Floatz Rating
BB64/100
Confidence
Indicative
Sponsor
Novartis Pharmaceuticals
Modality
Small molecule
Development Phase
Phase 4 / Approved
Status
Active
Evidence ledger · v0.2
Clinical Evidence
Clinical track record: trial progression, reported outcomes, safety signals, and endpoint quality.
66High confidence
Detailed axis rationale is planned and will be published soon.
| Trial | Phase | Status | N | Primary endpoint | Readout |
|---|---|---|---|---|---|
NCT06881823CT.gov Study to Assess [177Lu]Lu-PSMA-R2 (AAA602) and [225Ac]Ac-PSMA-R2 (AAA802) in Participants With PSMA-positive HRLPC | — | Withdrawn | — | — | — |
NCT06904313CT.gov Ultralow Dose PET Imaging for PSMA Expression | — | Recruiting | — | — | — |
NCT06756334CT.gov Head-to-head Comparison of [18F]AlF-PSMA-N5 With [18F]F-DCFPyL PET/CT in PCa Diagnosis, Recurrence, and Metastasis | — | Recruiting | — | — | — |
NCT06085664CT.gov A Pilot Presurgical Trial of REGN5678 (Anti-PSMA x CD28) in Patients With High-risk, Localized Prostate Cancer Followed by Radical Prostatectomy | — | Recruiting | — | — | — |
NCT05820724CT.gov PSMA PET Scan and mpMRI for Prostate Cancer Detection | — | Unknown | — | — | — |
NCT04687969CT.gov Multimodal Machine Learning Characterization of Solid Tumors | — | Completed | — | — | — |
NCT03495427CT.gov PSMA-PET Imaging for Detecting Early Metastatic Prostate Cancer in Men w/ High Decipher Test Scores | — | Recruiting | — | — | — |
NCT04266392CT.gov Molecular Imaging of Prostate Cancer Using Radiofluorinated PSMA Ligand | — | Completed | — | — | — |
NCT04030338CT.gov Prostate-Specific Membrane Antigen (PSMA) PET Scans in People Prostate Cancer | — | Active Not Recruiting | — | — | — |
NCT03860987CT.gov Neoadjuvant Androgen Deprivation Therapy Combined With Enzalutamide and Abiraterone Using Multiparametric MRI and 18FDCFPyL PET/CT in Newly Diagnosed Prostate Cancer | — | Completed | — | — | — |
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NCT02856100CT.gov Comparison of PSMA-based 18F-DCFPyL PET/CT to Conventional Imaging in the Evaluation of Patients With Castration-Resistant Prostate Cancer | — | Completed | — | — | — |
NCT02825875CT.gov Study of the Clinical Utility of PSMA Imaging in the Evaluation of Men With Prostate Cancer | — | Completed | — | — | — |
Competitive Position
Competitive setting: how crowded the indication is, class-level failures, and timing against rivals.
59High confidence
Detailed axis rationale is planned and will be published soon.
Same indication · Prostate Cancer
| Asset | Sponsor | Phase | Rating |
|---|---|---|---|
| Piflufolastat (this asset) | Novartis Pharmaceuticals | Approved | BB · 64 |
| Flotufolastat F 18 | Washington University School of Medicine | P4 | BBB |
| AVOLVE | Masonic Cancer Center, University of Minnesota | P4 | BBB |
| Degarelix | Bayer | P4 | BBB |
| Estramustine | The University of Texas Health Science Center, Houston | P3 | BBB |
| Avodart | Bay State Clinical Trials, Inc. | P4 | BB |
| Goserelin | Bayer | P4 | BB |
| Prednisone | Mayo Clinic | P4 | BB |
| Flutamide | VA Office of Research and Development | P4 | BB |
+42 more in the Prostate Cancer cohort
Other indications for Piflufolastat
| Indication | Sponsor | Phase | Rating |
|---|---|---|---|
| Prostate Adenocarcinoma | — | P4 | BB · 66 |
| Metastatic Prostate Carcinoma | — | P4 | BB · 66 |
| Prostate Neoplasm | — | P2/3 | B · 60 |
Scientific Foundation
Strength of the underlying biology: target validation, tractability, modality fit, and how related mechanisms have fared.
NR
Planned for methodology v0.2.
Development Feasibility
How realistically the program can be executed, drawing on modality precedent, enrollment dynamics, and sponsor delivery.
NR
Planned for methodology v0.2.
Commercial Opportunity
Commercial prize: addressable population, unmet need, and the value case for the indication.
NR
Planned for methodology v0.2.
IP & Exclusivity
Exclusivity position, covering patent protection and freedom-to-operate runway.
NR
Planned for methodology v0.2.
Manufacturing & Supply
Manufacturing and supply readiness, driven by modality process and scale-up risk.
NR
Planned for methodology v0.2.
Related assets
Citation
Floatz Terminal. Piflufolastat in Prostate Cancer. Methodology v0.2. Rated under v0.2 effective July 8, 2026. Last refreshed July 14, 2026. Accessed July 15, 2026. https://terminal.floatz.ai/assets/piflufolastat-prostate-cancer
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