Drugs / DCFPyL
DCFPyL
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed | US (FDA) | — | — | 2025-08-06 | “We are pleased the FDA accepted Aphelion’s NDA for the new piflufolastat F 18 formulation” lantheus.com ↗ |
Trials 3
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 01 trial | ||||||
| Phase 0 | NCT02420977 | Dec 2018 → Mar 2024 | prostate cancer | Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Completed | No outcome recorded |
| Phase 21 trial | ||||||
| Phase 2 | NCT04700332 | Feb 2021 → Jul 2022 overdue | prostate cancer | Hoag Memorial Hospital Presbyterian | Recruiting | No outcome recorded |
| Phase 41 trial | ||||||
| Phase 4 | NCT05919329 | Jun 2024 → Sep 2028 expected | castration-resistant prostate carcinoma, prostate adenocarcinoma | OHSU Knight Cancer Institute | Recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 8
All press releases naming this drug 14 releases
Evidence & citations 5 cited values
Every value below carries the sentence it was read from. 3 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | DCFPyL | ClinicalTrials.gov intervention name — accepted as the source's own label NCT04700332 ↗ |
| Known as | 18F-DCFPyL | “an investigational radioactive imaging agent (radiotracer) called 18F-DCFPyL” NCT02420977 ↗ |
| Known as | Piflufolastat | ClinicalTrials.gov intervention name — accepted as the source's own label NCT05919329 ↗ |
| Modality | Small molecule | “a novel small molecule PET radiotracer, DCFPyL” NCT02420977 ↗ |
| Route | Intravenous | “Given IV” NCT05919329 ↗ |