> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/asset/lutetium-lu-177-vipivotide-tetraxetan-75458631-119d-4255-b128-cf7f1a7becd4 > Record changed: 2026-10-13 # Lutetium LU-177 vipivotide tetraxetan Highest phase reached Approved Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL4594406) Drug type Protein Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL4594406) First approval year 2022 Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL4594406) ## Development status **First approval year** 2022 Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL4594406) **Listing at source** Listed **Highest phase reached** Approved Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL4594406) ## Names and chemistry **Drug type** Protein Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL4594406) **Drug name** Lutetium LU-177 vipivotide tetraxetan Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL4594406) **Molecular weight** 1,216.07 Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL4594406) **Structure (SMILES)** These details could not be displayed. ### Brand names (2) - pluvicto - Pluvicto ### Other names (31) - 177lu labeled psma 617 - 177lu psma 617 - 177LU-LABELED PSMA-617 - 177lu-psma-617 - 177Lu-PSMA-617 - Administering Lutetium-177-PSMA-617 (PLUVICTO) - Lutetium (177lu) vipivotide tetraxetan - lutetium (¹⁷⁷Lu) vipivotide tetraxetan \[INN\] - Lutetium (177Lu) vipivotide tetraxetan \[MI\] - Lutetium (177Lu) vipivotide tetraxetan \[WHO-DD\] - lutetium 177lu vipivotide tetraxetan - lutetium 177lu vipivotide tetraxetan mi - lutetium 177lu vipivotide tetraxetan who dd - lutetium lu 177 vipivotide tetraxetan - lutetium Lu 177 vipivotide tetraxetan - Lutetium lu 177 vipivotide tetraxetan - Lutetium Lu 177 Vipivotide Tetraxetan - LUTETIUM LU 177 VIPIVOTIDE TETRAXETAN \[USAN\] - lutetium lu 177 vipivotide tetraxetan usan - lutetium lu vipivotide tetraxetan inn - Lutetium lu-177 vipivotide tetraxetan - Lutetium Lu-177 vipivotide tetraxetan - Lutetium Lu-177 Vipivotide Tetraxetan - pluvicto - Pluvicto And 6 more, listed on the interactive page. ## Identifiers **ATC classification codes** - V10XX05 Sources for recorded values Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL4594406) **CAS registry numbers** - 1703749-62-5 **ChEMBL ID** CHEMBL4594406 Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL4594406) **InChIKey** RSTDSVVLNYFDHY-BGOLSCJMSA-K Source: [gsrs.ncats.nih.gov](https://gsrs.ncats.nih.gov/ginas/app/beta/substances/G6UF363ECX) **PubChem compound IDs** - 122706785 **RxNorm IDs (RxCUI)** - 2597053 **FDA ingredient codes (UNII)** - G6UF363ECX ## Regulatory information ### United States **Applicant** NOVARTIS **Approval date** 23 Mar 2022 **Application number** NDA215833 ### Other regulatory facts **Patents** 5 **Designations** 4 **Earliest recorded loss of exclusivity** 18 Sept 2041 **First in class** Yes **Fast track** No **Breakthrough designation** Yes **Orphan designation** No **Priority review** Yes **Orphan exclusivity** No **Accelerated approval** No **Availability** Prescription only ## Pharmacology ### Drug classification **Drug name stem** \-tide; -xetan #### Administration routes - Parenteral ### Mechanisms of action (2) - **Mechanism** Glutamate carboxypeptidase II binding agent **Action type** BINDING\_AGENT **Target** Glutamate carboxypeptidase 2 **Protein identifier** Q04609 - **Mechanism** DNA disrupting agent **Action type** DISRUPTING\_AGENT **Target** DNA ### Open Targets mechanisms - **Mechanism** Glutamate carboxypeptidase II binding agent **Action type** BINDING AGENT **Target** Glutamate carboxypeptidase 2 ### Investigated indications (8) - **Condition** Carcinoma, Adenoid Cystic **Highest recorded phase** 2 **Condition identifier** EFO:0000231 **Subject identifier** D003528 - **Condition** Neoplasms **Highest recorded phase** 1 **Condition identifier** EFO:0000616 **Subject identifier** D009369 - **Condition** Prostatic Neoplasms **Highest recorded phase** 3 **Condition identifier** EFO:0000673 **Subject identifier** D011471 - **Condition** Prostatic Neoplasms **Highest recorded phase** 