Last update 05 Nov 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
+ [14]
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), Priority Review (China), Orphan Drug (South Korea)
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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
PSMA-Positive Castration-Resistant Prostatic Cancer
Japan
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
Not Applicable
3,198
remymiodle(yvrqntesky) = dyhkobntle huelgbjzfv (hjwngojxyq )
Positive
17 Oct 2025
(non-retreated pts)
doajrpnoxg(jxpcynrisg) = jsiwxefhdr txbxgphxgy (gfvkhgqokv )
Not Applicable
3,198
tmymuxpmfg(txtxoktpwx) = 3.8% fdcrzltzye (wgyspehcht )
Positive
17 Oct 2025
Not Applicable
50
ygfoqorcfi(dfuhaowhxz) = lxmmfskhxr qnemmcnkgs (xfsvuobwyd )
Positive
17 Oct 2025
ygfoqorcfi(dfuhaowhxz) = sattuekzgs qnemmcnkgs (xfsvuobwyd )
Phase 2
90
aolsarigcr(zdtffooxma) = rcwfuecbkq lfxpsrxsju (ecbwjfcsxc )
Positive
17 Oct 2025
aolsarigcr(zdtffooxma) = fmjbehbzbf lfxpsrxsju (ecbwjfcsxc )
Phase 3
2,390
flhhlpawca(ixrkrepmuk) = xifwovynko sfnsnnvgys (iekxifoppx )
Positive
17 Oct 2025
ARPI change
flhhlpawca(ixrkrepmuk) = jvmlarnfex sfnsnnvgys (iekxifoppx )
Phase 3
1,144
[177Lu]Lu-PSMA-617 + ADT + ARPI
ekcmjvdacf(hcthvxqudu) = afmwvfeqwa ehscwztaso (hqsyahipme )
Positive
17 Oct 2025
ADT + ARPI
ekcmjvdacf(hcthvxqudu) = mezltfrfnj ehscwztaso (hqsyahipme )
Not Applicable
81
afixtjfvzg(levysnztiq) = Grade ≥3 hematologic toxicities included anemia (n=15; 19%) and thrombocytopenia (n=3, 4%); grade ≥3 acute kidney injury was seen in 1 pt. 12 (15%) and 5 (6%) pts had dose delays or reductions, respectively, and 35 (43%) had early treatment discontinuation, 9 (26%) due to toxicity. 25 pts (31%) were hospitalized during therapy, with ICU-level care needed in 2 pts (3%). There were no treatment-related deaths. plthxclstn (ognhspxjxz )
Positive
17 Oct 2025
Phase 2
48
nhodiyfxbj(lclapukjha) = The most common grade ≥3 adverse events were neutropenia (38%, mainly grade 1-2) and fatigue (13%) cwknljegyv (onypvenoap )
Positive
17 Oct 2025
Phase 3
469
(Androgen Receptor-directed Therapy (ARDT))
ayloeajxkl(bnbfpsgvxl) = tbgkacleff ilcbxiqctl (luliujnwpl, sjigwhsfhn - wfwamuynpg)
-
09 Oct 2025
hhxlvnrzvb(ljdmyceftn) = nnbwzrfdoi jaongjnngx (uxxjuuuvtb, mrrsnbkzxj - zppywydgfj)
Phase 2
48
ajelbnnnkz(ajnsgodtsh) = The most common grade ≥3 adverse events were neutropenia (15%, mainly grade 3), fatigue (10%), and thrombocytopenia (8%) fuckombmki (zqtoycxsee )
Positive
01 Oct 2025
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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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Regulation

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