{"entity":{"id":"fpi-2265","kind":"drug","name":"FPI-2265","aka":["Ac225-PSMA I&T"],"tldr":"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.","status":"phase-2","asOf":"2026-09-11","links":[{"label":"ClinicalTrials.gov: trials of FPI-2265","url":"https://clinicaltrials.gov/search?intr=FPI-2265"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["prostate"],"sections":[],"technologies":[],"targets":["psma"],"drugs":[],"companies":["astrazeneca"],"institutions":[],"pathways":[],"terms":[],"trials":["nct07611110","nct05219500","nct07590934","nct06909825"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"provenance":{"editedBy":"OnCo ingestion (ClinicalTrials.gov v2 + sponsor pipeline pages)","editedOn":"2026-09-11"},"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.","approvals":[],"mechanismSteps":[],"toxicity":[],"access":[],"regulatoryEvents":[]},"route":"/drugs/fpi-2265/","neighbours":{"cancer":[{"id":"prostate-mcrpc","kind":"cancer","name":"Metastatic castration-resistant prostate cancer","route":"/cancers/prostate-mcrpc/"},{"id":"prostate","kind":"cancer","name":"Prostate cancer","route":"/cancers/prostate/"}],"target":[{"id":"psma","kind":"target","name":"PSMA","route":"/targets/psma/"}],"company":[{"id":"astrazeneca","kind":"company","name":"AstraZeneca","route":"/companies/astrazeneca/"}],"trial":[{"id":"nct07611110","kind":"trial","name":"AZD2265 Compared With Standard of Care in PSMA-positive Metastatic Castration-resistant Prostate Cancer (VECTRA-01)","route":"/trials/nct07611110/"},{"id":"nct06909825","kind":"trial","name":"FPI-2265 (225Ac-PSMA-I&T) and Olaparib for Patients With Metastatic Castration-Resistant Prostate Cancer (mCRPC)","route":"/trials/nct06909825/"},{"id":"nct07590934","kind":"trial","name":"Phase Ib/II Platform Study of Multiple Anti-Cancer Agents in Participants With Metastatic Prostate Cancer","route":"/trials/nct07590934/"},{"id":"nct05219500","kind":"trial","name":"Targeted Alpha Therapy With 225Actinium-Prostate Specific Membrane Antigen (PSMA)-I&T of Castration-resISTant Prostate Cancer (TATCIST).","route":"/trials/nct05219500/"}],"technology":[{"id":"actinium-225-supply","kind":"technology","name":"Actinium-225 supply: thorium stocks, accelerators and radium targets","route":"/technologies/actinium-225-supply/"}]}}