Drugs / Flotufolastat F-18 Gallium
Flotufolastat F-18 Gallium
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 5
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 02 trials | ||||||
| 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 21 trial | ||||||
| Phase 2 | NCT06865768 | Apr 2025 → Dec 2028 expected | prostate carcinoma | Emory University | Recruiting | No outcome recorded |
| Phase 32 trials | ||||||
| Phase 3 | NCT05799248 | Apr 2023 → May 2024 | prostate cancer | MidLantic Urology | Unknown | No outcome recorded |
| Phase 3 | NCT04186819 | Mar 2020 → Jun 2021 | prostate cancer | Blue Earth Diagnostics | Completed | Mixed |
Press releases naming this drug 37 releases
Evidence & citations 7 cited values
Every value below carries the sentence it was read from. 7 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | flotufolastat F-18 gallium | “Flotufolastat F-18 Gallium” NCT05852041 ↗ |
| Known as | (18)F-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 2023 |
| Known as | Posluma | ChEMBL registry synonym — accepted as the source's own label CHEMBL5316156 ↗ |
| Known as | rhPSMA-7.3 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT05799248 ↗ |
| 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 ↗ |
| Modality | Diagnostic / imaging agent | “novel high-affinity prostate-specific membrane antigen (PSMA)-targeting radiopharmaceutical for prostate cancer (PCa) imaging” PMID 37414702 ↗ Jul 2023 |
| Route | Intravenous | “Single intravenous administration of rhPSMA-7.3 (18F) for PET Scan” NCT04186819 ↗ |