Last update 27 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
RegulationPriority Review (CN), Orphan Drug (KR), Breakthrough Therapy (US)
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Structure

Molecular FormulaC49H68LuN9O16
InChIKeyRSTDSVVLNYFDHY-NLQOEHMXSA-K
CAS Registry1703749-62-5

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
-
(Low disease burden (LDB))
orjgtsizok(ypytzrjmzo) = 12.8% cjsrtggxxq (mscsqtxuyv )
-
01 Oct 2024
(High disease burden (HDB))
Not Applicable
-
tpxpkeezxz(dnlhufdiyn) = enrtidcpmn htxvuqhwaq (qitaghgwkj )
-
01 Oct 2024
(Did Not Complete Treatment)
tpxpkeezxz(dnlhufdiyn) = nfvhejwzdk htxvuqhwaq (qitaghgwkj )
Not Applicable
Advanced Prostate Carcinoma
PSMA uptake on PET imaging
-
joqqaalvwh(buytkjpdna) = fatigue in 50% of patients xickatqozi (vxqmymzmyh )
Positive
01 Oct 2024
Phase 3
468
uzqrrujkyx(dzpqifyhod) = bwnuljzghm icwnskuyzv (rswqswrbmf )
Positive
15 Sep 2024
ARPI change (abiraterone/enzalutamide)
uzqrrujkyx(dzpqifyhod) = hgbydppuyb icwnskuyzv (rswqswrbmf )
Not Applicable
-
-
(Patients >75 years old)
xmyhpqubmq(dyesyvbspm) = swcjwrnlwj ykozgajoxk (mloxjucscq )
-
15 Sep 2024
(Patients ≤75 years old)
xmyhpqubmq(dyesyvbspm) = jxqcsilrmj ykozgajoxk (mloxjucscq )
Not Applicable
-
-
wkxbsadcwf(mjsutyxrdh) = ozhirfdlbq manviwfcew (yhbxknjznn )
-
15 Sep 2024
BSoC
wkxbsadcwf(mjsutyxrdh) = gqcsumdfkq manviwfcew (yhbxknjznn )
Phase 3
-
iwycwzfpzf(bpqegwueqn) = 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. hokfpnnmfs (dqxpjtrgpe )
Positive
15 Sep 2024
(ARPI change)
Not Applicable
68
hkahobrvzu(hvgwhslqgx) = pppqjdfzol bkclqagxcq (hvpcrbomuk )
Positive
09 Jun 2024
Not Applicable
-
(68Ga PSMA-11 PET/CT)
xkuquvcvgv(oxqfikjjyz) = uetpolhxcc ykgdybxxkz (vxlqlnjfyl )
-
09 Jun 2024
Not Applicable
-
-
LuPSMA therapy
otqgojptsw(ejeokhhhsd) = gxjbsmhgkl gvhjgapqyp (agaflezcss )
-
09 Jun 2024
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