Last reviewed 2026-04-23 · How we verify

177Lu-DOTA-TLX591

177Lu-DOTA-TLX591 is a radiolabeled peptide that targets the prostate-specific membrane antigen (PSMA) for targeted alpha-particle therapy.

177Lu-DOTA-TLX591 is a radiolabeled peptide that targets the prostate-specific membrane antigen (PSMA) for targeted alpha-particle therapy. Used for Metastatic castration-resistant prostate cancer.

At a glance

Mechanism of action

This radiopharmaceutical is designed to selectively bind to PSMA, a protein overexpressed on the surface of prostate cancer cells, allowing for targeted delivery of alpha-particle radiation to kill cancer cells while minimizing damage to surrounding healthy tissue.

Approved indications

• Metastatic castration-resistant prostate cancer

Common side effects

• Fatigue
• Nausea
• Vomiting
• Diarrhea
• Hematuria

Key clinical trials

• The Present Study Aims to Compare Patients Who Receive the Investigational Product (177Lu-DOTA-rosopatamab) Plus Standard of Care, in Comparison to Standard of Care Only (PHASE3)
• The Study of 177Lu-TLX591 Plus SOC Versus SOC Alone in Patients With mCRPC (ProstACT Global) (PHASE3)
• External Beam Therapy With Theranostic Radioligand Therapy for Oligometastatic Prostate Cancer (ProstACT TARGET) (PHASE2)
• 177Lu-DOTA-TLX591 Safety, Biodistribution and Dosimetry Study (PHASE1)

Primary sources

Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.

Competitive intelligence

For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:

• 177Lu-DOTA-TLX591 CI brief — competitive landscape report
• 177Lu-DOTA-TLX591 updates RSS · CI watch RSS
• Telix Pharmaceuticals (Innovations) Pty Limited portfolio CI