Drugs / 18F-DCFPyL
18F-DCFPyL
also known as
Piflufolastat F 18 · piflufolastat (18F) · PyL · PYLARIFY · [18F]DCFPyL (PyL) · Piflufolastat Flourine-18 (18F-DCFPyL)
Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | EU (EMA) | Pylclari | — | 2023-11-27 | europa.eu ↗ |
| Approved | US (FDA) | PYLARIFY | — | 2021-05-26 | fda.gov ↗ |
Trials 36
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 05 trials | ||||||
| Phase 0 | NCT03861676 | Aug 2023 → Dec 2028 expected | prostate cancer | Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Recruiting | No outcome recorded |
| Phase 0 | NCT04266392 | Dec 2019 → Oct 2021 | prostate cancer | Stony Brook University | Completed | No outcome recorded |
| Phase 0 | NCT03392181 | Jun 2018 → May 2026 overdue | prostate cancer | Northwestern University | Active not recruiting | No outcome recorded |
| Phase 0 | NCT03232164 | Feb 2017 → Nov 2024 | prostate cancer | University of Wisconsin, Madison | Completed | No outcome recorded |
| Phase 0 | NCT02691169 | Apr 2016 → Dec 2017 | prostate cancer | St. Joseph's Healthcare Hamilton | Unknown | No outcome recorded |
| Phase 16 trials | ||||||
| Phase 1 | NCT05394259 | Oct 2022 → Feb 2027 expected | breast cancer, hepatocellular carcinoma, malignant pancreatic neoplasm | M.D. Anderson Cancer Center | Recruiting | No outcome recorded |
| Phase 1 | NCT03619655 | Nov 2019 → Nov 2022 | prostate cancer | Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Terminated | No outcome recorded |
| Phase 1 | NCT03793543 | Mar 2019 → Mar 2020 | prostate cancer | Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Completed | No outcome recorded |
| Phase 1 | NCT03497377 | May 2016 → Apr 2020 | metastatic prostate carcinoma | Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Completed | No outcome recorded |
| Phase 1 | NCT03542773 | Feb 2015 → May 2022 | cancer, schwannoma | Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Completed | No outcome recorded |
| Phase 1 | NCT02151760 | May 2014 → Apr 2020 | metastatic prostate carcinoma | Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Completed | No outcome recorded |
| Phase 215 trials | ||||||
| Phase 2 | NCT06904313 | May 2025 → Jun 2030 expected | prostate cancer | Akiva Mintz | Recruiting | No outcome recorded |
| Phase 2 | NCT05155046 | Aug 2022 → Dec 2028 expected | cancer | National Cancer Institute (NCI) | Recruiting | No outcome recorded |
| Phase 2 | NCT05095519 | Sep 2021 → Mar 2026 overdue | hepatocellular carcinoma | Peter MacCallum Cancer Centre, Australia | Active not recruiting | No outcome recorded |
| Phase 2 | NCT04573231 | May 2021 → Aug 2026 | Her2-receptor negative breast cancer | University of Wisconsin, Madison | Completed | No outcome recorded |
| Phase 2 | NCT04727736 | May 2021 → Dec 2022 | prostate cancer | Ashok Muthukrishnan | Terminated | No outcome recorded |
| Phase 2 | NCT04390880 | Apr 2020 → Aug 2021 | prostate cancer | VA Greater Los Angeles Healthcare System | Completed | No outcome recorded |
| Phase 2 | NCT03976843 | Dec 2019 → Nov 2027 expected | prostate cancer | National Cancer Institute (NCI) | Active not recruiting | No outcome recorded |
| Phase 2 | NCT03860987 | Apr 2019 → May 2026 | prostate carcinoma | National Cancer Institute (NCI) | Completed | No outcome recorded |
| Phase 2 | NCT03585114 | Dec 2018 → Dec 2022 overdue | metastatic prostate carcinoma | Columbia University | Active not recruiting | No outcome recorded |
| Phase 2 | NCT03387514 | Dec 2018 → Jun 2021 | renal cell carcinoma | University of Wisconsin, Madison | Terminated | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT03471650 | Mar 2018 → Mar 2028 expected | prostate cancer | Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Active not recruiting | No outcome recorded |
| Phase 2 | NCT03302156 | Nov 2017 → Jan 2020 | female reproductive organ cancer | University of Wisconsin, Madison | Terminated | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT03181867 | Aug 2017 → Feb 2031 expected | prostate cancer | National Cancer Institute (NCI) | Active not recruiting | No outcome recorded |
| Phase 2 | NCT03001895 | Jul 2017 → Oct 2018 | prostate cancer | Sir Mortimer B. Davis - Jewish General Hospital | Completed | No outcome recorded |
| Phase 2 | NCT03173924 | Jun 2017 → Feb 2028 expected | metastatic prostate carcinoma | National Cancer Institute (NCI) | Active not recruiting | No outcome recorded |
| Phase 2/34 trials | ||||||
| Phase 2/3 | NCT07084909 | Nov 2025 → Sep 2027 | clear cell renal carcinoma | Lantheus Medical Imaging | Withdrawn | No outcome recorded Stop: Enrollment |
| Phase 2/3 | NCT03800784 | Oct 2019 → Oct 2021 | prostate cancer | Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Withdrawn | No outcome recorded Stop: Business |
| Phase 2/3 | NCT03852654 | Jul 2018 → Dec 2019 | prostate adenocarcinoma | Lida Jafari | Unknown | No outcome recorded |
| Phase 2/3 | NCT02981368 | Nov 2016 → Jul 2018 | prostate cancer | Progenics Pharmaceuticals, Inc. | Completed | No outcome recorded |
| Phase 31 trial · 1 met primary | ||||||
| Phase 3 | NCT03739684 | Nov 2018 → Aug 2019 | prostate adenocarcinoma | Progenics Pharmaceuticals, Inc. | Completed | Met primary |
| Phase 44 trials · 1 met primary | ||||||
| Phase 4 | NCT06604442 | Dec 2024 → Aug 2025 | prostate cancer | Blue Earth Diagnostics | Completed | Met primary |
| Phase 4 | NCT05568537 | Oct 2024 → Oct 2026 | prostate cancer | Corewell Health East | Withdrawn | No outcome recorded Stop: Business |
| Phase 4 | NCT06099093 | Apr 2024 → Dec 2026 expected | prostate carcinoma | Brigham and Women's Hospital | Recruiting | No outcome recorded |
| Phase 4 | NCT06074510 | Feb 2024 → Sep 2026 overdue | prostate cancer | Lantheus Medical Imaging | Active not recruiting | No outcome recorded |
| Phase not applicable1 trial | ||||||
| — | NCT02687139 | Oct 2015 → Apr 2019 | renal cell carcinoma | Johns Hopkins University | Completed | No outcome recorded |
| Comparator or background therapy6 trials | ||||||
| Phase 1 | NCT03253744 Background | Jul 2018 → May 2023 | prostate cancer | National Cancer Institute (NCI) | Completed | No outcome recorded |
| Phase 1/2 | NCT06881823 Comparator | Jun 2026 → Mar 2030 | prostate cancer | Novartis Pharmaceuticals | Withdrawn | No outcome recorded |
| Phase 1/2 | NCT06085664 Background | Dec 2023 → Jun 2028 expected | prostate cancer | M.D. Anderson Cancer Center | Recruiting | No outcome recorded |
| Phase 2 | NCT05849298 Background | Jan 2024 → Dec 2026 expected | prostate neoplasm | Novartis Pharmaceuticals | Active not recruiting | No outcome recorded |
| Phase 2 | NCT05616650 Background | Oct 2023 → Dec 2030 expected | prostate adenocarcinoma | National Cancer Institute (NCI) | Recruiting | No outcome recorded |
| Phase 3 | NCT05939414 Background | Mar 2024 → Apr 2028 expected | metastatic prostate carcinoma | Novartis Pharmaceuticals | Recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 7
| Date | Issuer | Release |
|---|---|---|
| 2026-09-30 | Lantheus Medical Imaging | Regulatory Lantheus Announces CMS Grants Transitional Pass-Through Status for PYLARIFY® TruVu (piflufolastat F 18) lantheus.com ↗ |
| 2026-03-06 | Lantheus Medical Imaging | Regulatory Lantheus Announces FDA Approval of PYLARIFY TruVu™ (piflufolastat F 18) Injection lantheus.com ↗ |
| 2025-08-06 | Lantheus Medical Imaging | Regulatory Lantheus Reports Second Quarter 2025 Financial Results and Provides Business Update lantheus.com ↗
This morning, the Company announced FDA acceptance of a new drug application (“NDA”) for a new formulation of piflufolastat F 18 PSMA PET imaging agent. |
| 2025-08-06 | Lantheus Medical Imaging | Regulatory Lantheus Announces FDA Acceptance of NDA for New Formulation for Market-Leading PSMA PET Imaging Agent lantheus.com ↗ |
| 2023-02-16 | Lantheus Medical Imaging | Results Lantheus Presents Data Reinforcing Real-World Clinical Utility of Piflufolastat F 18 PET Scanning in Men with Recurrent Prostate Cancer and Low PSA Levels lantheus.com ↗
The data we presented at ASCO GU emphasize the clinical utility of piflufolastat F 18 to assess the relevance and applicability of intended treatment management plans. |
| 2022-10-17 | Lantheus Medical Imaging | Results Lantheus Presentations at the European Association of Nuclear Medicine Annual Meeting Showcased Artificial Intelligence Data lantheus.com ↗
The results demonstrated that a change in automated PSMA scores in bone and lymph nodes is strongly associated with PSA response. |
| 2022-05-16 | Lantheus Medical Imaging | Results Lantheus Presents Results from a PYLARIFY AI™ Study at the American Urological Association (AUA) Annual Meeting lantheus.com ↗
The findings support further exploration of PYLARIFY AI as a tool to quantify treatment response not only in at the overall disease burden but also at the lesion level. |
All press releases naming this drug 15 releases
Evidence & citations 10 cited values
Every value below carries the sentence it was read from. 43 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | 18F-DCFPyL | “One such second-generation PSMA-binding compound, 18F-DCFPyl, has been developed and characterized at our institution, and offers superior imaging qualities compared to prior...” NCT03861676 ↗33“PyL, also known as \[18F\]DCFPyL, is a second-generation fluorinated prostate-specific membrane antigen (PSMA) targeted positron emission tomography (PET) imaging agent.” NCT03585114 ↗ “PSMA-PET radiopharmaceuticals, 18F-piflufolastat (18F-DCFPyL) and 18F-flotufolastat (18F-rhPSMA-7.3) in patients with biochemical recurrence (BCR) of prostate cancer” PMID 41729277 ↗ Feb 2026 |
| Known as | [18F]DCFPyL (PyL) | “[18F]DCFPyL (PyL)” NCT03585114 ↗ |
| Known as | piflufolastat (18F) | ClinicalTrials.gov intervention name — accepted as the source's own label NCT05939414 ↗ |
| Known as | Piflufolastat F 18 | “Piflufolastat F18 will first be given intravenously over about 5 seconds.” NCT05568537 ↗ |
| Known as | Piflufolastat Flourine-18 (18F-DCFPyL) | “Pylarify Piflufolastat Flourine-18 (18F-DCFPyL)” NCT05568537 ↗ |
| Known as | PyL | “The purpose of this study is to gain understanding of how PET-MR (positron emission tomography-magnetic resonance imaging) using the substance 18F-DCFPyL (PyL) may help in...” NCT03392181 ↗1“PyL, also known as \[18F\]DCFPyL, is a second-generation fluorinated prostate-specific membrane antigen (PSMA) targeted positron emission tomography (PET) imaging agent.” NCT03585114 ↗ |
| Known as | PYLARIFY | “To assess the diagnosis accuracy of PYLARIFY (piflufolastat F18 ) PET-CT for imaging patients with suspected metastatic pancreatic cancer, hepatocellular carcinoma (HCC) and...” NCT05394259 ↗1“Piflufolastat F 18 Intravenous Solution [PYLARIFY]” NCT06074510 ↗ |
| Action | Inhibit | “small molecule inhibitor of prostate-specific membrane antigen (PSMA)” NCT03173924 ↗ |
| Modality | Diagnostic / imaging agent | “PET radiotracer” NCT02151760 ↗ |
| Route | Intravenous | “will be injected into the IV line by slow push IV push.” NCT02151760 ↗ |