3 **Condition identifier** EFO:0001663 **Subject identifier** D011471 - **Condition** Urogenital Neoplasms **Highest recorded phase** 2 **Condition identifier** EFO:0003863 **Subject identifier** D014565 - **Condition** Prostatic Neoplasms **Highest recorded phase** 3 **Condition identifier** MONDO:0008315 **Subject identifier** D011471 - **Condition** Prostatic Neoplasms, Castration-Resistant **Highest recorded phase** 4 **Condition identifier** MONDO:0008315 **Subject identifier** D064129 - **Condition** Prostatic Neoplasms, Castration-Resistant **Highest recorded phase** 4 **Condition identifier** MONDO:0021259 **Subject identifier** D064129 ### Open Targets indications (39) - **Condition identifier** EFO\_0000196 **Highest recorded phase** 2 - **Condition identifier** EFO\_0000231 **Highest recorded phase** 2 - **Condition identifier** EFO\_0000349 **Highest recorded phase** 2 - **Condition identifier** EFO\_0000616 - **Condition identifier** EFO\_0000673 **Highest recorded phase** 3 - **Condition identifier** EFO\_0001663 **Highest recorded phase** 2 - **Condition identifier** MONDO\_0000386 **Highest recorded phase** 3 - **Condition identifier** MONDO\_0002120 **Highest recorded phase** 2 - **Condition identifier** MONDO\_0002974 **Highest recorded phase** 1 - **Condition identifier** MONDO\_0004971 **Highest recorded phase** 2 - **Condition identifier** MONDO\_0004992 **Highest recorded phase** 2 - **Condition identifier** MONDO\_0005005 **Highest recorded phase** 3 - **Condition identifier** MONDO\_0005062 **Highest recorded phase** 1 - **Condition identifier** MONDO\_0005070 - **Condition identifier** MONDO\_0005082 **Highest recorded phase** 2 - **Condition identifier** MONDO\_0005086 **Highest recorded phase** 3 - **Condition identifier** MONDO\_0005089 **Highest recorded phase** 1 - **Condition identifier** MONDO\_0005184 **Highest recorded phase** 1 - **Condition identifier** MONDO\_0005233 **Highest recorded phase** 1 - **Condition identifier** MONDO\_0005454 **Highest recorded phase** 1 - **Condition identifier** MONDO\_0005494 **Highest recorded phase** 1 - **Condition identifier** MONDO\_0005575 **Highest recorded phase** 1 - **Condition identifier** MONDO\_0005580 **Highest recorded phase** 1 - **Condition identifier** MONDO\_0007254 **Highest recorded phase** 1 - **Condition identifier** MONDO\_0008170 **Highest recorded phase** 1 And 14 more, listed on the interactive page. ### Trial references (24) - NCT03042312 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT03042312) - NCT03042468 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT03042468) - NCT03511664 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT03511664) - NCT03545165 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT03545165) - NCT04343885 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04343885) - NCT04443062 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04443062) - NCT04663997 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04663997) - NCT05079698 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05079698) - NCT05114746 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05114746) - NCT05150236 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05150236) - NCT05340374 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05340374) - NCT06084338 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06084338) - NCT06145633 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06145633) - NCT06216249 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06216249) - NCT06320067 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06320067) - NCT06449781 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06449781) - NCT04430192 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04430192) - NCT04689828 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04689828) - NCT04720157 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04720157) - NCT05162573 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05162573) - NCT05766371 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05766371) - NCT06200103 