drugsAgentPhase 3

Lutetium-177 PNT2002

aka 177Lu-PNT2002, 177Lu-PSMA-I&T (POINT/Lantheus)

A radioactive drug that homes in on a marker found on most prostate cancer cells, delivering radiation directly to the tumour, is being tested as a treatment for prostate cancer that has stopped responding to hormone therapy.

177Lu-PNT2002 is a PSMA-targeted radioligand therapy built on the PSMA-I&T ligand, labelled with beta-emitting no-carrier-added lutetium-177. POINT Biopharma developed it and Lantheus in-licensed exclusive worldwide commercial rights (excluding certain Asian territories) in December 2022; POINT was subsequently acquired by Eli Lilly. The FDA granted Fast Track designation for metastatic castration-resistant prostate cancer (mCRPC) in April 2023.

The pivotal phase 3 SPLASH trial (NCT04647526) randomised 412 patients with PSMA-expressing mCRPC who had progressed on an androgen receptor pathway inhibitor (ARPI) and refused or were ineligible for chemotherapy, 2:1 to 177Lu-PNT2002 (up to four cycles, 6.8 GBq per cycle every 8 weeks) versus a change to abiraterone or enzalutamide, with crossover allowed on progression. Topline results (December 2023) showed a statistically significant improvement in radiographic progression-free survival by blinded independent central review: median 9.5 months with 177Lu-PNT2002 versus 6.0 months with ARPI (HR 0.71, p=0.0088); overall survival was immature, with an interim HR of 1.11, and 84.6% of control-arm patients who progressed crossed over. Grade 3+ treatment-emergent adverse events, serious adverse events and discontinuations for toxicity were all numerically lower on 177Lu-PNT2002 than on ARPI.

As of the March 2026 status, 177Lu-PNT2002 has not received a marketing authorisation in any jurisdiction; further follow-up data were expected in 2024 ahead of a potential US new drug application.

Schematic of the modality · radioligand therapy · not a molecule; see the Radioligand therapy (beta emitters) page

See it in action

A PSMA-targeted small-molecule ligand (PSMA-I&T) labelled with no-carrier-added lutetium-177, a beta emitter, delivering targeted radiation to PSMA-expressing prostate cancer cells after intravenous infusion. Connects to PSMA.

1. What happens next: the radiopharmaceutical schematic

How it works, step by step · animated schematic, not to scale

Radioligand therapy (beta emitters) →

2. Step by step

auto-advancing · hover to pause

1.Lutetium-177 PNT2002 binds PSMA on the cancer cell or is taken up by it.

Modality

radioligand therapy

Mechanism

Brand / code

PNT2002

Dosing & schedule

Route: Intravenous infusion
Schedule: Up to 4 cycles at 6.8 GBq (±10%) per cycle, every 8 weeks (SPLASH trial regimen)

Source: pmc.ncbi.nlm.nih.gov/articles/PMC11745944/. Doses are for orientation; the current label governs.

Trials

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ClinicalTrials.gov · phase 2/3

refreshed 2026-10-19

5 studies0 recruiting4 Phase 21 Phase 3

Search “Lutetium-177 PNT2002” on ClinicalTrials.gov →

Counts are from a name search and may include unrelated studies; up to 100 studies are summarised.

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Lutetium-177 PNT2002

intervention: Lutetium-177 PNT2002

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