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1. 177lu-617-prostate-specific Membrane Antigen Ligand
2. 177lu-psma-617
1. 177lu-psma-617
2. G6uf363ecx
3. Vipivotide Tetraxetan Lu-177
4. 177lu-labeled Psma-617
5. Lutetium Lu-177 Vipivotide Tetraxetan
6. Vipivotide Tetraxetan Lutetium Lu-177
7. Lutetium (177lu) Vipivotide Tetraxetan
8. Lutetium (177lu) Vipivotide Tetraxetan [inn]
9. Lutetium Lu 177 Vipivotide Tetraxetan [usan]
10. Pluvicto
11. Unii-g6uf363ecx
12. Who 11429
13. Lutetium (177lu) Vipivotide Tetraxetan [who-dd]
14. 1703749-62-5
15. 1983157-55-6
16. Lutetate(3-)-177lu, (n-((((1s)-1-carboxy-5-(((2s)-3-(2-naphthalenyl)-1-oxo-2-(((trans-4-(((2-(4,7,10-tris((carboxy-.kappa.o)methyl)-1,4,7,10-tetraazacyclododec-1-yl-.kappa.n1,.kappa.n4,.kappa.n7,.kappa.n10)acetyl-.kappa.o)amino)methyl)cyclohexyl)carbonyl)amino)propyl)amino)pentyl)amino)carbonyl)-l-glutamato(6-))-, Hydrogen (1:3)
17. Lutetate(3-)-177lu, (n2-((((1s)-1,3-dicarboxypropyl)amino)carbonyl)-n6-(3-(2-naphthalenyl)-n-((trans-4-(((2-(4,7,10-tris((carboxy-.kappa.o)methyl)-1,4,7,10-tetraazacyclododec-1-yl-.kappa.n1,.kappa.n4,.kappa.n7,.kappa.n10)acetyl-.kappa.o)amino)methyl)cyclohexyl)carbonyl)-l-alanyl)-l-lysinato(6-))-, Hydrogen (1:3
| Molecular Weight | 1216.1 g/mol |
|---|---|
| Molecular Formula | C49H68LuN9O16 |
| Hydrogen Bond Donor Count | 8 |
| Hydrogen Bond Acceptor Count | 20 |
| Rotatable Bond Count | 24 |
| Exact Mass | 1215.42217 g/mol |
| Monoisotopic Mass | 1215.42217 g/mol |
| Topological Polar Surface Area | 374 Ų |
| Heavy Atom Count | 75 |
| Formal Charge | 0 |
| Complexity | 1860 |
| Isotope Atom Count | 1 |
| Defined Atom Stereocenter Count | 3 |
| Undefined Atom Stereocenter Count | 0 |
| Defined Bond Stereocenter Count | 0 |
| Undefined Bond Stereocenter Count | 0 |
| Covalently Bonded Unit Count | 2 |
Treatment of PSMA-expressing prostate cancer
Radiopharmaceuticals
Compounds that are used in medicine as sources of radiation for radiotherapy and for diagnostic purposes. They have numerous uses in research and industry. (Martindale, The Extra Pharmacopoeia, 30th ed, p1161) (See all compounds classified as Radiopharmaceuticals.)
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USDMF
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 35625
Submission : 2022-10-21
Status : Active
Type : II
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]NDC API
NDC Package Code : 71934-0024
Start Marketing Date : 2022-03-23
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1mg/mg)
Marketing Category : BULK INGREDIENT
NDC Package Code : 72775-001
Start Marketing Date : 2023-04-10
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1mg/mg)
Marketing Category : BULK INGREDIENT
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Drugs in Development
Details:
Pluvicto (lutetium Lu 177 vipivotide tetraxetan) is a prostate-specific membrane antigen, which is approved for the treatment of PSMA-positive metastatic castration-resistant prostate cancer.
Lead Product(s): Lutetium-177 Vipivotide Tetraxetan,68Ga-PSMA-11
Therapeutic Area: Oncology Brand Name: Pluvicto
Study Phase: Phase IIIProduct Type: Large molecule
Sponsor: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 04, 2024
Lead Product(s) : Lutetium-177 Vipivotide Tetraxetan,68Ga-PSMA-11
Therapeutic Area : Oncology
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Novartis Plans to File for Pluvicto Pre-Taxane Label Expansion in H2 2024
Details : Pluvicto (lutetium Lu 177 vipivotide tetraxetan) is a prostate-specific membrane antigen, which is approved for the treatment of PSMA-positive metastatic castration-resistant prostate cancer.
Brand Name : Pluvicto
Molecule Type : Large molecule
Upfront Cash : Not Applicable
April 04, 2024
Details:
Pluvicto (lutetium Lu 177 vipivotide tetraxetan) is a prostate-specific membrane antigen which is approved for the treatment of PSMA-positive metastatic castration-resistant prostate cancer.
