Last reviewed 2026-04-22 · How we verify

177Lu-TLX591

Telix Pharmaceuticals (Innovations) Pty Limited · Phase 3 active Small molecule

177Lu-TLX591 is a PSMA-targeted radioligand therapy Small molecule drug developed by Telix Pharmaceuticals (Innovations) Pty Limited. It is currently in Phase 3 development for Metastatic castration-resistant prostate cancer (mCRPC) with PSMA expression. Also known as: Lutetium (177Lu) rosopatamab tetraxetan.

177Lu-TLX591 is a lutetium-177 labeled radioligand that targets prostate-specific membrane antigen (PSMA) on prostate cancer cells to deliver targeted radiotherapy.

177Lu-TLX591 is a lutetium-177 labeled radioligand that targets prostate-specific membrane antigen (PSMA) on prostate cancer cells to deliver targeted radiotherapy. Used for Metastatic castration-resistant prostate cancer (mCRPC) with PSMA expression.

Likelihood of approval

61.3% vs 58.3% industry baseline

If approved by FDA: likely 2028–2030

Steps remaining: NDA/BLA submission

Confidence: High

Why this estimate

Baseline phase 3 → approval rate +58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
Oncology Phase 3 boost +3.0pp
Oncology Phase 3 trials have higher approval rates (~61%) than the cross-industry average due to clearer endpoints and FDA oncology pathway.

Predicted approval windows by jurisdiction (conditional on FDA approval)

Regulator	Country	Likely year	Lag vs FDA
FDA	US	2028–2030	—
EMA	EU	2029–2031	+0.7 yr
MHRA	GB	2029–2031	+0.7 yr
Health Canada	CA	2029–2032	+0.9 yr
TGA	AU	2029–2032	+1.2 yr
PMDA	JP	2029–2032	+1.5 yr
NMPA	CN	2030–2033	+2.3 yr
MFDS	KR	2029–2032	+1.4 yr
CDSCO	IN	2029–2033	+1.8 yr
ANVISA	BR	2030–2033	+2.3 yr

Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).

Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.

At a glance

Generic name	177Lu-TLX591
Also known as	Lutetium (177Lu) rosopatamab tetraxetan
Sponsor	Telix Pharmaceuticals (Innovations) Pty Limited
Drug class	PSMA-targeted radioligand therapy
Target	PSMA (prostate-specific membrane antigen)
Modality	Small molecule
Therapeutic area	Oncology
Phase	Phase 3

Mechanism of action

TLX591 is a PSMA-targeting radiopharmaceutical that binds to PSMA-expressing cells and delivers localized radiation via lutetium-177 decay. This theranostic approach allows selective irradiation of PSMA-positive tumors while minimizing exposure to healthy tissue. The compound is designed for treatment of metastatic castration-resistant prostate cancer (mCRPC).

Approved indications

Metastatic castration-resistant prostate cancer (mCRPC) with PSMA expression

Common side effects

Hematologic toxicity (anemia, thrombocytopenia, leukopenia)
Xerostomia (dry mouth)
Nausea
Fatigue
Renal toxicity

Key clinical trials

Primary sources

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

Source	Used for
ClinicalTrials.gov	Trial enrolment, design, endpoints, results

Competitive intelligence

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

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

Frequently asked questions about 177Lu-TLX591

What is 177Lu-TLX591?

177Lu-TLX591 is a PSMA-targeted radioligand therapy drug developed by Telix Pharmaceuticals (Innovations) Pty Limited, indicated for Metastatic castration-resistant prostate cancer (mCRPC) with PSMA expression.

How does 177Lu-TLX591 work?

177Lu-TLX591 is a lutetium-177 labeled radioligand that targets prostate-specific membrane antigen (PSMA) on prostate cancer cells to deliver targeted radiotherapy.

What is 177Lu-TLX591 used for?

177Lu-TLX591 is indicated for Metastatic castration-resistant prostate cancer (mCRPC) with PSMA expression.

Who makes 177Lu-TLX591?

177Lu-TLX591 is developed by Telix Pharmaceuticals (Innovations) Pty Limited (see full Telix Pharmaceuticals (Innovations) Pty Limited pipeline at /company/telix-pharmaceuticals-innovations-pty-limited).

Is 177Lu-TLX591 also known as anything else?

177Lu-TLX591 is also known as Lutetium (177Lu) rosopatamab tetraxetan.

What drug class is 177Lu-TLX591 in?

177Lu-TLX591 belongs to the PSMA-targeted radioligand therapy class. See all PSMA-targeted radioligand therapy drugs at /class/psma-targeted-radioligand-therapy.

What development phase is 177Lu-TLX591 in?

177Lu-TLX591 is in Phase 3.

What are the side effects of 177Lu-TLX591?

Common side effects of 177Lu-TLX591 include Hematologic toxicity (anemia, thrombocytopenia, leukopenia), Xerostomia (dry mouth), Nausea, Fatigue, Renal toxicity.

What does 177Lu-TLX591 target?

177Lu-TLX591 targets PSMA (prostate-specific membrane antigen) and is a PSMA-targeted radioligand therapy.

Drug class: All PSMA-targeted radioligand therapy drugs
Target: All drugs targeting PSMA (prostate-specific membrane antigen)
Manufacturer: Telix Pharmaceuticals (Innovations) Pty Limited — full pipeline
Therapeutic area: All drugs in Oncology
Indication: Drugs for Metastatic castration-resistant prostate cancer (mCRPC) with PSMA expression
Also known as: Lutetium (177Lu) rosopatamab tetraxetan

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing