FPI-2265 (225Ac-PSMA-I&T) is a PSMA-targeted alpha-emitting radiopharmaceutical in clinical development for metastatic castration-resistant prostate cancer (mCRPC). Current studies are evaluating safety, tolerability, and dose/regimen optimization in previously treated PSMA-positive mCRPC populations. It is being used in investigational trial settings rather than as an approved marketed medicine.
The global radioligand therapy market is projected to grow from $2.6 billion in 2025 to $4.8 billion by 2030 at 13.1% CAGR, driven by FDA label expansions, earlier-line treatment positioning, and substantial private investment in isotope production infrastructure.
Multiple pharmaceutical companies have initiated clinical trials for metastatic castration-resistant prostate cancer in February 2026, with over 180 companies developing 200+ pipeline therapies. Studies include combination therapies and novel drug candidates targeting advanced disease.
| NCT ID | Title | Status | Phase |
|---|---|---|---|
| NCT06909825 |
FPI-2265 (225Ac-PSMA-I&T) and Olaparib for Patients With Metastatic Castration-Resistant Prostate Cancer (mCRPC) |
ACTIVE_NOT_RECRUITING | PHASE2 |
| NCT06402331 |
FPI-2265 (225Ac-PSMA-I&T) for Patients With PSMA-Positive Metastatic Castration-Resistant Prostate Cancer (mCRPC) |
ACTIVE_NOT_RECRUITING | PHASE2 |
| NCT05219500 |
Targeted Alpha Therapy With 225Actinium-Prostate Specific Membrane Antigen (PSMA)-I&T of Castration-resISTant Prostate Cancer (TATCIST). |
ACTIVE_NOT_RECRUITING | PHASE2 |
