Last update 14 Nov 2024

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
+ [12]
Target
Mechanism
PSMA inhibitors(Prostate-specific membrane antigen inhibitors), Ionising radiation emitters
Inactive Indication
Originator Organization
Drug Highest PhaseApproved
First Approval Date
RegulationBreakthrough Therapy (US), Orphan Drug (KR), Priority Review (CN)
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Structure

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
PSMA-Positive Castration-Resistant Prostatic Cancer
EU
09 Dec 2022
PSMA-Positive Castration-Resistant Prostatic Cancer
IS
09 Dec 2022
PSMA-Positive Castration-Resistant Prostatic Cancer
LI
09 Dec 2022
PSMA-Positive Castration-Resistant Prostatic Cancer
NO
09 Dec 2022
Metastatic castration-resistant prostate cancer
CA
25 Aug 2022
Castration-Resistant Prostatic Cancer
US
23 Mar 2022
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Metastatic Prostate CarcinomaPhase 3
FR
01 Aug 2024
Oligometastatic Prostate CarcinomaPhase 3
US
12 Mar 2024
Oligometastatic Prostate CarcinomaPhase 3
JP
12 Mar 2024
Oligometastatic Prostate CarcinomaPhase 3
AU
12 Mar 2024
Oligometastatic Prostate CarcinomaPhase 3
AT
12 Mar 2024
Oligometastatic Prostate CarcinomaPhase 3
BE
12 Mar 2024
Oligometastatic Prostate CarcinomaPhase 3
CA
12 Mar 2024
Oligometastatic Prostate CarcinomaPhase 3
CZ
12 Mar 2024
Oligometastatic Prostate CarcinomaPhase 3
FR
12 Mar 2024
Oligometastatic Prostate CarcinomaPhase 3
HU
12 Mar 2024
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Not Applicable
Advanced Prostate Carcinoma
PSMA uptake on PET imaging
-
rzdlwxnnci(edsdpylrkg) = fatigue in 50% of patients gxfbijbefq (flbgzluqsg )
Positive
01 Oct 2024
Not Applicable
-
uymbjguuje(lchgnojgut) = dcfywrelsg wggoaxspda (kzgrqllvhm )
-
01 Oct 2024
(Did Not Complete Treatment)
uymbjguuje(lchgnojgut) = tfwyqxilao wggoaxspda (kzgrqllvhm )
Not Applicable
-
(Low disease burden (LDB))
ulmnnbobnp(dkbynwtfbm) = 12.8% ngtjyxvjlj (jokmjjndgp )
-
01 Oct 2024
(High disease burden (HDB))
Phase 3
-
otntgpugwe(ahsfqcqiec) = Despite higher incidences of haematologic TEAEs among patients receiving 177Lu-PSMA-617 compared with ARPI change, rates of complications or need for management of haematologic TEAEs were low and similar between treatment arms. ywqeslzugx (wjjwetwjmy )
Positive
15 Sep 2024
(ARPI change)
Phase 3
468
zcbtdmjpkx(uyiutzgtvt) = srkkcfejuz vqbubnnqtw (ahbbaxhvxj )
Positive
15 Sep 2024
ARPI change (abiraterone/enzalutamide)
zcbtdmjpkx(uyiutzgtvt) = vtqjnifvap vqbubnnqtw (ahbbaxhvxj )
Not Applicable
-
-
(Patients >75 years old)
pruvrplqjp(ixkeakkhas) = krgbddwirv awqcefefjq (bbalzznwke )
-
15 Sep 2024
(Patients ≤75 years old)
pruvrplqjp(ixkeakkhas) = zewoujcmbc awqcefefjq (bbalzznwke )
Not Applicable
-
-
ijcimnxfwf(bjfjhonvnl) = zoajflakrs jeifziaubs (kwauswzvhz )
-
15 Sep 2024
BSoC
ijcimnxfwf(bjfjhonvnl) = chznhrnwyg jeifziaubs (kwauswzvhz )
Not Applicable
-
aivlzpymxi(vaagtevoju) = predominant in 12 patients mccufggaxj (jtkoimrcpm )
-
09 Jun 2024
Phase 3
Metastatic castration-resistant prostate cancer
prostate-specific membrane antigen (PSMA)-positive
468
xhwdxroodl(ifphxzdqpn) = jybovwmkqe lukjilfovu (ytouosdrun, 6.77 - NE)
Positive
09 Jun 2024
ARPI change (abiraterone or enzalutamide)
xhwdxroodl(ifphxzdqpn) = jpckhkpbvk lukjilfovu (ytouosdrun, 4.04 - 5.95)
Not Applicable
-
-
LuPSMA therapy
dlckchulbs(zicaazvlbu) = bwgxodcqvv mmfdfvkxxs (jdxzibzfpd )
-
09 Jun 2024
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Core Patent

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Approval

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Regulation

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