# FPI-2265

Source: https://onco.cc/drugs/fpi-2265/  
OnCo record `fpi-2265` (Treatment). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

FPI-2265 is an experimental radioligand therapy from Fusion Pharmaceuticals in phase 2 trials for prostate cancer, aimed at PSMA.

## Summary

FPI-2265 is a radioligand therapy developed by Fusion Pharmaceuticals. Its target is PSMA (the sponsor names PSMA). The sponsor states: A PSMA-targeting ligand (PSMA-I&T) radiolabeled with the alpha-emitter actinium-225, delivering targeted alpha radiotherapy to PSMA-positive prostate cancer cells. ClinicalTrials.gov describes the intervention as: Small molecule capable of binding to the domain of PSMA radiolabeled with Ac225. It is the investigational product in 3 recruiting or active industry-led phase 2 and phase 3 interventional cancer trials, in prostate cancer. The largest, NCT05219500, plans to enrol 115 participants with primary completion was scheduled for 2025-05-30 on the registry. Status reflects the highest phase registered on ClinicalTrials.gov; no efficacy results are recorded here.

## Fields

- Kind: Treatment
- Status: phase-2
- Last checked: 2026-09-11
- Also known as: Ac225-PSMA I&T
- Tags: pipeline; ctgov-ingest
- Modality: radioligand
- Mechanism: A PSMA-targeting ligand (PSMA-I&T) radiolabeled with the alpha-emitter actinium-225, delivering targeted alpha radiotherapy to PSMA-positive prostate cancer cells.

## Sources

- ClinicalTrials.gov: trials of FPI-2265: https://clinicaltrials.gov/search?intr=FPI-2265

## Connected records

- cancers: [Metastatic castration-resistant prostate cancer](https://onco.cc/cancers/prostate-mcrpc/), [Prostate cancer](https://onco.cc/cancers/prostate/)
- targets: [PSMA](https://onco.cc/targets/psma/)
- companies: [AstraZeneca](https://onco.cc/companies/astrazeneca/)
- trials: [AZD2265 Compared With Standard of Care in PSMA-positive Metastatic Castration-resistant Prostate Cancer (VECTRA-01)](https://onco.cc/trials/nct07611110/), [FPI-2265 (225Ac-PSMA-I&T) and Olaparib for Patients With Metastatic Castration-Resistant Prostate Cancer (mCRPC)](https://onco.cc/trials/nct06909825/), [Phase Ib/II Platform Study of Multiple Anti-Cancer Agents in Participants With Metastatic Prostate Cancer](https://onco.cc/trials/nct07590934/), [Targeted Alpha Therapy With 225Actinium-Prostate Specific Membrane Antigen (PSMA)-I&T of Castration-resISTant Prostate Cancer (TATCIST).](https://onco.cc/trials/nct05219500/)
- technologies: [Actinium-225 supply: thorium stocks, accelerators and radium targets](https://onco.cc/technologies/actinium-225-supply/)

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