Lead Product(s): Lutetium-177 Vipivotide Tetraxetan
Therapeutic Area: Oncology Brand Name: Pluvicto
Study Phase: ApprovedProduct Type: Small molecule
Sponsor: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable January 05, 2024
Lead Product(s) : Lutetium-177 Vipivotide Tetraxetan
Therapeutic Area : Oncology
Highest Development Status : Approved
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Novartis Expands Pluvicto Production With Largest Advanced Manufacturing Facility
Details : Pluvicto (lutetium Lu 177 vipivotide tetraxetan) is a prostate-specific membrane antigen which is approved for the treatment of PSMA-positive metastatic castration-resistant prostate cancer.
Brand Name : Pluvicto
Molecule Type : Small molecule
Upfront Cash : Not Applicable
January 05, 2024
Details:
Pluvicto® is an intravenous radioligand therapy combining a targeting compound (a ligand) with a therapeutic radionuclide (a radioactive particle, in this case lutetium-177).
Lead Product(s): Lutetium-177 Vipivotide Tetraxetan
Therapeutic Area: Oncology Brand Name: Pluvicto
Study Phase: ApprovedProduct Type: Large molecule
Sponsor: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 13, 2022
Lead Product(s) : Lutetium-177 Vipivotide Tetraxetan
Therapeutic Area : Oncology
Highest Development Status : Approved
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Novartis Receives European Commission Approval for Pluvicto® as The First Targeted Radioligand Th...
Details : Pluvicto® is an intravenous radioligand therapy combining a targeting compound (a ligand) with a therapeutic radionuclide (a radioactive particle, in this case lutetium-177).
Brand Name : Pluvicto
Molecule Type : Large molecule
Upfront Cash : Not Applicable
December 13, 2022
Details:
Pluvicto (lutetium Lu 177 vipivotide tetraxetan) is an intravenous radioligand therapy combining a targeting compound (a ligand) with a therapeutic radionuclide (a radioactive particle, in this case lutetium-177).
Lead Product(s): Lutetium-177 Vipivotide Tetraxetan
Therapeutic Area: Oncology Brand Name: Pluvicto
Study Phase: ApprovedProduct Type: Large molecule
Sponsor: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 05, 2022
Lead Product(s) : Lutetium-177 Vipivotide Tetraxetan
Therapeutic Area : Oncology
Highest Development Status : Approved
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Novartis Pluvicto™ Shows Statistically Significant and Clinically Meaningful Radiographic Progre...
Details : Pluvicto (lutetium Lu 177 vipivotide tetraxetan) is an intravenous radioligand therapy combining a targeting compound (a ligand) with a therapeutic radionuclide (a radioactive particle, in this case lutetium-177).
Brand Name : Pluvicto
Molecule Type : Large molecule
Upfront Cash : Not Applicable
December 05, 2022
Details:
The positive CHMP opinion is based on Phase III VISION study, in which Pluvicto plus BSoC demonstrated significantly improved overall survival in PSMA-positive mCRPC patients previously treated with AR pathway inhibition and taxane-based chemotherapy compared to BSoC alone.
Lead Product(s): Lutetium-177 Vipivotide Tetraxetan
Therapeutic Area: Oncology Brand Name: Pluvicto
Study Phase: ApprovedProduct Type: Large molecule
Sponsor: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 14, 2022
Lead Product(s) : Lutetium-177 Vipivotide Tetraxetan
Therapeutic Area : Oncology
Highest Development Status : Approved
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Novartis Receives Positive CHMP Opinion for Pluvicto® for Patients with Progressive, PSMA-positiv...
Details : The positive CHMP opinion is based on Phase III VISION study, in which Pluvicto plus BSoC demonstrated significantly improved overall survival in PSMA-positive mCRPC patients previously treated with AR pathway inhibition and taxane-based chemotherapy com...
Brand Name : Pluvicto
Molecule Type : Large molecule
Upfront Cash : Not Applicable
October 14, 2022
Details:
Pluvicto® (lutetium (177Lu) vipivotide tetraxetan) is indicated for the treatment of adult patients with PSMA-positive mCRPC who have been treated with AR pathway inhibition and taxane-based chemotherapy or who are not medically suitable for taxanes.
Lead Product(s): Lutetium-177 Vipivotide Tetraxetan
Therapeutic Area: Oncology Brand Name: Pluvicto
Study Phase: ApprovedProduct Type: Large molecule
Sponsor: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 11, 2022
Lead Product(s) : Lutetium-177 Vipivotide Tetraxetan
Therapeutic Area : Oncology
Highest Development Status : Approved
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
MHRA Grants Marketing Authorisation for Novartis’ Radioligand Therapy Pluvicto® (Lutetium (¹...
Details : Pluvicto® (lutetium (177Lu) vipivotide tetraxetan) is indicated for the treatment of adult patients with PSMA-positive mCRPC who have been treated with AR pathway inhibition and taxane-based chemotherapy or who are not medically suitable for taxanes.
