Last reviewed 2026-06-02 · How we verify

177Lu-PMSA-617

UNICANCER · Phase 3 active Small molecule Under review Quality 0/100

177Lu-PMSA-617 is a Radioligand therapy Small molecule drug developed by UNICANCER. It is currently in Phase 3 development for Metastatic castration-resistant prostate cancer (mCRPC) with PSMA expression. Also known as: Pluvicto®.

177Lu-PMSA-617 is a radioligand therapy that delivers lutetium-177 radiation directly to prostate cancer cells expressing PSMA, causing targeted cell death.

177Lu-PMSA-617 is a treatment being studied for prostate cancer metastatic, specifically in patients with poor PSA response. It is a carbonic anhydrase IX binding agent, which is a type of BINDING AGENT according to ChEMBL.

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-PMSA-617
Also known as	Pluvicto®
Sponsor	UNICANCER
Drug class	Radioligand therapy
Target	PSMA (prostate-specific membrane antigen)
Modality	Small molecule
Therapeutic area	Oncology
Phase	Phase 3

Mechanism of action

This drug is a theranostic radiopharmaceutical combining a PSMA-targeting ligand (617) with the beta-emitting isotope lutetium-177. It binds to prostate-specific membrane antigen (PSMA) on prostate cancer cells and delivers localized radiation to kill tumor cells while minimizing exposure to healthy tissue. This approach enables both imaging and therapeutic delivery to PSMA-positive lesions.

Approved indications

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

Common side effects

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

Key clinical trials

Standard of Care +/- 177Lu-PSMA-617 In de Novo mHSPC Patients With Poor PSA Response (PEACE6-Poor Responders) (PHASE3)

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-PMSA-617 CI brief — competitive landscape report
177Lu-PMSA-617 updates RSS · CI watch RSS
UNICANCER portfolio CI

Frequently asked questions about 177Lu-PMSA-617

What is 177Lu-PMSA-617?

177Lu-PMSA-617 is a Radioligand therapy drug developed by UNICANCER, indicated for Metastatic castration-resistant prostate cancer (mCRPC) with PSMA expression.

How does 177Lu-PMSA-617 work?

177Lu-PMSA-617 is a radioligand therapy that delivers lutetium-177 radiation directly to prostate cancer cells expressing PSMA, causing targeted cell death.

What is 177Lu-PMSA-617 used for?

177Lu-PMSA-617 is indicated for Metastatic castration-resistant prostate cancer (mCRPC) with PSMA expression.

Who makes 177Lu-PMSA-617?

177Lu-PMSA-617 is developed by UNICANCER (see full UNICANCER pipeline at /company/unicancer).

Is 177Lu-PMSA-617 also known as anything else?

177Lu-PMSA-617 is also known as Pluvicto®.

What drug class is 177Lu-PMSA-617 in?

177Lu-PMSA-617 belongs to the Radioligand therapy class. See all Radioligand therapy drugs at /class/radioligand-therapy.

What development phase is 177Lu-PMSA-617 in?

177Lu-PMSA-617 is in Phase 3.

What are the side effects of 177Lu-PMSA-617?

Common side effects of 177Lu-PMSA-617 include Hematologic toxicity (anemia, thrombocytopenia, leukopenia), Xerostomia (dry mouth), Nausea, Fatigue, Kidney toxicity.

What does 177Lu-PMSA-617 target?

177Lu-PMSA-617 targets PSMA (prostate-specific membrane antigen) and is a Radioligand therapy.

Drug class: All Radioligand therapy drugs
Target: All drugs targeting PSMA (prostate-specific membrane antigen)
Manufacturer: UNICANCER — full pipeline
Therapeutic area: All drugs in Oncology
Indication: Drugs for Metastatic castration-resistant prostate cancer (mCRPC) with PSMA expression
Also known as: Pluvicto®

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