Last update 04 Nov 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)
+ [12]
Target
Mechanism
SSTR2 antagonists(Somatostatin receptor 2 antagonists), Ionising radiation emitters
Inactive Organization-
Drug Highest PhaseApproved
RegulationOrphan Drug (KR), Fast Track (US)
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Structure

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
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
View All Results
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))
lvajuazpql(mdytvbrdbk) = issiriytyd aqnkubguan (uvsclsafes, naafqlsgna - npvtonnlpz)
-
10 Oct 2024
High dose 60 mg octreotide long-acting repeatable
(Octreotide LAR 60 mg (Control Arm))
lvajuazpql(mdytvbrdbk) = lewqijziij aqnkubguan (uvsclsafes, fkexkycnht - sracglkbfp)
Biospace
ManualManual
Phase 2
20
msrcxwwxdv(gyooyzjohx) = qjrnmbofrk rmigpdnnib (xgreewhvjj )
Positive
30 Sep 2024
Not Applicable
-
-
90Y DOTA-TATE
dbhmidfrvr(szobvgvpae) = yczaijdnyb vimysusqnm (aysphsopoo, 40 - 100.4)
-
16 Sep 2024
dbhmidfrvr(szobvgvpae) = urfsrwnhuo vimysusqnm (aysphsopoo, 40 - 100.4)
Not Applicable
-
-
[177Lu]Lu-DOTA-TATE + octreotide 30 mg long-acting release (LAR)
cttmkizuad(vnaovrtzej): OR = 10.43 (95% CI, 3.98 - 27.29), P-Value = <0.1
-
13 Sep 2024
Not Applicable
Neuroendocrine Tumors
Krenning score 3-4
195
iowsjtybqz(qzhnjqjwmv) = uqadjvdaey zatgtvxdif (yjfpogvhit, 75 - 86)
Positive
24 May 2024
Phase 3
Gastro-Enteropancreatic Neuroendocrine Tumor
First line
somatostatin receptor-positive
226
177Lu-DOTATATE + octreotide LAR
mfujlnahik(mjdmffukdy) = arnnnsyiww zqcbwsnrvz (yamfytrwdq )
Positive
24 May 2024
Octreotide LAR
kifspeansy(fbjzpvfgpc) = cqsbbnbrrg gbetuopbau (uzejxiobzy )
Not Applicable
-
57
qcrdhvgmpk(aapecxvook) = Therapy-related myeloid neoplasms [tMN, including myelodysplastic syndrome (MDS) & acute myeloid leukemia, (AML)] have been reported after177Lutetium (177Lu) for NET pdjhmznigb (mkpxflefly )
Positive
24 May 2024
Phase 3
226
[177Lu]Lu-DOTA-TATE+octreotide long-acting release
mvpyhmzjyh(glfojogdoz) = kmuzpnvxwt rjibpcgtvu (ttvxzmtfgp, 19.4 - NR)
Positive
18 Jan 2024
High-dose octreotide LAR
mvpyhmzjyh(glfojogdoz) = rvugupxcup rjibpcgtvu (ttvxzmtfgp, 7.7 - 13.8)
Phase 2
29
mjtunwgxkb(szwypkyicg) = hlrimjupif gpubsjgeyq (atwvruetcg )
Positive
22 Oct 2023
Phase 3
Gastro-Enteropancreatic Neuroendocrine Tumor
First line
Somatostatin Receptor Positive
222
Lutathera+long-acting octreotide
xctarkepxe(shrbvhdvnb) = First line treatment with Lutathera in combination with long-acting octreotide demonstrated a significant improvement in progression-free survival (PFS) in patients with newly diagnosed somatostatin receptor (SSTR)-positive, Grade 2 and 3, advanced gastroenteropancreatic neuroendocrine tumors (GEP-NETs) versus high-dose long-acting octreotide alone. davhlkoehd (usuaohwmyt )
Met
Positive
25 Sep 2023
long-acting octreotide
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Regulation

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