Brand Name : Pluvicto
Molecule Type : Large molecule
Upfront Cash : Not Applicable
August 11, 2022
Details:
As part of the agreement with Novartis, Lantheus will provide PYLARIFY for the selection of patients with prostate cancer and Novartis will provide all PYLARIFY related clinical imaging data to Lantheus.
Lead Product(s): Lutetium-177 Vipivotide Tetraxetan
Therapeutic Area: Oncology Brand Name: Pluvicto
Study Phase: ApprovedProduct Type: Large molecule
Sponsor: Novartis Pharmaceuticals Corporation
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Collaboration March 29, 2022
Lead Product(s) : Lutetium-177 Vipivotide Tetraxetan
Therapeutic Area : Oncology
Highest Development Status : Approved
Partner/Sponsor/Collaborator : Novartis Pharmaceuticals Corporation
Deal Size : Undisclosed
Deal Type : Collaboration
Lantheus Announces Collaboration to Support Prostate Cancer Clinical Development
Details : As part of the agreement with Novartis, Lantheus will provide PYLARIFY for the selection of patients with prostate cancer and Novartis will provide all PYLARIFY related clinical imaging data to Lantheus.
Brand Name : Pluvicto
Molecule Type : Large molecule
Upfront Cash : Undisclosed
March 29, 2022
Details:
Advanced Accelerator Applications (AAA) and Endocyte, Inc., both Novartis companies, successfully completed full-scale development of Pluvicto and also received Breakthrough Therapy designation from the U.S. FDA last year.
Lead Product(s): Lutetium-177 Vipivotide Tetraxetan
Therapeutic Area: Oncology Brand Name: Pluvicto
Study Phase: ApprovedProduct Type: Large molecule
Sponsor: Advanced Accelerator Applications
Deal Size: $172.0 million Upfront Cash: $12.0 million
Deal Type: Agreement March 29, 2022
Lead Product(s) : Lutetium-177 Vipivotide Tetraxetan
Therapeutic Area : Oncology
Highest Development Status : Approved
Partner/Sponsor/Collaborator : Advanced Accelerator Applications
Deal Size : $172.0 million
Deal Type : Agreement
Details : Advanced Accelerator Applications (AAA) and Endocyte, Inc., both Novartis companies, successfully completed full-scale development of Pluvicto and also received Breakthrough Therapy designation from the U.S. FDA last year.
Brand Name : Pluvicto
Molecule Type : Large molecule
Upfront Cash : $12.0 million
March 29, 2022
Details:
ITM to supply Advanced Accelerator Applications on an industrial scale with its high-quality n.c.a. lutetium-177 as core component of newly approved radiotherapeutic, Pluvicto for treatment of adult patients with prostate-specific membrane antigen and positive mCRPC.
Lead Product(s): Lutetium-177 Vipivotide Tetraxetan
Therapeutic Area: Oncology Brand Name: Pluvicto
Study Phase: ApprovedProduct Type: Large molecule
Sponsor: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 25, 2022
Lead Product(s) : Lutetium-177 Vipivotide Tetraxetan
Therapeutic Area : Oncology
Highest Development Status : Approved
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Details : ITM to supply Advanced Accelerator Applications on an industrial scale with its high-quality n.c.a. lutetium-177 as core component of newly approved radiotherapeutic, Pluvicto for treatment of adult patients with prostate-specific membrane antigen and po...
Brand Name : Pluvicto
Molecule Type : Large molecule
Upfront Cash : Not Applicable
March 25, 2022
Details:
FDA approval was based on VISION trial, where patients with pre-treated PSMA-positive mCRPC who received Pluvicto plus standard of care had a statistically significant reduction in risk of death1; both alternate primary endpoints of OS and radiographic PFS were met.
Lead Product(s): Lutetium-177 Vipivotide Tetraxetan
Therapeutic Area: Oncology Brand Name: Pluvicto
Study Phase: ApprovedProduct Type: Large molecule
Sponsor: Advanced Accelerator Applications
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 23, 2022
Lead Product(s) : Lutetium-177 Vipivotide Tetraxetan
Therapeutic Area : Oncology
Highest Development Status : Approved
Partner/Sponsor/Collaborator : Advanced Accelerator Applications
Deal Size : Not Applicable
Deal Type : Not Applicable
Novartis Pluvicto™ Approved by FDA as First Targeted Radioligand Therapy for Treatment of Progre...
Details : FDA approval was based on VISION trial, where patients with pre-treated PSMA-positive mCRPC who received Pluvicto plus standard of care had a statistically significant reduction in risk of death1; both alternate primary endpoints of OS and radiographic P...
Brand Name : Pluvicto
Molecule Type : Large molecule
Upfront Cash : Not Applicable
March 23, 2022
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