Drugs / 18F-rhPSMA-7.3
18F-rhPSMA-7.3
also known as
rhPSMA-7.3 (18F) · Flotufolastat F-18 Gallium · Posluma · rhPSMA-7.3 · 18F-flotufolastat · F-18 flotufolastat · Fluorine F 18 rhPSMA-7.3
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | US (FDA) | POSLUMA | — | 2023-05-25 | fda.gov ↗ |
Trials 14 · a red edge is where a trial was stopped
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 03 trials | ||||||
| Phase 0 | NCT05707182 | Apr 2025 → Dec 2026 | prostate cancer | University of Alabama at Birmingham | Withdrawn | No outcome recorded |
| Phase 0 | NCT06813898 | Apr 2025 → Feb 2027 expected | prostate adenocarcinoma | Northwestern University | Recruiting | No outcome recorded |
| Phase 0 | NCT05852041 | Jun 2023 → May 2026 overdue | prostate adenocarcinoma | Northwestern University | Recruiting | No outcome recorded |
| Phase 12 trials | ||||||
| Phase 1 | NCT04978675 | Aug 2021 → Jun 2024 | prostate adenocarcinoma | M.D. Anderson Cancer Center | Completed | No outcome recorded |
| Phase 1 | NCT03995888 | Jun 2019 → Apr 2020 | prostate cancer | Blue Earth Diagnostics | Completed | No outcome recorded |
| Phase 23 trials | ||||||
| Phase 2 | NCT07593079 | Jul 2026 → Aug 2027 expected | metastatic prostate carcinoma | Washington University School of Medicine | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT06865768 | Apr 2025 → Dec 2028 expected | prostate carcinoma | Emory University | Recruiting | No outcome recorded |
| Phase 2 | NCT06617481 | Sep 2024 → Sep 2027 expected | — | AdventHealth | Recruiting | No outcome recorded |
| Phase 34 trials | ||||||
| Phase 3 | NCT05799248 | Apr 2023 → May 2024 | prostate cancer | MidLantic Urology | Unknown | No outcome recorded |
| Phase 3 | NCT05678322 | Jan 2023 → May 2025 overdue | prostate cancer | NYU Langone Health | Active not recruiting | No outcome recorded |
| Phase 3 | NCT04186845 | May 2020 → Apr 2021 | prostate cancer | Blue Earth Diagnostics | Completed | No outcome recorded |
| Phase 3 | NCT04186819 | Mar 2020 → Jun 2021 | prostate cancer | Blue Earth Diagnostics | Completed | No outcome recorded |
| Phase 41 trial | ||||||
| Phase 4 | NCT06479187 | Jun 2024 → Jun 2026 overdue | metastatic prostate carcinoma | Brigham and Women's Hospital | Active not recruiting | No outcome recorded |
| Phase not applicable1 trial | ||||||
| — | NCT07011342 | Oct 2025 → Nov 2028 expected | prostate cancer | Hackensack Meridian Health | Recruiting | No outcome recorded |
Evidence & citations 10 cited values
Every value below carries the sentence it was read from. 17 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | 18F-rhPSMA-7.3 | “Diagnostic Performance and Safety of Positron Emission Tomography with (18)F-rhPSMA-7.3 in Patients with Newly Diagnosed Unfavourable Intermediate- to Very-high-risk Prostate...” PMID 37414702 ↗ Jul 20237“18F-rhPSMA-7.3 (18F-flotufolastat) is a high-affinity prostate-specific membrane antigen-targeted diagnostic radiopharmaceutical for PET imaging in patients with prostate cancer.” PMID 38782456 ↗ Jul 2024 “a novel theranostic PET radiopharmaceutical, 18F-rhPSMA-7.3, to optimise its use for imaging of prostate cancer” PMID 33846844 ↗ Apr 2021 |
| Known as | 18F-flotufolastat | “18F-rhPSMA-7.3 (18F-flotufolastat) is a high-affinity prostate-specific membrane antigen-targeted diagnostic radiopharmaceutical for PET imaging in patients with prostate cancer.” PMID 38782456 ↗ Jul 2024 |
| Known as | F-18 flotufolastat | “Patients will undergo baseline PSMA PET/CT (PET1) with 18F-rhPSMA-7.3 (F-18 flotufolastat, Posluma).” NCT07593079 ↗ |
| Known as | Flotufolastat F-18 Gallium | “Flotufolastat F-18 Gallium” NCT05852041 ↗ |
| Known as | Fluorine F 18 rhPSMA-7.3 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT04978675 ↗ |
| Known as | Posluma | “18F-rhPSMA-7.3 (Posluma) injection is a radioactive diagnostic agent that is administered in the form of an intravenous injection.” NCT07011342 ↗2“Patients will undergo baseline PSMA PET/CT (PET1) with 18F-rhPSMA-7.3 (F-18 flotufolastat, Posluma).” NCT07593079 ↗ “18F-rhPSMA-7.3 (Posluma)” NCT06617481 ↗ |
| Known as | rhPSMA-7.3 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT04186819 ↗ |
| Known as | rhPSMA-7.3 (18F) | “A prospective, Phase 3, multi center, single-arm, imaging study investigating the safety and diagnostic performance of Radio-hybrid Prostate Specific Membrane Antigen (rhPSMA)...” NCT04186819 ↗3“rhPSMA-7.3 (18F) will be administered intravenously as a single-dose injection.” NCT05678322 ↗ |
| Modality | Diagnostic / imaging agent | “very promising PET radiopharmaceutical for diagnostic imaging of prostate cancer” PMID 33846844 ↗ Apr 2021 |
| Route | Intravenous | “Single intravenous administration of rhPSMA-7.3 (18F) for PET Scan” NCT03995888 ↗ |