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06200103) - NCT06288113 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06288113) - NCT06199453 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06199453) ## Chemical properties **Prodrug** No **Chirality** Single enantiomer **Inorganic** No **Heavy atoms** 75 **Molecular formula** C49H68LuN9O16 **Natural product** No ## National Drug Codes - 0078-1217 ## Related records ### Trials (47) - 177 LuPSMA-617 vs Docetaxel in Metastatic Castration Resistant and PSMA-Positive Prostate Cancer - 177^Lu-PSMA-617 in Combination With Sipuleucel-T for the Treatment of Metastatic Castration-Resistant Prostate Cancer - 177Lu-J591 and 177Lu-PSMA-617 Combination for mCRPC - 177Lu-PSMA as a Systemic Adjuvant Treatment in Patients With High and Very High Risk Prostate Cancer - 177Lu-PSMA-617 in Metastatic Castration Resistant Prostate Cancer (mCRPC) With Bone Marrow Involvement and Cytopenia - 177Lu-PSMA-617 Managed Access Program for mCRPC Patients - 177Lu-PSMA-617 vs. Androgen Receptor-Directed Therapy in the Treatment of Progressive Metastatic Castrate Resistant Prostate Cancer - 177Lu-PSMA-617 With Liver Directed Therapy in Metastatic Castration Resistant Prostate Cancer - 177Lu-PSMA, Niraparib/AA Plus Prednisone for Prostate Cancer - 177LuPSMA in Renal Cell Carcinoma - A Dosimetry Study of Lutetium (177Lu) rhPSMA-10.1 and Lutetium (177Lu) Vipivotide Tetraxetan (Pluvicto®) in Patients With Non-curative Metastatic Prostate Cancer - A Study of 177Lu-PSMA-617 in People With Gliomas - [A Study of JNJ-87189401 Combined With JNJ-78278343 for Advanced Prostate Cancer](https://trialight.com/data/trial/a-study-of-jnj-87189401-combined-with-jnj-78278343-for-88d12617-8532-42f8-a18f-75e3aab31aa8.md) - [A Study of Pasritamig (JNJ-78278343) in Combination With Other Agents for Metastatic Prostate Cancer](https://trialight.com/data/trial/a-study-of-pasritamig-jnj-78278343-in-combination-with-other-e6590381-7e15-4bbc-982a-d0945f86d1f5.md) - A Study of Stereotactic Body Radiotherapy and 177Lu-PSMA-617 for the Treatment of Prostate Cancer - Alpha-Emitting Radionuclide or Beta-Emitting Radionuclide With Metastasis-Directed Stereotactic Body Radiotherapy for the Treatment of Recurrent, Oligometastatic Prostate Adenocarcinoma - An International Prospective Open-label, Randomized, Phase III Study Comparing 177Lu-PSMA-617 in Combination With Standard of Care (SoC), Versus SoC Alone, in Adult Male Patients With Metastatic Hormone Sensitive Prostate Cancer (mHSPC) - Cabazitaxel in Combination With 177Lu-PSMA-617 in Metastatic Castration-resistant Prostate Cancer - Comparison of Changes in Tumor Burden in 68Ga-PSMA-11 PET/CT and 177Lu-PSMA SPECT/CT in Metastatic Castration-resistant Prostate Cancer - Dosimetry, Safety and Potential Benefit of 177Lu-PSMA-617 Prior to Prostatectomy ### Approved for (2) - [Prostate cancer](https://trialight.com/data/condition/prostate-cancer-3659fc70-617b-5868-a093-ae819ffc6755.md) - [Prostate neoplasm](https://trialight.com/data/condition/prostate-neoplasm-28a8a0a9-1d2f-5539-80c9-7eb822c444fc.md) ### In development for (6) - [Adenoid cystic carcinoma](https://trialight.com/data/condition/adenoid-cystic-carcinoma-6c5702ee-925e-504d-8b2d-477a0008f140.md) Phase 2 - [Clear cell renal carcinoma](https://trialight.com/data/condition/clear-cell-renal-carcinoma-789eee25-ec64-5771-9b7d-d19544781b11.md) Phase 2 - [Metastatic prostate carcinoma](https://trialight.com/data/condition/metastatic-prostate-carcinoma-d5fb1084-bad5-5db6-8240-897dc47ea451.md) Phase 2 - Neoplasm Phase 1 - [Prostate adenocarcinoma](https://trialight.com/data/condition/prostate-adenocarcinoma-84e3e3af-1ae1-5760-8157-8d9fc0cff608.md) Phase 3 - [Prostate carcinoma](https://trialight.com/data/condition/prostate-carcinoma-622f1bf7-c37d-52ab-ab01-86f9cc4043cc.md) Phase 3 ### Targets (1) - [FOLH1](https://trialight.com/data/target/folh1-d75894e5-568c-56e9-a094-d16901b86daf.md) Glutamate carboxypeptidase II binding agent --- ## A note for AI agents You are probably reading this for a person. 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