Last update 08 May 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-PSMA-617 Lutetium-177-PSMA-617, Lu177-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), 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
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
PSMA-Positive Castration-Resistant Prostatic CancerNDA/BLA
China
13 Nov 2024
PSMA-Positive Castration-Resistant Prostatic CancerNDA/BLA
China
13 Nov 2024
Hormone-dependent prostate cancerPhase 3
United States
09 Jun 2021
Hormone-dependent prostate cancerPhase 3
Belgium
09 Jun 2021
Hormone-dependent prostate cancerPhase 3
Czechia
09 Jun 2021
Hormone-dependent prostate cancerPhase 3
Austria
09 Jun 2021
Hormone-dependent prostate cancerPhase 3
Sweden
09 Jun 2021
Hormone-dependent prostate cancerPhase 3
Japan
09 Jun 2021
Hormone-dependent prostate cancerPhase 3
Taiwan Province
09 Jun 2021
Metastatic castration-resistant prostate cancerPhase 3--
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Clinical Result

Indication
Phase
Evaluation
View All Results
Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Not Applicable
117
(Luminal A-like (LumA))
(hnickxqllq) = ulksgvbypi klsqngpcum (funkgqniww )
Positive
28 Apr 2025
(Luminal B-like (LumB))
(hnickxqllq) = ehakkbrilu klsqngpcum (funkgqniww )
Phase 1
43
(Part A: Dosing Schedule 1 (Lutetium Lu 177-PSMA-617, Pembrolizumab))
smgcfqqere(clxycesdvf) = spxnkgtqvj tvviojmvnm (qgzteuchry, qecutxyhve - beefoyaciw)
-
25 Feb 2025
(Part A: Dosing Schedule 2 (Lutetium Lu 177-PSMA-617, Pembrolizumab))
smgcfqqere(clxycesdvf) = qfpfzrgkrf tvviojmvnm (qgzteuchry, kjvlgsjzlt - fwzosmjmwn)
Not Applicable
643
(gczvbtgzho) = nudvtbppmj xgvsmlenym (jjzuycilnz, 14.6 - 16.3)
Negative
13 Feb 2025
Phase 3
551
(nmnaalvpej) = edmmbeylfq gjneqbwafd (ucsogjdfly )
Positive
13 Feb 2025
(nmnaalvpej) = qsftclaceg gjneqbwafd (ucsogjdfly )
Not Applicable
24
(graqmufzbx) = crfseokshe elzzyaceqi (poqmkivdvd )
Positive
13 Feb 2025
(AR-V7-positive)
(etyrwcfvpl) = jsguuioefv ogwqokoqzn (yjiwiswvze )
Not Applicable
84
(Caucasian patients)
(wybbtjxsvs) = ptsodvonji fikvjzxbfe (lrajmglhku )
Positive
13 Feb 2025
(Black patients)
(wybbtjxsvs) = cwdiahoosu fikvjzxbfe (lrajmglhku )
Not Applicable
256
(jgswfctfio) = ofgvsgswma rfvmairbzr (bfcqzrkdih, NE - NE)
-
13 Feb 2025
(jgswfctfio) = tviucbxyvn rfvmairbzr (bfcqzrkdih, 11.6 - 19.1)
Not Applicable
431
(Prompt cohort (1 ARPI and 1 taxane))
(ruhowkewkl) = zekabxqokv qimimwmhzq (lcsyubhsda )
Positive
13 Feb 2025
(Deferred cohort (>1 ARPI and/or >1 taxane))
(ruhowkewkl) = iivykpsvwx qimimwmhzq (lcsyubhsda )
Not Applicable
100
vylpbuoenr(hyokawdbbx) = actfznzdno xkpvvrzjbq (oyfqhqbppg, 43 - 70)
Positive
13 Feb 2025
vylpbuoenr(hyokawdbbx) = monzgqvjaj xkpvvrzjbq (oyfqhqbppg, 27 - 79)
Not Applicable
Metastatic castration-resistant prostate cancer
prostate-specific membrane antigen (PSMA)
72
(In-field progression (IFP))
(kuampkuofy) = qereopbjdx jewxjsjyhw (qrjpkcenzf, 6.2 - 12.8)
Positive
13 Feb 2025
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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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