TLX-591 companion diagnostic (Telix Pharmaceuticals)

镓[68Ga]戈泽肽

Report date: 2026/05/25 20:02:40
NMEFirst In Class

Base Information

Drug NameTLX-591 companion diagnostic (Telix Pharmaceuticals)
Drug Alias Name镓[68Ga]戈泽肽Gallium-68 labeled PSMA-11注射用镓[68Ga]戈泽肽药盒(68Ga)Glu-urea-Lys(Ahx)-HBED-CCGa-68 labeled Glu-urea-Lys(Ahx)-HBED-CC +[43] 
ClassificationDiagnostic agent (In vivo)Radiation-emitting products > Nuclides > Gallium > 68GaRadiation-emitting products > Radionuclide Drug Conjugates +[5] 
Mechanisms of ActionPositron-emission tomography enhancersIonising radiation emittersProstate-Specific Membrane Antigen inhibitors
TargetsProstate-Specific Membrane Antigen
Therapy Area/IndicationsDiagnostic agentsSolid tumoursNeoplasm Recurrence, Local +[11] 
Global Approved IndicationsDiagnostic agentsProstatic Neoplasms
Approved Indications in ChinaDiagnostic agentsProstatic Neoplasms
Original Approved Country/TerritoryUnited States
Original Approved Date2020/12/01
Country/TerritoryBelgiumCanadaUnited States +[9] 
CombinationsNo
Global Highest StatusApproved
Highest Status in ChinaApproved
Originator CompaniesAdvanced Nuclear Medicine Ingredients (Anmi)
China Registration ClassN/A

Develop Information

Active CompaniesTelix Pharmaceuticals (Innovations) Pty LtdBiokosmos SaBAMF Health Inc +[16] 
Inactive CompaniesAdvanced Nuclear Medicine Ingredients (Anmi)University of Texas Southwestern Medical CenterGrand River Aseptic Manufacturing Inc +[16] 
Active IndicationsDiagnostic agentsSolid tumoursNeoplasm Recurrence, Local +[11] 
Inactive IndicationsN/A

Other Information

ATC CodeV09
Related LinksN/A