Drugs / Fluorescein
Fluorescein
also known as
fluorescein sodium · Fluorescite · Fluorescéine · Fluorescéine Sodique Faure · sodium fluorescein
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | US (FDA) | FUNDUSCEIN-25 | — | 1976-11-10 | fda.gov ↗ |
Trials 21
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 04 trials | ||||||
| Phase 0 | NCT04008121 | Nov 2025 → Dec 2026 expected | diabetic retinopathy, macular degeneration, retinal vein occlusion | MediBeacon | Recruiting | No outcome recorded |
| Phase 0 | NCT03297489 | Nov 2017 → Feb 2021 | fallopian tube carcinoma, ovarian carcinoma, primary peritoneal carcinoma, uterine adnexa cancer | Roswell Park Cancer Institute | Completed | No outcome recorded |
| Phase 0 | NCT01979003 | Sep 2014 → Oct 2019 | endometrial cancer | University of Arkansas | Completed | No outcome recorded |
| Phase 0 | NCT01384695 | Jun 2009 → Feb 2014 | Barrett esophagus, gastroesophageal reflux disease | Anandasabapathy, Sharmila, M.D. | Terminated | No outcome recorded Stop: Enrollment |
| Phase 11 trial | ||||||
| Phase 1 | NCT04071080 | Aug → Nov 2019 | — | UpTru Inc. | Completed | No outcome recorded |
| Phase 1/22 trials | ||||||
| Phase 1/2 | NCT00847522 | Feb 2009 → Jul 2016 | cancer | University of Utah | Completed | No outcome recorded |
| Phase 1/2 | NCT01614184 | May 2008 → Jun 2013 | breast cancer | University of Utah | Withdrawn | No outcome recorded |
| Phase 25 trials | ||||||
| Phase 2 | NCT06873815 | Mar 2025 → Mar 2027 expected | extramammary Paget disease | Memorial Sloan Kettering Cancer Center | Recruiting | No outcome recorded |
| Phase 2 | NCT06054178 | Nov 2024 → May 2025 | Warthin tumor, pleomorphic adenoma, thyroid gland disorder | Stanford University | Completed | No outcome recorded |
| Phase 2 | NCT04351373 | Oct 2021 → May 2022 | acoustic neuroma | Mayo Clinic | Completed | No outcome recorded |
| Phase 2 | NCT04597801 | Dec 2020 → Jun 2022 | brain neoplasm | Technical University of Munich | Completed | No outcome recorded |
| Phase 2 | NCT02519920 | Apr → Dec 2015 | skin pigmentation disorder | Shandong University | Unknown | No outcome recorded |
| Phase 32 trials | ||||||
| Phase 3 | NCT07356349 | Jan → Sep 2026 overdue | substance-related disorder | UpTru Inc. | Not yet recruiting | No outcome recorded |
| Phase 3 | NCT03291977 | Oct 2017 → Jan 2022 | adult glioblastoma | Rennes University Hospital | Completed | No outcome recorded |
| Phase 44 trials · 1 met primary | ||||||
| Phase 4 | NCT05664555 | Feb 2023 → Mar 2024 | retinal disorder | Seoul National University Bundang Hospital | Completed | Met primary |
| Phase 4 | NCT02534818 | Jun → Nov 2015 | gastric intestinal metaplasia | Shandong University | Unknown | No outcome recorded |
| Phase 4 | NCT02478346 | May 2015 → Dec 2018 | brain neoplasm, cerebrovascular disorder | AdventHealth | Unknown | No outcome recorded |
| Phase 4 | NCT02028325 | Dec 2013 → Oct 2014 | brain neoplasm, intracranial arterial disease | Indiana University | Terminated | No outcome recorded Stop: Enrollment |
| Phase not applicable3 trials | ||||||
| — | NCT02857374 | Nov 2016 → Aug 2018 | cutaneous melanoma | Roswell Park Cancer Institute | Completed | No outcome recorded |
| — | NCT01886235 | Sep 2013 → Jun 2015 | cutaneous melanoma | Roswell Park Cancer Institute | Completed | No outcome recorded |
| — | NCT01034670 | Jun 2009 → Sep 2017 | gastric cancer, gastrointestinal stromal tumor | Stanford University | Terminated | No outcome recorded Stop: Business |
| Comparator or background therapy9 trials | ||||||
| Phase 0 | NCT07546617 Background | Apr 2026 → Apr 2027 expected | anosmia | Dartmouth-Hitchcock Medical Center | Active not recruiting | No outcome recorded |
| Phase 2 | NCT02691923 Comparator | Mar 2016 → Dec 2025 overdue | brain cancer | David W. Roberts | Recruiting | No outcome recorded |
| Phase 3 | NCT07230548 Comparator | Jun → Oct 2020 | eye adnexa disorder | Medical University of Vienna | Completed | No outcome recorded |
| — | NCT03823144 Background | Feb 2019 → Sep 2027 expected | brain cancer, colorectal carcinoma, exocrine pancreatic carcinoma, female breast carcinoma +5 | Mayo Clinic | Recruiting | No outcome recorded |
| — | NCT03220711 Background | Jul 2017 → Jun 2022 | adenomatous colon polyp, colon dysplasia, inflammatory bowel disease | University of Michigan | Terminated | No outcome recorded Stop: Business |
| — | NCT02547909 Background | May 2016 → Oct 2017 | endometriosis of intestine | Dr. Ofir Harnoy MD | Withdrawn | No outcome recorded |
| — | NCT02703558 Comparator | Mar 2016 → Jan 2018 | — | Johns Hopkins University | Withdrawn | No outcome recorded |
| — | NCT02552004 Background | Oct 2015 → Dec 2017 | benign neoplasm, cancer, inflammatory disease | IHU Strasbourg | Completed | No outcome recorded |
| — | NCT02628496 Background | Apr 2015 → Jan 2017 | laryngeal neoplasm | Washington University School of Medicine | Withdrawn | No outcome recorded Stop: Business |
Evidence & citations 8 cited values
Every value below carries the sentence it was read from. 32 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Fluorescein | “Fluorescein (Fluorescéine sodique FAURE) will be given intravenously during the induction of the anesthesia” NCT03291977 ↗ |
| Known as | fluorescein sodium | “Fluorescein sodium is administered intravenously with a bolus injection of 5 mg per kg of bodyweight 20-40 minutes prior to the planned tumor resection.” NCT04597801 ↗13“after intravenous injection of 2.5 mL of 10% fluorescein sodium” PMID 30466375 ↗ Nov 2018 |
| Known as | Fluorescite | “Fluorescite® (fluorescein injection, USP) 10% fluorescein sodium diluted to from 1% to 0.001% in sterile saline, 0.25 ml injected intradermally peri-tumoral or peri-areolar.” NCT01614184 ↗ |
| Known as | Fluorescéine | ClinicalTrials.gov intervention name — accepted as the source's own label NCT03291977 ↗ |
| Known as | Fluorescéine Sodique Faure | “Fluorescein (Fluorescéine sodique FAURE) will be given intravenously during the induction of the anesthesia” NCT03291977 ↗ |
| Known as | sodium fluorescein | “Here we present a new application of a clinically approved fluorescent agent, sodium fluorescein, to enhance nerve visualization during surgery.” PMID 40034788 ↗ Feb 2025 |
| Modality | Diagnostic / imaging agent | “fluorescent contrast agent, Fluorescein 5ml” NCT01384695 ↗ |
| Route | Topical | “100 mcg topical” NCT01034670 ↗ |