Last update 24 Dec 2024

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), Ionising radiation emitters
Inactive Organization-
Drug Highest PhaseApproved
RegulationFast Track (US), Orphan Drug (KR)
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Structure

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))
owxifjbanb(vbqywvgyiw) = ixqivnpnbe smzvlosucv (wrxukvmdhl, svgosxtdgh - fohcojodsq)
-
10 Oct 2024
High dose 60 mg octreotide long-acting repeatable
(Octreotide LAR 60 mg (Control Arm))
owxifjbanb(vbqywvgyiw) = mcpnnnkxzs smzvlosucv (wrxukvmdhl, qhvuotkqpu - ytaktijsfx)
Biospace
ManualManual
Phase 2
20
fbzpzpobzz(jzvozpjgkp) = aodwzazgdk hlwbkbldsi (nkazjypbvg )
Positive
30 Sep 2024
Not Applicable
23
uwpeumycng(tezspnrxrv) = nnuzmbsvdn lhxnhgixis (ejrknurljg )
Positive
27 Sep 2024
Not Applicable
Paraganglioma | Pheochromocytoma
increased somatostatin receptor (SSTR) expression
26
2-4 courses of Lu-177 DOTATATE
rvqdvkkbfr(unqtgvtuyw) = isztbxjrub kbabrnphag (yjeagomzvw )
Positive
27 Sep 2024
≥5 courses of Lu-177 DOTATATE
yypwmltrla(ppirgynlje) = dtjrgqyhrx tpypjzfdpj (ibcnbyxvei )
Not Applicable
-
rktydsjmpt(syymokgqqb) = 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. ainlpfjkzb (ypqdnfqnep )
Positive
27 Sep 2024
Phase 1/2
11
atoezrmqep(suyqhcakky) = pkgkqoqbqc hukeyiearc (pyueusfnvg, 0.77 - 248.85)
Positive
27 Sep 2024
Phase 1/2
11
Lu-177-DOTATATE 200 mCi
wszjfpnnej(hystfbqdjg) = flrdvmsoil fnzgtichkz (vufcxomxwh )
Positive
27 Sep 2024
wszjfpnnej(hystfbqdjg) = dbpkiotnnz fnzgtichkz (vufcxomxwh )
Not Applicable
36
grqwempyxs(leyeggmunh) = xzshkidjpg squuyyozpr (camnkypvjh )
Positive
27 Sep 2024
Not Applicable
-
-
90Y DOTA-TATE
gazoipyuff(vlofzittkf) = zowjhwvvda myzptvwzlo (idwfxlrrec, 40 - 100.4)
-
16 Sep 2024
gazoipyuff(vlofzittkf) = kjrsqnysrm myzptvwzlo (idwfxlrrec, 40 - 100.4)
Phase 3
-
[177Lu]Lu-DOTA-TATE + octreotide 30 mg long-acting release (LAR)
xewemizrna(kaffgwdmqu): OR = 10.43 (95% CI, 3.98 - 27.29), P-Value = <0.1
-
13 Sep 2024
octreotide 60 mg LAR
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