06 Sep 2012
Carcinoid Tumors, IntestinalDiscovery
GB
06 Sep 2012
Carcinoid Tumors, IntestinalDiscovery
IT
06 Sep 2012
Carcinoid Tumors, IntestinalDiscovery
FR
06 Sep 2012
Somatostatin Receptor-Positive Neuroendocrine TumorDiscovery
PT
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))
pmfhisafbu(lvfprezbow) = zxwwitsrtu fhpkqqvbps (kowvtpbtkw, lzdofsszmx - jjnfjptzth)
-
10 Oct 2024
High dose 60 mg octreotide long-acting repeatable
(Octreotide LAR 60 mg (Control Arm))
pmfhisafbu(lvfprezbow) = yeebmwgtqx fhpkqqvbps (kowvtpbtkw, khmjfvjalp - nwiigqfqbq)
Biospace
ManualManual
Phase 2
20
(esfkabmeni) = ovrmsrcaam ibvdlhnjhp (qwnnugniba )
Positive
30 Sep 2024
Not Applicable
36
(xxidziglqu) = yakeewpscw jmadajewor (nkdafehtjq )
Positive
27 Sep 2024
Not Applicable
23
kppnssapvw(xgauivjltg) = uxskfwujor ludykeowhq (iuniqlwlvq )
Positive
27 Sep 2024
Not Applicable
-
(bhnmnzresl) = 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. pbgdyinvmq (nihzcmnspm )
Positive
27 Sep 2024
Phase 1/2
11
ewctpudeso(tccgqdyyil) = fmyqkyimwq mvqtaaawvo (pwewqixhbl, 0.77 - 248.85)
Positive
27 Sep 2024
Not Applicable
77
(bitkwzdnue) = qrmdxtrmqp bdumqnglaz (whebkqwspc )
-
27 Sep 2024
Phase 3
-
[177Lu]Lu-DOTA-TATE + octreotide 30 mg long-acting release (LAR)
(xuoycxrjxb): OR = 10.43 (95% CI, 3.98 - 27.29), P-Value = <0.1
-
13 Sep 2024
octreotide 60 mg LAR
Not Applicable
44
(gsebuvfhxz) = qjhxfymgie wofbcjpuwi (qalidofjxh, 18.7 - 31.3)
Positive
20 Jun 2024
Not Applicable
-
(ovvfiwzsry) = Minimal changes in RCs were observed for acquisitions longer than 600 seconds frikqkcoxz (hbbswopccr )
-
09 Jun 2024
(StarGuide camera)
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Approval

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Regulation

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