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Copper Cu 64-DOTA-TLX592

Radiopharmaceutical · Acts on prostate-specific membrane antigen (FOLH1) · developed by Telix Pharmaceuticals Pty

Early Phase 1 Most advanced trial (none active)

TLX Developer

1 Registered trials

What is Copper Cu 64-DOTA-TLX592?

Copper Cu 64-DOTA-TLX592 is a radiopharmaceutical comprising a humanized monoclonal antibody targeting prostate-specific membrane antigen (PSMA) conjugated to a DOTA chelator and labeled with the positron-emitting radioisotope copper Cu 64. It is designed for PET imaging to detect and quantify PSMA-expressing tumor cells in metastatic prostate cancer.

Summary written with AI from the sources listed at the end of this page.

At a glance

Also known as: 64Cu-DOTA-TLX592
Drug type: Radiopharmaceutical
Targets: prostate-specific membrane antigen (FOLH1) (antigen)
Mechanism: Acts on prostate-specific membrane antigen (FOLH1)
Therapy area: Oncology
Developer: Telix Pharmaceuticals Pty Limited (TLX)
FDA status: Investigational, not approved in the US. Most advanced trial: Early Phase 1

🧪 Clinical trials

Trial	Phase	Condition	Status	Sponsor
NCT04726033	Early Phase 1	Metastatic Prostate Cancer	Completed	TLX

Trials of the companies BioRadar tracks, from ClinicalTrials.gov, most advanced phase first.

Conditions studied

Metastatic Prostate Cancer

Other drugs acting on FOLH1

Gallium Ga 68 Gozetotide FDA approved ES414 Phase 1 Lutetium Lu 177 Rosopatamab Tetraxetan Phase 2

More from Telix Pharmaceuticals Pty

177Lu girentuximab Phase 1/2 177Lu-TLX591 Phase 3 89Zr-DFOsq-olaratumab Phase 1 Iodine I 131 IPA Phase 1 Lutetium Lu 177 Rosopatamab Tetraxetan Phase 2 Samarium Sm 153-DOTMP Phase 1 Zirconium Zr 89 Girentuximab Phase 3

Sources

Updated Oct 3, 2026. Something wrong or missing? Report it on the TLX page.

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Data: FDA (Drugs@FDA, Purple Book, DailyMed), NIH (NCI Thesaurus, GSRS, RxNorm), ClinicalTrials.gov • Informational purposes only, not medical or investment advice. • All drugs A–Z