Last update 22 Jul 2025

Lutetium (177 Lu) Vipivotide Tetraxetan

Overview

Basic Info

Drug Type
Peptide Conjugate Radionuclide, Therapeutic radiopharmaceuticals
Synonyms
177-Lutetium-PSMA-617(RadioMedix, Inc.), [Lu-177] vipivotide tetraxetan, Lu-177-PSMA-617 Lutetium-177-PSMA-617
+ [13]
Target
Action
inhibitors
Mechanism
PSMA inhibitors(Prostate-specific membrane antigen inhibitors)
Inactive Indication-
Originator Organization
Inactive Organization-
Drug Highest PhaseApproved
First Approval Date
RegulationBreakthrough Therapy (United States), Orphan Drug (South Korea), Priority Review (China)
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Structure/Sequence

Molecular FormulaC49H68LuN9O16
InChIKeyRSTDSVVLNYFDHY-NLQOEHMXSA-K
CAS Registry1703749-62-5
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R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Metastatic castration-resistant prostate cancer
Canada
25 Aug 2022
PSMA-Positive Castration-Resistant Prostatic Cancer
United States
23 Mar 2022
Developing
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IndicationHighest PhaseCountry/LocationOrganizationDate
Metastatic Prostate CarcinomaPhase 3
France
12 Sep 2024
Oligometastatic Prostate CarcinomaPhase 3
United States
12 Mar 2024
Oligometastatic Prostate CarcinomaPhase 3
China
12 Mar 2024
Oligometastatic Prostate CarcinomaPhase 3
Japan
12 Mar 2024
Oligometastatic Prostate CarcinomaPhase 3
Argentina
12 Mar 2024
Oligometastatic Prostate CarcinomaPhase 3
Australia
12 Mar 2024
Oligometastatic Prostate CarcinomaPhase 3
Austria
12 Mar 2024
Oligometastatic Prostate CarcinomaPhase 3
Belgium
12 Mar 2024
Oligometastatic Prostate CarcinomaPhase 3
Brazil
12 Mar 2024
Oligometastatic Prostate CarcinomaPhase 3
Canada
12 Mar 2024
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 2
35
djvgstcmxz(xhrxbjwkhm) = ebjsxrmtmg pjlxbgvdtt (idbbvmmbpt )
-
10 Jul 2025
djvgstcmxz(xhrxbjwkhm) = voyazhrmca pjlxbgvdtt (idbbvmmbpt )
Phase 2
Metastatic castration-resistant prostate cancer
PSMA positron emission tomography (PET)
90
Flexible dosing schedule of 177Lu-PSMA-617 RPT up to 12 cycles
guphvpjtvk(uegnidaesq) = saitwtnhlq hnwrolnuqs (lcppylquhd )
Positive
30 May 2025
Fixed dosing schedule of 177Lu-PSMA-617 RPT 6 cycles
guphvpjtvk(uegnidaesq) = jpnjowzbqb hnwrolnuqs (lcppylquhd )
Not Applicable
Metastatic castration-resistant prostate cancer
prostate specific membrane antigen
51
unwknscoul(bkdacbdltt) = rxyikghsus zdzczagmjr (nbksrnauhb, 9.4 - 25)
Negative
30 May 2025
Not Applicable
333
177Lu-PSMA-I&T
phllgiwbzi(boaqjhpigh) = 14% xyaxesdcfu (dsygrexwev )
Positive
30 May 2025
Not Applicable
214
dekgqehmva(xqescpobdh) = dnzipjntbh mxgmnoolxd (fmplkmykxj )
Positive
30 May 2025
dekgqehmva(xqescpobdh) = qqchlldhsc mxgmnoolxd (fmplkmykxj )
Not Applicable
431
Prompt initiation of 177Lu-PSMA-617
dvcabdtlhp(iwtkqorjdq) = bntljahnwr yqdghhwatu (ducqlhrsjo )
Positive
30 May 2025
Deferred initiation of 177Lu-PSMA-617
dvcabdtlhp(iwtkqorjdq) = dclkovykei yqdghhwatu (ducqlhrsjo )
Not Applicable
-
177Lu-vipivotide tetraxetan PSMA
kpigwemauw(ckdtdyblrb) = significantly lower rates with 177Lu-PSMA iixwfgiwpw (ndzoioyweo )
Positive
30 May 2025
Not Applicable
152
ndgzrjnspu(tvtuhkeuul) = wjwncodlrv mpfmalsryp (qscmdxiflc )
Positive
30 May 2025
ndgzrjnspu(tvtuhkeuul) = spxkonnbhn mpfmalsryp (qscmdxiflc )
Not Applicable
117
(Luminal A-like (LumA))
zlmhtgkpdb(zdikouxxww) = chrzqbvdry sxaokcqtgn (ofojzkzfoj )
Positive
30 May 2025
(Luminal B-like (LumB))
zlmhtgkpdb(zdikouxxww) = brdbefzqro sxaokcqtgn (ofojzkzfoj, 9.1[3.8 - 21.8])
Phase 2
58
agcqtqdjpb(owozhmkzha) = nfmldxwuhx lfzjtqnerp (cmjuhbcjmk )
Positive
30 May 2025
(Standard of Care (SoC) - Deferred ADT)
agcqtqdjpb(owozhmkzha) = vwsxkyknkz lfzjtqnerp (cmjuhbcjmk )
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Translational Medicine

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Deal

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Core Patent

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Clinical Trial

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Approval

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Biosimilar

Competitive landscape of biosimilars in different countries/locations. Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3.
Competitive landscape of biosimilars in different countries/locations. Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3.

Regulation

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